[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"triple-negative-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:triple-negative-breast-cancer":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,181,0,25,[9,47,72,96,123,199,210,229,253,276,315,355,390,419,445,471,497,520,545,565,586,608,656,678,705],{"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":25,"conditions":26,"keywords":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100053502","phase-1-study-of-autologous-car-t-cells-targeting-b7-h3-in-tnbc-ic9-carb7-h3-t-cells-100053502",false,"NCT06347068","Study of Autologous CAR-T Cells Targeting B7-H3 in TNBC iC9-CAR.B7-H3 T Cells","Study of Administration of T Cells Expressing B7-H3 Specific Chimeric Antigen Receptors and Containing the Inducible Caspase 9 Safety Switch in Subjects With Triple Negative Breast Cancer","Inclusion Criteria:\n\nUnless otherwise noted, subjects must meet all of the following criteria to participate in in all phases of the study:\n\n1. Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information explained to, understood by and signed by the subject or legally authorized representative.\n2. Age ≥ 18 years at the time of consent.\n3. Karnofsky score of \\> 60% (see APPENDIX VI- Karnofsky Scale))\n4. Histologically confirmed TNBC (ER-, PR-, HER2-negative)\n\n   1. ER- and PR-negative: defined as \\\u003C 1% staining by immunohistochemistry (IHC)\n   2. HER2-negative: defined as IHC 0-1+ or fluorescence in situ hybridization (FISH) ratio \\\u003C 2.0\n\nExclusion Criteria:\n\n1. Patients with a history of symptomatic CNS involvement or multiple metastases requiring whole-brain radiation.\n2. Subjects with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n3. Subject does not have a measurable and or evaluable disease as defined by RECIST 1.1","ALL","18 Years",{"count":20,"type":21},42,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This phase 1, single-center, open-label study explores the safety of escalating doses of chimeric antigen receptor T cells (CAR-T) cells in subjects with relapsed\u002Frefractory triple-negative breast cancer (TNBC).",[27,28,29,30],"Breast Cancer","Relapse","Resistant Cancer","Triple Negative Breast Cancer",[32,33],"cellular therapy","biologic therapy","RECRUITING","2026-07-09",{"date":37,"type":38},"2026-07-13","ACTUAL",{"date":40,"type":38},"2024-06-27",{"date":42,"type":21},"2030-05",{"name":44,"class":45},"UNC Lineberger Comprehensive Cancer Center","OTHER",1,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"100546318","phase-3-sacituzumab-tirumotecan-mk-2870-plus-pembrolizumab-versus-tpc-in-tnbc-who-did-not-achieve-pcr-mk-2870-012-100546318","NCT06393374","Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)","A Phase 3, Randomized, Open-label, Study to Compare the Efficacy and Safety of Adjuvant MK-2870 in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice (TPC) in Participants With Triple-Negative Breast Cancer (TNBC) Who Received Neoadjuvant Therapy and Did Not Achieve a Pathological Complete Response (pCR) at Surgery","Inclusion Criteria:\n\n* Has centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO\u002FCAP) guidelines\n* Has no evidence of locoregional or distant relapse, as assessed by the treating physician\n* Had neoadjuvant treatment based on the KEYNOTE-522 regimen (pembrolizumab with carboplatin\u002Ftaxanes and pembrolizumab with anthracycline-based chemotherapy) followed by surgery according to National Comprehensive Cancer Network (NCCN) treatment guidelines for TNBC\n* Had adequate excision and surgical removal of all clinically evident disease in the breast and\u002For lymph nodes and have adequately recovered from surgery\n* Has non-pathologic complete response at surgery\n* Is able to continue on adjuvant pembrolizumab\n* Randomization must be conducted within 16 weeks from surgical resection\n* Completed adjuvant radiation therapy (if indicated) and recovered before randomization\n* Has provided tissue from the surgical resection for central laboratory determination of trophoblast cell surface antigen 2 (TROP2) status\n* If capable of producing sperm, the participant agrees to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention (120 days for sacituzumab tirumotecan and 95 days for capecitabine \\[no restriction for pembrolizumab\\]): agrees to refrain from donating sperm AND is either abstinent and agrees to remain abstinent or uses highly effective contraception\n* For females (assigned at birth), is not pregnant or breastfeeding and ≥1 of the following applies: is not a participant of childbearing potential (POCBP) OR is a POCBP and uses highly effective contraception after the last dose of study intervention (210 days for sacituzumab tirumotecan, 120 days for pembrolizumab, and 185 days for capecitabine). Abstains from breastfeeding during the study intervention period and for at least 120 days after study intervention\n* Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline (except alopecia)\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)\n* An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before first dose of study treatment\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B birus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization\n\nExclusion Criteria:\n\n* Has a known germline breast cancer gene (BRCA) mutation (deleterious or suspected deleterious) and is eligible for adjuvant therapy with olaparib where olaparib is approved and available\n* Has Grade \\>2 peripheral neuropathy\n* History of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or severe corneal disease that prevents\u002Fdelays corneal healing\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to \\>480 ms, and\u002For other serious cardiovascular and cerebrovascular diseases within 6 months prior to study intervention\n* Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC) or a topoisomerase I inhibitor-containing ADC\n* Received anticancer therapy in the adjuvant phase including but not limited to chemotherapy, small molecule anticancer drugs, poly (adenosine diphosphate ribose) polymerase (PARP) inhibitors, ADCs, and\u002For immunotherapy, with the exception of adjuvant radiation therapy\n* Is currently receiving a strong inducer\u002Finhibitor of cytochrome P450 3A4 (CYP3A4) that cannot be discontinued for the duration of the study. The required washout period before starting sacituzumab tirumotecan is 2 weeks\n* Except for pembrolizumab as neoadjuvant therapy for early-stage TNBC: received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein-4 \\[CTLA-4\\], OX-40 \\[cluster of differentiation (CD) 134\\], or CD137)\n* Except for chemotherapy as neoadjuvant therapy for early-stage TNBC: Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization\n* Received prior radiotherapy within 3 weeks of start of study intervention or required corticosteroids for radiation related toxicities that cannot be discontinued before the first dose of study intervention\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed\n* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration\n* Has known additional malignancy that is progressing or has required active treatment within the past 5 years\n* Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication\n* Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed\n* Has history of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease\n* Has active infection requiring systemic therapy\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has concurrent active hepatitis B and hepatitis C virus infection\n* Has history of allogeneic tissue\u002Fsolid organ transplant",{"count":55,"type":21},1530,[57],"PHASE3","This is a randomized, open-label study comparing the efficacy and safety of adjuvant sacituzumab tirumotecan (MK-2870) in combination with pembrolizumab compared to treatment of physician's choice (TPC) in participants with triple-negative breast cancer (TNBC) who received neoadjuvant therapy and did not achieve a pathological complete response (pCR) at surgery. The primary objective is to compare sacituzumab tirumotecan plus pembrolizumab to TPC (pembrolizumab or pembrolizumab plus capecitabine) with respect to invasive disease-free survival (iDFS) per investigator assessment. It is hypothesized that sacituzumab tirumotecan plus pembrolizumab is superior to TPC with respect to iDFS per investigator assessment.",[60],"Triple-Negative Breast Cancer","2026-06-26",{"date":63,"type":38},"2026-06-29",{"date":65,"type":38},"2024-06-24",{"date":67,"type":21},"2037-12-14",{"name":69,"class":70},"Merck Sharp & Dohme LLC","INDUSTRY",304,{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":79,"minAge":18,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":46},"100645166","phase-3-a-study-of-trastuzumab-rezetecan-in-combination-with-adebrelimab-versus-investigators-choice-of-therapy-in-subjects-with-residual-triple-negative-breast-cancer-100645166","NCT07679360","A Study of Trastuzumab Rezetecan in Combination With Adebrelimab Versus Investigator's Choice of Therapy in Subjects With Residual Triple Negative Breast Cancer","A Phase III, Multicenter, Randomized, Open-Label Parallel-Controlled Study of Trastuzumab Rezetecan (SHR-A1811) in Combination With Adebrelimab (SHR-1316) Versus Investigator's Choice of Therapy in Subjects With Primary Triple Negative Breast Cancer Who Have Residual Invasive Disease Following Neoadjuvant Therapy","Inclusion Criteria:\n\n1. Pathologically confirmed invasive triple negative breast cancer.\n2. Pathologic evidence of residual invasive carcinoma in the breast or axillary lymph nodes following completion of preoperative therapy.\n3. Previous neoadjuvant therapy must meet the requirements of the protocol.\n4. Has received radical surgery for breast cancer.\n5. ECOG PS 0\\~1.\n6. Adequate organ functions.\n7. Women of childbearing potential must be willing to use highly effective form of contraception.\n\nExclusion Criteria:\n\n1. Stage IV metastatic breast cancer.\n2. Previous invasive breast cancer or ductal carcinoma in situ.\n3. Bilateral breast cancer.\n4. Any clinical evidence indicating the exist of recurrent diseases after surgery.\n5. History of other malignancy within the last 5 years, excluding cured skin basal cell carcinoma and cervical carcinoma in situ.\n6. Previously received antibody coupled drug (ADC) therapy with topoisomerase inhibitors as effective payloads.\n7. Previously received HER2 targeted therapy.\n8. Active or previously recorded autoimmune or inflammatory diseases.\n9. History of immunodeficiency.\n10. Participants with known or suspected interstitial pneumonia.\n11. Presence of active Hepatitis B.\n12. Known to have active tuberculosis infection.\n13. Uncontrolled infections requiring intravenous injection of antibiotics, antiviral drugs, or antifungal drugs for treatment.\n14. Within the 6 months prior to randomization, there was a history of myocardial infarction, severe\u002Funstable angina, symptomatic congestive heart failure, ≥ Grade 2 supraventricular or ventricular arrhythmias, and any grade of ventricular fibrillation.\n15. Known allergy to any investigational drug or its excipients.\n16. Other medical conditions that would interfere with study participation or follow-up.","FEMALE","75 Years",{"count":82,"type":21},1000,[57],"It is a randomized, open label, positive drug controlled, multicenter design Phase III clinical trial, aims to compare the efficacy and safety of SHR-A1811 combined with Adebrelimab and the treatment selected by the researchers in the adjuvant treatment of triple negative breast cancer with invasive residual cancer after neoadjuvant treatment, and to explore the PK characteristics and immunogenicity of SHR-A1811 and Adebrelimab.",[30],"NOT_YET_RECRUITING","2026-06-25",{"date":89,"type":38},"2026-07-01",{"date":91,"type":21},"2026-07",{"date":93,"type":21},"2032-12",{"name":95,"class":70},"Suzhou Suncadia Biopharmaceuticals Co., Ltd.",{"id":97,"slug":98,"hasResults":12,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":22,"phases":105,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":122},"100468301","phase-1-a-study-of-emiltatug-ledadotin-emi-le-in-participants-with-solid-tumors-100468301","NCT05377996","A Study of Emiltatug Ledadotin (Emi-Le) in Participants With Solid Tumors","A Phase 1\u002F2, First-in-human, Multicenter Study of Emiltatug Ledadotin (Emi-Le) in Participants With Solid Tumors","Inclusion Criteria:\n\n* Recurrent or advanced solid tumor and has disease\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Participants in DES must have at least one measurable disease (target) lesion as defined by RECIST version 1.1.\n* Tumor tissue, either archival or from a fresh tumor biopsy, available for testing or be willing to undergo a minimally invasive tumor biopsy to obtain tumor tissue for local testing, if not medically contraindicated, prior to Cycle 1 Day 1\n* Brain magnetic resonance imaging (MRI) during the Screening period unless obtained within 30 days prior to Screening (based on standard clinical care), if they meet either of the following criteria:\n\n  1. All participants with TNBC\n  2. Participants with a history of brain metastases or with neurologic symptoms or signs suspicious for brain metastases.