[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Daiichi Sankyo\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":683},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,34,0,25,[9,49,77,102,129,154,179,204,233,259,283,309,335,357,384,409,437,460,499,523,547,572,603,637,660],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100602936","phase-2-study-of-datopotamab-deruxtecan-plus-carboplatin-or-cisplatin-versus-gemcitabine-plus-carboplatin-or-cisplatin-in-participants-with-locally-advanced-or-metastatic-urothelial-carcinoma-100602936",false,"NCT07129993","Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma","A Randomized, Open-Label, Phase 2\u002F3 Study of Datopotamab Deruxtecan (Dato-DXd) Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma (la\u002FmUC) Who Progressed During or After Enfortumab Vedotin (EV) Plus Pembrolizumab Combination Treatment TROPION-Urothelial03 (TU03)","Key Inclusion Criteria:\n\n* Adult ≥18 years at the time the ICF is signed (if the legal age of consent is \\> 18 years old, then follow the local regulatory requirements).\n* Histologically or cytologically confirmed unresectable locally advanced (T4b, any N; or any T, N 2-3) or metastatic (any T, any N, M1) urothelial carcinoma of the bladder, renal pelvis, ureter, or urethra.\n\nParticipants with urothelial carcinoma (transitional cell) with squamous differentiation or mixed cell types are eligible if the histology is predominantly urothelial.\n\n\\> Note 1: Urachal, small cell, and adenocarcinoma histology is not permitted.\n\n* Note 2: Participants with la\u002FmUC and a history of nonclinically active prostate cancer are allowed into the trial if:\n\n  1. Participant does not have radiological metastasis of a proven prostate cancer.\n  2. Participant with nonmetastatic prostate cancer do not have rising PSA (as determined using local testing by a validated or approved test method) defined as follows:\n\n     * Increase in PSA within 2 consecutive measurements separated by at least 1 week (completed within 4 weeks prior to consent or within Screening) and neither of the measurements with an absolute value above 2 ng\u002FmL.\n  3. Participant does not currently receive androgen deprivation therapy for the treatment of prostate cancer.\n* Note 3: Participant with MIBC (T2-T4aN0M0 or T1-T4aN1M0) who received EV (or other agents with a vedotin payload) plus pembrolizumab (or other PD-1\u002FPD-L1 inhibitors) as neoadjuvant\u002Fadjuvant therapy and progressed during treatment or within 12 months of treatment completion may be considered for enrollment, with approval from the Sponsor's Medical Monitor or designee.\n\n  * Must provide tumor tissue sample from archival tissue or newly obtained pretreatment biopsy for exploratory biomarker testing. Tumor tissue sample should not be collected from a lesion that was irradiated unless documentation can be provided confirming that the tumor tissue was collected at least 3 months after radiation and the lesion increased\u002Fappeared since radiation occurred. Tumor tissue must be of sufficient quantity (as defined in the Laboratory Manual).\n\n    a. Archival tissue collected after the most recent anticancer treatment and within 12 months before the informed consent date is preferred.\n  * Must be considered eligible to receive cisplatin- or carboplatin-containing chemotherapy, in the investigator's judgment. Participants eligible for cisplatin will receive cisplatin. If a participant received gemcitabine, carboplatin, or cisplatin for early UC in the adjuvant\u002Fneoadjuvant setting, the decision to rechallenge the participant with platinum therapy will be at the discretion of the investigator. Participants only receive carboplatin if they are ineligible for cisplatin. Participants are cisplatin-ineligible if they meet any of the following criteria:\n\n    1. GFR \\\u003C60 mL\u002Fmin (GFR may be estimated by calculated CrCl using the Cockcroft-Gault formula, Modification of Diet in Renal Disease, or 24-hour urine)\n\nFor Phase 2 part:\n\n* Participants with a GFR \\\u003C60 mL\u002Fmin but ≥50 mL\u002Fmin but have no other cisplatin ineligibility criteria (items b, c, and d) may be considered cisplatin-eligible based on the investigator's clinical judgment.\n\nFor Phase 3 Part:\n\n* Participants with borderline renal function CrCl ≥40 mL\u002Fmin to \\\u003C60 mL\u002Fmin who have no other cisplatin ineligibility criteria (items b, c, and d) may receive cisplatin using a split-dose regimen, administered as cisplatin 35 mg\u002Fm2 on Days 1 and 8 of each 21-day cycle, for a maximum of 4 to 6 cycles.\n* In participants with CrCl ≥50 mL\u002Fmin to \\\u003C60 mL\u002Fmin, full-dose cisplatin may also be administered at the investigator's discretion, based on the overall clinical assessment.\n\nThe dosing schedule and dose level for Dato-DXd or gemcitabine are not altered when combined with either split-dose or full-dose cisplatin.\n\nFor both Phase 2 and Phase 3:\n\nb. NCI-CTCAE Grade ≥2 audiometric hearing loss c. NCI-CTCAE Grade ≥2 peripheral neuropathy d. NYHA Class III heart failure\n\n• Must have experienced radiographic progression or relapse during or after 1L of EV (or other agents with a vedotin payload) and pembrolizumab (or other PD-1\u002FPD-L1 inhibitors).\n\nParticipants who discontinued EV (or other agents with a vedotin payload) and pembrolizumab (or other PD-1\u002FPD-L1 inhibitors) in 1L due to toxicity are eligible if they have experienced disease progression following discontinuation. Participant who received EV (or other agents with a vedotin payload) plus pembrolizumab (or other PD-1\u002FPD-L1) inhibitors in a neoadjuvant\u002Fadjuvant setting and progressed during treatment or within 12 months of treatment completion will also be considered for enrollment, after approval by the Sponsor's Medical Monitor or Sponsor's designee.\n\nKey Exclusion Criteria:\n\n* Has had prior systemic therapy other than the combination of EV and pembrolizumab for la\u002FmUC. The following participants may be considered eligible after approval by the Sponsor's Medical Monitor or Sponsor's designee.\n\n  a. Participant who progressed during or after treatments with assets that include either anti-Nectin 4 or vedotin payload (MMAE or other microtubule inhibitors) combined with PD1\u002FPD-L1 inhibitors in 1L la\u002FmUC.\n* Treatment with any of the following:\n\n  1. History of an allogeneic bone marrow or solid organ transplant.\n  2. Concomitant treatment with any prohibited medications in this protocol.\n  3. Prior TROP2 directed ADC therapy.\n* Uncontrolled or significant cardiovascular disease, including:\n\n  1. QTcF interval \\>470 ms based on the average of triplicate 12-lead (ECG per local read) at screening.\n  2. Myocardial infarction within 6 months prior to randomization.\n  3. Uncontrolled angina pectoris within 6 months prior to randomization.\n  4. NYHA Class 3 or 4 congestive heart failure at screening.\n  5. Uncontrolled hypertension (resting systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg within 28 days before randomization that is not resolved despite maximal medical therapy).\n* Has a history of non-infectious ILD\u002Fpneumonitis including radiation pneumonitis that required steroids, has current ILD\u002Fpneumonitis, or has suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at Screening.\n* Has clinically severe pulmonary compromise as judged by the investigator resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (eg, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.) or any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (eg, rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.), or prior complete pneumonectomy.\n* Toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet improved to NCI-CTCAE version 5.0 Grade ≤1 or baseline. Note: Participants may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to Grade \\>2 for at least 3 months prior to randomization and managed with standard of care treatment) which the investigator deems related to previous anticancer therapy, comprised of (including but not limited to):\n\n  1. Anticancer therapy-induced neuropathy\n  2. Residual toxicities from prior immunotherapy treatment: Grade 1 or Grade 2 endocrinopathies which may include:\n* Hypothyroidism\u002F hyperthyroidism\n* Type I diabetes\n* Hyperglycemia\n* Adrenal insufficiency\n* Adrenalitis c. Skin hypopigmentation (vitiligo)","ALL","18 Years",{"count":20,"type":21},630,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","This is a global, multicenter, randomized, open-label, Phase 2\u002F3 study of Dato-DXd plus carboplatin or cisplatin versus gemcitabine plus carboplatin or cisplatin in participants with la\u002FmUC who progressed during or after EV plus pembrolizumab combination treatment.\n\nThis trial will start with part A, Phase 2. During part A, Phase 2, preliminary efficacy and safety will be assessed, and the recommended Phase 3 dose (RP3D) will be identified when the data allow sufficient assessment of activity, safety, and tolerability. The Phase 3 part will start contingent upon the assessment in the Phase 2 part, taking into consideration the totality of information.",[28,29],"Urothelial Cancer","Bladder Cancer",[31,32,33,34,35],"Urothelial Carcinoma","Dato-DXd","TROPION","DS-1062a","Datopotamab Deruxtecan","RECRUITING","2026-07-01",{"date":39,"type":40},"2026-07-02","ACTUAL",{"date":42,"type":40},"2025-09-26",{"date":44,"type":21},"2030-01-22",{"name":46,"class":47},"Daiichi Sankyo","INDUSTRY",100,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":12,"sex":57,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},"100579031","phase-3-study-of-trastuzumab-deruxtecan-with-bevacizumab-versus-bevacizumab-monotherapy-for-first-line-maintenance-in-her2-expressing-ovarian-cancer-destiny-ovarian01-100579031","NCT06819007","Study of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy for First-line Maintenance in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01)","A Phase 3, Open-label, Multicenter, Randomized Trial of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy as First-line Maintenance Therapy in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01\u002FENGOT-ov89\u002FGEICO144- O\u002FGOG-3112\u002FAPGOT-OV13)","DO-01","Key Inclusion Criteria:\n\n1. Sign and date the tissue prescreening ICF, prior to HER2 central testing. Sign and date the Main ICF, prior to the start of any trial- specific qualification procedures. Consent to optional PGx prior to any PGx procedures.\n\n   \\*For participants in the safety run-in phase, a safety run-in ICF needs to be signed and dated prior to the start of any trial-specific qualification procedures.\n2. Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is \\>18 years old.\n3. Has histologically confirmed diagnosis of epithelial high-grade ovarian, fallopian tube or primary peritoneal carcinoma per local assessment (including but not limiting to serous, endometrioid, clear cell, carcinosarcoma, mucinous).\n4. Is newly diagnosed FIGO Stage III or IV.\n5. Has HER2 expression per 2016 ASCO-CAP gastric cancer IHC scoring (3+\u002F2+\u002F1+) guidelines1 by prospective central testing.\n\n   \\*For participants in the safety run-in phase, HER2 expression assessed by either local (require using ASCO-CAP gastric cancer IHC scoring \\[IHC 3+\u002F2+\u002F1+\\] guidelines) or central assessment (if available) is acceptable. Submission of the pathology report is required for participants enrolled based on local HER2 IHC results.\n6. Has adequate tumor tissue sample available for assessment of HER2 by central laboratory. Tumor tissue block or sufficient tissue slides are required for HER2 testing and retrospective HRD status determination.\n\n   \\*Participants in the safety run-in phase who are enrolled based on local HER2 IHC results are recommended to provide tumor tissue sample from the same specimen for central assessment.\n7. Has a local HRD or BRCA test result available. Participants with BRCA-wildtype will have a local HRD test results, as applicable.\n8. Has received up to 6 cycles of standard of care bevacizumab in combination with frontline platinum- based chemotherapy as per approved indication and clinical guidelines and is eligible to continue single agent bevacizumab maintenance per standard of care and investigator discretion.\n\nKey Exclusion Criteria:\n\n1. Has ovarian, fallopian tube, or peritoneal cancer of non-epithelial origin.\n2. Has a known or suspected deleterious BRCA alteration as per local test that makes the patient eligible for PARP inhibitor.\n3. Participant to receive PARP inhibitor as maintenance per standard of care and investigator discretion. Reasons for which the participant is not eligible for PARP inhibitor will be recorded in the eCRF as follows:\n\n   * HRD negative\n   * HRD positive with SD as best response after platinum\n   * HRD positive non-serous histology Note: For participants enrolled from the Republic of Korea\n   * HRD tested, but inconclusive\n   * HRD positive but safety concern (safety concern to be specified).\n4. Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug products and other monoclonal antibodies.\n5. Previous Cerebral-Vascular Accident, Transient Ischemic Attack or Sub- Arachnoids Hemorrhage within 6 months prior to randomization.\n\n   \\*Note: For participants enrolled from the Republic of Korea,\n6. Has evidence of bleeding diathesis or significant coagulopathy (in the absence of anticoagulation therapy).\n7. Has a history of hemorrhagic disorders, abdominal fistula, gastrointestinal perforation, or active gastrointestinal bleeding within 6 months before randomization.\n8. Evidence of active or ongoing bowel obstruction.\n9. Has a medical history of myocardial infarction within 6 months before randomization, symptomatic congestive heart failure (New York Heart Association Class II to IV).\n\n   Participants with troponin levels above the upper limit of normal at Screening (as defined by the manufacturer), and without any myocardial infarction related symptoms should have a cardiologic consultation during the Screening Period to rule out myocardial infarction.\n10. Has a corrected QT interval prolongation to \\>480 msec based on average of the Screening triplicate 12-lead ECG.\n11. Has a history of (non-infectious) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at Screening.","FEMALE",{"count":59,"type":21},582,[25],"This clinical trial is designed to evaluate the efficacy and safety of T-DXd in combination with bevacizumab versus bevacizumab monotherapy as first-line maintenance therapy, in participants with human epidermal growth factor 2 (HER2)-expressing (immunohistochemistry \\[IHC\\] 3+\u002F2+\u002F1+) advanced high-grade epithelial ovarian cancer.",[63],"Ovarian Cancer",[65,66,67,68,69],"Ovarian cancer","epithelial ovarian cancer","HER2","Trastuzumab Deruxtecan","Bevacizumab",{"date":39,"type":40},{"date":72,"type":40},"2025-03-19",{"date":74,"type":21},"2032-01-31",{"name":46,"class":47},208,{"id":78,"slug":79,"hasResults":12,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},"100585189","phase-3-study-of-trastuzumab-deruxtecan-pembrolizumab-and-platinum-based-chemotherapy-in-first-line-her2-overexpressing-non-small-cell-lung-cancer-100585189","NCT06899126","Study of Trastuzumab Deruxtecan, Pembrolizumab, and Platinum-based Chemotherapy in First-line HER2 Overexpressing Non-small Cell Lung Cancer","A Phase 3, Multicenter, Randomized, Open-label Trial of Trastuzumab Deruxtecan in Combination With Pembrolizumab Versus Platinum-based Chemotherapy in Combination With Pembrolizumab, as First-line Therapy in Participants With Locally Advanced Unresectable or Metastatic HER2 Overexpressing and PD-L1 TPS \u003C50% Non-squamous Non-small Cell Lung Cancer (DESTINY-Lung06)","DESTINY-Lung06","Inclusion Criteria:\n\n1. Sign and date the Tissue Screening ICF, prior to any Tissue Screening procedure. Sign and date the Main ICF, prior to the start of any trial-specific qualification procedures.\n\n   Sign and date the Optional PGx ICF (included in the Main ICF) prior to any PGx procedure, and the Pregnant Partner ICF, if applicable.\n2. Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is \\>18 years old.\n3. Histologically documented non-squamous locally advanced unresectable or metastatic\n\n   NSCLC and meets all of the following criteria:\n\n   Has Stage IV NSCLC disease or Stage IIIB or IIIC disease but is not a candidate for surgical resection or definitive chemoradiation at the time of randomization (based on the American Joint Committee on Cancer, Eighth Edition). Has no known AGAs (based on the local test results obtained using validated or approved tests as required per local regulation) that have locally available therapies targeting their AGAs in the first-line advanced\u002Fmetastatic setting.\n\n   Has no known HER2 mutation based on existing test results (if approved or validated local test is available). Note: Participants with mixed histology are eligible if non-squamous NSCLC is the predominant histology. Mixed tumors will be classified based on the predominant cell type.\n4. Has not been treated with systemic anticancer therapy for advanced or metastatic non-squamous NSCLC. Participants who received adjuvant or neoadjuvant therapy other than those listed below, including ICI (ie, anti-PD-1\u002FPD-L1) or a platinum-based regimen, are eligible if the last dose of adjuvant\u002Fneoadjuvant therapy was given at least 6 months before the date of the first trial dose if their disease has progressed at least 6 months after the last dose date of adjuvant\u002Fneoadjuvant therapy.\n\n   1. Any agent, including an ADC, containing a chemotherapeutic agent targeting topoisomerase I.\n   2. HER2-targeted antibody-based anticancer therapy.\n5. Has adequate tumor tissue sample (not previously irradiated) available for assessment of HER2 and PD-L1 expression by central or Sponsor-specified laboratory. A new biopsy is required if the participant's most recent archival tumor tissue sample cannot be supplied.\n\nDetails pertaining to tumor tissue submission can be found in the Trial Laboratory Manual.\n\nExclusion Criteria:\n\n1. Has a medical history of MI within 6 months before randomization\u002Fenrollment or symptomatic CHF (NYHA Class II to Class IV). Participants with troponin levels above the ULN at Screening (as defined by the manufacturer) and without any MI-related symptoms must be ruled out for MI. It is highly recommended that the investigator refer such participants for a cardiologic consultation during the Screening Period.\n2. Has a QTc prolongation to \\>480 ms based on the average of the Screening triplicate 12- lead ECG.\n3. Has a history of (non-infectious) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at Screening.\n4. Has clinically severe pulmonary compromise resulting from intercurrent, pulmonary illnesses including, but not limited to:\n\n   1. Any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the trial randomization, severe asthma, severe COPD, restrictive lung disease, pleural effusion).\n   2. Any auto immune, connective tissue, or inflammatory disorders with potential pulmonary involvement (eg, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis).\n\n   Severe conditions are those defined as impacting daily activities and\u002For requiring use of supplemental oxygen.