\n\nExclusion Criteria:\n\n* Prior treatment with an Antibody Drug Conjugate (ADC) containing an auristatin payload. Prior treatment with another ADC containing other payloads is allowed.\n* Major surgery within 28 days of starting study treatment, systemic anticancer therapy within the time period of 28 days or 5 half-lives of the prior therapy before starting study treatment (14 days or 5 half-lives for small molecule targeted therapy), whichever is less, or palliative radiation therapy to the chest within 3 months of starting study treatment or to other anatomic sites within 14 days of starting study treatment.\n* Diagnosis of additional malignancy that required active treatment (including surgery, systemic therapy, and radiation) within 2 years prior to screening, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix.\n* Untreated CNS metastases (including new and progressive brain metastases), history of leptomeningeal metastasis or carcinomatous meningitis.\n* Prior B7-H4 targeted treatment.\n* History of cirrhosis, hepatic fibrosis, esophageal or gastric varices, or other clinically significant liver diseases.\n* Current severe, uncontrolled systemic disease (e.g. clinically significant cardiovascular, pulmonary, or metabolic disease) or intercurrent illness that could increase the risk of serious adverse events (SAEs) or interfere with per-protocol evaluations, in the judgment of either the Sponsor or the Investigator.\n* Clinically significant cardiovascular disease\n* Active keratitis (inflammation of the cornea of the eye)",{"count":104,"type":21},360,[24,106],"PHASE2","A Study of Emi-Le in Participants with Solid Tumors",[30,27,109,110,111,112,113],"Endometrial Cancer","Ovarian Cancer","Fallopian Tube Cancer","Primary Peritoneal Cavity Cancer","Adenoid Cystic Carcinoma","2026-06-24",{"date":63,"type":38},{"date":117,"type":38},"2022-08-15",{"date":119,"type":21},"2027-12",{"name":121,"class":70},"Day One Biopharmaceuticals, Inc.",26,{"id":124,"slug":125,"hasResults":12,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":12,"sex":17,"minAge":130,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":22,"phases":133,"briefSummary":134,"conditions":135,"keywords":162,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":191,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":198},"100407463","phase-1-the-evaluation-of-pc14586-in-patients-with-advanced-solid-tumors-harboring-a-tp53-y220c-mutation-pynnacle-100407463","NCT04585750","The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","A Phase 1\u002F2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","Inclusion Criteria:\n\n* At least 18 years of age or 12 to 17 years of age after Safety Review Committee approval.\n* Locally advanced or metastatic solid malignancy with a TP53 Y220C mutation\n* Eastern Cooperative Oncology Group (ECOG) status of 0 or 1\n* Previously treated with one or more lines of anticancer therapy and progressive disease\n* Adequate organ function\n* Measurable disease per RECIST v1.1 (Phase 2)\n\nAdditional Criteria for Inclusion in Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Anti-PD-1\u002FPD-L1 naive or must have progressed on treatment\n* Measurable disease\n\nExclusion Criteria:\n\n* Anti-cancer therapy within 21 days (or 5 half-lives) of receiving the study drug\n* Radiotherapy within 14 days of receiving the study drug\n* Primary CNS tumor\n* History of leptomeningeal disease or spinal cord compression\n* Brain metastases, unless neurologically stable and do not require steroids to treat associated neurological symptoms\n* Stroke or transient ischemic attack within 6 months prior to screening\n* Heart conditions such as unstable angina within 6 months prior to screening, uncontrolled hypertension, a heart attack within 6 months prior to screening, congestive heart failure, prolongation of QT interval, or other rhythm abnormalities\n* Strong CYP3A4 inducers and strong CYP2C9 inhibitors\u002Finducers within 14 days of first dose of rezatapopt\n* History of gastrointestinal (GI) disease that may interfere with absorption of study drug or patients unable to take oral medication\n* History of prior organ transplant\n* Known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer\n* Known, active uncontrolled Hepatitis B, Hepatitis C, or human immunodeficiency virus infection\n\nAdditional Criteria for Exclusion from Phase 2 (rezatapopt monotherapy)\n\n* Known KRAS mutation, defined as a single nucleotide variant (SNV) (Phase 2)\n\nAdditional Criteria for Exclusion from Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and discontinued from that treatment due to a Grade 3 or higher immune-related AE (irAE)\n* Received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention\n* Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy within 7 days prior to the first dose of study drug\n* Hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients\n* Active autoimmune disease that has required systemic treatment in past 2 years\n* History of radiation pneumonitis\n* History of (non-infectious) or active pneumonitis \u002F interstitial lung disease that required steroids\n* Active infection requiring systemic therapy\n* Known history of HIV infection\n* Has previously received rezatapopt","12 Years",{"count":132,"type":21},300,[24,106],"The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation. The Phase 1 portion of the study will assess the safety, tolerability and preliminary efficacy of multiple dose levels of rezatapopt as monotherapy and in Phase 1b in combination with pembrolizumab.",[136,137,138,139,140,110,109,141,142,27,143,144,145,146,147,148,149,150,151,152,153,30,154,155,156,157,158,159,160,161],"Advanced Solid Tumor","Advanced Malignant Neoplasm","Metastatic Cancer","Metastatic Solid Tumor","Lung Cancer","Prostate Cancer","Colorectal Cancer","Other Cancer","Locally Advanced","Head and Neck Cancer","Gall Bladder Cancer","Small Cell Lung Cancer","Small Cell Lung Cancer ( SCLC )","Small Cell Lung Carcinoma","NSCLC","NSCLC (Non-small Cell Lung Cancer)","SCLC","Non-Small Cell Lung Carcinoma","TNBC","HER2+ Breast Cancer","Non-Small Cell Lung Cancer","ER\u002FPR Positive Breast Cancer","HER2- Breast Cancer","HER2-positive Breast Cancer","HER2-negative Breast Cancer","ER\u002FPR(+), Her2(-) Breast Cancer",[163,164,165,166,167,168,169,170,171,172,173,174,175,176,177,178,179,180,181,182,183,184,185,186,187,188,189,190],"PC14586","p53","Y220C","Phase 1","Phase 1\u002F2","PMV","PMV Pharma","p53 mutation","TP53","TP53 mutation","p53 mutant","p53 reactivator","pembrolizumab","Keytruda","combination","PD-1","PD-L1","anti-PD-1","Merck","MSD","IgG4","mAb","Phase 1b","NGS","Next Generation Sequencing","precision","Phase 2","Rezatapopt",{"date":61,"type":38},{"date":193,"type":38},"2020-10-29",{"date":195,"type":21},"2027-12-31",{"name":197,"class":70},"PMV Pharmaceuticals, Inc",77,{"id":200,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":22,"phases":202,"briefSummary":25,"conditions":203,"keywords":204,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":207,"completionDateStruct":208,"leadSponsor":209,"locationsCount":46},"100542761",{"count":20,"type":21},[24],[27,28,29,30],[32,33],"2026-06-23",{"date":87,"type":38},{"date":40,"type":38},{"date":42,"type":21},{"name":44,"class":45},{"id":211,"slug":212,"hasResults":12,"nctId":213,"briefTitle":214,"officialTitle":214,"acronym":215,"eligibilityCriteria":216,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":22,"phases":219,"briefSummary":220,"conditions":221,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":227,"locationsCount":46},"100609700","phase-1-neoadjuvant-complete-response-customized-treatment-approach-for-definitive-management-of-breast-cancer-100609700","NCT07217990","Neoadjuvant Complete Response Customized Treatment Approach for Definitive Management of Breast Cancer","NoCUT-BC","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female, aged 18 years or older\n4. Early-stage breast cancer diagnosis (cT1-3 N0 or cT1-2 N1) and a Human Epidermal Receptor 2 (HER2)-positive or triple negative breast cancer (TNBC) tumor molecular subtype\n5. Planning to receive neoadjuvant chemotherapy (NAC) and radiation therapy (RT)\n\nExclusion Criteria:\n\n1. Pregnancy or lactation\n2. Inmate or prisoner\n3. Treatment with an investigational drug or other intervention throughout their breast cancer treatment\n4. Patients with skin involvement and\u002For distant metastases",{"count":218,"type":21},84,[24,106],"This study will evaluate the efficacy and non-inferiority of a non-surgical approach for the treatment of patients with locally advanced breast cancer.",[27,159,30],"2026-06-20",{"date":114,"type":38},{"date":225,"type":21},"2026-09-15",{"date":195,"type":21},{"name":228,"class":45},"Ohio State University Comprehensive Cancer Center",{"id":230,"slug":231,"hasResults":12,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":12,"sex":79,"minAge":236,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":22,"phases":239,"briefSummary":241,"conditions":242,"keywords":243,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":46},"100644767","study-of-the-therabionic-p1-device-in-patients-with-metastatic-triple-negative-breast-cancer-after-progression-100644767","NCT07672431","Study of the TheraBionic P1 Device in Patients With Metastatic Triple Negative Breast Cancer After Progression","A Pilot Study of the Efficacy of the TheraBionic P1 Device in Patients With Metastatic Triple Negative Breast Cancer in the Third-line Setting","Inclusion Criteria:\n\n* Participant must have histologically confirmed invasive breast cancer that is hormone receptor (HR) negative and Human Epidermal Growth Factor Receptor 2 (HER2) negative according to the American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines (Estrogen Receptor (ER) and progesterone receptor (PR) \\\u003C 1% and HER2 negative by immuno-histochemistry (IHC) and\u002For fluorescent in situ hybridization \\[FISH\\]\n* Participant must have evaluable disease as defined by the investigator using CT, MRI, or positron emission tomography (PET) scan\n* Participant must have refractory disease and failed, not tolerated, or progressed on at least two lines of prior standard therapeutic regimens for mTNBC.\n\n  • Participant must have a washout period of at least 14 days between the last line of treatment and the start of study treatment.\n* Participant must be a woman of 22 years of age or older.\n* Participant must have a life expectancy of at least three months\n* Participant must have an Eastern Cooperative Oncology Group (ECOG) performance score of 0-2\n* It is unknown what effects this treatment has on human pregnancy or development of the embryo or fetus. Therefore, women of child-bearing potential must agree to avoid becoming pregnant and male participants should avoid impregnating a female partner and donating sperm starting at initiation of treatment up until at least 12 weeks after treatment discontinuation\n\n  * Surgically sterile (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy)\n  * Post-menopausal, defined as no menses for at least 12 months prior to the screening visit without alternative medical causation.\n  * Agree to practice true abstinence from sexual intercourse when this is in line with the preferred and usual lifestyle of the participant. Periodic abstinence methods such as calendar, ovulation, symptothermal, or post ovulation tracking are not acceptable.\n  * Not in a sexual relationship in which they may become pregnant (i.e. same-sex relationship)\n  * If they are of child-bearing potential, agree to use at least one highly effective AND at least one additional method of contraception. Withdrawal is not an acceptable contraceptive method.\n\nExclusion Criteria:\n\n* Participants with known active secondary malignancy, unless, in the opinion of the investigator, it is unlikely to interfere with the safety and efficacy of the endpoints.\n* Participants with known untreated brain metastases will be excluded from this clinical trial. Stable brain metastases will be allowed, and it will be confirmed by stable brain magnetic resonance imaging (MRI) with and without contrast within 8 weeks of signing consent.\n* Participants who are taking any other investigational drugs\n* Participants who are pregnant or breastfeeding. If a breastfeeding participant would like to be part of this study, breastfeeding must be discontinued\n* Participants with active oral mucosal inflammation, ulceration, or other pathology that could interfere with the use of TheraBionic P1 device (for example: mucositis, thrush, bleeding mucosal lesions, oral herpes, aphthous stomatitis, mouth ulcers, chancre sores, gingivostomatitis, herpangina, aphthae).\n* Participants who plan to receive calcium channel blockers and any agent blocking L-type of T-type voltage gated calcium channels (for example: amlodipine, nifedipine, ethosuximide, supplemental vitamin C\u002Fascorbic acid, etc.) unless their medical treatment is discontinued prior to treatment. Participant must agree to abstain from using calcium channel blockers for the duration of treatment on study\n* Participants who plan to receive anticancer therapy that blocks L-type or T-type voltage gated calcium channels (i.e., eribulin, rucaparib, or niraparib) as part of their third line treatment. Participants who have received eribulin, rucaparib, or niraparib as part of a previous line of therapy are eligible, provided there has been at least 14 days between the last date of treatment and the start of study treatment.\n* Participants that do not agree to be followed according to the study protocol or have cognitive or physical inability to follow the treatment plan\n* Participants with a known severe (e.g., anaphylactic) allergy to nickel","22 Years",{"count":238,"type":21},24,[240],"NA","The goal of this clinical trial is to learn if adding the TheraBionic P1 device to standard of care third line treatment for adult women with metastatic triple negative breast cancer (mTNBC) who have failed, not tolerated, or progressed on standard first- and second-line treatment options can work better than the standard of care alone. The main questions it aims to answer is:\n\n* will the addition of the TheraBionic P1 device to standard of care third line treatment affect progression free and overall survival in these participants",[30],[244],"mTNBC","2026-06-19",{"date":63,"type":38},{"date":248,"type":21},"2026-09",{"date":250,"type":21},"2028-12-31",{"name":252,"class":45},"Barbara Ann Karmanos Cancer Institute",{"id":254,"slug":255,"hasResults":12,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":4,"eligibilityCriteria":259,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":260,"targetDuration":4,"studyType":22,"phases":262,"briefSummary":263,"conditions":264,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":268,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":275},"100596550","phase-1-a-study-of-ly4175408-in-participants-with-advanced-cancer-100596550","NCT07046923","A Study of LY4175408 in Participants With Advanced Cancer","A First-in-Human, Phase 1a\u002F1b Trial to Assess the Safety, Tolerability and Preliminary Efficacy of LY4175408, an Antibody Drug Conjugate Targeting Protein Tyrosine Kinase 7-Expressing Tumor Cells, in Participants With Selected Advanced Solid Tumors","Inclusion Criteria:\n\n* Have one of the following advanced or metastatic solid tumor cancers:\n\n  * Non-small cell lung cancer (NSCLC)\n  * Small cell lung cancer (SCLC)\n  * Endometrial cancer\n  * Triple negative breast cancer (TNBC) (characterized by HR-negative disease and HER2-negative expression according to American Society of Clinical Oncology (ASCO) - College of American Pathologists guidelines).\n* Received all standard therapies for which the individual was deemed to be an appropriate candidate by the treating investigator (except in Cohort B1 and B2 expansion, which require participants who are treatment naive in the advanced metastatic setting); OR the individual is refusing the remaining most appropriate standard of care treatment; OR there is no standard therapy available for the disease.\n* Eastern Cooperative Oncology Group (ECOG) performance status of greater than or equal to (≤) 1.\n* For dose optimization\u002Fdose and expansion cohorts (Cohort A2, Cohort B\u002FC): Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n* Cohorts B1\u002FB2: NSCLC with no known actionable genomic alterations. ≤2 prior lines of systemic therapy for advanced or metastatic disease in safety lead-in; no prior systemic therapy in expansion\n\nExclusion Criteria:\n\n* Prior treatment with a protein tyrosine kinase 7 (PTK7) antibody-drug conjugate (ADC) with a topoisomerase I inhibitor as payload (prior therapy with a PTK7 ADC with a non-topoisomerase I inhibitor payload OR non-PTK7 ADC with any payload is permitted). Prior topoisomerase I-based ADCs are not allowed in cohorts A2, B1 or B2.\n* Any serious unresolved toxicities from prior therapy.\n* Individual with known or suspected history of uncontrolled central nervous system (CNS) metastases.\n* Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection.\n* Significant cardiovascular disease.\n* Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) \\> 470 milliseconds (ms)\n* History of pneumonitis\u002Finterstitial lung disease.\n* Individuals who are pregnant, breastfeeding, or plan to breastfeed during the trial or within 30 days of the last dose of trial intervention.",{"count":261,"type":21},240,[24],"The purpose of this study is to measure the safety and efficacy of LY4175408 in participants with selected advanced cancer. In addition, this study will evaluate how much LY4175408 gets into the bloodstream, how it is broken down, and how long it takes the body to get rid of it. Participation could last up to 4 years.",[265,149,266,267,30],"Carcinoma, Non-Small-Cell Lung","Endometrial Neoplasms","Neoplasm Metastasis",{"date":205,"type":38},{"date":270,"type":38},"2025-07-28",{"date":272,"type":21},"2030-07",{"name":274,"class":70},"Eli Lilly and Company",27,{"id":277,"slug":278,"hasResults":12,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":283,"targetDuration":4,"studyType":22,"phases":285,"briefSummary":286,"conditions":287,"keywords":293,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":307,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":314},"100439677","phase-1-study-to-assess-adverse-events-and-pharmacokinetics-in-adult-participants-with-non-small-cell-lung-cancer-head-and-neck-squamous-cell-carcinoma-and-other-solid-tumors-receiving-intravenous-infusion-of-azirkitug-alone-or-in-combinations-with-budigalimab-bevacizumab-or-telisotuzumab-adizutecan-100439677","NCT05005403","Study to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma and Other Solid Tumors, Receiving Intravenous Infusion of Azirkitug Alone or in Combination(s) With Budigalimab, Bevacizumab, or Telisotuzumab Adizutecan","A Global First-in-Human Study in NSCLC, HNSCC, and Solid Tumors With Azirkitug as a Single Agent and in Combination(s) With Budigalimab, Bevacizumab, or Telisotuzumab Adizutecan","Inclusion Criteria:\n\n* Pre Treatment biopsy or archive tissue within 6 months without intervening treatment\n* Eastern Cooperative Oncology Group (ECOG) performance status of \\\u003C= 0 or 1 and a life expectancy of \\>= 3 months.\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST)\n* Laboratory values meeting criteria outlined in the protocol\n* NSCLC - Advanced or metastatic progressed on standard of care (SOC) including chemotherapy and prior anti-PD-(L)1 antibody (separately or in combination). Actionable gene alterations are eligible if failed targeted therapeutic options.\n* HSNCC - Advanced\u002Fmetastatic progressed on platinum and PD-1\u002FPD-LI in recurrent or metastatic setting.\n* Micro Satellite Stable Colorectal Cancer (MSS-CRC) - Progressed on Oxaliplatin, Irinotecan, a fluoropyrimidine, anti-EGFR, VEGF or VEGFR therapies, BRAFV600E or HER2, other targetable mutations targeted with locally approved therapy, TAS-102, Regorafenib and not MSI-h or MMR-deficient\n* Gastric and Gastroesophageal Junction adenocarcinoma (GEA) - Advanced\u002Fmetastatic progressed on at least 1 prior cytotoxic chemotherapeutic regimen and if applicable immune checkpoint inhibitor and\u002For HER2 therapy\n* High-Grade Serous Ovarian Cancer (HGSOC) - Progressed serous epithelial ovarian, fallopian tube or primary peritoneal cancer post SOC and not eligible for surgical resection. Platinum resistant cannot have \\>5 lines of prior therapy.\n* Pancreatic Adenocarcinoma (PDAC) - Advanced\u002Fmetastatic progressed after SOC. Includes adenosquamous carcinoma and post-Whipple.\n* Triple Negative Breast Cancer (TNBC) - Progressed after 1 or 2 systemic therapy that must have included taxane and treatment naïve to immunotherapy targeting T-cell co-stimulation\n\nExclusion Criteria:\n\n* Pancreatic Ductal Adenocarcinoma (PDAC) - Excludes neuroendocrine or acinar pancreatic carcinoma and participants with coagulopathy or at risk of or history of Deep vein thrombosis (DVT)\u002FPE\n* No major surgery within 28 days prior to dosing\n* No active autoimmune\u002Fimmunodeficiency disease with limited exceptions\n* Combination treatment excludes participants treated with anti-programmed cell death protein 1(PD-1)\u002FProgrammed cell death ligand 1 (PD-L1) who had immune mediated toxicity G3 or greater, interstitial lung disease, or hypersensitivity Combination treatment may also require no significant cardiac deficiencies and\u002For events\n* Pregnancy\n* Excluded medications include anticancer therapy within 5 half-live or 28 days (whichever is shorter), agent targeting Chemokine Receptor (CCR)8, live vaccines, immunosuppressive medication with limited exceptions",{"count":284,"type":21},694,[24],"Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-Small Cell Lung Cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. Head and Neck Squamous Cell Carcinoma (HNSCC) is a solid tumor, a disease in which cancer cells form in the tissues of the head and neck. The purpose of this study is to assess adverse events and pharmacokinetics of azirkitug as a monotherapy and in combination with budigalimab, bevacizumab, or telisotuzumab adizutecan.\n\nBevacizumab is an approved product, while budigalimab, azirkitug, and telisotuzumab adizutecan are investigational drugs being developed for the treatment of NSCLC, HNSCC, and other solid tumors. Study doctors put the participants in groups called treatment arms. The maximum-tolerated dose (MTD)\u002Fmaximum administered dose (MAD) of azirkitug will be explored. Each treatment arm receives a different dose of azirkitug in monotherapy and in combination with budigalimab, bevacizumab, or telisotuzumab adizutecan. Approximately 694 adult participants will be enrolled in the study across approximately 80 sites worldwide.\n\nParticipants will receive azirkitug as a monotherapy or in combination with budigalimab, bevacizumab, or telisotuzumab adizutecan as an Intravenous (IV) Infusion for an estimated treatment period of up to 2 years.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.",[156,288,289,290,291,292,30],"Head and Neck Squamous Cell Carcinoma","Micro Satellite Stable Colorectal Cancer","Gastric\u002FEsophageal Cancer","High-Grade Serous Ovarian Cancer","Pancreatic Cancer",[156,150,288,294,295,296,297,298,289,299,300,301,302,291,303,304,30,154,305,306],"HNSCC","Solid Tumors","Budigalimab","ABBV-181","ABBV-514","MSS-CRC, Gastric Cancer","Esophageal Cancer","GEA","GEJ","HGSOC","Pancreatic Cancer, PDAC","Telisotuzumab Adizutecan","ABBV-400",{"date":205,"type":38},{"date":309,"type":38},"2021-11-01",{"date":311,"type":21},"2027-07",{"name":313,"class":70},"AbbVie",48,{"id":316,"slug":317,"hasResults":12,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":321,"eligibilityCriteria":322,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":323,"targetDuration":4,"studyType":22,"phases":325,"briefSummary":326,"conditions":327,"keywords":334,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":354},"100551821","phase-1-a-study-of-ly4052031-in-participants-with-advanced-or-metastatic-urothelial-cancer-or-other-solid-tumors-100551821","NCT06465069","A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors","A Phase 1a\u002F1b Study of LY4052031, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Advanced or Metastatic Urothelial Carcinoma or Other Solid Tumors","NEXUS-01","Inclusion Criteria:\n\n* Have one of the following solid tumor cancers:\n\n  * Cohort A1: urothelial carcinoma, triple negative breast cancer, non-small cell lung cancer, esophageal cancer, pancreatic cancer, ovarian cancer, cervical cancer (squamous cell carcinoma), head and neck squamous cell carcinoma or prostate cancer\n  * Cohort A2\u002FB1\u002FB2: urothelial carcinoma\n  * Cohort C: triple negative breast cancer, non-small cell lung cancer, ovarian cancer, cervical cancer, HNSCC (head and neck squamous cell carcinoma), esophageal cancer, pancreatic cancer, or prostate cancer\n* Prior Systemic Therapy Criteria:\n\n  * Cohort A1\u002FC: Individual has received all standard therapies for which the participant was deemed to be an appropriate candidate by the treating investigator; OR there is no standard therapy available for the disease. There is no restriction on number of prior therapies\n  * Cohort A2\u002FB1\u002FB2: Individual must have received at least one prior regimen in the advanced or metastatic setting. There is no restriction on number of prior therapies.\n* Prior enfortumab vedotin specific requirements:\n\n  * Cohorts A1\u002FA2\u002FC: prior treatment with enfortumab vedotin is allowed, but not required\n  * Cohort B1: individual must be enfortumab vedotin naive in the advanced\u002Fmetastatic setting\n  * Cohort B2: individual must have received enfortumab vedotin in the metastatic\u002Fadvanced setting.