\n5. Had a prior complete pneumonectomy.",{"count":86,"type":21},686,[25],"This clinical trial is designed to assess the efficacy and safety of trastuzumab deruxtecan (T-DXd; Enhertu®) in combination with pembrolizumab versus platinum-based chemotherapy in combination with pembrolizumab in participants with no prior therapy for locally advanced unresectable or metastatic non-squamous NSCLC, whose tumors have HER2-overexpressing and PD-L1 TPS \\\u003C50% without known AGA that have locally available therapies targeting their AGAs in first-line advanced\u002Fmetastatic setting.",[90],"Non-small Cell Lung Cancer",[92,93],"DESTINY","NSCLC","2026-06-30",{"date":39,"type":40},{"date":97,"type":40},"2025-10-24",{"date":99,"type":21},"2032-11-24",{"name":46,"class":47},160,{"id":103,"slug":104,"hasResults":12,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":112,"conditions":113,"keywords":116,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},"100572300","phase-3-study-of-tdxd-chemotherapy-pembrolizumab-and-trastuzumab-in-first-line-metastatic-her2-positive-gastric-or-gastroesophageal-junction-cancer-100572300","NCT06731478","Study of TDXd, Chemotherapy, Pembrolizumab, and Trastuzumab in First-Line Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer","A Multicenter, Randomized, Open-Label, Phase 3 Trial of Trastuzumab Deruxtecan (Enhertu®) Plus Chemotherapy Plus or Minus Pembrolizumab Versus Chemotherapy Plus Trastuzumab Plus or Minus Pembrolizumab as First-Line Treatment in Participants With Unresectable, Locally Advanced or Metastatic HER2-Positive Gastric Or Gastroesophageal Junction (GEJ) Cancer (Destiny-Gastric05)","Inclusion Criteria\n\n1. Sign and date the Tissue Prescreening ICF, prior to central HER2 and PD-L1 CPS testing. Sign and date the Main Screening ICF, prior to the start of any trial-specific qualification procedures. Sign and date the Optional PGx ICF (included in the Main Screening ICF) prior to any PGx procedure.\n2. Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is \\>18 years old.\n3. Previously untreated, unresectable, locally advanced or metastatic gastric or GEJ adenocarcinoma histologically confirmed by pathology report. Prior treatment in the perioperative and\u002For adjuvant setting is permissible, provided there is \\>6 months between the end of perioperative or neoadjuvant treatment and the diagnosis of recurrent disease.\n\n   Note: Prior use of IO (ie, anti-PD-1\u002FPD-L1) therapy in the (neo)adjuvant setting is allowed as long as there is \\>6 months between the end of IO therapy and the diagnosis of recurrent disease.\n4. Centrally determined HER2-positive (IHC 3+ or IHC 2+\u002FISH-positive) gastric or GEJ cancer as classified by the American Society of Clinical Oncology-College of American Pathologists for GC on a tumor biopsy as detected by prospective central test on new (core, incisional, excisional biopsy) or existing tumor tissue taken at the time of diagnosis of locally advanced or metastatic disease.\n\n   Note: Archival samples taken from a previous diagnostic or surgical biopsy not previously irradiated can be accepted. Details pertaining to tumor tissue submission can be found in the Study Laboratory Manual.\n5. Centrally determined tumor PD-L1 CPS using the PD-L1 assay:\n\n   * For the Main Cohort: PD-L1 CPS ≥1\n   * For the Exploratory Cohort: PD-L1 CPS \\\u003C1\n6. All participants must provide a tumor sample for tissue-based IHC staining to centrally determine HER2 expression, PD-L1 CPS, and other correlatives. The mandatory FFPE or new biopsy tumor sample can be from either the primary tumor or metastatic biopsy. Specimens with limited tumor content (as centrally determined) and cytology samples are inadequate for defining tumor HER2 and PD-L1 status.\n7. At least 1 target measurable lesion on CT or MRI, assessed by the investigator based on RECIST v1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions.\n8. LVEF ≥50% within 28 days before randomization.\n\nExclusion Criteria\n\n1. Prior exposure to other HER2-targeting therapies (including ADCs).\n2. Lack of physiological integrity of the upper gastrointestinal tract (ie, severe Crohn disease that results in malabsorption) or malabsorption syndrome that would preclude feasibility of oral chemotherapy for participants planned to be offered capecitabine as part of the study treatment.\n3. Known total or partial DPD enzyme deficiency. Note: Screening for DPD enzyme deficiency is required only in regions\u002Fcountries where DPD testing is SoC and with unknown DPD status. For regions\u002Fcountries where DPD testing is not SoC, local practice should be followed. In Spain and Italy, screening for DPD enzyme deficiency is mandatory for all participants with unknown DPD status.\n4. Contraindications to trastuzumab, 5-FU, capecitabine, cisplatin, or oxaliplatin treatment as per local label.\n5. Medical history of myocardial infarction within 6 months before randomization or symptomatic CHF (New York Heart Association Class II to IV). Participants with troponin levels above ULN at Screening (as defined by the manufacturer) and without any myocardial infarction -related symptoms should have a cardiologic consultation during the Screening Period to rule out myocardial infarction.\n6. Has a corrected QT interval (QTcF) prolongation to \\>470 ms (females) or \\>450 ms (males) based on the average of the screening triplicate 12-lead ECG.\n7. Has a history of (non-infectious) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at Screening\n8. Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the trial randomization, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc).",{"count":110,"type":21},726,[25],"This clinical trial is designed to assess the efficacy and safety of the triplet combination of trastuzumab deruxtecan (ENHERTU, T-DXd, DS-8201a) plus a fluoropyrimidine plus pembrolizumab versus standard of care (SoC) chemotherapy plus trastuzumab plus pembrolizumab as first-line therapy in participants with unresectable, locally advanced or metastatic HER2-positive tumor PD-L1 CPS ≥1 gastric or GEJ cancer in the Main Cohort. An Exploratory Cohort will also be evaluated to assess the efficacy and safety of T-DXd plus a fluoropyrimidine versus SoC chemotherapy plus trastuzumab in participants with unresectable, locally advanced or metastatic HER2-positive tumor PD-L1 CPS \\\u003C1 gastric or GEJ cancer.",[114,115],"Gastric Cancer","Gastroesophageal Junction Cancer",[117,68,118,119,120],"Enhertu","Chemotherapy","DS-8201a","HER2 positive","2026-06-29",{"date":37,"type":40},{"date":124,"type":40},"2025-02-27",{"date":126,"type":21},"2030-02-01",{"name":46,"class":47},250,{"id":130,"slug":131,"hasResults":12,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":22,"phases":138,"briefSummary":140,"conditions":141,"keywords":143,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":147,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},"100498099","phase-1-a-study-of-ds-1103a-combination-therapy-in-participants-with-advanced-solid-tumors-100498099","NCT05765851","A Study of DS-1103a Combination Therapy in Participants With Advanced Solid Tumors","A Phase 1, 2-Part, Multicenter, First-In-Human Dose-Escalation and Dose-Expansion Study of DS-1103a Combination Therapy in Subjects With Advanced Solid Tumors","Inclusion Criteria:\n\n* Sign and date the informed consent form (ICF), prior to the start of any study-specific qualification procedures\n* Adults ≥18 years of age at the time the ICF is signed (please follow local regulatory requirements if the legal age of consent for study participation is \\>18 years old)\n* Pathologically documented HER2-expressing or HER2-mutated (activating mutation) solid tumor that is unresectable or metastatic\n* Is willing and able to provide tumor tissue\n* Presence of at least 1 measurable lesion based on computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1\n* Has a left ventricular ejection fraction (LVEF) ≥50% by either an echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before enrollment\n* Has adequate organ and bone marrow function within 14 days before the start of study treatment. Transfusion (red blood cell or platelet) or granulocyte-colony stimulating factor (G-CSF) administration is not allowed within 14 days prior to the day on which bone marrow function is assessed, or at any time after this day and prior to Cycle 1 Day 1.\n* A woman of childbearing potential (WOCBP) is eligible to participate if she is not pregnant as confirmed by highly sensitive pregnancy test and agrees to adhere to a contraceptive method that is highly effective during the Treatment Period and for at least the time needed to eliminate each study drug after the last dose.\n* A male participant capable of producing sperm is eligible to participate if he agrees to adhere to the contraception methods as specified in the protocol and avoids donating sperm during the Treatment Period and for at least the time needed to eliminate each study drug.\n* Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions\n\nDose-escalation Phase:\n\n* Has progressed or was non-responsive to available therapies and for which no standard or available anticancer therapy exists\n* Has a pathologically documented HER2-expressing or HER2-mutated solid tumor\n\nDose-expansion Phase:\n\n* Has pathologically documented specific HER2 altered advanced solid tumor type\n* Has received prior therapy as specified in the protocol\n\nExclusion Criteria:\n\n* Has had prior treatment with an anti-CD47 or anti-signal regulatory protein α (SIRPα) therapy.\n* Has an inadequate treatment washout period prior to start of study treatment as specified in the protocol\n* Medical history of myocardial infarction (MI) within 6 months before study enrollment, symptomatic congestive heart failure (CHF) (New York Heart Association \\[NYHA\\] Class II to IV\n* Has a QT interval corrected with Fridericia's formula (QTcF) prolongation to \\>470 ms (females) or \\>450 ms (males) based on average of the screening triplicate 12-lead electrocardiogram (ECG)\n* Has a history of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at Screening\n* Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms\n* Has multiple primary malignancies within 3 years. Exceptions are specified in the protocol.\n* Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug products or other monoclonal antibodies\n* Has an uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals\n* Is requiring concomitant use of chronic systemic (IV or oral) corticosteroids or other immunosuppressive medications during the study\n* Has received a live, attenuated vaccine (messenger ribonucleic acid \\[mRNA\\] and replication-deficient adenoviral vaccines are not considered live, attenuated vaccines) within 30 days prior to first exposure to study drug(s)\n* Has substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the investigator, interfere with the participant's participation in the clinical study or evaluation of the clinical study results.\n* Has active or uncontrolled human immunodeficiency virus (HIV) infection as determined by plasma HIV ribonucleic acid (RNA) viral load and CD4 count.\n* Has active or uncontrolled HBV or HCV. Hepatitis B and C screening testing is required. Participants are eligible only if they meet criteria as specified in the protocol.\n* Has unresolved toxicities from previous anticancer therapy\n* Female who is pregnant, breastfeeding, or planning to become pregnant\n* Has lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder\n* Any autoimmune, connective tissue or inflammatory disorders\n* Prior complete pneumonectomy\n* Any of the following within 6 months of enrollment: Cerebrovascular accident, transient ischemic attack, or other arterial thromboembolism event\n* Psychological, social, familial, or geographical factors that would prevent regular follow-up\n* Any active or chronic corneal disorders, other active ocular conditions requiring ongoing therapy, or any clinically significant corneal disease that prevents adequate monitoring of drug-induced keratopathy\n* Uncontrolled hypertension (resting systolic blood pressure \\>180 mmHg or diastolic blood pressure \\>110 mmHg) and\u002For severe arrhythmia within 28 days before enrollment",{"count":137,"type":21},108,[139],"PHASE1","This study will evaluate the safety and efficacy of DS-1103a combination therapy in participants with advanced solid tumors.",[142],"Advanced Solid Tumor",[142,144,145,146],"DS-1103a","CD47","SIRPa",{"date":37,"type":40},{"date":149,"type":40},"2023-05-30",{"date":151,"type":21},"2030-05-15",{"name":46,"class":47},8,{"id":155,"slug":156,"hasResults":12,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":22,"phases":163,"briefSummary":164,"conditions":165,"keywords":168,"overallStatus":170,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":178},"100645357","phase-1-first-in-human-trial-of-ds1025a-in-participants-with-advanced-solid-tumors-100645357","NCT07681882","First-in-Human Trial of DS1025a in Participants With Advanced Solid Tumors","A Phase 1, Multicenter, Open-label, First-in-Human Trial of DS1025a in Participants With Advanced Solid Tumors","To be eligible to participate in this trial, an individual must meet all the following criteria:\n\n1. Sign and date the main ICF, prior to the start of any trial-specific procedures.\n2. Adults ≥18 years of age at the time the ICF is signed (Please follow local regulatory requirements if the legal age of consent for trial participation is \\>18 years old).\n3. Histologically documented, advanced, metastatic, or unresectable solid tumors.\n4. Relapsed or refractory disease, following at least 1 line of therapy, not amenable to standard therapy.\n5. Is willing to provide a newly obtained tumor tissue sample at screening, if not clinically contraindicated and at an acceptable risk as determined by the Investigator. If a fresh tumor biopsy is not clinically feasible or would pose unacceptable risk, an archival tumor tissue sample (obtained within 24 months of consent) must be submitted.\n6. Has measurable disease based on local CT\u002FMRI imaging as assessment by the Investigator using RECIST v1.1; radiographic tumor assessment must be performed within 28 days prior to initiation of trial intervention.\n7. ECOG PS of 0 or 1 assessed no more than 28 days prior to initiation of trial intervention.\n8. Has adequate organ and bone marrow function as assessed by local laboratory within 14 days prior to initiation of trial intervention as defined in the protocol.\n9. A WOCBP is eligible to participate if the following conditions are met:\n\n   * Participant is not pregnant as confirmed by highly sensitive pregnancy test\n   * Participant does not plan to breastfeed during the Trial Intervention Period and for at least 8 months after last dose of trial intervention.\n   * Participant agrees to adhere to a contraceptive method that is highly effective with low user dependency only and agrees not to donate eggs (ova, oocytes) to others or freeze\u002Fstore eggs during the Treatment Period and for at least the time needed to eliminate the trial intervention after the last dose.\n10. A male participant capable of producing sperm is eligible to participate if he agrees to the following during the intervention period and for at least the time needed to eliminate the trial intervention:\n\n    * Avoid donating sperm.\n    * Adhere to approved contraception method as specified in the protocol.\n\nAn individual who meets any of the following criteria will be excluded from participation in this trial:\n\n1. Prior treatment with an anti-CD25 therapy.\n2. Treatment discontinuation history due to toxicity to a DXd-ADC agent and considered not able to tolerate DS1025a based on the discussion between the investigator and the Sponsor (for participants who have DXd-ADC treatment history).\n3. Inadequate washout period before initiation of trial intervention as specified in the protocol.\n4. Has spinal cord compression or clinically active central nervous system tumors, including metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.\n5. Uncontrolled or significant cardiovascular disease as specified in the protocol.\n6. Any of the following within the past 6 months prior to initiation of trial intervention: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.\n7. Participants with any history of interstitial lung disease (ILD)\u002Fpneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at screening.\n8. Lung-specific intercurrent clinically significant illnesses as specified in the protocol.\n9. Has clinically significant pulmonary compromise or requirement for supplemental oxygen.\n10. History of other active malignancy within 3 years prior to initiation of trial intervention, with the exception of those with a negligible risk of metastasis or death (eg, 5-year OS rate \\>90%) and treated with expected curative outcome\n11. Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE v 6.0, Grade ≤1 or baseline.\n12. History of hypersensitivity to any excipients in DS1025a or any known contraindication to treatment with, including hypersensitivity to, the trial intervention.\n13. Has a known history of HLH.\n14. Has a known active infection, or reactivation of latent following infections as specified in the protocol among participants who received treatment such as antivirals, antifungals, or IV antibiotics within 14 days prior to first dose of trial intervention.\n15. Has active or uncontrolled HBV infection.\n16. Has active or uncontrolled HCV infection.\n17. Has active or uncontrolled HIV infection.\n18. Has an active, known, or suspected autoimmune disease.\n19. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (\\>10 mg daily prednisone equivalents) or any other form of immunosuppressive therapy within 14 days prior to the trial intervention.",{"count":162,"type":21},45,[139],"This clinical trial is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy signals of DS1025a, given as a single agent to participants with advanced, metastatic, or unresectable solid tumors.",[142,166,167],"Metastatic Solid Tumor","Unresectable Solid Tumor",[142,166,167,169],"DS1025a","NOT_YET_RECRUITING","2026-06-26",{"date":39,"type":40},{"date":174,"type":21},"2026-08-03",{"date":176,"type":21},"2029-01-21",{"name":46,"class":47},3,{"id":180,"slug":181,"hasResults":12,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":22,"phases":188,"briefSummary":189,"conditions":190,"keywords":193,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":203},"100609902","phase-1-a-first-in-human-trial-of-ds3790a-in-participants-with-hematological-malignancies-100609902","NCT07220616","A First-in-Human Trial of DS3790a in Participants With Hematological Malignancies","A Phase 1\u002F2, Multicenter, Open-Label, Multi-Cohort, First-in Human Trial of DS3790a, a DXd-ADC Targeting CD37, for Hematological Malignancies","To be eligible to participate in this trial, an individual must meet all the following criteria:\n\n1. Sign and date the ICF, prior to the start of any trial-specific procedures.\n2. Adults \\>=18 years at the time the ICF is signed.\n3. History of one of the histologically documented hematologic malignancies according to the 5th edition of WHO classification as specified in the protocol.\n4. NHL participants only: Agree to provide baseline tumor tissue samples as specified in the protocol.\n5. ECOG PS of 0, 1 or 2 assessed no more than 14 days prior to initiation of trial intervention.\n6. Has adequate organ and bone marrow function as assessed by local laboratory within 14 days prior to initiation of trial intervention as specified in the protocol.\n7. Has an LVEF \\>=50% by either an ECHO or MUGA within 28 days before the trial starts.\n8. Life expectancy of at least 3 months.\n9. Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other trial procedures, and trial restrictions.\n10. A woman of childbearing potential is eligible to participate if she meets all criteria as specified in the protocol.\n11. A male participant capable of producing sperm is eligible to participate if he agrees to all criteria as specified in the protocol.