\n* Measurability of disease\n\n  * Cohort A1: measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1)\n  * Measurable disease is required as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) for all Cohorts. Cohort A1 may permit non-measurable disease as defined by RECIST v1.1\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Have adequate archival tumor tissue sample available or undergo a screening biopsy if allowed per country specific regulations\n\nExclusion Criteria:\n\n* Individual with known or suspected uncontrolled CNS metastases\n* Individual with uncontrolled hypercalcemia\n* Individual with uncontrolled diabetes\n* Individual with evidence of corneal keratopathy or keratitis, and history of corneal transplant\n* Any serious unresolved toxicities from prior therapy\n* Significant cardiovascular disease\n* Recent thromboembolic event and\u002For clinically significant bleeding disorder\n* Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 ms\n* History of pneumonitis\u002Finterstitial lung disease\n* History of Grade ≥3 skin toxicity when receiving enfortumab vedotin\n* Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention",{"count":324,"type":21},420,[24],"The purpose of this study is to find out whether the study drug, LY4052031, is safe, tolerable and effective in participants with advanced, or metastatic solid tumors including urothelial cancer. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.",[139,328,136,329,30,330,300,292,110,331,288,141,332,333],"Recurrent Solid Tumor","Urinary Bladder Neoplasm","Non-small Cell Lung Cancer","Cervical Cancer","Renal Pelvis Cancer","Bladder Cancer",[333,335,336,337,338,339,332,340,341,342,343,344,345],"Bladder Neoplasm","Bladder Urothelial Carcinoma","Urinary Bladder Cancer","Urinary Tract Cancer","Urothelial Neoplasms","Ureter Cancer","Nectin-4","Antibody Drug Conjugate (ADC)","Triple Negative Breast Cancer (TNBC)","Non-small Cell Lung Cancer (NSCLC)","Head and Neck Squamous Cell Carcinoma (HNSCC)","2026-06-17",{"date":348,"type":38},"2026-06-18",{"date":350,"type":38},"2024-07-01",{"date":352,"type":21},"2027-05",{"name":274,"class":70},34,{"id":356,"slug":357,"hasResults":12,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":4,"eligibilityCriteria":361,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":362,"targetDuration":4,"studyType":22,"phases":364,"briefSummary":365,"conditions":366,"keywords":372,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":389},"100631678","phase-1-a-study-of-ide034-in-adult-participants-with-locally-advancedmetastatic-solid-tumors-types-100631678","NCT07503808","A Study of IDE034 in Adult Participants With Locally Advanced\u002FMetastatic Solid Tumors Types","An Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE034 in Adult Participants With Locally Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n1. Participant must be at least 18 years of age or the age of maturity per local regulations\n2. Participants with advanced recurrent or metastatic solid tumors expressing B7-H3 and PTK7 in the following indications: NSCLC, ESCC, endometrial cancer, HGSOC, HNSCC, TNBC (estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 \\[HER2\\] negative), CRC, and CRPC who have radiologically progressed or recurred on at least one line of therapy or is intolerant to additional effective standard therapies.\n3. Archival tissue sample for testing\n4. Measurable disease\n5. Have Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.\n6. Have adequate bone marrow and organ function.\n7. Able to comply with contraceptive\u002Fbarrier requirements\n\nExclusion Criteria:\n\n1. Known symptomatic brain metastases or leptomeningeal metastasis\n2. Known primary CNS malignancy and any other malignancies within 2 years prior to the first dose.\n3. Have uncontrolled tumor-associated pain\n4. Have clinically significant cardiac abnormalities and\u002For cerebrovascular disease (stroke) within 6 months before the first dose\n5. Active uncontrolled infection\n6. Have history of interstitial pneumonitis, current noninfectious pneumonitis requiring steroid therapy; known or suspected interstitial pneumonitis as seen on screening imaging; other moderate to severe lung diseases seriously affecting respiratory function within 3 months before the first dose.\n7. Have history of severe infections within 4 weeks prior to the start of study treatment, including but not limited to bacteremia, severe pneumonia, or other serious infectious complications requiring hospitalization.\n8. Have history of immunodeficiency, with a positive human immunodeficiency virus (HIV) test at screening.\n9. Participants with known or suspected viral hepatitis\n10. Have history of active tuberculosis within 1 year before enrollment\n11. If participants had adverse reactions to previous antitumor treatment that have not recovered to guidelines of CTCAE Grade ≤ 1 and Grade 2 peripheral neurological symptoms\n12. Have received chemotherapy within 3 weeks of first dose of IMP; immunotherapy or biologic targeted antitumor treatments within 3 weeks before the first dose of IMP or other investigational products within 4 weeks of first dose of IMP\n13. Administration of any of the following\n\n    1. Current use or anticipated need for food or drugs that are known strong CYP3A4\u002F5 inhibitors or inducers\n    2. Have prior treatment with B7-H3 or PTK7 antibody-drug conjugate (ADC).\n    3. Have prior treatment with a topoisomerase I inhibitor (TOP1i), including an ADC with a TOP1i payload, within 6 months of first dose of IMP\n    4. Have received radiotherapy within 2 weeks prior to study entry\n    5. Have undergone major surgery or trauma within 4 weeks prior to study entry.\n    6. Have received live attenuated vaccine within 28 days prior to the first dose or are expected to receive live attenuated vaccine during the study treatment.\n    7. Female participants who are pregnant, lactating, or planning to become pregnant during the study period to 7 months after the last dose of IMP.\n    8. Are known to be allergic to any component or excipient of the IMP product or have a history of severe allergic reactions to other monoclonal antibody\u002Ffusion protein drugs.\n    9. Participants with complications in the eye including ulcers in the eye, and severe dry eye",{"count":363,"type":21},150,[24],"This is a Phase 1a\u002F1b, open-label, multicenter dose escalation and dose expansion clinical study to evaluate the safety, PK, immunogenicity and preliminary efficacy of IDE034 in participants with locally advanced\u002Fmetastatic solid tumor types that express B7-H3 and PTK7.",[367,368,288,142,369,370,371,30],"Esophageal Squamous Cell Carcinoma","High Grade Serous Ovarian Cancer","Castration-resistant Prostate Cancer","Non Small Cell Lung Cancer","Endometrium Cancer",[367,373,109,288,294,374,154,142,375,369,376,330,150,377,303,378,379,380],"ESCC","Triple-negative Breast Cancer","CRC","CRPC","High-grade Serous Ovarian Cancer","Advanced, Metastic Solid Tumors","B7-H3 (CD276) and Protein Tyrosine Kinase 7 (PTK7)","IDE034","2026-06-16",{"date":348,"type":38},{"date":384,"type":38},"2026-02-24",{"date":386,"type":21},"2027-07-30",{"name":388,"class":70},"IDEAYA Biosciences",15,{"id":391,"slug":392,"hasResults":12,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":4,"eligibilityCriteria":396,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":397,"enrollmentInfo":398,"targetDuration":4,"studyType":22,"phases":400,"briefSummary":401,"conditions":402,"keywords":406,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":411,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":418},"100613057","phase-1-phase-i-study-of-177lulu-dfc413-in-patients-with-solid-tumors-100613057","NCT07261631","Phase I Study of [177Lu]Lu-DFC413 in Patients With Solid Tumors","A Phase I Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Dosimetry, and Preliminary Activity of [177Lu]Lu-DFC413 and Safety and Imaging Properties of [68Ga]Ga-NNS309 in Patients With Solid Tumors","Inclusion Criteria:\n\n* Adults ≥ 18 years with one of the following indications:\n* Locally advanced unresectable or metastatic PDAC, with disease progression following, or intolerance to cytotoxic therapy, unless patient was ineligible to receive such therapy\n* Locally advanced unresectable or metastatic NSCLC without any actionable genomic alterations with disease progression following, or intolerance to chemotherapy and immunotherapy, unless patient was ineligible to receive such therapy, or locally advanced unresectable or metastatic NSCLC with an actionable genomic alteration with disease progression following, or intolerance to chemotherapy and targeted therapy, unless patient was ineligible to receive such therapy\n* Locally advanced unresectable or metastatic HR+\u002FHER2- ductal and lobular breast cancer with disease progression following, or intolerance to, hormone therapy and CDK inhibitor, and at least one additional line of therapy, unless patient was ineligible to receive such therapy\n* Locally advanced unresectable or metastatic triple negative breast cancer (TNBC) with disease progression following, or intolerance to, at least two lines of therapy, unless patient was ineligible to receive such therapy\n* Locally advanced or metastatic unresectable CRC with disease progression following, or intolerance to cytotoxic chemotherapy, unless patient was ineligible to receive such therapy. Patients with known microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) status must also have had disease progression following, or intolerance to, immune checkpoint inhibitor therapy, unless patient was ineligible to receive such therapy\n* (Dose expansion only) Locally advanced unresectable or metastatic soft tissue sarcoma (excluding GIST and Kaposi) with disease progression following, or intolerance to, at least one line of systemic therapy\n* Patients must have lesions showing 68Ga-NNS309 uptake\n\nExclusion Criteria:\n\n* Absolute neutrophil count (ANC) \\\u003C 1.5 x 109\u002FL, hemoglobin \\\u003C 9 g\u002FdL, or platelet count \\\u003C 100 x 109\u002FL\n* QT interval corrected by Fridericia's formula (QTcF) ≥ 470 msec\n* eGFR \\\u003C 60 mL\u002Fmin\u002F1.73m2, calculated using CKD-EPI 2021 or measured\n* Unmanageable urinary tract obstruction or urinary incontinence\n* Presence of symptomatic CNS metastases, or CNS metastases that require local CNS-directed therapy\n* Any prior radioligand therapy\n* Radiation therapy within 4 weeks prior to the first dose of \\[177Lu\\]Lu-DFC413\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","100 Years",{"count":399,"type":21},180,[24],"The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of \\[177Lu\\]Lu-DFC413 and safety and imaging properties of \\[68Ga\\]Ga-NNS309 in patients aged ≥ 18 years with solid tumors",[403,156,404,30,142,405],"Pancreatic Ductal Adenocarcinoma","HR+\u002FHER2- Ductal and Lobular Breast Cancer","Soft Tissue Sarcoma",[407,150,408,375,409,410],"PDAC","Breast cancer","STS","Radioligand therapy (RLT)",{"date":346,"type":38},{"date":413,"type":38},"2025-11-24",{"date":415,"type":21},"2029-05-09",{"name":417,"class":70},"Novartis Pharmaceuticals",8,{"id":420,"slug":421,"hasResults":12,"nctId":422,"briefTitle":423,"officialTitle":424,"acronym":4,"eligibilityCriteria":425,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":426,"targetDuration":4,"studyType":22,"phases":428,"briefSummary":429,"conditions":430,"keywords":431,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":437,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":443,"locationsCount":46},"100616043","phase-1-personalized-cancer-vaccine-pcv-strategy-in-triple-negative-breast-cancer-patients-100616043","NCT07300475","Personalized Cancer Vaccine (PCV) Strategy in Triple Negative Breast Cancer Patients","Phase 1 Clinical Trial of a Personalized Cancer Vaccine (PCV) Strategy +\u002F- AB248 (CD8-selective IL-2 Mutein Fusion Protein) in Patients With a New Diagnosis of Triple Negative Breast Cancer Undergoing Neoadjuvant Chemoimmunotherapy","Step 0 Inclusion Criteria:\n\n* Newly diagnosed, previously untreated, locally advanced non-metastatic triple negative breast cancer (as defined by the most recent ASCO\u002FCAP guidelines). Permissible staging per AJCC is as follows:\n\n  * T1c, N1-N2\n  * T2, N0-N2\n  * T3, N0-N2\n* At least 18 years of age.\n* Adequate tissue available for nucleic acid isolation\u002FPCV design or willing to undergo biopsy if adequate tissue is not available.\n* Adequate cardiac function per treating physician and a candidate for the KEYNOTE 522 regimen (or receiving the KEYNOTE 522 regimen for no more than one month). Note that patients who are already receiving the KEYNOTE 522 regimen at the time of screening must have adequate archival tissue for nucleic acid isolation\u002FPCV design (biopsy will not be permitted).\n* TIL percentage \\\u003C 10% (performed on SOC biopsy).\n* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nStep 0 Exclusion Criteria:\n\n* Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial.\n* Received prior chemotherapy, targeted therapy, or radiation therapy within the past 12 months.\n* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another co-inhibitory T-cell receptor.\n* Currently receiving any other investigational agents.\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in the study.\n* Received a live vaccine within 30 days of the first dose of pembrolizumab.\n* Active autoimmune disease that has required systemic treatment in the past 2 years.\n* Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab.\n* History of (non-infectious) pneumonitis that required steroids, or current pneumonitis.\n* Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. Patients with a known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Function Classification; to be eligible for this trial, patients should be a class 2B or better.\n* Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative pregnancy test within 7 days of study entry.\n* Known history of active TB (bacillus tuberculosis).\n* Known history of HIV.\n* Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing not required in the absence of known history of infection.\n* History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection.\n\nStep 1 Inclusion Criteria:\n\n* ECOG performance status ≤ 1 within 10 days of initiation of PCV\n* Adequate bone marrow and organ function within 28 days of initiation of PCV as defined below:\n\n  * Absolute neutrophil count ≥ 1.0 K\u002Fcumm\n  * Platelets ≥ 100 K\u002Fcumm\n  * Hemoglobin ≥ 8.0 g\u002FdL\n  * Total bilirubin ≤ 1.5 x IULN\n  * AST(SGOT)\u002FALT(SGPT) ≤ 3.0 x IULN\n  * Creatinine clearance \\> 30 mL\u002Fmin by Cockcroft-Gault\n* The effects of the PCV on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 6 months after last dose of PCV. Should a woman become pregnant or suspect she is pregnant while participating in this study or should a man suspect he has fathered a child, s\u002Fhe must inform her treating physician immediately.\n* Received at least 4 months of the KEYNOTE 522 regimen.\n\nStep 1 Exclusion Criteria:\n\n* Currently receiving any other investigational agents.\n* Pregnant and\u002For breastfeeding.\n* Experiencing ongoing AEs related to the SOC KEYNOTE 522 regimen that have not resolved to \\\u003C grade 3. Patients may be permitted to enroll with a grade 3 AE with approval of the PI and treating physician.\n* QTcF \\> 470 msec.",{"count":427,"type":21},30,[24],"This is a phase 1 clinical trial to evaluate the safety, feasibility and immunogenicity of a personalized cancer vaccine (PCV) strategy with or without CD8-selective IL-2 mutein fusion protein in patients with triple negative breast cancer undergoing neoadjuvant chemoimmunotherapy.",[30],[432,433,434,435],"Personalized medicine","IL-2","Cancer neoantigen","Personalized cancer vaccine","2026-06-11",{"date":438,"type":38},"2026-06-15",{"date":440,"type":21},"2026-08-01",{"date":442,"type":21},"2035-04-30",{"name":444,"class":45},"Washington University School of Medicine",{"id":446,"slug":447,"hasResults":12,"nctId":448,"briefTitle":449,"officialTitle":450,"acronym":4,"eligibilityCriteria":451,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":452,"targetDuration":4,"studyType":22,"phases":454,"briefSummary":449,"conditions":455,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":463,"startDateStruct":464,"completionDateStruct":466,"leadSponsor":468,"locationsCount":470},"100601788","phase-1-a-study-to-investigate-safety-of-azd6750-in-adult-participants-with-select-advanced-or-metastatic-solid-tumors-100601788","NCT07115043","A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors","A Phase I\u002FII Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6750, a CD8 Guided IL-2 Agent Alone and in Combination With Other Anti-cancer Agents in Participants With Select Advanced or Metastatic Solid Tumors","Inclusion criteria:\n\n* Participant ≥ 18 year\n* ECOG PS of 0 to 1\n* Provision of 'archival' tumor specimen\n* At least one measurable lesion according to RECIST v1.1,\n* Minimum life expectancy of 12 weeks\n* Adequate and stable cardiac function\n* Adequate bone marrow, liver and kidney function\n* Body weight ≥ 35 kg\n* Capable of giving signed informed consent\n\nModule 1 specific inclusion criteria:\n\n• Participants with locally advanced or metastatic select solid tumors (MM, Squamous cell carcinoma of skin, MCC, NSCLC, Head and neck squamous cell carcinoma, Gastric cancer\u002Fgastroesophaegeal junction cancer, RCC, HGSOC, Triple negative breast cancer) who have received adequate SoC\n\nModule 2 specific inclusion criteria:\n\n* Participants with Stage IV NSCLC Dose Escalation\u002FBackfills\n\n  1. Have received at least one prior regimen in metastatic setting (2L+ NSCLC). Participants with actionable tumor alterations should have received targeted therapy if locally available OR\n  2. Have not received systemic therapy (1L NSCLC) and have PD-L1 expression ≥ 1%.\n\n     Dose Expansion\n\n  \u003C!-- -->\n\n  1. Have not received systemic therapy (1L NSCLC) and have PD-L1 expression ≥ 1%.\n\n     Exclusion criteria:\n* Any evidence of:\n\nSevere or uncontrolled systemic diseases including respiratory, cardiac or tumor-related conditions\n\n* History or planned organ or allogeneic stem cell transplantation.\n* Active or prior documented autoimmune or inflammatory disorders, within the past 3 years\n* Any prior toxicities that led to permanent discontinuation of prior immunotherapy\n* Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anti-cancer therapy\n* Brain metastases unless treated, asymptomatic, stable, and not requiring continuous corticosteroids\n* Acute untreated or symptomatic malignant spinal cord compression, or a history of leptomeningeal carcinomatosis.\n* Active uncontrolled or chronic infection of hepatitis B, hepatitis C\n* Prior history of Grade ≥ 3 non-infectious pneumonitis.\n* Participant requires chronic immunosuppressive therapy (including steroids \\> 10 mg prednisone\u002Fday or equivalent).\n* Receipt of live attenuated vaccine within 30 days.\n\nModule 2 specific exclusion criteria:\n\n* Previous treatment with anti-TIGIT therapy\n* 1L NSCLC participants with genetic alteration such as EGFR that has a targeted therapy in 1L as per local SoC",{"count":453,"type":21},60,[24,106],[456,330,457,458,459,30,288,460,461],"Melanoma","Squamous Cell Carcinoma (Skin)","Renal Cell Carcinoma","Merkel Cell Carcinoma","Gastric Cancer\u002FGastroesophageal Junction Cancer","High Grade Serous Ovarian Carcinoma","2026-06-10",{"date":436,"type":38},{"date":465,"type":38},"2025-07-29",{"date":467,"type":21},"2029-10-02",{"name":469,"class":70},"AstraZeneca",13,{"id":472,"slug":473,"hasResults":12,"nctId":474,"briefTitle":475,"officialTitle":476,"acronym":4,"eligibilityCriteria":477,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":478,"targetDuration":4,"studyType":22,"phases":480,"briefSummary":481,"conditions":482,"keywords":483,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":489,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":494,"locationsCount":496},"100487941","phase-3-study-of-sacituzumab-govitecan-hziy-and-pembrolizumab-versus-treatment-of-physicians-choice-in-patients-with-triple-negative-breast-cancer-who-have-residual-invasive-disease-after-surgery-and-neoadjuvant-therapy-ascent-05aft-65-optimice-rdgbg-119nsabp-b-63-100487941","NCT05633654","Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05\u002FAFT-65 OptimICE-RD\u002FGBG 119\u002FNSABP B-63)","A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy","Key Inclusion Criteria:\n\n* Age \\> 18 years, with residual invasive triple negative breast cancer (TNBC) in the breast or lymph nodes after neoadjuvant therapy and surgery:\n\n  * TNBC criteria for the study is defined as estrogen receptor (ER) and progesterone receptor (PR) ≤ 10%, human epidermal growth factor receptor 2 (HER2)-negative per American Society of Clinical Oncology and College of American Pathologists (ASCO\u002FCAP) guidelines (immunohistochemistry (IHC) and\u002For in situ hybridization (ISH)).\n* Adequate excision and surgical removal of all clinically evident of disease in the breast and\u002For lymph nodes and have adequately recovered from surgery.\n* Submission of both pre-neoadjuvant treatment diagnostic biopsy and resected residual invasive disease tissue.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n* Individuals must have received appropriate radiotherapy aligned with local\u002Finstitutional practice and have recovered prior to starting study treatment.\n* Adequate organ function.\n\nKey Exclusion Criteria:\n\n* Stage IV (metastatic) breast cancer as well as history of any prior (ipsi- or contralateral) invasive breast cancer.\n* Prior treatment with another stimulatory or coinhibitory T-cell receptor agent (eg, cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), OX-40, cluster of differentiation 137 (CD137), prior treatment with any HER2-directed agent, prior endocrine therapy for \\> 4 weeks or planned concurrent endocrine therapy while receiving on-study treatment.\n* Evidence of recurrent disease following preoperative therapy and surgery.\n* Prior treatment with topoisomerase 1 inhibitors or antibody-drug conjugates (ADCs) containing a topoisomerase inhibitor.\n* Individuals with germline breast cancer gene (BRCA) mutations.\n* Myocardial infarction or unstable angina pectoris within 6 months of enrollment or history of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias or Left ventricular ejection fraction (LVEF) of \\\u003C 50%\n* Active serious infections requiring anti-microbial therapy.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":479,"type":21},1514,[57],"The goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC) which includes either pembrolizumab or pembrolizumab plus capecitabine in participants with triple negative breast cancer that still remains after surgery and pre-surgical treatment.",[30],[484,485,486,487],"AFT-65","GBG 119","NSABP B-63","OptimICE-RD","2026-06-09",{"date":462,"type":38},{"date":491,"type":38},"2022-12-12",{"date":493,"type":21},"2031-08",{"name":495,"class":70},"Gilead Sciences",350,{"id":498,"slug":499,"hasResults":12,"nctId":500,"briefTitle":501,"officialTitle":502,"acronym":4,"eligibilityCriteria":503,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":504,"targetDuration":4,"studyType":22,"phases":506,"briefSummary":507,"conditions":508,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":512,"startDateStruct":513,"completionDateStruct":515,"leadSponsor":517,"locationsCount":519},"100445155","phase-1-mem-288-oncolytic-virus-alone-and-in-combination-with-standard-of-care-therapy-in-advanced-solid-tumors-100445155","NCT05076760","MEM-288 Oncolytic Virus Alone and in Combination With Standard of Care Therapy in Advanced Solid Tumors","Phase I Study Evaluating MEM-288 Oncolytic Virus Alone and in Combination With Standard of Care Therapy in Advanced Solid Tumors","Inclusion Criteria:\n\n1. Ability to understand and provide informed consent.\n2. Willingness and ability to comply with scheduled study visits and procedures.\n3. Adult men or women age ≥ 18 years.\n4. ECOG performance status of 0 or 1.\n5. Part 1A monotherapy: Advanced\u002Fmetastatic NSCLC, cSCC, Merkel cell, melanoma, TNBC, pancreatic cancer, or head and neck cancer.\n6. Parts 1B and 1C combination: Advanced\u002Fmetastatic NSCLC which has progressed following front-line anti-PD-1\u002FPD-L1 with or without concurrent chemotherapy.\n7. Per each tumor type shown below, the specific initial standard of care therapies after which the subjects with specific histologies must have progressed have been included. Subjects will have been treated with at least one or more than one line of therapy prior to enrollment in the study.\n\n   1. Non-small cell lung cancer (NSCLC)\n\n      Part 1A monotherapy\n      * Must have progressed on standard therapy, including platinum-based chemotherapy and checkpoint inhibitor therapy (combined or sequential).\n      * Patients with tumors that have known actionable molecular alteration such in EGFR, ALK, ROS-1, BRAF, RET, MET, and KRAS must have progressed on standard directed molecular therapy, and platinum-based chemotherapy.\n\n      Part 1B MEM-288 plus nivolumab combination\n      * Must have first progression more than (\\>) 84 days following initiation (cycle 1 day 1) of their most recent anti-PD-1 or PD-L1 checkpoint inhibitor therapy with or without concurrent chemotherapy\n\n      Part 1C MEM-288 plus docetaxel combination must have either:\n      * first progression with anti-PD-1 or PD-L1 checkpoint inhibitor therapy with or without concurrent chemotherapy, or\n      * progressed following initial first line anti-PD-1 or PD-L1 monotherapy followed by 2nd line platinum chemotherapy (with or without continuation of their first line anti-PD-1 or PD-L1 therapy).\n   2. Cutaneous squamous-cell carcinoma (cSCC)\n\n      * Must have progressed on standard therapy, including platinum-based chemotherapy and\u002For checkpoint inhibitor therapy.