\n\nAn individual who meets any of the following criteria will be excluded from participating in this trial:\n\n1. Prior Allo-SCT.\n2. Prior solid organ transplantation.\n3. Inadequate washout period before initiation of trial intervention as specified in the protocol.\n4. Evidence of brain or leptomeningeal disease (spinal cord or CNS metastases) based on history and physical examination, unless treated and with radiologically documented lack of progression within 4 weeks prior to initiation of trial intervention.\n5. Uncontrolled or significant cardiovascular disease as specified in the protocol.\n6. Any of the following within the past 6 months prior to enrollment: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.\n7. Has a history of (noninfectious) ILD\u002Fpneumonitis that required corticosteroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n8. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder and any autoimmune, connective tissue, or inflammatory disorder with potential pulmonary involvement, or prior pneumonectomy.\n9. Has been diagnosed with another malignancy within the previous 3 years.\n10. Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia and lymphocytopenia) not yet resolved to NCI-CTCAE Version 5.0, Grade \\\u003C=1 or baseline.\n11. Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection.\n12. Has active or uncontrolled HBV, HCV, or HIV infections.",{"count":187,"type":21},420,[139,24],"This clinical trial is designed to assess the safety, preliminary efficacy, and pharmacokinetics (PK) of DS3790a monotherapy and combination regimens in participants with hematological malignancies.",[191,192],"Hematological Malignancies","B-cell Non-Hodgkin Lymphoma",[191,194,195],"DS3790a","B-cell non-Hodgkin lymphoma","2026-06-23",{"date":171,"type":40},{"date":199,"type":40},"2026-01-16",{"date":201,"type":21},"2030-11-30",{"name":46,"class":47},5,{"id":205,"slug":206,"hasResults":12,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":22,"phases":213,"briefSummary":214,"conditions":215,"keywords":218,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":232},"100579428","phase-2-evaluation-of-two-dose-levels-of-quizartinib-as-maintenance-in-flt3-itd--acute-myeloid-leukemia-patients-in-complete-remission-100579428","NCT06824168","Evaluation of Two Dose Levels of Quizartinib as Maintenance in FLT3-ITD (+) Acute Myeloid Leukemia Patients in Complete Remission","A Phase 2, Multicenter, Randomized, Open-label Trial to Evaluate Safety and Efficacy of Two Dose Levels of Quizartinib as Maintenance for Adult Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia in Complete Remission","Key Inclusion Criteria:\n\n1. Adults ≥18 years of age or the minimum legal adult age (whichever is greater) on the day of signing the ICF (no upper limit of age).\n2. Newly diagnosed, morphologically documented primary AML or AML secondary to myelodysplastic syndrome or a myeloproliferative neoplasm based on the World Health Organization (WHO) 2008\u002F2016 classification.\n3. Participant has confirmed FLT3-ITD-positive (≥0.05 SR or ≥5% VAF) activating mutation from initial diagnosis in bone marrow or peripheral blood as determined by a local institution's validated molecular testing.\n4. Participants must have confirmed, morphologically documented CR1, on the most recent BMA, based on the local laboratory results, performed within 28 days prior to C1D1 of maintenance therapy. Complete remission will be defined as \\\u003C5% blasts in the bone marrow with no morphologic characteristics of acute leukemia (e.g., Auer Rods), no evidence of extramedullary disease, and no leukemic blasts in the peripheral blood.\n\n   Complete blood count recovery is required with absolute neutrophil count of more than 1.000 × 109\u002FL and platelets more than 100 × 109\u002FL (IWG criteria).27\n5. Participant must meet the following prior therapy requirements:\n\n   1. Has received at least one cycle of induction therapy but no more than two to achieve CR1. The induction cycles can be the same regimen or different regimens and may contain conventional agents only (e.g., cytarabine + daunorubicin or idarubicin: \"7 + 3\" or \"5 + 2\"), or a combination with FLT3 inhibitors.\n   2. Has not received more than four cycles of consolidation therapy. Regimens may contain conventional agents only.\n   3. FLT3 inhibitors are permitted as part of the induction or consolidation treatment.\n\n   Participants who received FLT3 inhibitors before enrollment in the trial will need a washout period of 14 days.\n6. Able to begin the maintenance phase within 60 days of D1 of the last consolidation cycle received.\n7. Eastern Cooperative Oncology Group (ECOG) PS of 0 to 2.\n\nKey Exclusion Criteria:\n\n1. Diagnosis of acute promyelocytic leukemia (APL), French-American-British classification M3 or WHO classification of APL with translocation, t(15;17)(q22;q12), or BCR-ABL positive leukemia (i.e., chronic myelogenous leukemia in blast crisis); participants who undergo diagnostic workup for APL and treatment with all-trans retinoic acid (ATRA), but who are found not to have APL, are eligible (treatment with ATRA must be discontinued before starting induction chemotherapy).\n2. Diagnosis of AML secondary to prior chemotherapy or radiotherapy for other neoplasms.\n3. Prior treatment for AML, except for the following allowances:\n\n   1. Induction and consolidation therapy, as previously described (inclusion criterion #5)\n   2. Leukapheresis\n   3. Hydroxyurea to treat hyperleukocytosis\n   4. Cranial radiotherapy for central nervous system (CNS) leukostasis\n   5. Prophylactic intrathecal chemotherapy\n   6. Growth factor\u002Fcytokine support\n4. Participant had received allo-HSCT as part of AML treatment.\n5. Treatment with any strong or moderate CYP3A inducers within 2 weeks or 5 half-lives of randomization whichever is longer\n6. Uncontrolled or significant cardiovascular disease, including the following:\n\n   1. QTcF interval \\>450 ms (based on average of triplicate ECG at Screening)\n   2. Diagnosed or suspected congenital long QT syndrome or known family history of congenital long QT syndrome\n   3. History of clinically relevant ventricular arrhythmias, such as ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes\n   4. Participant has bradycardia of less than 50 beats per minute (bpm; as determined by central reading), unless the participant has a pacemaker\n   5. History of second- or third-degree heart block. Candidates with a history of heart block may be eligible if they currently have pacemakers and have no history of fainting or clinically relevant arrhythmia with pacemakers.\n   6. Myocardial infarction within 6 months prior to screening\n   7. Uncontrolled angina pectoris within 6 months prior to screening\n   8. New York Heart Association Class 3 or 4 congestive heart failure\n   9. LVEF ≤45% or institutional lower limit of normal\n   10. Uncontrolled hypertension (resting systolic blood pressure \\>180 mmHg or diastolic blood pressure \\>110 mmHg despite optimal medical management)\n   11. Complete left or right bundle branch block\n   12. Severe aortic stenosis",{"count":212,"type":21},130,[24],"This clinical two-arm trial is designed to evaluate two doses of quizartinib as maintenance therapy after induction\u002Fconsolidation in participants with FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) (+) acute myeloid leukemia (AML) in first complete remission (CR) who have not received allogeneic hematopoietic stem cell transplantation (allo-HSCT).",[216,217],"Acute Myeloid Leukemia","Leukemia",[219,220,221,222,223],"acute myeloid leukemia","quizartinib","FLT3","allo-HSCT","leukemia","2026-06-17",{"date":226,"type":40},"2026-06-22",{"date":228,"type":40},"2025-07-18",{"date":230,"type":21},"2032-07-14",{"name":46,"class":47},58,{"id":234,"slug":235,"hasResults":12,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":22,"phases":241,"briefSummary":242,"conditions":243,"keywords":245,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":258},"100512322","phase-3-trastuzumab-deruxtecan-t-dxd-in-patients-who-have-hormone-receptor-negative-and-hormone-receptor-positive-her2-low-or-her2-ihc-0-metastatic-breast-cancer-100512322","NCT05950945","Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer","A Phase 3b, Multicenter, Global, Interventional, Open-label Study of Trastuzumab Deruxtecan (T-DXd), an Anti-HER2-Antibody Drug Conjugate (ADC), in Subjects Who Have Unresectable and\u002For Metastatic HER2-low or HER2 Immunohistochemistry (IHC) 0 Breast Cancer (DESTINY-Breast15)","Inclusion Criteria:\n\n* Sign and date the main informed consent form\n* Must agree to provide a newly obtained or archival baseline biopsy from primary and\u002For metastatic lesion.\n* Pathologically documented Breast Cancer (BC) tumor\n\n  * Is unresectable and\u002For metastatic.\n  * Is hormone receptor-negative or hormone receptor-positive.\n\n    * Must include percentage of positively stained cells to characterize if hormone receptor-positive or -negative.\n  * Has confirmed HER2 IHC 1+ or IHC 2+\u002FISH- (HER2-low) status or HER2 IHC 0 status as determined according to ASCO CAP 2018 guidelines1 based on sample collected during Tissue Screening as described above.\n  * Was never previously HER2-positive (IHC 3+ or IHC 2+\u002FISH+) on prior pathology testing (per ASCO CAP guidelines).\n  * Was never previously treated with anti-HER2 therapy in the metastatic setting.\n* Has had at least one and up to two prior lines of therapy in the metastatic setting.\n\n  * In participants with hormone receptor-positive HER2-low metastatic BC (Cohort 3):\n\n    * Has recurrent disease \\\u003C2 years from the initiation of adjuvant ET OR\n    * Has disease progression on CDK4\u002F6 inhibitor-based regimen within 12 months of completion of adjuvant therapy with a CDK4\u002F6 inhibitor OR\n    * Has disease progression within the first 12 months of CDK4\u002F6 in the first line metastatic setting\n* Presence of at least one measurable lesion based on computed tomography or magnetic resonance imaging.\n* Participants with brain metastases are allowed in the study. The brain lesion(s) should be small (\\\u003C2 cm), untreated, asymptomatic, not requiring urgent medical intervention, and are asymptomatic and clinically stable.\n* Has an Eastern Cooperative Oncology Group performance status of 0 or 1.\n* Has a minimum life expectancy of 12 weeks at Screening.\n* Has a left ventricular ejection fraction ≥50% within 28 days before enrollment.\n* Has adequate organ and bone marrow function within 28 days before enrollment.\n* Has adequate treatment washout period before enrollment.\n* Male and female subjects of reproductive\u002Fchildbearing potential must agree to use a highly effective form of contraception.\n\nExclusion Criteria:\n\n* Prior treatment with an antibody drug conjugate (ADC).\n* Uncontrolled or significant cardiovascular disease.\n* Has a corrected QT interval prolongation.\n* Has a history of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at Screening.\n* Has spinal cord compression or clinically active central nervous system metastases.\n* Has multiple primary malignancies within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, other solid tumors curatively treated, or contralateral BC.\n* Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug product.\n* Has a history of severe hypersensitivity reactions to other monoclonal antibodies.\n* Has an uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.\n* Active primary immunodeficiency, known uncontrolled active human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection.\n* Has history of receiving a live, attenuated vaccine (messenger RNA and replication-deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first exposure to study drug.\n* Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤1 or baseline.\n* Is pregnant or breastfeeding or planning to become pregnant.\n* Lung-specific intercurrent clinically significant illnesses.\n* Any autoimmune, connective tissue, or inflammatory disorders.\n* Prior complete pneumonectomy.",{"count":128,"type":21},[25],"This study will evaluate the safety and efficacy of trastuzumab deruxtecan (T-DXd) in participants with human epidermal growth factor receptor 2 (HER2)-low or HER2 immunohistochemistry (IHC) 0 (who are both hormone receptor \\[HR\\]-negative and HR-positive) unresectable and\u002For metastatic breast cancer.",[244],"Breast Cancer",[246,247,248,244,249],"Trastuzumab Derextecan","Enhertu®","DS8201-a","Anti-HER2-Antibody Drug Conjugate","2026-06-11",{"date":252,"type":40},"2026-06-12",{"date":254,"type":40},"2023-12-30",{"date":256,"type":21},"2027-10-01",{"name":46,"class":47},88,{"id":260,"slug":261,"hasResults":12,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":266,"phases":4,"briefSummary":267,"conditions":268,"keywords":271,"overallStatus":278,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":282,"locationsCount":178},"100634105","medical-access-program-for-ifinatamab-deruxtecan-in-3l-pretreated-extensive-stage-small-cell-lung-cancer-100634105","NCT07535359","Medical Access Program for Ifinatamab Deruxtecan in 3L+ Pretreated Extensive-stage Small Cell Lung Cancer","Medical Access Program for Ifinatamab Deruxtecan (I-DXd, DS-7300a)","Patients are only eligible after signing the informed consent form and must meet all of the following criteria to be eligible for the Medical Access Program.\n\nInclusion Criteria:\n\n* The patient has at least one SCLC lesion that has not been previously irradiated.\n* The patient is aged ≥18 years or older.\n* The patient has histologically or cytologically documented ES-SCLC.\n* The patient had prior therapy with platinum-based chemotherapy and one additional treatment as systemic therapy for extensive-stage disease.\n* The patient has received prior treatment with a minimum of two previous lines of systemic therapy.\n* The patient has a documented radiological disease progression on or after the most recent systemic therapy.\n* The patient has an ECOG PS of 0-1.\n* The patient has a life expectancy of ≥3 months\n* The patient has adequate organ and bone marrow function as defined in the protocol within 7 days prior to Cycle 1 Day 1 of I-DXd treatment. Transfusion (red blood cell or platelet) or granulocyte-colony stimulating factor (G-CSF) administration is not allowed within 2 weeks prior to screening laboratory tests.\n* Male and female patients of reproductive\u002Fchildbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the program and for at least 8 months for females and 5 months for males after the last dose of I-DXd.\n* Female patients of childbearing potential must have a negative serum pregnancy test within 3 days prior to enrolment.\n* Female patients agree to not donate, or retrieve for their own use, ova throughout the participation in the MAP and for 8 months following the last dose of I-DXd. Preservation of ova may be considered prior to enrolment in this program.\n* Male patients are surgically sterile or willing to use highly effective birth control throughout the participation in the MAP and for 5 months following the last dose of I DXd.\n* Male patients agree not to freeze or donate sperm throughout participation in the MAP and for 5 months following the last dose of I-DXd. Preservation of sperm may be considered prior to enrolment in this program.\n\nPatients who meet any of the following criteria will not be eligible for the Medical Access Program.\n\nExclusion Criteria:\n\n* The Patient is eligible for other treatment options or can enroll in an open clinical trial with patients with pre-treated ES-SCLC.\n* The patient has received prior treatment with orlotamab, enoblituzumab, or other B7-H3 targeted agents, including I-DXd.\n* The patient has been discontinued from an ADC that consists of an exatecan derivative (e.g., trastuzumab deruxtecan) due to treatment-related toxicities.\n* The patient has had an inadequate washout period before randomization as defined in the protocol.\n* The patient has clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms.\n* The patient has experienced any of the following events within the past 6 months:\n\n  1. cerebrovascular accident, or\n  2. transient ischemic attack, or\n  3. another arterial thromboembolic event.\n* The patient has a clinically significant corneal disease.\n* The patient has uncontrolled or significant cardiovascular disease as defined in the protocol.\n* The patient has any history of ILD\u002Fpneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at screening.\n* The patient has a clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses as defined in the protocol.\n* The patient is on chronic steroid treatment (dose of 10 mg daily or more prednisone equivalent), except for low-dose inhaled steroids (for asthma\u002FCOPD), topical steroids (for mild skin conditions), or intra-articular steroid injections.\n* The patient has a history of allogeneic bone marrow, stem cell, or solid organ transplant.\n* The patient has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE V5.0, Grade ≤1 or baseline.\n* The patient has a history of hypersensitivity to the drug substances, inactive ingredients in the drug product, or severe hypersensitivity reactions to other monoclonal antibodies.\n* The patient has a documented ongoing uncontrolled systemic bacterial, fungal, or viral infection.\n* The patient has active or uncontrolled hepatitis B or C infection.\n* The patient has an active, known, or suspected autoimmune disease. The following patients may be enrolled as an exception:\n\n  1. Type I diabetes mellitus, hypothyroidism only requiring hormone replacement\n  2. Skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or\n  3. Conditions not expected to recur in the absence of an external trigger.\n* The patient has any evidence of severe or uncontrolled systemic diseases (including active bleeding diatheses, psychiatric illness\u002Fsocial situations, substance abuse) or other factors that, in the physician's opinion, make it undesirable for the patient to participate in the MAP or would jeopardize compliance with the protocol. Screening for chronic conditions is not required.\n* The patient has received a live vaccine within 30 days prior to the first dose of I-DXd.\n* Female patients who are pregnant, breastfeeding, or intend to become pregnant during the MAP.\n* The patient has active or uncontrolled human immunodeficiency virus (HIV) infection. Participants must be tested for HIV viral load before enrollment if acceptable by local regulations or independent review boards\u002FIndependent ethics committee.\n* The patient has active or uncontrolled hepatitis B virus (HBV) infection. Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have an undetectable HBV viral load prior to enrolment.\n* The patient has active or uncontrolled hepatitis C virus (HCV) infection. Participants with a history of hepatitis C infection are eligible if the HCV viral load is undetectable in the absence of antiviral therapy during the previous 4 weeks.","EXPANDED_ACCESS","The purpose of this Medical Access Program (also referred to as an Expanded Access Program in the USA) is to provide access to I-DXd for eligible patients with extensive-stage small cell lung cancer (ES-SCLC) after two or more prior lines of treatment (including at least one platinum-based regimen), and for eligible patients who have no suitable treatment options and are not able to enter a clinical study.",[269,270],"SCLC","Extensive-stage Small Cell Lung Cancer",[272,273,274,275,276,277],"Ifinatamab Deruxtecan","Medical Access Program","3L+ SCLC","DS7300a","I-DXd","Extensive-stage small cell lung cancer","AVAILABLE","2026-06-05",{"date":281,"type":40},"2026-06-09",{"name":46,"class":47},{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":289,"eligibilityCriteria":290,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":291,"targetDuration":4,"studyType":22,"phases":293,"briefSummary":294,"conditions":295,"keywords":297,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":308},"100531700","phase-3-a-study-of-ifinatamab-deruxtecan-versus-treatment-of-physicians-choice-in-subjects-with-relapsed-small-cell-lung-cancer-100531700","NCT06203210","A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer","A Phase 3, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice (TPC) in Subjects With Relapsed Small Cell Lung Cancer (SCLC) (IDeate-Lung02)","IDeate-Lung02","Inclusion Criteria\n\nParticipants must meet all the following criteria to be eligible for randomization into the study:\n\n1. Sign and date the informed consent form prior to the start of any study-specific qualification procedures.