\n   3. Merkel cell Carcinoma\n\n      * Must have progressed on standard checkpoint inhibitor therapy.\n   4. Melanoma\n\n      * Subjects must have received a BRAF inhibitor as monotherapy or in combination with other targeted agents for BRAF V600E mutant melanoma.\n      * Subjects must have received an anti-PD-1\u002F PD-L1inhibitor as monotherapy or combination with anti-CTLA-4 inhibitor or other therapies.\n   5. Pancreatic cancer\n\n      * Progression after systemic chemotherapy which included either gemcitabine or Fluorouracil (5-FU)-based regimen (including capecitabine).\n   6. Triple negative breast cancer (TNBC)\n\n      * Prior treatment (for advanced, metastatic or (neo)adjuvant) must have included a taxane and\u002For anthracycline-based therapy.\n   7. Head and Neck Cancer\n\n      * Prior treatment requirement in the metastatic or unresectable locally advanced setting include:\n      * Subjects must have received a platinum containing chemotherapy regimen for treatment of primary tumor in locally advanced, or metastatic settings\n      * Subjects must have received an anti-PD-1\u002F PD-L1 as monotherapy or in combination with chemotherapy.\n8. Progressed following therapy with at least one PD-1 or PD-L1 checkpoint inhibitor (regardless of PD-L1 expression status), except for patients with pancreatic cancer.\n\n   a) Prior progression on a PD-1 or PD-L1 checkpoint inhibitor should be unequivocal; progression that occurs within the first 8 weeks of treatment on these agents should be confirmed with a second CT at least 4 weeks apart (to exclude pseudo-progression).\n9. Patients with activating EGFR mutation or ALK rearrangement which is expected to be responsive to available tyrosine kinase inhibitor therapy, must have been previously treated with an applicable tyrosine kinase inhibitor.\n10. Tumor lesion which is deemed feasible for biopsy and injection under CT or ultrasound guidance (based on size, location, and visibility) by an interventional radiologist, and patient willing and able to provide tissue from biopsy of this lesion. Injected tumor should be \\> 1 cm3 in volume and should not encase or be inseparable from vital structures such as major nerves or blood vessels.\n\n    a) For Part 1 monotherapy patients treated at the first dose level, the tumor for injection must be an accessible cutaneous, subcutaneous, or superficial lymph node lesion that is palpable.\n11. Measurable disease, as defined per RECIST version 1.1.\n12. Prior history of brain metastases are eligible, provided:\n\n    1. Brain metastases have been treated\n    2. Asymptomatic from the brain metastases\n    3. Corticosteroids prescribed for the management of brain metastases have been discontinued at least 7 days before registration to study\n    4. Brain metastases are stable on pre-registration imaging\n    5. No evidence of leptomeningeal disease\n13. Life expectancy \\> 3 months.\n14. Adequate organ and marrow function as defined below:\n\n    1. Absolute neutrophil count (ANC) ≥1.5 x 10\\^9\u002FL\n    2. Hemoglobin ≥90 g\u002FL (or ≥9 g\u002FdL)\n    3. Platelets ≥100 x 10\\^9\u002FL\n    4. Calculated creatinine clearance of \\>50 mL\u002Fmin using Cockcroft Gault equation\n    5. Total bilirubin ≤ 1.5 x institutional upper limit of normal\n    6. AST (SGOT) and ALT (SGPT) ≤2.5 x institutional upper limit of normal\n    7. If Alkaline Phosphatase ≥ 2.5 x institutional upper limit of normal, then AST and ALT must be ≤ 1.5 x institutional upper limit of normal\n15. Patients of childbearing age must not be pregnant and must use established contraceptive strategies:\n\n    1. Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n    2. Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 1 year.\n    3. Male subjects should agree to use an adequate method of barrier contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.\n\nExclusion Criteria:\n\n1. Pregnant or breast feeding.\n2. Serious uncontrolled medical disorder, psychiatric condition or laboratory abnormalities that, in the opinion of the investigator, may increase the risk associated with study participation or may interfere with the interpretation of study results.\n3. Major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic), or significant traumatic injury, within 4 weeks prior to starting study treatment or has not recovered from side effects of such procedure. Video-assisted thoracic surgery (VATS) and mediastinoscopy are exceptions and patients can receive study treatment ≥1 week after these procedures.\n4. History of clinically significant noninfectious interstitial pneumonitis (i.e., limiting activities of daily living or requiring therapeutic intervention), including clinically significant radiation pneumonitis.\n5. Residual toxicity from prior anticancer therapy of grade 3 or greater (CTCAE v5.0), with the exception of alopecia.\n6. Concurrent use of other anticancer approved or investigational agents.\n7. Clinically significant, uncontrolled heart disease and\u002For recent cardiac event (within 6 months), such as:\n\n   1. unstable angina within 6 months prior to screening\n   2. myocardial infarction within 6 months prior to screening\n   3. history of documented congestive heart failure (New York Heart Association functional classification III-IV)\n   4. cardiac arrhythmias not controlled with medication\n8. Active autoimmune disease requiring disease modifying therapy (except vitiligo, Grave's, or psoriasis not requiring systemic treatment).\n9. Any form of active primary or secondary immunodeficiency.\n10. Receiving ≥10 mg daily prednisone (or equivalent).\n11. Prior malignancy (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, cervical\u002Fdysplasia endometrial, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required or anticipated to be required during the study period.\n12. Active systemic infections requiring intravenous antibiotics.\n13. Prior therapy with anti-tumor vaccines or other immune-stimulatory antitumor agents (other than FDA approved and National Comprehensive Cancer Network \\[NCCN\\] recommended systemic therapies).\n14. Prisoners or subjects who are involuntarily incarcerated, or who are compulsorily detained for treatment of either a psychiatric or physical illness.\n15. Any unresolved grade 2 irAE (except adequately treated endocrine irAE).\n16. Any toxicity that led to permanent discontinuation of prior anti-PD-1\u002FPD-L1 immunotherapy.",{"count":505,"type":21},40,[24],"This is a multipart, open-label, multi-center dose escalation, dose expansion phase I clinical trial designed to evaluate the safety, tolerability, maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), and preliminary efficacy of MEM-288 in patients with advanced solid tumors. Eligible subjects must have a tumor lesion(s) which is accessible for injection.\n\nThe dose escalation phase (Part 1A - advanced solid tumors) has completed and is closed to enrollment. This phase evaluated multiple doses of MEM-288 dosed via intratumoral injection once every 3 weeks to assess safety, tolerability, preliminary efficacy, and to determine the MTD.\n\nThe dose expansion phase has multiple parts for advanced NSCLC. Part 1B has completed after evaluation of MEM-288 dosed via intratumoral injection in combination with standard of care nivolumab dosed via intravenous injection.\n\nIn a separate dose expansion arm (Part 1C) that is open for enrollment, patients with advanced NSCLC will be randomized to receive either an initial priming dose of MEM-288 injected into an accessible lesion (s) alone (Day 1) followed by MEM-288 in combination with standard of care docetaxel every 3 weeks up to 6 doses or MEM-288 injected into an accessible lesion(s) in combination with standard of care docetaxel therapy Day 1 and every 3 weeks up to 6 doses.\n\nThe study rationale is that the oncolytic effect of MEM-288 combined with the presence of CD40L and type 1 IFN in injected tumors will provide a strong signal for DC-mediated T cell activation leading to generation of systemic anti-tumor T cell responses with broad specificity akin to what is observed in the abscopal effect.",[509,510,138,370,511,459,456,292,30,145],"Solid Tumor","Advanced Cancer","Cutaneous Squamous Cell Carcinoma",{"date":436,"type":38},{"date":514,"type":38},"2022-04-21",{"date":516,"type":21},"2031-12",{"name":518,"class":70},"Memgen, Inc.",2,{"id":521,"slug":522,"hasResults":12,"nctId":523,"briefTitle":524,"officialTitle":525,"acronym":4,"eligibilityCriteria":526,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":527,"targetDuration":4,"studyType":22,"phases":529,"briefSummary":530,"conditions":531,"keywords":535,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":537,"lastUpdatePostDateStruct":538,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":543,"locationsCount":46},"100533350","phase-2-arx788-for-treating-patients-with-her2-low-locally-advanced-unresectable-or-metastatic-breast-cancer-100533350","NCT06224673","ARX788 for Treating Patients With HER2-low Locally Advanced Unresectable or Metastatic Breast Cancer","Phase II Open-label Study of ARX788 (Anti-HER2 Antibody Drug Conjugate (ADC)) for Patients With HER2-low Locally Advanced Unresectable or Metastatic Breast Cancer","Inclusion Criteria:\n\n* Male or female participants age 18 years or greater with ability to provide written informed consent for the study.\n* Eastern Cooperative Oncology Group (ECOG) score of 0-2.\n* Estimated life expectancy of at least at 6 months per investigator assessment.\n* Ability to understand and the willingness to sign a written informed consent document.\n* Pathologically documented HER2-low locally advanced unresectable or metastatic breast cancer (MBC). NOTE: human epidermal growth factor receptor 2 (HER2)-low status determined by HER2 immunohistochemistry (IHC) 1+ or 2+ and no evidence of HER2 gene amplification by in situ hybridization (ISH)\u002Ffluorescence in situ hybridization (FISH), which can be documented from any tumor sample during the patient's cancer treatment history (early-stage or metastatic).\n\n  * Cohort 1: Participants with hormone receptor positive (HR+)\u002FHER2-low locally advanced unresectable or MBC. HR+ status defined as estrogen receptor \\>= 10% and\u002For progesterone receptor ≥ 10% and HER2 low.\n  * Cohort 2: Participants with hormone receptor negative (HR-)\u002FHER2-low locally advanced unresectable or MBC. Considered HR- if estrogen receptor (ER) and progesterone receptor (PR) \\\u003C 10% and HER2-low.\n* Presence of at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. NOTE: Participant's with at least one measurable lytic bone lesion are eligible.\n* Availability of tumor block or formalin-fixed paraffin-embedded (FFPE) tissue as 10 precut unstained slides will be collected for the HER2 status evaluation and biomarker analysis based on the most recent tumor tissue sample. NOTE: New pretreatment biopsy tissue is preferred as HER2 status may change, but a fresh biopsy is not required. The study team and investigator will make every attempt to get archival tissue. Participants who do not have archival or new tumor tissue available may be eligible after discussion with the study principal investigator (PI).\n* Participants with stable and treated brain metastases are eligible if the participants meet the following criteria:\n\n  * Prior stereotactic radiosurgery (SRS) should be completed \\>=7 days before study treatment initiation.\n  * Prior whole-brain radiation therapy should be completed \\>=14 days before study treatment initiation.\n  * Any ongoing use of systemic corticosteroids does not exceed 2 mg of dexamethasone (or equivalent) daily.\n* Participants must have received at least one prior line of chemotherapy or ADC therapy for locally advanced unresectable or metastatic disease. Prior checkpoint inhibitor therapy is allowed.\n* Hemoglobin ≥ 8.0 g\u002FdL\n* Absolute neutrophil count ≥ 1.0 x 10\\^9\u002FL\n* Platelets ≥ 100,000 x 10\\^9\u002FL\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal, unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase (SGOT)) \\\u003C 3 x institutional upper limit of normal. In participants with liver metastases, \\\u003C= 5 x institutional upper limit of normal is allowed.\n* Alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase (SGPT)) \\\u003C 3 x institutional upper limit of normal. In participants with liver metastases, \\\u003C=5 x institutional upper limit of normal is allowed.\n* Creatinine ≤ 1.5 x within institutional upper limit of normal OR creatinine clearance glomerular filtration rate (GFR) ≥ 50 mL\u002Fmin\u002F1.73 m, calculated using the Cockcroft-Gault equation\n* Adequate cardiac function as assessed by left ventricular ejection fraction ≥ 50% or institutional lower limit of normal.\n* Human immunodeficiency virus (HIV)-infected individuals on effective antiretroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy.\n* Individuals with a history of hepatitis C virus (HCV) infection must have been treated without detectable HCV RNA.