\n2. Adults ≥18 years or the minimum legal adult age (whichever is greater) at the time the informed consent form is signed.\n3. Has histologically or cytologically documented extensive-stage small cell lung cancer (ES-SCLC).\n4. The participant must provide adequate baseline tumor samples with sufficient quantity and quality of tumor tissue content.\n5. Has received prior therapy with only one prior platinum-based line as systemic therapy for SCLC with at least 2 cycles of therapy and a chemotherapy free-interval of ≥30 days.\n6. Has at least 1 measurable lesion according to RECIST v1.1 as assessed by the investigator.\n7. Has documentation of radiological disease progression on or after the most recent systemic therapy.\n8. Has ECOG PS of ≤1 within 7 days prior to Cycle 1 Day 1 (C1D1).\n9. Has no evidence of brain or leptomeningeal disease (spinal cord or central nervous system \\[CNS\\] metastases) based on history and physical examination. Subjects must require no treatment with steroids or anticonvulsants and have a stable neurologic status for at least 2 weeks prior to the first dose of study drug.\n\nExclusion Criteria\n\nParticipants who meet any of the following criteria will be disqualified from entering the study:\n\n1. Has received prior treatment with orlotamab, enoblituzumab, or other B7 homologue 3 (B7-H3) targeted agents, including I-DXd.\n2. Prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities.\n3. Has received any of the comparators used in this study or any topoisomerase I inhibitor.\n4. Has inadequate washout period before randomization as specified in the protocol.\n5. Has any of the following conditions within the past 6 months: cerebrovascular accident, transient ischemic attack, or another arterial thromboembolic event.\n6. Has uncontrolled or significant cardiovascular disease.\n7. Has clinically significant corneal disease.\n8. Has any history of ILD\u002Fpneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at Screening. Participants may be eligible if they had history of radiation pneumonitis that did not require steroids.\n\n   Examples of suspected ILD\u002Fpneumonitis by imaging include the presence of lung parenchymal fibrosis, such as combined pulmonary fibrosis and emphysema (CPFE) and any radiographic features consistent with ILA, including but not limited to, extensive ground glass opacities, reticular opacities, traction bronchiectasis, and honeycombing.\n9. Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, including, but not limited to, any underlying pulmonary disorder and potential pulmonary involvement caused by any autoimmune, connective tissue, or inflammatory disorders, prior pneumonectomy, or requirement for supplemental oxygen.",{"count":292,"type":21},540,[25],"This study was designed to compare the efficacy and safety of I-DXd with treatment of physician's choice in participants with relapsed small cell lung cancer (SCLC).",[296],"Small Cell Lung Cancer",[298,299,276],"Small cell lung cancer","Ifinatamab deruxtecan","2026-05-29",{"date":302,"type":40},"2026-06-02",{"date":304,"type":40},"2024-05-21",{"date":306,"type":21},"2029-02-22",{"name":46,"class":47},232,{"id":310,"slug":311,"hasResults":12,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":4,"eligibilityCriteria":315,"healthyVolunteers":12,"sex":57,"minAge":18,"maxAge":4,"enrollmentInfo":316,"targetDuration":4,"studyType":22,"phases":318,"briefSummary":319,"conditions":320,"keywords":322,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":334},"100594671","phase-3-study-of-trastuzumab-deruxtecan-versus-standard-of-care-chemotherapy-for-her2-expressing-ihc-32-endometrial-cancer-100594671","NCT07022483","Study of Trastuzumab Deruxtecan Versus Standard of Care Chemotherapy for HER2-Expressing (IHC 3+\u002F2+) Endometrial Cancer","A Phase 3, Multicenter, Randomized, Open-label Trial of Trastuzumab Deruxtecan Versus Standard of Care Chemotherapy With or Without Radiotherapy as Adjuvant Treatment for HER2-Expressing (IHC 3+\u002F2+) Endometrial Cancer (DESTINY-Endometrial02\u002F GOG-3122\u002F ENGOT-en30\u002FGINECO)","Key Inclusion Criteria\n\n* Adults ≥18 years at the time the ICF is signed (Please follow local regulatory requirements if the legal age of consent for trial participation is \\>18 years old)\n* Has histologically confirmed diagnosis of epithelial endometrial carcinoma. All histology's are allowed except for sarcomas (carcinosarcomas are allowed).\n* Is newly diagnosed FIGO 2023 Stage IIC (including Stage IICmp53abn) or Stage III Note: FIGO 2023 Stage IIC includes disease with aggressive histological types (aggressive histological types are composed of high-grade EECs (grade 3), serous, clear cell, undifferentiated, mixed, mesonephric-like, gastrointestinal mucinous type carcinomas, and carcinosarcomas) with any myometrial involvement. FIGO 2023 Stage III includes disease with local and\u002For regional spread of the tumor of any histological subtype.\n* Has HER2-expression (IHC 3+\u002F2+) per 2016 ASCO-CAP gastric cancer IHC scoring guidelines as confirmed by central laboratory testing.\n* Has adequate archived tumor tissue sample (sample from surgery is strongly recommended) available for assessment of HER2 status by central laboratory.\n\nKey Exclusion Criteria\n\n* Has uterine mesenchymal tumor such as an endometrial stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas. Adenosarcomas are also not allowed.\n* Has recurrent or FIGO 2023 Stage IV\n* Has measurable residual tumor after surgery as determined by BICR assessment.\n* Is known to have a POLE mutation from an approved and\u002For validated local test, according to local regulations, if available\n* Has a medical history of MI within 6 months before randomization\u002Fenrollment, symptomatic CHF (NYHA Class II to IV). Participants with troponin levels above ULN at SCR (as defined by the manufacturer), and without any MI related symptoms should have a cardiologic consultation during SCR Period to rule out MI.\n* Has a QTcF prolongation to \\> 480 msec based on average of the SCR triplicate12-lead ECG. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of the trial enrollment, severe asthma, severe COPD, restrictive lung disease, pleural effusion, etc.) and any autoimmune, connective tissue, or inflammatory disorder with potential pulmonary involvement (eg, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or prior pneumonectomy.\n* Has a history of (noninfectious) ILD\u002Fpneumonitis that required corticosteroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at SCR.",{"count":317,"type":21},710,[25],"This study is designed to assess efficacy and safety of T-DXd adjuvant therapy, with or without radiotherapy, post-surgery in anticancer treatment naïve (including neoadjuvant therapy) endometrial cancer with various HER2 expression levels.",[321],"Endometrial Cancer",[323,324,325,67],"endometrial cancer","cancer","T-DXd","2026-05-27",{"date":328,"type":40},"2026-05-28",{"date":330,"type":40},"2025-09-30",{"date":332,"type":21},"2032-03-23",{"name":46,"class":47},61,{"id":336,"slug":337,"hasResults":12,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":4,"eligibilityCriteria":341,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":342,"targetDuration":4,"studyType":22,"phases":343,"briefSummary":344,"conditions":345,"keywords":347,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":350,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":356},"100373683","phase-1-study-of-ifinatamab-deruxtecan-ds-7300a-i-dxd-in-participants-with-advanced-solid-malignant-tumors-100373683","NCT04145622","Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors","Phase I\u002FII, Two-Part, Multicenter First-in-Human Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Subjects With Advanced Solid Malignant Tumors (IDeate-PanTumor01)","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.\n* Has at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 on computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by Investigator. Measurable lesions should not be from a previously irradiated site. If the lesion at a previously irradiated site is the only selectable target lesion, a radiological assessment showing significant progression of the irradiated lesion should be provided by the Investigator\n* Has adequate cardiac, hematopoietic, renal and hepatic functions\n* Has an adequate treatment washout period prior to start of study treatment\n* Has a pathologically documented advanced\u002Funresectable or metastatic head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, squamous and adenocarcinoma non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), bladder cancer, sarcoma, endometrial cancer, melanoma, adenocarcinoma CRPC (primary neuroendocrine or histologically confirmed neuroendocrine differentiated prostate cancer is not allowed), breast cancer that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.\n\nFor Expansion Cohort 4 2L ESCC participants only:\n\n* Has disease progression a post platinum-based and an immune checkpoint inhibitor (ICI) treatment per global or local guidelines, with a maximum of one prior line of systemic therapy for unresectable advanced or metastatic ESCC.\n\nExclusion Criteria:\n\n* Has prior treatment with B7-H3 targeted agent, including I-DXd.\n* Has had prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (e.g., trastuzumab deruxtecan) due to treatment-related toxicities.\n* Has multiple primary malignancies within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, superficial GI tract tumors and non-muscle invasive bladder cancer curatively resected by endoscopic surgery.\n* Uncontrolled significant cardiovascular disease\n* Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder, or any autoimmune, connective tissue or inflammatory disorders with potential pulmonary involvement, prior pneumonectomy, or requirement for supplemental oxygen\n* Has an uncontrolled infection requiring systemic therapy.\n* Has substance abuse or any other medical conditions that would increase the safety risk to the subject or interfere with participation of the subject or evaluation of the clinical study in the opinion of the Investigator.",{"count":128,"type":21},[139,24],"This is a single group study of participants with advanced solid tumors who have not been cured by other treatments. It is the first time the drug will be used in humans, and will be in two parts.\n\nThe primary purpose of the parts are:\n\n* Dose Escalation Part: To evaluate the safety and tolerability and to determine the maximum tolerated dose and the recommended dose for expansion of ifinatamab deruxtecan (I-DXd).\n* Dose Expansion Part: To investigate the safety, tolerability and antitumor activity of I-DXd when administered as a single agent.\n\nThis study is expected to last approximately 5 years from the time the first participant is enrolled to the time the last participant is off the study.\n\nThe number of treatment cycles is not fixed in this study. Participants who continue to benefit from the study treatment may continue, unless:\n\n* they withdraw\n* their disease gets worse\n* they experience unacceptable side effects.",[142,346],"Malignant Solid Tumor",[142,348,349],"Malignant Tumor","Ifinatamab deruxtecan (I-DXd)",{"date":300,"type":40},{"date":352,"type":40},"2019-11-03",{"date":354,"type":21},"2029-10-31",{"name":46,"class":47},28,{"id":358,"slug":359,"hasResults":12,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":4,"eligibilityCriteria":363,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":364,"targetDuration":4,"studyType":22,"phases":366,"briefSummary":367,"conditions":368,"keywords":370,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":383},"100528457","phase-2-a-study-of-raludotatug-deruxtecan-r-dxd-in-subjects-with-platinum-resistant-high-grade-ovarian-primary-peritoneal-or-fallopian-tube-cancer-100528457","NCT06161025","A Study of Raludotatug Deruxtecan (R-DXd) in Subjects With Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer","A Phase 2\u002F3, Multicenter, Randomized Study of Raludotatug Deruxtecan (R-DXd), a CDH6-directed Antibody-drug Conjugate, in Subjects With Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer","Inclusion Criteria:\n\n* Sign and date the informed consent form prior to the start of any study-specific qualification procedures.\n* Age ≥18 years or the minimum legal adult age (whichever is greater) at the time the informed consent form is signed.\n* Participants with histologically or cytologically documented high-grade serous ovarian cancer (OVC), high-grade endometrioid OVC, primary peritoneal cancer, or fallopian tube cancer.\n* For Phase 2 (Part A) Participants must have at least 1 lesion, not previously irradiated, amenable to biopsy, and must consent to provide a pretreatment biopsy and on-treatment biopsy tissue sample (on-treatment biopsy sample not required for the Phase 3 part of the study). Fresh pretreatment biopsy may be waived for subjects who consent to provide an archival tumor tissue sample from a lesion not previously irradiated, performed within 6 months of consent and performed after treatment with their most recent cancer therapy regimen.\n* For Phase 2 (Part A): Has received at least 1 but no more than 3 prior systemic lines of anticancer therapy. For Phase 3 (Part B): Has received at least 1 but no more than 4 prior systemic lines of anticancer therapy:\n\n  * Neoadjuvant +\u002F-adjuvant considered 1 line of therapy.\n  * Maintenance therapy (eg, bevacizumab, poly-ADP ribose polymerase \\[PARP\\] inhibitors) will be considered part of the preceding line of therapy.\n  * Therapy changed due to toxicity in the absence of progression will be considered part of the same line.\n  * Hormonal therapy will be counted as a separate line of therapy, unless it was given as maintenance.\n  * At least 1 line of therapy containing bevacizumab, unless the subject is not eligible for treatment with bevacizumab due to precautions\u002Fintolerance. Note: Subjects must have progressed radiologically on or after their most recent line of systemic therapy. Biochemical progression will not be considered progression for this study.\n* Has platinum-resistant disease. If a subject had only 1 line of platinum therapy, must have received at least 4 cycles of platinum, must have had a best response of not PD, and then progressed between \\>90 and ≤180 days after the date of the last dose of platinum If a subject had 2 or 4 lines of platinum therapy, must have received at least 2 cycles of platinum and have progressed on or within 180 days after the date of the last dose of platinum.\n* If mirvetuximab soravtansine (MIRV) is locally available: Has had prior treatment with MIRV for participants with documented high-folate receptor alpha expression, unless the participant is not eligible for treatment with mirvetuximab soravtansine due to precautions\u002Fintolerance, or if the treatment is not approved or available locally.\n* Has at least 1 measurable lesion evaluated by computed tomography or magnetic resonance imaging according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per investigator assessment.\n* Eastern Cooperative Oncology Group performance status of 0 or 1.\n* Has adequate organ and bone marrow function as assessed by local laboratory (within 14 days before start of study drug administration).\n* Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures and study restrictions.\n* For Phase 3 (Part B) only: Subjects must be eligible for one of the treatments included in the investigator's choice of chemotherapy arm.\n\nExclusion Criteria\n\n* Has clear cell, mucinous, or sarcomatous histology, mixed tumors containing any histology, or low-grade\u002Fborderline OVC. (Note for Phase 3 \\[Part B\\]: seromucinous, low-grade serous carcinoma or ovarian sarcoma, carcinosarcoma and undifferentiated carcinoma are excluded.)\n* Inadequate washout period before Cycle 1 Day 1, defined as follows:\n\n  * Major surgery \\\u003C28 days\n  * Radiation therapy \\\u003C28 days (if palliative stereotactic radiation therapy without abdominal radiation, ≤14 days)\n  * Systemic anticancer therapy (including antibody-drug therapy, retinoid therapy, and hormonal therapy) \\\u003C28 days or 5 half-lives, whichever is shorter, before starting study drug\n  * Chloroquine\u002Fhydroxychloroquine \\\u003C14 days\n  * Exposure to another investigational drug within 28 days prior to start of study treatment or current participation in other therapeutic investigational procedures\n* Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. Subjects with untreated and asymptomatic brain metastases or subjects with treated brain metastases who are no longer symptomatic and who require no treatment with steroids may be included in the study if they have recovered from the acute toxic effect of radiotherapy, at the investigator's discretion A minimum of 2 weeks must have elapsed between the end of radiotherapy and randomization and there should be no evidence of progression or need for steroid treatment or anticonvulsants for at least 2 weeks prior to randomization. Note: If there is a history or suspicion of central nervous system. Note: If there is a history or suspicion of central nervous system metastasis, a CT scan of the head or MRI of the brain must be performed at baseline.\n* Any of the following within the past 6 months prior to randomization: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.\n* Uncontrolled or significant cardiovascular disease, including the following:\n\n  * QT interval corrected with Fridericia's formula interval \\>470 ms.\n  * Diagnosed or suspected long QT syndrome.\n  * History of clinically relevant ventricular arrhythmias, such as ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes.\n  * The participant has bradycardia of less than 50 bpm, unless the subject has a pacemaker.\n  * History of second- or third-degree heart block. Candidates with a history of heart block may be eligible if they currently have pacemakers and have no history of fainting or clinically relevant arrhythmia with pacemakers.\n  * Myocardial infarction within 6 months prior to screening.\n  * Uncontrolled angina pectoris within 6 months prior to screening.\n  * New York Heart Association Class 3 or 4 congestive heart failure.\n  * Left ventricular ejection fraction \\\u003C50% or institutional lower limit of normal as measured by echocardiography or multigated acquisition (MUGA) scan.\n  * Coronary\u002Fperipheral artery bypass graft within 6 months prior to screening\n  * Uncontrolled hypertension (HgCTCAE Grade ≥3 hypertension as per NCI-CTCAE version 5.0).\n  * Complete left or right bundle branch block.\n* Has a history of (noninfectious) ILD\u002Fpneumonitis that required corticosteroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n* Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, pleural effusion, etc) and any autoimmune, connective tissue, or inflammatory disorders with potential pulmonary involvement (eg, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc), or prior pneumonectomy.\n* Chronic steroid treatment (\\>10 mg\u002Fday), with the exception of the following:\n\n  * Inhaled steroids for asthma or COPD\n  * Mineralocorticoids (eg, fludrocortisone) for subjects with orthostatic hypotension\n  * Topical steroids for mild skin conditions\n  * Low-dose supplemental corticosteroids for adrenocortical insufficiency\n  * Premedication for treatment groups and\u002For premedication in case of any hypersensitivity\n  * Intra-articular steroid injections\n* History of malignancy other than epithelial OVC, primary peritoneal cancer, or fallopian tube cancer within 3 years prior to enrollment, with the exception of those with a negligible risk of metastasis or death (eg, 5-year OS rate \\>90%) and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, ductal carcinoma in situ, or Stage 1 uterine cancer).\n* Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE Version 5.0, Grade ≤1 or baseline. Note: Subjects may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to Grade \\>2 for 3 months prior to randomization and managed with SOC treatment) that the investigator deems related to previous anticancer therapy, following discussion with the Sponsor, such as the following:\n\n  * Chemotherapy-induced neuropathy\n  * Fatigue\n  * Endocrinopathies, which may include hypothyroidism, hyperthyroidism, Type 1 diabetes, hyperglycemia, and adrenal insufficiency\n  * Skin pigmentation (vitiligo)\n* For Phase 2 (Part A): Prior exposure to other CDH6-targeted agents or an ADC that consists of an exatecan derivative that is a topoisomerase I inhibitor (eg, trastuzumab deruxtecan or datopotamab deruxtecan). For Phase 3 (Part B): Prior exposure to other CDH6-targeted agents or an antibody-drug conjugate containing a topoisomerase I inhibitor.\n* History of hypersensitivity to any excipients in the R-DXd or any known contraindication to treatment with, including hypersensitivity to, the study drug(s).\n* Has an active or uncontrolled human immunodeficiency virus (HIV) infection.\n* Has any evidence of severe or uncontrolled systemic diseases (including active bleeding diatheses or active infection, substance abuse) or other factors that, in the investigator's opinion, makes it undesirable for the subject to participate in the study or which would jeopardize compliance with the protocol. Screening for chronic conditions is not required.\n* Has an active or uncontrolled hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Hepatitis B and Hepatitis C Screening tests are required.\n\nSubjects are eligible if:\n\n1. Hepatitis B virus surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.\n2. History of hepatitis C infection: eligible if the HCV viral load is below the level of detection in the absence of antiviral therapy during the previous 4 weeks.\n3. Have normal transaminase values, or, if liver metastases are present, abnormal transaminases with a result of AST\u002FALT \\\u003C3 × ULN, which are not attributable to HCV infection.\n\n   * Female who is pregnant or breastfeeding or intends to become pregnant during the study.\n   * Psychological, social, familial, or geographical factors that would prevent regular follow-up.\n   * Prior or ongoing clinically relevant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the subject; alter the absorption, distribution, metabolism, or excretion of the study drug; or confound the assessment of study results.\n   * Has a history of receiving live-attenuated vaccine (messenger RNA \\[mRNA\\] and replication-deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first exposure to study intervention.\n   * For Phase 3 (Part B) only: Has clinical symptoms or radiographic evidence of intestinal obstruction.\n   * For Phase 3 (Part B) only: Has ascites or pleural effusions that require repeated drainage (less than 4 weeks between drainages).",{"count":365,"type":21},860,[24,25],"This study will evaluate the safety and efficacy of R-DXd therapy in participants with ovarian, peritoneal, or fallopian tube cancer.",[369],"Solid Cancer",[371,65,372,373,374],"Primary pertioneal cancer","Fallopian tube cancer","Raludotatug Deruxtecan (R-DXd)","Cadherin 6 (CDH6)","2026-05-20",{"date":377,"type":40},"2026-05-22",{"date":379,"type":40},"2024-02-27",{"date":381,"type":21},"2030-04-30",{"name":46,"class":47},146,{"id":385,"slug":386,"hasResults":12,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":391,"targetDuration":4,"studyType":22,"phases":393,"briefSummary":394,"conditions":395,"keywords":398,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":408},"100607503","phase-1-a-study-of-ds9051b-in-participants-with-advanced-or-metastatic-adrenocortical-carcinoma-and-metastatic-castration-resistant-prostate-cancer-100607503","NCT07189403","A Study of DS9051b in Participants With Advanced or Metastatic Adrenocortical Carcinoma and Metastatic Castration-resistant Prostate Cancer","A Phase 1, First-in-human (FIH), Multicenter, Open-label Trial of DS9051b in Participants With Advanced or Metastatic Adrenocortical Carcinoma (ACC) and Metastatic Castration-resistant Prostate Cancer (mCRPC)","General Inclusion Criteria for All Participants\n\n1. Sign and date the main ICF, prior to the start of any trial-specific procedures.\n2. Adults ≥18 years of age at the time the ICF is signed (Follow local regulatory requirements if the legal age of consent for trial participation is \\>18 years old)\n3. Histologically confirmed diagnosis of ACC or adenocarcinoma of the prostate\n4. ECOG PS of 0 or 1 assessed no more than 14 days prior to C1D1. (ECOG PS of 2 due to cancer pain is acceptable)\n5. Has adequate organ and bone marrow function as assessed by local laboratory within 14 days prior to C1D1 as defined below. Organ and bone marrow function criteria must also be met when laboratory tests are repeated within 3 days of initiation of trial intervention as appropriate.\n\n   Additional Inclusion Criteria for Participants with mCRPC\n6. Treatment with at least 1 line (or more) of ARPI therapy for CSPC or in CRPC for a minimum of 12 weeks (eg, abiraterone, enzalutamide, darolutamide, apalutamide).\n7. Treatment with at least 1 line (or more) of chemotherapy, having ineligibility for chemotherapy or refusal of chemotherapy.\n8. Documented disease progression by one or more of the following criteria:\n\n   * PSA progression as defined by PCWG3 criteria.\n   * Soft tissue disease progression as defined by RECIST 1.1 criteria.\n   * Bone disease progression as defined by Prostate Cancer Working Group 3 criteria.\n\nAn individual who meets any of the following criteria will be excluded from participation in this trial:\n\n1. History of pituitary gland dysfunction.\n2. Active or uncontrolled autoimmune disease requiring systemic treatment.\n3. Any medical condition (other than the cancer disease) requiring a dose of concurrent systemic corticosteroid treatment greater than 5 mg of prednisone and\u002For 100 μg of fludrocortisone per day (or equivalent).\n4. Active infection or other medical conditions that would make corticosteroids contraindicated.\n5. Has spinal cord compression or clinically active central nervous system metastases, defined as untreated, clinically progressive, symptomatic, or requiring systemic therapy with corticosteroids or anticonvulsants or local therapy (ie, radiotherapy) to control associated symptoms.\n6. Uncontrolled or significant cardiovascular disease.\n7. History of another primary malignancy (beyond the indication\\[s\\] under study) except for:\n\n   * Malignancy treated with curative intent and with no known active disease ≥3 years before the first dose of trial intervention and of low potential risk for recurrence.\n   * Non-melanoma skin cancer, lentigo maligna, or lentigo maligna melanoma treated with curative intent and without evidence of disease.\n   * Carcinoma in situ treated with curative intent and without evidence of disease.\n   * Participants with a history of prostate cancer (tumor\u002Fnode\u002Fmetastasis stage) of Stage ≤T2cN0M0 without biochemical recurrence or progression and who, in the opinion of the investigator, are not deemed to require active intervention.\n8. Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE version 5.0, Grade ≤1 or baseline.\n9. Participants who cannot swallow whole DS9051b tablets and\u002For follow DS9051b administration schedule at protocol-defined frequency due to some reasons (eg, dysphagia etc).\n10. Known gastrointestinal disease or gastrointestinal procedure that may interfere with absorption of trial intervention including proton pump inhibitors and antacids.",{"count":392,"type":21},40,[139],"This FIH study is designed to assess the safety, tolerability, and preliminary efficacy signals of DS9051b in participants with ACC and mCRPC.",[396,397],"Advanced or Metastatic Adrenocortical Carcinoma","Metastatic Castration-resistant Prostate Cancer",[399,400],"Advanced or metastatic adrenocortical carcinoma","Metastatic castration-resistant prostate cancer","2026-05-19",{"date":377,"type":40},{"date":404,"type":40},"2025-11-04",{"date":406,"type":21},"2028-03-01",{"name":46,"class":47},6,{"id":410,"slug":411,"hasResults":12,"nctId":412,"briefTitle":413,"officialTitle":414,"acronym":4,"eligibilityCriteria":415,"healthyVolunteers":12,"sex":416,"minAge":18,"maxAge":4,"enrollmentInfo":417,"targetDuration":4,"studyType":22,"phases":419,"briefSummary":420,"conditions":421,"keywords":422,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":436},"100611727","phase-1-a-study-of-valemetostat-ds-3201b-in-combination-with-darolutamide-in-metastatic-castration-resistant-prostate-cancer-mcrpc-100611727","NCT07244341","A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)","A Phase 1, Multicenter Trial Evaluating the Safety, Tolerability, and Efficacy of Valemetostat (DS-3201) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)","Key Inclusion Criteria:\n\nThe clinical site will screen for the full inclusion criteria per protocol.\n\n1. Adult males ≥18 years of age at the time the ICF is signed (Please follow local regulatory requirements if the legal age of consent for trial participation is \\>18 years old).\n2. Histologically confirmed adenocarcinoma of the prostate. Cases exhibiting neuroendocrine differentiation are eligible for enrollment, except those with a diagnosis of pure small cell carcinoma, which is excluded.\n3. Evidence of disease progression as per the PCWG3 modified RECIST v1.1 criteria.\n4. Evidence of metastatic disease as confirmed by radiographic imaging (CT, MRI, or bone scan).\n5. Ongoing androgen deprivation at time of enrollment.\n\n   • For participants currently being treated with luteinizing hormone-releasing hormone agonists or antagonists, therapy must have been initiated at least 4 weeks prior to enrollment and treatment must be continued throughout the trial.\n6. Baseline PSA expression level of ≥2 ng\u002FmL, according to a documented testing result.\n7. Prior therapy with an Androgen Receptor Pathway Inhibitors (ARPI).\n8. ECOG PS of 0 or 1 assessed no more than 28 days prior to enrollment.\n9. Is willing and able to provide adequate fresh or archival tumor samples with sufficient quantity and tissue quality. A mandatory newly obtained pretreatment biopsy is required, if not clinically contraindicated and at an acceptable risk as determined by the investigator. If newly obtained tissue samples are not possible to obtain, archival tissue obtained from a lesion not previously irradiated and collected after the most recent prior therapy is acceptable.\n10. A male participant capable of producing sperm is eligible to participate if he agrees to the following during the intervention period and for at least the time needed to eliminate each trial intervention. The length of time required to continue contraception after the last dose for each trial intervention is 3 months.\n\n    * Must not freeze or donate sperm starting at screening and throughout the Treatment Period, and for at least 3 months after the final trial intervention administration.\n\nNote: Preservation of sperm should be considered before enrollment in this trial.\n\n• Adhere to either of the following contraception methods:\n\n* True abstinence from penile-vaginal intercourse, when this is in line with the preferred and usual lifestyle of the participant, OR\n* Uses a penile\u002Fexternal condom when having penile-vaginal intercourse with an NPOCBP, PLUS partner use of an additional contraceptive method, as a condom may break or leak Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical trials. If the contraception requirements in the local label for any trial interventions are more stringent than those above, the local label requirements are to be followed.\n\nKey Exclusion Criteria:\n\nThe clinical site will screen for the full exclusion criteria per protocol.\n\n1. Prior treatment with any epigenetic agents including but not limited to EZH1, EZH2, EZH1\u002F2, or PRC2 inhibitors.\n2. Has a super scan as seen in the baseline bone scan. A super scan is defined as an intense symmetric activity in the bones and diminished renal parenchymal activity on baseline bone scan, such that the presence of additional metastases in the future could not be evaluated.\n3. Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms.\n4. Uncontrolled or significant cardiovascular disease,\n5. Prior malignancy, active within the previous 3 years except for locally curable cancers that have been apparently cured or successfully resected, such as basal or squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the stomach, or carcinoma in situ of the breast.\n6. Has active or uncontrolled HBV infection.\n7. Has active or uncontrolled HCV infection.\n8. Has active or uncontrolled HIV infection.","MALE",{"count":418,"type":21},60,[139],"This study will assess the safety and tolerability of valemetostat in combination with darolutamide in participants with Metastatic Castration Resistant Prostate Cancer (mCRPC).",[397],[423,424,425,426,427],"Metastatic Castration Resistant Prostate Cancer","DS-3201","Valemetostat","Darolutamide","mCRPC","2026-05-12",{"date":430,"type":40},"2026-05-15",{"date":432,"type":40},"2025-12-03",{"date":434,"type":21},"2029-11-30",{"name":46,"class":47},19,{"id":438,"slug":439,"hasResults":12,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":4,"eligibilityCriteria":443,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":444,"targetDuration":4,"studyType":22,"phases":446,"briefSummary":447,"conditions":448,"keywords":449,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":452,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":459},"100606979","phase-1-a-study-of-ds5361b-in-participants-with-advanced-solid-tumors-100606979","NCT07182591","A Study of DS5361b in Participants With Advanced Solid Tumors","A Phase 1, Open-label, Multicenter, First-in-Human Trial of DS5361b in Participants With Advanced Solid Tumors","Key Inclusion Criteria:\n\nThe clinical site will screen for the full inclusion criteria per protocol.\n\n1. Adults ≥18 years of age at the time the ICF is signed (Please follow local regulatory requirements if the legal age of consent for trial participation is \\>18 years old).\n2. Has histologically- or cytologically documented recurrent, metastatic, or unresectable solid tumors that are refractory to or intolerable with standard treatment or for which no standard treatment is available (For Part 1 and Part 2 only).\n3. Participants need to have documented TMB or MSI status using a validated or approved genomic test as per applicable regulations prior to Cycle 1 Day 1. In Part 1 and Part 2, participants need to have documented TMB-H and\u002For MSI-H status. In Part 3, participants need to have documented TMB-H status.\n4. Has measurable disease based on local CT\u002FMRI imaging as assessment by the investigator using RECIST v1.1.\n5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.\n6. Has adequate organ and bone marrow function as assessed by local laboratory within 14 days prior to initiation of trial intervention.\n7. For HNSCC participants only: have documented results from local testing of HPV for oropharyngeal cancer. If HPV status has previously been tested using this procedure, no retesting is required.\n\n   Dose Expansion (Part 3) Only:\n8. Has histologically or cytologically confirmed, Stage IV NSCLC without actionable gene alteration.\n\n   * No prior systemic therapy.\n   * Participants with PD-L1 TPS ≥1%.\n9. Has histologically or cytologically confirmed recurrent or metastatic HNSCC that is considered incurable by local therapies.\n\n   * No prior systemic therapy administered in the recurrent or metastatic setting.\n   * Participants with PD-L1 CPS ≥1.\n\nKey Exclusion Criteria:\n\n1. Has spinal cord compression or clinically active central nervous system metastases.\n2. Has a history of leptomeningeal carcinomatosis.\n3. Uncontrolled or significant cardiovascular disease.\n4. Any of the following within the past 6 months prior to enrollment: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.\n5. Has a history of (noninfectious) interstitial lung disease (ILD)\u002Fpneumonitis that required corticosteroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out.\n6. Clinically severe pulmonary compromise (ie, requiring any supplemental oxygen).\n7. Has any evidence of severe or uncontrolled systemic diseases.\n8. Has active or uncontrolled HBV infection. Hepatitis B SCR testing is required.\n9. Has active or uncontrolled HCV infection. Hepatitis C SCR testing is required.\n10. For the dose escalation phase (Part 1 and Part 2), has HIV infection. For the dose expansion part (Part 3), has active or uncontrolled HIV infection.\n11. Prior organ transplantation, including allogeneic stem cell transplantation.\n12. Has an active, known, or suspected autoimmune disease.\n13. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to the trial intervention.",{"count":445,"type":21},192,[139],"This study aims to assess the safety, tolerability, and preliminary efficacy and to determine the MTD of DS5361b in monotherapy and combination with pembrolizumab in participants with advanced or metastatic solid tumors.",[142],[450,451],"First-in-Human","Advanced Solid Tumors",{"date":453,"type":40},"2026-05-14",{"date":455,"type":40},"2025-10-02",{"date":457,"type":21},"2030-12-03",{"name":46,"class":47},7,{"id":461,"slug":462,"hasResults":12,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":4,"eligibilityCriteria":466,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":467,"targetDuration":4,"studyType":22,"phases":469,"briefSummary":470,"conditions":471,"keywords":481,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":492,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":498},"100529338","phase-2-a-study-of-her3-dxd-in-subjects-with-locally-advanced-or-metastatic-solid-tumors-100529338","NCT06172478","A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors","HERTHENA-PanTumor01 (U31402-277): A Phase 2, Multicenter, Multicohort, Open-Label, Proof of Concept Study of Patritumab Deruxtecan (HER3-DXd; U3-1402) in Subjects With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria\n\nParticipants must meet all of the following criteria to be eligible for enrollment into the study:\n\n1. Sign and date the informed consent form prior to the start of any study-specific qualification procedures. A separate tissue screening consent will be obtained from all subjects to meet the baseline tumor tissue requirement.\n2. Participants aged ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is \\>18 years old).