\n* Participants must have recovered from all acute toxicities from prior therapies to ≤ grade 1 or baseline (except for alopecia and neuropathy) per the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) v 5.0.\n* Male and female subjects of reproductive\u002Fchildbearing potential must agree to use a highly effective form of contraception or total sexual abstinence during and upon completion of the study; and for at least 3 months after the last dose of study drug for women of childbearing potential (WOCBP) and at least 5 months after the last dose of study drug for men whose partners are WOCBP.\n* Male subjects must agree to not freeze or donate sperm starting at Screening and throughout the study period, and at least 5 months after the final study drug administration.\n* Female subjects must agree to not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 3 months after the final study drug administration.\n\nExclusion Criteria:\n\n* Has a prior history of treatment with ARX-788 or auristatin analogues.\n* Has a history of allergic reaction to any component of ARX788.\n* Has exposure to any other investigational or commercial anti-cancer agents or therapies administered with the intention to treat malignancy within 14 days before the first dose of study treatment. NOTE: Anti-hormonal therapy may be administered up to 7 days prior to the first dose of study treatment.\n* Radiotherapy outside of the brain administered \\\u003C7 days prior to first dose of ARX788\n* Prior or current history of interstitial lung disease (ILD), pneumonitis, or other clinically significant lung disease with the exception of disease that is directly attributable to the presence of lung metastases from their underlying cancer.\n* Participants with significant pulmonary conditions, defined as any of the following:\n\n  * Any prior history of drug-induced immune-mediated pneumonitis.\n  * Prior history of radiation therapy to the chest of \\> 18 gray (Gy) with residual sequelae considered clinically significant by investigator assessment.\n  * Radiographic evidence of radiation fibrosis involving \\> 15% of the lung parenchyma associated with clinical symptoms.\n  * Any requirement for supplemental oxygen.\n* Clinically-significant ocular findings including history of keratitis, keratopathy, and\u002For active eye disease (excluding glaucoma).\n* History of congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, or myocardial infarction within 6 months prior to enrollment. QTcF prolongation of \\>470 msec (females) or \\>450 msec (males) based screening ECG.\n* Has a diagnosis of leptomeningeal carcinomatosis. NOTE: Stable brain metastases are allowed.\n* Has an active systemic or psychiatric illness that would impact the patient's ability to receive study therapy.\n* Has an uncontrollable intercurrent illness, infection (including participants with active, symptomatic Coronavirus disease of 2019 (COVID-19) infections), or other conditions that could limit study compliance or interfere with study assessments.\n* Has a history of an additional malignancy that is progressing or has required active treatment within the past 3 years. NOTE: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ (excluding carcinoma in situ of the bladder or high-grade cervical dysplasia in the last three years), and thyroid cancer not requiring cytotoxic agents that have undergone potentially curative therapy are not excluded.\n* Pregnancy or breastfeeding.\n* Has an active, uncontrolled hepatitis B, hepatitis C, and\u002For human immunodeficiency virus (HIV) infection. Participants with adequately controlled hepatitis B, hepatitis C, and\u002For HIV are allowed. NOTE: HIV and hepatitis B and C testing are not required for screening. Testing will only be done if clinically indicated.",{"count":528,"type":21},36,[106],"This phase II trial tests how well ARX788 works in treating patients diagnosed with HER2-low, locally advanced unresectable or metastatic breast cancer. ARX788 is an antibody-drug conjugate (ADC) that is given by infusion (diluted and injected slowly into veins). Antibodies are proteins which are naturally produced by the body's immune system to help fight infections. ARX788 consists of antibodies that have been attached to a toxin that has the potential to kill cancer cells. ARX788 sticks to a protein called human epidermal growth factor receptor (HER2), which is found on some breast cancer cells. Giving ARX788 may be safe and effective in treating patients with HER2-low locally advanced unresectable metastatic breast cancer.",[532,30,533,534],"HER2 Low Breast Carcinoma","Hormone-receptor-positive Breast Cancer","Hormone Receptor Positive Breast Carcinoma",[536],"Antibody-drug Conjugate","2026-06-08",{"date":436,"type":38},{"date":540,"type":38},"2026-06-05",{"date":542,"type":21},"2029-11-30",{"name":544,"class":45},"Laura Huppert, MD, BA",{"id":546,"slug":547,"hasResults":12,"nctId":548,"briefTitle":549,"officialTitle":550,"acronym":551,"eligibilityCriteria":552,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":553,"targetDuration":4,"studyType":22,"phases":555,"briefSummary":556,"conditions":557,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":558,"startDateStruct":559,"completionDateStruct":561,"leadSponsor":563,"locationsCount":122},"100606682","phase-3-neoadjuvant-therapy-comparing-sacituzumab-govitecanpembrolizumab-vs-soc-chemotherapy-in-clinical-stage-ii-iii-triple-negative-early-breast-cancer-100606682","NCT07178730","NeoAdjuvant Therapy Comparing Sacituzumab Govitecan+Pembrolizumab vs. SoC Chemotherapy in Clinical Stage II-III, Triple-negative Early Breast Cancer","NeoAdjuvant Dynamic Marker - Adjusted Personalized Therapy Comparing Sacituzumab Govitecan+Pembrolizumab vs. SoC Chemotherapy in Clinical Stage II-III, Triple-negative Early Breast Cancer","ADAPT-TN-IV","Inclusion Criteria:\n\nMinimal eligibility criteria to be met for registration in the clinical trial:\n\n1. TNBC: ER = 0%, PR = 0%, and HER2- (i.e., immunohistochemistry \\[IHC\\] with DAKO score ≤ 1 or fluorescence in situ hybridization \\[FISH\\]-negative)\n2. or TNBC-like: ER ≤ 10% positive cells in IHC, PR \\\u003C 10% positive cells in IHC, and HER2- (i.e., IHC with DAKO score ≤ 1 or FISH negative)\n3. All patients, independent from gender\n4. ≥18 years at diagnosis\n5. Histologically confirmed unilateral, primary invasive carcinoma of the breast Note: bilateral, multicentric, or multifocal carcinoma may be included, if there is a clear target (primary) lesion, that is subject to treatment decisions and solely evaluated and documented for study purposes. Histological confirmation of all lesions as TNBC is mandatory.\n6. Clinical stage II-III at baseline\n7. No clinical evidence for distant metastasis (M0)\n8. Cognitive and language skills to complete quality of life (QoL) questionnaires\n\n   Additional eligibility criteria to be met for assignment to cohort I or II:\n9. Completed 9-12 weeks of NACT with CARBO + PEM or PAC q1w + PEM q3w with the last dose of NACT given less than 2 weeks ago. Patients may also be considered if their NACT treatment was switched to nab-PAC due to intolerance to PAC.\n\n   * Patients with progressive disease during taxane-CARBO treatment are allowed to participate in cohort II after consultation with sponsor, provided that at least 6-9 weeks of NACT with taxane-CARBO q1w and PEM q3w have been administered\n   * Patients experiencing toxicities due to PEM, in case of contraindications or other medical reasons against PEM administration (with or without permanent discontinuation of PEM) can nevertheless be included, even if PEM will not be administered anymore. The number of patients starting the study without PEM is limited to 10%.\n10. Tumour block available for central pathology review\n11. Performance Status ECOG ≤ 1 or Karnofsky Index ≥ 80%\n12. Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements\n13. The patient must be capable of giving informed consent and be willing and able to comply with the requirements and restrictions in this protocol and accessible for treatment and follow-up\n14. Laboratory requirements (female and male patients, ≤ 14 days old)\n\n    * Neutrophils \\> 1.5 109\u002FL,\n    * Platelets \\> 100 109\u002FL,\n    * Total bilirubin \\\u003C 1 x upper level of normal (ULN),\n    * ASAT (sGOT) \\\u003C 2.5 x ULN,\n    * ALAT (sGPT) \\\u003C 2.5 x ULN,\n    * Creatinine ≤1.5 × ULN OR clearance ≥30 mL\u002Fmin for participant with creatinine levels \\>1.5 × institutional ULN\n15. Clinical assessments:\n\n    \\- Normal Electrocardiogram (ECG) (within 42 days prior to induction treatment)\n16. Negative pregnancy test (urine or serum) within ≤ 14 days prior to registration in premenopausal patients and immediate implementation of adequate contraceptive measures.\n\n    Note: Pregnancy testing is to be repeated according to Schedule of Activities.\n17. The following age-specific requirements apply:\n\n    * Women aged \\\u003C50 years will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range for the site.\n    * Women aged ≥ 50 years will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatments.\n18. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods outlined for women of child-bearing potential and need to discontinue HRT to allow confirmation of post-menopausal status prior to randomization\u002Fstudy enrolment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can participate without use of a contraceptive method.\n19. Female patients of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception, presented in Table 1 (see Section 4.4.2), from the time of enrolment and must agree to continue using such precautions for 7 months after the last dose of IMP. Not all methods of contraception are highly effective. Female patients must refrain from breastfeeding while on study and for 7 months after the last dose of IMP. Complete heterosexual abstinence for the duration of the study and drug washout period is an acceptable contraceptive method if it is line with the patient's usual lifestyle (consideration must be made to the duration of the clinical trial); however, periodic, or occasional abstinence, the rhythm method, and the withdrawal method are not acceptable.\n20. Female patients must not donate, or retrieve for their own use, ova from the time of randomization and throughout the study treatment period, and for at least 7 months after the final study drug administration. They should refrain from breastfeeding throughout this time. Preservation of ova may be considered prior to enrolment in this study.\n21. A male participant must agree to use a contraception as detailed in Appendix C of this protocol during the treatment period and for at least 7 months after the last dose of study treatment and refrain from donating sperm during this period.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to the compounds or incorporated substances of the IMPs\n2. Prior malignancy with a disease-free survival of \\\u003C 5 years, except curatively treated basalioma of the skin or pTis of the cervix uteri\n3. Any history of invasive breast cancer\n4. Previous or concurrent treatment with cytotoxic agents for any non-oncological reason unless clarified with sponsor\n5. Concurrent treatment with other experimental drugs\n6. Participation in another interventional clinical trial with or without any investigational, not marketed drug within 30 days or 5 half-lives of the respective drug, whichever is longer, prior to study entry. In case of other interventional trial contact Sponsor.\n7. Concurrent pregnancy: patients of childbearing potential or potentially childbearing partners of male patients must implement a highly effective (less than 1% failure rate) non-hormonal contraceptive measures during the study treatment\n8. Breast feeding woman\n9. Reasons indicating risk of poor compliance\n10. Patients not able to consent\n11. Known polyneuropathy ≥ grade 2\n12. Severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study including recovery from major surgery, autoimmune disease, known psychiatric\u002Fsubstance abuse disorders, acute cystitis, ischuria, and chronic kidney disease\n13. Uncontrolled infection requiring i.v. antibiotics, antivirals, or antifungals\n14. History of pneumonitis haemolytic anaemia, myocarditis, sclerosing cholangitis and exocrine pancreatic insufficiency, medical history of allogenic stem cell transplants, or solid organ transplant\n15. Active primary immunodeficiency, known human immunodeficiency virus (HIV) infection. Patients should be tested for HIV prior to randomization if required by local regulations or ethics committee. Patients who test positive for HIV-antibody are excluded.\n16. Active hepatitis B virus (HBV) or hepatitis C virus (HCV). In patients with a history of HBV or HCV, patients with the following detectable viral loads will be excluded.\n17. Patients who test positive for hepatitis B surface antigen (HBsAg). Patients who test positive for hepatitis B core antibody (anti-HBc) will require HBV DNA by quantitative polymerase chain reaction (PCR) for confirmation of active disease.