\n3. Has locally advanced unresectable or metastatic disease (not curable by surgery or radiation) as follows:\n\n   Cutaneous (acral and non-acral) melanoma\n   1. Histologically or cytologically confirmed cutaneous (acral or non-acral) melanoma\n   2. Disease progression while on or after having received treatment with ≥1 prior line of anti-programmed cell death protein (PD-1) or anti-programmed death-ligand 1 (PD-L1) based therapy (previous use of other immune checkpoint inhibitors \\[ICIs\\] \\[ie, anti-CTLA4, anti- LAG-3\\] is acceptable). Prior anti-PD-(L)1 therapy in the adjuvant setting is allowed if there is recurrence within 12 weeks of the last dose. If the participant had BRAFm melanoma, they must have had disease progression on BRAF\u002FMEK inhibitor therapy as well.\n\n      Squamous cell carcinomas of the head and neck\n   3. Squamous cell carcinoma of the head and neck (with a primary location of oral cavity,oropharynx, larynx, hypopharynx) that is human papillomavirus (HPV) positive or negative (as determined by local standard). Excludes tumor location in the nasopharynx, nasal cavity, paranasal sinuses, and unknown primary locations.\n   4. Disease progression after having received treatment with ≥1 and \\\u003C3 prior lines of systemic therapy in the unresectable recurrent or metastatic setting.\n\n      Must have had disease progression on anti-PD-(L)1 (either as monotherapy or in combination with chemotherapy or other therapies). Must also have had disease progression on a platinum-based chemotherapy (PBC) regimen either in the recurrent or metastatic setting or in the locally advanced setting with curative intent.\n\n      Gastric or GEJ adenocarcinoma\n   5. Tumor tissue must be confirmed as negative for HER2 expression (immunohistochemistry \\[IHC\\] 0\u002F1+ or IHC 2+\u002Fin situ hybridization negative) as classified by American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO-CAP) guidelines and determined prior to enrollment by assessment in a local laboratory that is Clinical Laboratory Improvement Amendments certified (US sites) or accredited based on specific country regulations.\n   6. Disease progression after having received treatment with ≥2 prior lines of therapy that include PBC with or without anti-PD-1 therapy.\n\n      Ovarian Carcinoma\n   7. Pathologically documented high-grade serous epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.\n   8. Documented disease progression ≥4 weeks after the last dose of PBC and \\\u003C6 months of last dose of PBC in the advanced or metastatic setting. Prior use of folate reductase alpha targeting antibody-drug conjugate (ADC) (ie, mirvetuximab soravtansine) is allowed.\n\n      Cervical Cancer\n   9. Pathologically or cytologically documented recurrent or persistent squamous, adenosquamous, or adenocarcinoma of the uterine cervix.\n   10. Disease progression after having received ≥1 line of systemic therapy in the recurrent or metastatic setting. This may include prior anti-PD-(L)1 treatment and\u002For tissue factor directed ADC (tisotumab vedotin \\[TV\\]) per regional standard of care.\n\n       Endometrial Cancer\n   11. Pathologically or cytologically documented endometrial cancer (carcinoma of any histological sub-type or endometrial carcinosarcoma), irrespective of microsatellite instability (MSI) or mismatch repair (MMR) status.\n   12. Documented disease progression after having received ≥1 prior line of therapy (maximum of 3) PBC containing systemic treatment and an anti-PD(L)-1 therapy-containing regimen (combined or sequential) in the advanced\u002Fmetastatic setting.\n\n       Bladder Cancer\n   13. Pathologically or cytologically documented locally advanced\u002Funresectable or metastatic urothelial carcinoma of the bladder, renal pelvis, ureter, or urethra. Histological variants are allowed if urothelial histology is predominant. Small cell\u002Fneuroendocrine tumors are not allowed even if mixed histology.\n   14. Relapsed or progressed after treatment with ≥1 prior line of therapy (maximum of 3) that contains anti-PD-(L)1 therapy in the perioperative or metastatic setting. At least 1 line of therapy must also contain one of the following treatment modalities: chemotherapy or enfortumab vedotin. Prior fibroblast growth factor receptor (FGFR)-inhibitor treatment for those who are eligible are allowed.\n\n       * Required treatments can be given in combination or sequentially\n       * Prior cisplatin-based therapy or PD-(L)1 inhibitor therapy given for the treatment of muscle invasive urothelial carcinoma is counted as 1 line of therapy\n       * The same regimen administered twice in different disease settings will be counted as 1 line of prior therapy\n       * Participants in the second-line setting who have previously received enfortumab vedotin and pembrolizumab in combination can be enrolled.\n\n       Esophageal Carcinoma\n   15. Pathologically or cytologically documented esophageal squamous cell carcinoma.\n   16. Must have documented disease progression after having received 2 prior lines of therapy including previous PBC with or without an anti-PD-1 therapy-containing regimen (combined or sequential) in the advanced\u002Fmetastatic setting.\n\n       Pancreatic Carcinoma\n   17. Pathologically or cytologically documented unresectable or metastatic pancreatic adenocarcinoma.\n   18. Relapsed or disease progression after having received 1 prior line of systemic therapy in the locally advanced\u002Fmetastatic setting.\n\n       Prostate Cancer\n   19. Pathologically or cytologically documented unresectable locally advanced or metastatic castration-resistant prostate cancer (CRPC).\n   20. Adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology.\n   21. Surgically or medically castrated, with testosterone levels of \\\u003C50 ng\u002FdL.\n   22. Documented objective progression as determined by radiographic progression for subjects with measurable disease after androgen deprivation.\n   23. Relapsed or disease progression after having received treatment with ≥1 of the following novel hormonal agents: abiraterone, enzalutamide, apalutamide, or darolutamide.\n   24. Relapsed or disease progression after having received ≥1 cytotoxic chemotherapy regimen that included a taxane.\n\n       Gastric Cancer 2L\n   25. Must have had gastric or GEJ adenocarcinoma confirmed as negative for HER2 expression (IHC 0\u002F1+ or IHC 2+\u002Fin situ hybridization negative) as classified by American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO-CAP) guidelines and determined prior to enrollment by assessment in a local laboratory that is Clinical Laboratory Improvement Amendments certified (US sites) or accredited based on specific country regulations.\n   26. Disease progression after having received treatment with only 1 prior line of systemic anti-cancer therapy that includes 5-FU-based chemotherapy with or without an anti-PD-1 therapy. For subjects whose tumors are claudin (CLDN) 18.2 positive, treatment with 5-FU based chemotherapy with CLDN18.2 directed therapy in the first-line setting is allowed.\n\n   Non-small Cell Lung Cancer aa. Histologically or cytologically documented metastatic or locally advanced nonsquamous NSCLC not amenable to curative surgery or radiation bb. Documentation of absence of actionable driver mutation (ie, ALK rearrangement, BRAF V600E mutation, EGFR-activating mutations \\[exon 19 deletion or L858R mutation\\], EGFR exon 20 insertion mutation, HER2 mutation, KRAS G12C mutation, MET exon 14 skipping mutation, NTRK 1\u002F2\u002F3 gene fusion, RET rearrangement, or ROS1 rearrangement). New testing for these genomic alterations is not required for Screening.\n\n   cc. Relapsed or disease progression after receiving only anti-PD-(L)1 and PBC (ie, platinum doublet) administered in combination or sequentially for metastatic disease.\n\n   Breast Cancer dd. Pathologically documented breast cancer that is assessed as HER2 negative (IHC2+\u002FISH-, IHC1+, or IHC0 per ASCO\u002FCAP guidelines), and HR positive (either ER and\u002For PgR positive \\[ER or PgR ≥1%\\] per ASCO\u002FCAP guidelines). The HER2 and HR results must be from a tumor sample obtained in the metastatic setting.\n\n   ee. Participant must have received one line of chemotherapy for mBC, but not more than one line and must have a clinically or radiologically documented evidence of tumor progression on or after CDK 4\u002F6 inhibitor combined with endocrine therapy; previous treatments with phosphoinositide 3-kinase (PI3K) inhibitors, mammalian target of rapamycin (mTOR) inhibitors, protein kinase B (PKB) inhibitors also known as AKT-inhibitors and poly ADP ribose polymerase (PARP)-inhibitors are allowed.\n4. Has ≥1 measurable lesion on CT or MRI as per RECIST v1.1 by investigator assessment. Prostate cancer participants with bone only disease may be eligible.\n5. Provides a pretreatment tumor tissue sample that meets 1 of the following collection requirements:\n\n   1. Tumor biopsy from ≥1 lesion not previously irradiated and performed since progression with the most recent systemic cancer therapy regimen and prior to signature of the tissue ICF (ARCHIVAL PRETREATMENT sample).\n\n      OR\n   2. Newly obtained pretreatment tumor biopsy from ≥1 lesion not previously irradiated and amenable to sampling, after signature of tissue ICF (FRESH PRETREATMENT sample)\n6. Has Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at screening.\n\nExclusion Criteria\n\nParticipants who meet any of the following criteria will be disqualified from entering the study:\n\n1. Has HER2-positive gastric cancer as classified by ASCO-CAP guidelines and determined prior to enrollment by assessment in a local laboratory that is Clinical Laboratory Improvement Amendments certified (US sites) or accredited based on specific country regulations.\n2. Has nasopharyngeal cancer.\n3. Has mucosal or uveal melanoma.\n4. Has a history of (non-infectious) interstitial lung disease (ILD), that required corticosteroids, has current ILD\u002Fpneumonitis, or suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n5. Has clinically severe respiratory compromise (based on the investigator's assessment) resulting from intercurrent pulmonary illnesses\n6. Is receiving chronic systemic corticosteroids dosed at \\>10 mg prednisone daily or equivalent anti-inflammatory activity or any form of immunosuppressive therapy prior to Cycle 1 Day 1.\n\n   Participants who require use of bronchodilators, inhaled or topical steroids, or local steroid injections may be included in the study.\n7. Had prior treatment with an anti-HER3 antibody and\u002For antibody-drug conjugate (ADC) that consists of an exatecan derivative that is a topoisomerase I inhibitor (eg, trastuzumab deruxtecan).\n8. Has history of other active malignancy within 3 years prior to Cycle 1 Day 1, except the following:\n\n   1. Adequately treated nonmelanoma skin cancer\n   2. Adequately treated intraepithelial carcinoma of the cervix\n   3. Any other curatively treated in situ disease\n9. Has any evidence of severe or uncontrolled diseases (eg, active bleeding diatheses, active serious infection) psychiatric illness\u002Fsocial situations, geographical factors, substance abuse, or other factors that, in the investigator's opinion, make it high risk for the subject to participate in the study or that would jeopardize compliance with the protocol\n10. Has previously received topoisomerase-1 inhibitors (e.g., irinotecan) treatment in the advanced or metastatic disease setting.",{"count":468,"type":21},740,[24],"This is a proof-of-concept study designed to investigate HER3-DXd monotherapy in locally advanced unresectable or metastatic solid tumors. The study is enrolling cohorts of participants with melanoma \\[cutaneous\u002Facral\\], squamous cell carcinomas of the head and neck (SCCHN), HER2-negative gastric cancer ovarian carcinoma, cervical cancer, endometrial cancer, bladder cancer, esophageal carcinoma, pancreatic carcinoma, prostate cancer, second-line gastric cancer, lung cancer, and breast cancer.",[142,472,473,114,474,475,321,29,476,477,478,479,480,244],"Melanoma","Head and Neck Cancer","Ovarian Carcinoma","Cervical Cancer","Esophageal Cancer","Pancreatic Carcinoma","Prostate Cancer","Non-small Cell Lung Cancer (NSCLC)","Lung Cancer",[142,472,473,114,482,483,484,485,486,487,488,489,490,491,480,244],"Ovarian carcinoma","Cervical cancer","Endometrial cancer","Bladder cancer","Esophageal carcinoma","Pancreatic carcinoma","Prostate cancer","Patritumab Deruxtecan","HER3-DXd","U3-1402",{"date":430,"type":40},{"date":494,"type":40},"2024-02-26",{"date":496,"type":21},"2028-10-10",{"name":46,"class":47},85,{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":4,"eligibilityCriteria":505,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":506,"targetDuration":4,"studyType":22,"phases":507,"briefSummary":508,"conditions":509,"keywords":510,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":515,"startDateStruct":517,"completionDateStruct":519,"leadSponsor":521,"locationsCount":522},"100506498","phase-1-first-in-human-study-of-ds-3939a-in-participants-with-advanced-solid-tumors-100506498","NCT05875168","First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors","Phase 1\u002F2, Open-label, Multicenter, First-in-Human Study of DS-3939a in Subjects With Advanced Solid Tumors","Inclusion Criteria:\n\n* Sign and date the main Informed Consent Form (ICF).\n* Has a left ventricular ejection fraction ≥50% by either an echocardiogram or multigated acquisition within 28 days of enrollment.\n* Has adequate organ function.\n* Measurable disease based on RECIST V1.1.\n* Eastern Cooperative Oncology Group performance status score of 0 or 1.\n\nAdditional inclusion criteria for Part 1\n\n* Has a histologically or cytologically documented locally advanced, metastatic, or unresectable solid malignant tumors.\n\nAdditional inclusion criteria for Part 2\n\n* Has a histologically or cytologically documented locally advanced, metastatic, or unresectable cancer meeting the protocol criteria and documented radiographic disease progression during or after the most recent anticancer therapy.\n* Is able to provide either of the following baseline tumor samples:\n\n  * Fresh tumor biopsy samples meeting either of the following requirements that were obtained during the Main Screening or Tissue Screening Period, or\n  * Fresh core needle biopsy sample\n  * Biopsy samples obtained with forceps or cryobiopsy, such as bronchoscopic or transbronchial lung biopsy (if the sample amount is equivalent to core needle biopsy and processing after sample collection follows the procedure described in the Study Laboratory Manual)\n  * FFPE tumor tissue samples obtained by biopsy or surgery performed within 6 months before signing the main ICF. If samples were obtained prior to the start of the most recent anticancer therapy, the Sponsor Medical Monitor should be consulted regarding the adequacy of the sample.\n\nExclusion Criteria:\n\n* Has had prior treatment targeting mucin 1 (MUC1) or TA-MUC1.\n* Has spinal cord compression or clinically active central nervous system metastases.\n* Has multiple primary malignancies, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated, with no evidence of disease for ≥3 years.\n* Has a history of noninfectious interstitial lung disease (ILD)\u002Fpneumonitis (including suspected one), has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at Screening.\n* Has active or uncontrolled human immunodeficiency virus (HIV) infection.\n* Has evidence of active or uncontrolled hepatitis B virus or hepatitis C virus infection.\n* Any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.\n* Has an active, known, or suspected autoimmune disease.\n* Current participation in other therapeutic investigational procedures, except for participation in Long Term Follow-Up without any investigational treatment.",{"count":292,"type":21},[139,24],"This study will evaluate the safety, tolerability, and efficacy of DS-3939a in participants with advanced solid tumors.",[142,166],[511,512,513],"DS-3939a","anti-body drug conjugate","advanced\u002Fmetastatic solid tumors","2026-04-16",{"date":516,"type":40},"2026-04-20",{"date":518,"type":40},"2023-08-18",{"date":520,"type":21},"2027-02-15",{"name":46,"class":47},33,{"id":524,"slug":525,"hasResults":12,"nctId":526,"briefTitle":527,"officialTitle":528,"acronym":4,"eligibilityCriteria":529,"healthyVolunteers":530,"sex":17,"minAge":18,"maxAge":531,"enrollmentInfo":532,"targetDuration":4,"studyType":22,"phases":534,"briefSummary":535,"conditions":536,"keywords":538,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":539,"lastUpdatePostDateStruct":540,"startDateStruct":542,"completionDateStruct":544,"leadSponsor":546,"locationsCount":178},"100573017","phase-1-assessment-of-quizartinib-pharmacokinetic-in-subjects-with-severe-hepatic-impairment-100573017","NCT06740799","Assessment of Quizartinib Pharmacokinetic in Subjects With Severe Hepatic Impairment","A Phase 1, Multicenter, Open-Label, Single-Dose Study to Assess the Pharmacokinetics, Safety and Tolerability of Quizartinib in Subjects With Severe Impaired Hepatic Function","Key Inclusion Criteria:\n\n1. Voluntarily consents to participate in this study and provides written informed consent before the start of any study-specific procedures.\n2. Male and female subjects 18 to 75 years of age (inclusive), with a body mass index (BMI) of 18 kg\u002Fm2 to 37 kg\u002Fm2 (inclusive) with a minimum body weight of 40 kg at Screening.\n3. In females, documented surgical sterilization (ie, documented hysterectomy, bilateral tubal ligation, or bilateral salpingo-oophorectomy, Essure® with hysterosalpingogram \\[documentation to confirm tubal occlusion 12 weeks after procedure\\]), postmenopausal status for at least 1 year (follicle stimulating hormone \\[FSH\\] \\> 40 mIU\u002FmL serum and estradiol \\\u003C40 pg\u002FmL \\[\\\u003C147 pmol\u002FL\\] at Screening), or agreement to have a sterile male partner, or agreement to use 1 of the means of contraception from Screening until 7 months after the dose of quizartinib 4. In females, agreement to not retrieve eggs\u002Fova via assisted reproductive technology (ART) either for their own use or donation while on the study or for 7 months after the last dose of study drug, whichever is later.\n\n5\\. In males, documented surgical sterilization, sexual abstinence, or agreement to use 1 of the means of contraception from Screening until 4 months after the dose of quizartinib 6. In males, agreement to avoid sperm donation for 4 months after the dose of quizartinib\n\nKey Exclusion:\n\n1. Any serious and\u002For unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormality except hepatic impairment) that could interfere with safety, obtaining informed consent, compliance to the study procedures, or the validity of the study results.\n2. In the opinion of the investigator, history of a clinically significant illness within 4 weeks prior to administration of quizartinib.\n3. Subjects with primary biliary cirrhosis or primary sclerosing cholangitis.\n4. Subjects with history of Gilbert's syndrome.\n5. Presence or history of clinically severe adverse reaction to any drug or known hypersensitivity to any of the ingredients (including inactive ingredients) of quizartinib.\n6. History of stomach or intestinal surgery or resection that would potentially alter absorption and\u002For excretion of orally administered drugs (with the exception of appendectomy, hernia repair, and\u002For cholecystectomy).",true,"75 Years",{"count":533,"type":21},12,[139],"This study will evaluate and compare the PK in subjects with severe HI to that of matched healthy control subjects with normal hepatic function.",[537],"Hepatic Impairment",[220],"2026-03-26",{"date":541,"type":40},"2026-04-01",{"date":543,"type":40},"2024-09-30",{"date":545,"type":21},"2026-10-31",{"name":46,"class":47},{"id":548,"slug":549,"hasResults":12,"nctId":550,"briefTitle":551,"officialTitle":552,"acronym":4,"eligibilityCriteria":553,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":554,"targetDuration":4,"studyType":22,"phases":556,"briefSummary":557,"conditions":558,"keywords":560,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":564,"startDateStruct":566,"completionDateStruct":568,"leadSponsor":570,"locationsCount":571},"100594150","phase-1-a-study-of-subcutaneous-trastuzumab-deruxtecan-in-participants-with-metastatic-solid-tumors-100594150","NCT07015697","A Study of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors","A Phase 1, Multicenter Trial of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors","Key Inclusion Criteria:\n\n1. Sign and date the ICF, prior to the start of any trial- specific qualification procedures.\n2. Adults ≥18 years or the minimum legal adult age (whichever is greater).\n3. a) Disease State: If HER2 status is required for eligibility (for all populations, except \"Pan-tumor, heavily pretreated, with no SoC\"), a documented HER2 test result must be available. A participant population would only be considered in regions where T-DXd is approved for that indication and an approved or validated test is available, if required per country regulations. Note: for all indications, all local HR testing and HER2 testing shall be per ASCO\u002FCAP guidelines, as applicable, in the advanced setting, using a validated or approved test as required per local regulations. The most recent available samples should be used to confirm eligibility, if applicable. For full description of each population, see below. Breast Cancer: adults with pathologically documented unresectable or metastatic breast cancer HER2-positive BC: have received a prior anti-HER2-based regimen. For HER2-positive BC participants in Part 2 only, prior anti-HER2 based therapy should have been received in either:\n\n   * the metastatic setting, or\n   * the neoadjuvant or adjuvant setting and have developed disease recurrence during or within 6 months of completing therapy. HR-, HER2-low BC: have received a prior systemic cytotoxic therapy in the metastatic setting; or developed disease recurrence during or within 6 months of completing (neo)adjuvant chemotherapy. HR+, HER2-low\u002Fultralow BC: have received previous ET AND an additional line of ET must not be the next line of treatment considered in the participant's best interest.\n   * For participants in Part 2 with HR+ HER-2low\u002Fultralow BC, the following criteria also apply:\n   * had disease progression while receiving 1 previous line of ET with a CDK4\u002F6i and is not expected to benefit from immediate use of a second line of ET, OR\n   * had disease progression on at least 2 previous lines of ET with or without a target therapy such as CDK4\u002F6, mTOR or PI3-K inhibitors) administered for the treatment of metastatic disease\n   * of note:\n   * If the 1 line was given while in the adjuvant setting, if disease recurrence occurred while on the first 24 months of adjuvant ET, that will be considered a line of therapy and only 1 additional line of ET will be required in the metastatic setting, with or without targeted therapy (such as CDK4\u002F6, mTOR or PI3-K inhibitors)\n   * Any progression after discontinuing or completing a course of adjuvant ET will not be considered a line of therapy\n   * Single agent PARP inhibitor therapy does not count as ET or as cytotoxic is not considered a line of ET\n   * Changes in dosing schedules, or discontinuations\u002Frestarting of the same drugs or the addition of a targeted therapy to an ET without progression (eg, adding a CDK4\u002F6 inhibitor to a current aromatase inhibitor regimen) will not be considered separate lines of therapy.\n   * participants may not have received more than 2 prior lines of cytotoxic therapy in the recurrent or metastatic setting. NSCLC, HER2 mut: adults with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, and who have received a prior systemic therapy.\n\n   Gastric Cancer, HER2-positive: adults with locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+\u002FISH+) gastric or gastroesophageal junction adenocarcinoma who have received a prior anti-HER2-based regimen Pan-tumor, HER2-positive: adults with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior treatment or have no satisfactory alternative treatment options Heavily pretreated tumors: adults with unresectable or metastatic solid tumors (other than described above), who have received prior systemic treatment and have no satisfactory treatment alternative b) Part 2 only: At least 1 RECIST 1.1 measurable lesion on CT or MRI.\n4. Radiologic or objective evidence of disease progression on or after the last systemic therapy prior to starting trial intervention.\n5. Part 2 only: confirmation of availability of the most recent available adequate FFPE archival tumor tissue sample obtained in the advanced setting, or provision of newly obtained tumor tissue if clinically feasible and at an acceptable risk as determined by the Investigator.\n6. ECOG PS of 0 to 1.\n\nKey Exclusion Criteria:\n\n1. Prior treatment with ADC that consists of an exatecan derivative that is a topoisomerase I inhibitor; NOTE exception for SDC 1 and 2, where prior exposure to such agents is permitted provided the following are met:\n\n   1. At least 1 year has elapsed since last dose of exatecan derivative ADC.\n   2. The participant did not discontinue nor reduce the dose due to toxicity.\n   3. The participant did not experience any drug-related Grade 3\u002F4 toxicity.\n   4. The participant did not experience ILD of any grade while on or after the exatecan derivative ADC treatment.\n2. Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug products.\n3. Has a history of severe hypersensitivity reactions to other monoclonal antibodies.\n4. Medical history of MI within 6 months before enrollment or symptomatic CHF (New York Heart Association class II to IV). Participants with troponin levels above ULN at screening (as defined by the manufacturer), and without any MI-related symptoms should have a cardiologic consultation during the Screening Period to rule out MI.\n5. Has a corrected QT interval (QTcF) prolongation to \\> 480 ms (regardless of participant's sex) based on average of the screening triplicate 12-lead ECG.\n6. Has a history of (non-infectious) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.",{"count":555,"type":21},76,[139],"This is a dose escalation, and dose expansion study of T-DXd plus hyaluronidase administered subcutaneously, to assess the safety, tolerability, PK and efficacy of SC T-DXd plus hyaluronidase in participants with metastatic solid tumors.",[559],"Recurrent or Metastatic Solid Tumors",[325,561,562],"solid tumor","subcutaneous","2026-03-18",{"date":565,"type":40},"2026-03-20",{"date":567,"type":40},"2025-07-17",{"date":569,"type":21},"2028-12-31",{"name":46,"class":47},26,{"id":573,"slug":574,"hasResults":12,"nctId":575,"briefTitle":576,"officialTitle":577,"acronym":4,"eligibilityCriteria":578,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":579,"targetDuration":4,"studyType":22,"phases":581,"briefSummary":582,"conditions":583,"keywords":587,"overallStatus":170,"whyStopped":4,"lastUpdateSubmitDate":595,"lastUpdatePostDateStruct":596,"startDateStruct":598,"completionDateStruct":600,"leadSponsor":602,"locationsCount":4},"100629436","phase-3-a-study-of-bempedoic-acidezetimibehigh-intensity-statin-in-patients-without-cardiovascular-events-100629436","NCT07474649","A Study of Bempedoic Acid\u002FEzetimibe\u002FHigh-intensity Statin in Patients Without Cardiovascular Events","Effects of Bempedoic Acid\u002FEzetimibe\u002FHigh-intensity Statin on Plaque Regression and Stabilisation of Coronary Atherosclerosis Among Patients Without Cardiovascular Events","Inclusion Criteria:\n\nIn order to be eligible to participate in this trial, a potential participant must meet all of the following criteria:\n\n1. Age ≥18 years\n2. Having provided informed consent for participation in this trial\n3. Lipid-lowering treatment-naïve\n4. Presence of extensive coronary atherosclerosis meeting all of the criteria below:\n\n   * Unequivocal atherosclerosis in ≥5 American Heart Association (AHA) coronary segments (corresponding to a risk equivalent of obstructive coronary artery disease) and coronary artery disease - reporting and data system (CAD-RADS) category 1, 2, or 3\n   * Not expected to be a candidate for revascularisation during the duration of the trial\n   * Untreated LDL-C ≥2.6 mmol\u002FL and ≤4.5 mmol\u002FL (where a diet without pharmacological treatment is considered 'untreated')\n5. Able to provide informed consent\n\nExclusion Criteria:\n\nA potential participant who meets any of the following criteria will be excluded from participation in this trial:\n\n1. Known or suspected heterozygous or homozygous familial hypercholesterolaemia or familial combined hyperlipidaemia\n2. Known contraindication for BA, EZE, atorvastatin, and\u002For rosuvastatin. A participant with a contraindication for atorvastatin, can be assigned to triple therapy with rosuvastatin, and vice versa.\n3. Not expected to remain on a stable dose of high intensity triple therapy for the duration of the trial.\n4. History of myocardial infarction, stroke, or peripheral artery disease (PAD), and\u002For coronary revascularisation (percutaneous coronary intervention \\[PCI\\] or coronary artery bypass grafting \\[CABG\\])\n5. Significant stenosis in the left main artery (≥50%) or proximal LAD artery (≥70%), or 3-vessel coronary artery disease (≥70% stenosis in major branches), clinically indicated for revascularisation\n6. Known significant liver disease (e.g., positive hepatitis B or hepatitis C serology) or significant hepatic dysfunction (aspartate aminotransferase \\[AST\\] or alanine aminotransferase \\[ALT\\] \\>3 x upper limit of normal \\[ULN\\])\n7. Known history of gout and\u002For uric acid levels at Screening ≥6.8 mg\u002FdL\n8. Known estimated glomerular filtration rate (eGFR) \\\u003C40 mL\u002Fmin\u002F1.73m² and\u002For receiving dialysis\n9. Active malignancy (not including non-melanoma skin cancer)\n10. Pregnant or breastfeeding\n11. Body mass index (BMI) \\>35 kg\u002Fm²\n12. Anticipated life expectancy \\\u003C52 weeks at the discretion of the local investigator\n13. Requiring emergent procedures or having any evidence of ongoing or active clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure with systolic blood pressure \\\u003C90 mmHg, severe congestive heart failure (New York Heart Association \\[NYHA\\] III or IV), or acute pulmonary oedema\n14. Suspicion of acute coronary syndrome (where acute myocardial infarction and unstable angina have not been ruled out)\n15. Complex congenital heart disease\n16. Known or suspected severe valvular heart disease or valvular heart disease anticipated to require intervention within 52 weeks at the discretion of the local investigator\n17. Cardiac arrythmia or tachycardia with significant likelihood of resulting in poor PCD-CTA image quality (especially atrial fibrillation or frequent premature beats)\n18. Intracoronary stents\n19. Prior pacemaker, internal defibrillator, or abandoned lead implantation\n20. Prosthetic heart valves\n21. Contraindications to contrast media or other medications needed for proper imaging (e.g., beta blockers and nitroglycerin)\n22. Use of any experimental or investigational drug within 40 days or 5 half-lives prior to Screening (whichever is longer), or parallel participation in another interventional study",{"count":580,"type":21},103,[25],"The overall objective of the trial is to evaluate the effect of the triple therapy consisting of bempedoic acid (BA), ezetimibe (EZE), and high-intensity atorvastatin or rosuvastatin on changes in coronary plaque burden and plaque morphology in patients with coronary atherosclerosis without significant obstructive coronary artery disease and without prior history of an ischemic vascular event.",[584,585,586],"Coronary Atherosclerosis","Mixed Dyslipidemia","Hypercholesterolemia",[588,589,590,591,592,593,594],"Coronary atherosclerosis","Primary non-familial hypercholesterolaemia","Mixed dyslipidaemia","Bempedoic acid","Ezetimibe","Atorvastatin","Rosuvastatin","2026-03-16",{"date":597,"type":40},"2026-03-19",{"date":599,"type":21},"2026-06-01",{"date":601,"type":21},"2028-10-02",{"name":46,"class":47},{"id":604,"slug":605,"hasResults":12,"nctId":606,"briefTitle":607,"officialTitle":608,"acronym":4,"eligibilityCriteria":609,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":610,"targetDuration":4,"studyType":22,"phases":612,"briefSummary":613,"conditions":614,"keywords":615,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":628,"lastUpdatePostDateStruct":629,"startDateStruct":631,"completionDateStruct":633,"leadSponsor":635,"locationsCount":636},"100541453","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-ifinatamab-deruxtecan-i-dxd-in-subjects-with-recurrent-or-metastatic-solid-tumors-ideate-pantumor02-100541453","NCT06330064","A Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02)","A Phase 1B\u002F2 Pan-Tumor, Open-Label Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02)","Participants must meet all of the following criteria to be included in the study:\n\nCommon Inclusion Criteria for All Participants\n\n1. Participant must have at least 1 lesion, not previously irradiated, amenable to core biopsy and must consent to provide a pretreatment biopsy tissue sample. An archival tumor tissue sample obtained within 6 months of consent and after progression during\u002Fafter treatment with the participant's most recent cancer therapy regimen is also acceptable.\n2. Participants ages ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is \\>18 years).\n3. At least 1 measurable lesion on computed tomography (CT) or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), as assessed by the investigator.\n4. Documentation of radiological disease progression on or after the previous standard-of-care regimen in the advanced\u002Fmetastatic setting.\n5. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n\nAdditional Inclusion Criteria for EC Participants\n\n1. Pathologically or cytologically documented EC of any histological carcinoma subtype or endometrial carcinosarcoma, irrespective of microsatellite instability or mismatch repair status.\n2. Relapse or progression after a platinum-containing systemic treatment and an immune checkpoint inhibitor (ICI)-containing regimen (combined or sequential). Subjects with actionable target tumor mutation should have been previously treated with targeted therapy, with a maximum of 3 prior lines of therapy for endometrial carcinoma or carcinosarcoma. Neoadjuvant\u002Fadjuvant therapy may count as 1 line of therapy if the subject progressed within 6 months after completion of therapy.\n\nAdditional Inclusion Criteria for HNSCC Participants\n\n1. Pathologically or cytologically documented unresectable or metastatic squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx, excluding nasopharynx, nasal cavity and paranasal sinuses, and unknown primary.\n2. Has disease progression after platinum-based and ICI treatment, whether administered in combination or separately. Subjects with actionable target tumor mutation should have been previously treated with targeted therapy, with a maximum of 2 prior therapy lines for unresectable or metastatic HNSCC.\n3. Participants without radiographic evidence of major blood vessel invasion\u002Finfiltration or tumor demonstrating a \\>90-degree abutment or encasement of a major blood vessel.\n4. Participants with no prior history of Grade ≥3 bleeding as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 within 28 days prior to the start of study drug related to the current head and neck cancer may be included in the study.\n5. Documented p16 status for oropharyngeal cancer (historical results are acceptable if available).\n\nAdditional Inclusion Criterion for PDAC Participants\n\n1\\. Pathologically or cytologically documented unresectable or metastatic pancreatic adenocarcinoma that has relapsed or progressed after 1 prior line of gemcitabine-based systemic therapy in the locally advanced\u002Fmetastatic setting or after 2 lines of therapy if the subject has actionable target tumor mutation and has been previously treated with targeted therapy. No prior treatment with topoisomerase I inhibitors, such as irinotecan or topotecan.\n\nAdditional Inclusion Criteria for CRC Participants\n\n1. Pathologically or cytologically documented unresectable or metastatic CRC with microsatellite stable status.\n2. Relapse or progression after 1 prior line of systemic therapy including a fluoropyrimidine plus oxaliplatin with or without anti-vascular endothelial growth factor (VEGF) monoclonal antibody (mAb) or anti-epidermal growth factor receptor mAb therapy, as clinically indicated, or relapse or progression after 2 lines of therapy if the subject has received targeted therapy.\n\n   Note: Prior adjuvant\u002Fneoadjuvant systemic cytotoxic chemotherapy will count as 1 line of prior systemic therapy if there is documented disease progression during therapy or within 6 months of chemotherapy completion.\n3. No prior treatment with topoisomerase I inhibitors, such as irinotecan or topotecan.\n\nAdditional Inclusion Criteria for HCC Participants\n\n1. Pathologically or cytologically documented unresectable or metastatic HCC (fibrolamellar and mixed hepatocellular\u002Fcholangiocarcinoma subtypes are not eligible) or noninvasive diagnosis of HCC as per the American Association for the Study of Liver Diseases (AASLD) criteria in subjects with a confirmed diagnosis of cirrhosis.\n2. Relapse or progression after 1 prior line of an ICI-containing regimen (combination or monotherapy) in the locally advanced\u002Fmetastatic setting, with a maximum of 2 prior lines. Subjects with actionable target tumor mutation should have been previously treated with targeted therapy.\n3. Barcelona Clinic Liver Cancer (BCLC) Stage B or C.\n4. Liver function status should be Child-Pugh (CP) Class A.\n5. Albumin-Bilirubin (ALBI) Grade 1 within 7 days prior to the first dose of study drug.\n6. Participants with large esophageal varices at risk of bleeding must be treated with conventional medical intervention: beta blockers or endoscopic treatment.\n\nAdditional Inclusion Criteria for Ad-eso\u002FGEJ\u002FGastric Participants\n\n1. Pathologically or cytologically documented unresectable or metastatic Ad-eso\u002FGEJ\u002FGastric that has relapsed or progressed after 1 prior line of systemic therapy in the locally advanced\u002Fmetastatic setting. Subjects with PD-(L)1+ or MSI-H\u002FdMMR should receive ICI treatment if ICIs are standard of care in the country, unless the subject is ineligible for ICI treatment.\n2. If the participant has known history of HER2 positivity (defined by IHC 3+ or IHC 2+ and in situ hybridization \\[ISH\\] positive, as classified by American Society of Clinical Oncology - College of American Pathologists \\[ASCO CAP\\]) or actionable target, the subject must have been previously treated with a targeted therapy.\n\nAdditional Inclusion Criteria for UC Participants\n\n1. Pathologically or cytologically documented unresectable or metastatic UC of the bladder, renal pelvis, ureter, or urethra. Participants with histological variants are allowed if urothelial histology is predominant. Small cell\u002Fneuroendocrine tumors are not allowed even if mixed histology.\n2. Relapse or progression after at least 1 prior line of ICI-containing systemic therapy, and 1 prior line of systemic chemotherapy, given in combination with other anticancer therapy or separately, with a maximum of 3 prior therapy lines.\n\n   1. At least 1 line of therapy should include enfortumab vedotin in countries where enfortumab vedotin is approved and available.\n   2. Perioperative systemic therapies will be counted as 1 line of therapy.\n   3. To meet inclusion criteria requirement of prior ICI-containing therapy, use in the perioperative or metastatic setting will suffice.\n   4. Subjects with actionable target tumor mutation should have been previously treated with targeted therapy.\n   5. The same regimen administered twice in different disease settings will be counted as 1 line of prior therapy.\n\nAdditional Inclusion Criteria for CC Participants\n\n1. Histologically confirmed unresectable or metastatic CC that was previously treated with ≥1 prior line of systemic therapy in the locally advanced or metastatic setting. Subjects with actionable target tumor mutation should have been previously treated with targeted therapy.\n2. Participants should receive prior anti-programmed death 1\u002Fprogrammed death-ligand 1 treatment and\u002For tisotumab vedotin if those are standard of care in the country, unless the subject is ineligible for these treatments.\n\nAdditional Inclusion Criteria for OVC Participants\n\n1. Histologically confirmed high-grade serous OVC, high-grade endometrioid OVC, primary peritoneal cancer, or fallopian tube cancer that was previously treated with at least 1 line of platinum-based therapy and bevacizumab unless the subject is ineligible for treatment with bevacizumab.\n2. Participant is no longer considered eligible for platinum-based therapy per the investigator's opinion or has progressed less than 180 days after the last dose of platinum therapy.\n3. Participant is not considered primary platinum refractory and has not progressed during platinum treatment or within 4 weeks after the completion of platinum treatment.\n4. Subjects with actionable target tumor mutation should have been previously treated with targeted therapy.\n\nAdditional Inclusion Criteria for BTC Participants\n\n1. Pathologically or cytologically documented unresectable or metastatic BTC (intra- or extrahepatic cholangiocarcinoma or gallbladder carcinoma).\n2. Relapse or progression after at least 1 prior line of systemic therapy, or 2 prior lines of systemic therapy if the participant has an actionable target and has received targeted therapy.\n3. Histological subtypes other than ampullary cancer, small cell cancer, lymphoma, sarcoma, neuroendocrine tumors, mixed tumor histology, and\u002For mucinous cystic neoplasms (Please note that the histological subtypes listed here are not allowed.)\n\nAdditional Inclusion Criteria for HER2-Low BC Participants\n\n1. Pathologically or cytologically documented unresectable or metastatic BC.\n2. Low HER2 expression, defined as IHC 2+\u002FISH- or IHC 1+ (ISH- or untested), according to ASCO-CAP 2018 HER2 testing guidelines, based on most recent testing, regardless of hormonal status.\n3. Progression on or after treatment with trastuzumab deruxtecan (T-DXd).\n4. Relapse or progression after at least 2 and a maximum of 3 prior lines of systemic therapy. Subjects with metastatic hormone receptor (HR)+ BC who have received endocrine-based therapy and have received at least 2 and a maximum of 3 prior lines of additional systemic therapy in the metastatic setting. Subjects with actionable target tumor mutation should have been previously treated with targeted therapy.\n\nAdditional Inclusion Criteria for HER2 IHC 0 BC Participants\n\n1. Pathologically or cytologically documented unresectable or metastatic BC.\n2. Negative for HER2 expression, defined as IHC 0 (ISH- or untested) according to ASCO-CAP 2018 HER2 testing guidelines, based on the most recent testing, regardless of hormonal status.\n3. Relapse or progression after at least 2 and a maximum of 3 prior lines of systemic therapy. Participants with metastatic HR+ BC who have received endocrine-based therapy and have received at least 2 and a maximum of 3 prior lines of additional systemic therapy in the metastatic setting. Subjects with actionable target tumor mutation should have been previously treated with targeted therapy.\n\nAdditional Inclusion Criteria for Cutaneous (Acral and Non-acral) Melanoma Subjects\n\n1. Histologically or cytologically confirmed cutaneous (acral and non-acral) melanoma.\n2. Disease progression while on or after having received treatment with ≥1 prior line of ICI based therapy. Prior anti-PD-(L)1 therapy in the adjuvant setting may be counted as 1 line if there is recurrence within 12 weeks of the last dose. If the subject had BRAF mutated melanoma or other actionable target tumor mutation, they must have had disease progression on targeted therapy as well.\n\nParticipants who meet any of the following criteria will be disqualified from entering the study:\n\n1. Prior treatment with orlotamab, enoblituzumab, or other B7-homologue 3 (B7-H3)-targeted agents, including I-DXd.\n2. Prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, T-DXd) due to treatment-related toxicities.\n3. Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms.\n4. Inadequate treatment washout period before enrollment as specified in the protocol.",{"count":611,"type":21},520,[24],"This study is designed to assess the efficacy and safety of ifinatamab deruxtecan (I-DXD) in the following tumor types: endometrial cancer (EC); head and neck squamous cell carcinoma (HNSCC); pancreatic ductal adenocarcinoma (PDAC); colorectal cancer (CRC); hepatocellular carcinoma (HCC); adenocarcinoma of esophagus, gastroesophageal junction, and stomach (Ad-Eso\u002FGEJ\u002Fgastric); urothelial carcinoma (UC); ovarian cancer (OVC); cervical cancer (CC); biliary tract cancer (BTC); human epidermal growth factor 2 (HER2)-low breast cancer (BC); HER2 immunohistochemistry (IHC) 0 BC; and cutaneous melanoma.",[559],[616,484,617,618,619,620,621,65,483,622,623,624,625,626,627,275],"Recurrent or metastatic solid tumors","Head and neck squamous cell carcinoma","Colorectal cancer","Hepatocellular carcinoma","Adenocarcinoma of esophagus, gastroesophageal junction, and stomach","Urothelial carcinoma","Biliary tract cancer","Human epidermal growth factor 2 (HER2)-low breast cancer","HER2 immunohistochemistry 0 breast cancer","Cutaneous melanoma","Pancreatic ductal adenocarcinoma","Ifinatamab deruxtecan (I-DXD)","2026-02-10",{"date":630,"type":40},"2026-02-12",{"date":632,"type":40},"2024-04-10",{"date":634,"type":21},"2028-07-25",{"name":46,"class":47},119,{"id":638,"slug":639,"hasResults":12,"nctId":640,"briefTitle":641,"officialTitle":642,"acronym":4,"eligibilityCriteria":643,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":644,"targetDuration":4,"studyType":22,"phases":646,"briefSummary":647,"conditions":648,"keywords":650,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":652,"lastUpdatePostDateStruct":653,"startDateStruct":655,"completionDateStruct":657,"leadSponsor":659,"locationsCount":232},"100543928","phase-1-a-study-of-i-dxd-in-combination-with-atezolizumab-with-or-without-carboplatin-as-first-line-induction-or-maintenance-in-subjects-with-extensive-stage-small-cell-lung-cancer-ideate-lung03-100543928","NCT06362252","A Study of I-DXd in Combination With Atezolizumab With or Without Carboplatin as First-Line Induction or Maintenance in Subjects With Extensive Stage-Small Cell Lung Cancer (IDeate-Lung03)","A Phase 1b\u002F2, Multicenter, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody-Drug Conjugate (ADC), in Combination With Atezolizumab With or Without Carboplatin as First-line Induction or Maintenance, in Subjects With Extensive-stage Small Cell Lung Cancer (ES-SCLC) (IDeate-Lung03)","A full list of inclusion\u002Fexclusion criteria are available in the protocol.\n\nInclusion Criteria\n\nParticipants must meet all of the following criteria to be eligible for enrollment into the study:\n\n1. Sign and date the informed consent form (ICF), prior to the start of any study-specific qualification procedures.\n2. Adults ≥18 years or the minimum legal adult age (whichever is greater) at the time the ICF is signed.\n3. Has histologically or cytologically confirmed diagnosis of ES-SCLC who will require first-line (IL) therapy.\n4. For Cohort 1, participant has received 4 cycles of 1L induction therapy with carboplatin, etoposide, and atezolizumab for ES-SCLC with ongoing CR PR, CR, or SD per RECIST v1.1 assessed by the investigator.\n\n   For Cohort 2, participant has received no prior treatment for ES-SCLC.\n5. For Cohort 2, participant has at least one measurable lesion according to RECIST v1.1 on computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by the investigator.\n6. For Cohort 2, participant must have at least one lesion, amenable to core biopsy, and must consent to provide a pretreatment biopsy tissue sample and on-treatment biopsy.\n7. Has ECOG PS of ≤1 (assessed within 7 days before enrollment\u002Frandomization).\n8. Has adequate organ and bone marrow function within 7 days before the start of study treatment as specified in the study protocol.\n9. A female subject of childbearing potential (POCBP) is eligible to participate if the following conditions are met:\n\n   1. Subject is not pregnant as confirmed by highly sensitive pregnancy test during Screening (within 3 days prior to enrollment\u002Frandomization)\n   2. Subject does not breastfeed during the treatment period and for at least 8\u002F5\u002F6 months after last dose of I-DXd\u002Fatezolizumab\u002Fcarboplatin, respectively.\n   3. Subject agrees to adhere to a contraceptive method that is highly effective and agrees not to donate eggs (ova, oocytes) to others or freeze\u002Fstore eggs during the treatment period and for at least the time needed to eliminate each study drug after the last dose. The length of time required to continue contraception and avoid donating\u002Ffreezing eggs after last dose for I-DXd\u002Fatezolizumab\u002Fcarboplatin is 8\u002F5\u002F6 months, respectively. Preservation of eggs may be considered prior to first dose of study drug.\n10. A male subject capable of producing sperm is eligible to participate if he agrees to the following during the intervention period and for at least the time needed to eliminate each study drug. The length of time required to continue contraception and avoid donating sperm after last dose for I-DXd\u002Fatezolizumab\u002Fcarboplatin is 6\u002F5\u002F6 months, respectively.\n\n    1. Avoid donating sperm.\n    2. Adhere to either of the contraception methods: true abstinence from penile-vaginal intercourse or uses a penile\u002Fexternal condom when having penile-vaginal intercourse with a non-subject of childbearing potential plus partner use of an additional contraceptive method.\n11. Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions.\n\nExclusion Criteria\n\nParticipants who meet any of the following criteria will be disqualified from entering the study:\n\n1. Has received prior treatment with orlotamab, enoblituzumab, or other B7-H3 targeted agents, including I-DXd.\n2. Prior discontinuation of an ADC that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities.\n3. Has received prior treatment with CD137 agonists or ICIs, including anti-cytotoxic T-cell lymphocyte-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, except for atezolizumab for Cohort 1.\n4. Has inadequate washout period before enrollment\u002Frandomization as specified in the study protocol.\n5. Has any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, or another arterial thromboembolic event.\n6. Has clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, defined as untreated and symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms.\n7. Has clinically significant corneal disease.\n8. Has uncontrolled or significant cardiovascular disease,.\n9. Has history of (non-infectious) ILD\u002Fpneumonitis that required corticosteroids, current ILD\u002Fpneumonitis, or suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at Screening.\n10. Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses\n11. Is on chronic steroid treatment (dose of 10 mg daily or more prednisone equivalent), except for low-dose inhaled steroids (for asthma\u002Fchronic obstructive pulmonary disease, topical steroids (for mild skin conditions), or intra-articular steroid injections.\n12. Has history of malignancy other than SCLC within the 5 years prior to randomization\u002Fenrollment, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, superficial gastrointestinal tract tumors, and non-muscle invasive bladder cancer curatively resected by endoscopic surgery.\n13. Has history of allogeneic bone marrow, stem cell, or solid organ transplant.\n14. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE V5.0, Grade ≤1 or baseline.\n15. Has history of hypersensitivity to the drug substances, inactive ingredients in the drug product or severe hypersensitivity reactions to other monoclonal antibodies.\n16. Has evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection.\n17. Has active or uncontrolled human immunodeficiency virus (HIV) infection.\n18. Has active or uncontrolled hepatitis B or C virus (HBV or HCV) infection.\n19. Has history of autoimmune disease.\n20. Has any evidence of severe or uncontrolled systemic diseases.\n21. Has received a live vaccine within 30 days prior to the first dose of study drug.\n22. Is a female who is pregnant or breastfeeding or planning to become pregnant.\n23. Has prior or ongoing clinically relevant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the participant; alter the absorption, distribution, metabolism, or excretion of the study drug; or confound the assessment of study results.\n24. Has psychological, social, familial, or logistical factors that would prevent regular follow-up",{"count":645,"type":21},123,[139,24],"This study is designed to evaluate the safety and efficacy of ifinatamab deruxtecan (I-DXd) in combination with immune checkpoint inhibitor (ICI) atezolizumab with or without carboplatin in participants with extensive stage-small cell lung cancer (ES-SCLC) in the first-line (1L) setting.",[649],"Extensive Stage-small Cell Lung Cancer",[651,299,276],"Extensive stage-small cell lung cancer (ES-SCLC)","2026-02-04",{"date":654,"type":40},"2026-02-06",{"date":656,"type":40},"2024-07-22",{"date":658,"type":21},"2026-12-30",{"name":46,"class":47},{"id":661,"slug":662,"hasResults":12,"nctId":663,"briefTitle":664,"officialTitle":665,"acronym":4,"eligibilityCriteria":666,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":667,"targetDuration":4,"studyType":22,"phases":669,"briefSummary":670,"conditions":671,"keywords":672,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":675,"lastUpdatePostDateStruct":676,"startDateStruct":677,"completionDateStruct":679,"leadSponsor":681,"locationsCount":682},"100534873","phase-1-a-study-of-valemetostat-tosylate-in-combination-with-dxd-adcs-in-subjects-with-solid-tumors-100534873","NCT06244485","A Study of Valemetostat Tosylate in Combination With DXd ADCs in Subjects With Solid Tumors","A Phase 1b, Multicenter, Open-Label Study of Valemetostat Tosylate in Combination With DXd ADCs in Subjects With Solid Tumors","Key Inclusion Criteria\n\nAll participants must meet all of the following criteria, as well as all criteria from the relevant sub-protocol to be eligible for enrollment:\n\n* At least 18 years or the minimum legal adult age (whichever is greater) at the time the ICF is signed.\n* Has at least 1 measurable lesion based on investigator imaging assessment (computed tomography or magnetic resonance imaging) using RECIST v 1.1 at Screening.\n* Is willing to provide an adequate tumor sample.\n* Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at Screening.\n\nAdditional Key Inclusion for Sub-Protocol A:\n\n* Diagnosed with pathologically documented breast cancer that:\n\n  1. Is unresectable or metastatic.\n  2. Has progressed on and would no longer benefit from endocrine therapy in hormone receptor-positive subjects in the opinion of the investigator.\n  3. Has been treated with at least 1 and at most 2 prior lines of chemotherapy in the recurrent or metastatic setting.\n  4. Has a history of low HER2 expression, defined as IHC 2+ \u002FISH-negative or IHC 1+ (ISH-negative or untested). ), as classified by the American Society of Clinical Oncology\u002FCollege of American Pathologists 2018 HER2 testing guidelines.\n  5. Was never previously HER2-positive (IHC 3+ or IHC 2+\u002FISH+) on prior pathology testing (per American Society of Clinical Oncology\u002FCollege of American Pathologists guidelines\n\n     Additional Key Inclusion for Sub-Protocol B:\n\n     • Gastric or GEJ adenocarcinoma that is (a) unresectable or metastatic or (b) has progressed on trastuzumab or approved trastuzumab biosimilar-containing regimen.\n\n     Additional Key Inclusion for Sub-Protocol C:\n* Pathologically documented Stage IIIB, IIIC, or IV non-squamous NSCLC with or without AGA at the time of enrollment.\n* Must meet prior therapy requirements:\n\n  * Participants without AGA: (a) received platinum-based chemotherapy in combination with α-PD-1\u002Fα -PD-L1 mAb as a prior line of therapy or (b) received platinum-based chemotherapy and α -PD-1\u002F α -PD-L1 mAb (in either order) sequentially as 2 prior lines of therapy.\n  * Participants with AGA: (a) has been treated with at least 1 or 2 prior lines of applicable targeted therapy that is locally approved for participant's genomic alteration at the time of Screening, (b) participants who have received platinum-based chemotherapy as a prior line of cytotoxic therapy, (c) may have received α -PD-1\u002Fα -PD-L1 mAb alone or in combination with a cytotoxic agent\n\nKey Exclusion Criteria\n\n* Has previously been treated with any enhancer of zeste homolog inhibitors.\n* Uncontrolled or significant cardiovascular disease.\n* Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.\n* Has leptomeningeal carcinomatosis or metastasis.\n* Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses.\n* Current use of moderate or strong cytochrome P450 (CYP)3A inducers.\n* Systemic treatment with corticosteroids (\\>10 mg daily prednisone equivalents).\n* History of severe hypersensitivity reactions to other monoclonal antibodies (mAbs).\n* Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection requiring treatment with intravenous (IV) antibiotics, antivirals, or antifungals.\n* Female who is pregnant or breastfeeding or intends to become pregnant during the study.\n* Psychological, social, familial, or geographical factors that would prevent regular follow-up.\n\nAdditional Key Exclusion for Sub-Protocol A:\n\n* Has previously received any anti-HER2 therapy in the metastatic setting.\n* Has received prior treatment with an antibody-drug conjugate that consists of an exatecan derivative that is a topoisomerase I inhibitor, including either as part of prior treatment history or within prior participation in a clinical study.\n\nAdditional Key Exclusion for Sub-Protocol B:\n\n\\* Participants who have received an antibody-drug conjugate consisting of an exatecan derivative that is a topoisomerase I inhibitor.\n\nAdditional Key Exclusion for Sub-Protocol C:\n\n\\* Has received any agent, including an ADC, containing a chemotherapeutic agent targeting topoisomerase I or TROP2-targeted therapy including Dato-DXD",{"count":668,"type":21},210,[139],"This study will evaluate the safety, tolerability, and efficacy of valemetostat tosylate in combination with DXd ADC in patients with advanced solid tumors.",[142],[142,673,674],"Valemetostat tosylate","DXD Antibody-drug Conjugates","2026-02-02",{"date":652,"type":40},{"date":678,"type":40},"2024-02-16",{"date":680,"type":21},"2028-11-01",{"name":46,"class":47},38,""]