\n18. Patients who test positive for HCV antibody will require HCV RNA by quantitative PCR for confirmation of active disease. Patients with a known history of HCV or a positive HCV antibody test will not require an HCV antibody test at enrolment and will only require HCV RNA by quantitative PCR for confirmation of active disease.\n19. Patients who received live vaccines within 30 days prior to randomization.\n20. Patients who are submitted to an institution by virtue of an order of a court or a governmental authority must be excluded from participation.",{"count":554,"type":21},765,[57],"TNBC is a heterogeneous disease with distinct pathological, genetic, and clinical features among subtypes. Treatment results for high-risk primary TNBC remain poor compared to other breast cancer subtypes. Preoperative chemotherapy is the standard of care for patients with stage II or III primary TNBC. Multiple lines of clinical evidence demonstrate that TNBC patients who achieve a pCR to NACT, (ypT0\u002Fis ypN0), have an excellent long-term prognosis. A meta-analysis of individual patient data confirmed a strong association of pCR after NACT with improved long-term event-free survival (EFS, hazard ratio \\[HR\\] 0.24) and overall survival (OS, HR 0.16) benefit. Taxane- and anthracycline-based neoadjuvant regimens generally result in pCR rates between 25-50% \\[REFs\\], whereas the addition of platinum increases pCR rates to approximately 50-55%.\n\nThe KEYNOTE-522 trial has demonstrated that the addition of the immune-checkpoint inhibitor PEM to anthracycline- (AC), taxane- and platinum-based NACT resulted in a significant increase in pCR rates to nearly 65%, associated with a significant reduction of recurrences (EFS, HR 0.65 at 5 years) and improvement of OS (HR 0.66). Based on these results, the KEYNOTE-522 regimen has been approved by the FDA and EMA and has become the standard of care for patients with stage II or III TNBC.\n\nDespite this significant progress, two major questions remain unresolved which will be investigated in the ADAPT-TN-IV trial:\n\n1. Do all patients require the full 6 months of NACT as per KEYNOTE-522 or is there a subgroup of patients who are sufficiently treated with 12 weeks of NACT plus PEM?\n2. Can incorporation of ADCs into the KEYNOTE-522 regimen improve response and outcomes in patients without an optimal early response? The outcome of patients with residual disease after 24 weeks of NACT and PEM remains suboptimal and there is an urgent need for more effective strategies. ADCs such as SG have demonstrated superior efficacy compared to standard chemotherapy in metastatic TNBC, resulting in substantially higher response rates and improved progression-free (PFS) and OS. Combination studies of ADCs and immunotherapy in metastatic TNBC have demonstrated significant activity, suggesting possible synergistic activity It is therefore a logical next step to investigate, whether the incorporation of SG in the NACT regimen can improve pCR rates and EFS results in patients who have residual clinical disease after 12 weeks of NACT with CARBO\u002FPAC + PEM.",[27,374],{"date":537,"type":38},{"date":560,"type":21},"2026-06-30",{"date":562,"type":21},"2033-03-31",{"name":564,"class":45},"West German Study Group",{"id":566,"slug":567,"hasResults":12,"nctId":568,"briefTitle":569,"officialTitle":570,"acronym":4,"eligibilityCriteria":571,"healthyVolunteers":12,"sex":17,"minAge":572,"maxAge":4,"enrollmentInfo":573,"targetDuration":4,"studyType":22,"phases":574,"briefSummary":575,"conditions":576,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":578,"lastUpdatePostDateStruct":579,"startDateStruct":580,"completionDateStruct":581,"leadSponsor":583,"locationsCount":46},"100615827","phase-1-gcar1-a-chimeric-antigen-receptor-car-t-cell-therapy-for-relapsedrefractory-gpnmb-expressing-solid-tumours-100615827","NCT07297667","GCAR1, a Chimeric Antigen Receptor (CAR) T-CELL Therapy for Relapsed\u002FRefractory GPNMB-Expressing Solid Tumours","A Phase I Study of GCAR1, a Chimeric Antigen Receptor (CAR) T-CELL Therapy for Participants With Selected Relapsed\u002FRefractory GPNMB-Expressing Solid Tumours","Inclusion Criteria:\n\n* Archival tumour specimen must be positive for GPNMB with high expression by immunohistochemistry (central laboratory testing).\n* Histologically and\u002For cytologically confirmed diagnosis of one of the following tumours that is advanced\u002F metastatic\u002F recurrent or unresectable, for which no curative therapy exists.\n* alveolar soft part sarcoma\n* renal cell carcinoma (excluding clear cell)\n* triple negative breast cancer (ER, PR and HER-2 negative as defined by ASCO\u002FCAP criteria)\n* Must have a formalin fixed paraffin embedded tissue block (from primary or metastatic tumour) available and must have provided informed consent for the release of the block.\n* Presence of radiologically documented disease.\n* Measurable disease as defined by RECIST 1.1.\n* ASPS participants ≥ 15 years of age.\n* TNBC and RCC participants ≥ 18 years of age.\n* ECOG performance status of 0 or 1 or Karnofsky or Lansky \\> 60.\n* Anticipated life expectancy of ≥ 6 months.\n* Must have received prior systemic therapy as shown below;\n* ASPS - completed all systemic therapy available that has been shown to improve survival (unless contraindicated).\n* TNBC\n\n  1. Progressive disease following at least one line of systemic treatment for metastatic disease which must include an ADC (all participants) and an ICI (participants whose tumours express PD-L1).\n  2. ≤3 lines of treatment for metastatic disease.\n  3. Must have had at least 1 prior line of cytotoxic chemotherapy for breast cancer, in any setting, which must have included an anthracycline and a taxane (unless contraindicated).\n* RCC - must have progressive disease following at least one line of systemic treatment for metastatic disease that must have included an ICI and a VEGFR targeted agent (unless contraindicated).\n* Participants must have recovered to ≤ grade 1 from all reversible toxicity related to prior therapies.\n* Adequate washout must be followed per protocol.\n* Previous major surgery is permitted ≥21 days prior to enrollment\n* Prior external beam radiation is permitted ≥28 prior to enrollment. Concurrent radiotherapy is not permitted.\n* Adequate hematologic and biochemical parameters.\n* Consent and assent, when applicable, must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant or their parent\u002F legal guardian (if applicable) must sign a consent form prior to screening onto the trial to document their willingness to participate.\n* Fit for leukapheresis and has adequate venous access for cell collection.\n* Must be accessible for treatment and follow up at the participating centre for a minimum of 12 months or for as long as is deemed necessary by the treating physician.\n* Participants of childbearing potential must have agreed to use a highly effective contraceptive method.\n\nExclusion criteria\n\n* Participants on active anticancer therapy for other advanced or metastatic malignancies.\n* Concurrent treatment with other anti-cancer therapy\n* Prior therapy with a gene therapy product or any adoptive T cell therapy or prior GPNMB targeting therapy.\n* Live attenuated vaccination administered within 30 days prior to or planned within 30 days after GCAR1 therapy.\n* Primary immunodeficiency or history of severe autoimmune disease (including: Crohn's disease, rheumatoid arthritis, systemic lupus) requiring immunosuppressive agents\u002F systemic disease modifying agents within 2 years of enrollment.\n* Active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the participant to be managed according to the protocol including but not limited to:\n* Hepatitis B or C virus (HBV or HCV). For participants with previous HBV or HCV infection who are currently on treatment, they are eligible if they have an undetectable viral load via quantitative PCR and\u002For nucleic acid testing\n* HIV positive by serology and PCR\n* Uncontrolled fungal, bacterial, viral or other infection\n* Current infection with HTLV-1\n* Tuberculosis\n* Syphilis\n* West Nile Virus\n* Untreated and\u002For uncontrolled cardiovascular conditions and\u002For symptomatic cardiac dysfunction (including cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects) or unstable angina congestive heart failure or myocardial infarction within the previous year.\n* Known sensitivity or allergy to fludarabine, cyclophosphamide or any of their components, or to GCAR1 or any of its components.\n* Active intracerebral metastases or leptomeningeal disease. Participants who have received definitive treatment, are clinically stable and do not require corticosteroids are eligible to participate in the trial.\n* Pregnant or breastfeeding women.","15 Years",{"count":427,"type":21},[24],"Only enrolling in Canada.\n\nThe purpose of this study is to identify the highest dose of GCAR1, a chimeric antigen receptor (CAR-T) cell therapy, that can be tolerated without causing very severe side effects, and to see what effects GCAR1 has on selected cancers",[577,458,30],"Alveolar Soft Part Sarcoma","2026-06-04",{"date":537,"type":38},{"date":560,"type":21},{"date":582,"type":21},"2033-09-01",{"name":584,"class":585},"Canadian Cancer Trials Group","NETWORK",{"id":587,"slug":588,"hasResults":12,"nctId":589,"briefTitle":590,"officialTitle":591,"acronym":592,"eligibilityCriteria":593,"healthyVolunteers":12,"sex":79,"minAge":18,"maxAge":4,"enrollmentInfo":594,"targetDuration":4,"studyType":22,"phases":595,"briefSummary":596,"conditions":597,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":599,"lastUpdatePostDateStruct":600,"startDateStruct":602,"completionDateStruct":603,"leadSponsor":605,"locationsCount":607},"100620463","omission-of-surgery-for-triple-negative-breast-cancer-in-complete-response-after-neoadjuvant-chemo-immunotherapy-100620463","NCT07357948","Omission of Surgery for Triple-negative Breast Cancer in Complete Response After Neoadjuvant Chemo-immunotherapy","Omission of Surgery for Triple-negative Breast Cancer in Complete Response Confirmed by MRI and Macrobiopsy After Neoadjuvant Chemo-immunotherapy: a Randomized, Multicenter Phase II Trial.","OMICHIR","Inclusion Criteria:\n\n1. Sex and age: Female, aged 18 years or older.\n2. Histological type: Invasive breast carcinoma of no special type (NST).\n3. Triple-negative phenotype, defined by:\n\n   * Estrogen receptor (ER) \\\u003C 10%,\n   * Progesterone receptor (PR) \\\u003C 10%,\n   * HER2-negative status according to ASCO\u002FCAP criteria (IHC score 0-1+, or 2+ without amplification by in situ hybridization).\n4. High proliferation index: Ki-67 \\> 30%.\n5. Primary tumor classified as T2, i.e. tumor size between 2 and 5 cm on imaging at diagnosis (mammography, ultrasound, and breast MRI).\n6. No regional lymph node involvement or distant metastasis, confirmed by 18F-FDG PET-CT performed prior to neoadjuvant treatment.\n7. Completion of the full neoadjuvant chemo-immunotherapy (NCIT) protocol according to the KEYNOTE-522 regimen (≥7 cycles including pembrolizumab).\n8. Breast-conserving surgery deemed feasible based on the initial surgical assessment.\n9. Radiological complete response (rCR) on post-NCIT breast MRI, associated with a negative vacuum-assisted biopsy (VAB) of the clip-marked tumor bed, confirming the absence of residual invasive or in situ disease.\n10. Written informed consent obtained prior to any study-specific procedure.\n11. Ability of the patient to comply with the protocol requirements and scheduled follow-up.\n12. Affiliation with a national health insurance system, in accordance with French regulations.\n\nExclusion Criteria:\n\n1. Presence of regional recurrence or metastatic disease at inclusion.\n2. History of thoracic, breast, or regional lymph node irradiation, regardless of indication.\n3. Invasive lobular carcinoma, excluded due to its different response profile and increased risk of multifocal residual disease.\n4. Presence of ductal carcinoma in situ (DCIS) on diagnostic biopsy, or diffuse suspicious microcalcifications on mammography, precluding reliable assessment of complete response.\n5. Bilateral breast cancer (except for localized and treated contralateral DCIS), or history of ipsilateral or contralateral invasive breast cancer.\n6. Multifocal or multicentric disease detected on imaging (mammography, ultrasound, or breast MRI).\n7. Skin involvement or inflammatory breast cancer, identified on imaging or clinical examination.\n8. History of malignancy other than breast cancer, unless the disease has been in complete remission for ≥ 5 years and is considered at low risk of recurrence, with the exception of:\n\n   * Treated carcinoma in situ of the cervix, endometrium, or colon,\n   * Melanoma in situ,\n   * Completely excised cutaneous basal cell or squamous cell carcinoma.\n9. Severe or progressive non-malignant disease limiting life expectancy to less than 10 years, in the investigator's judgment.\n10. Presence of a high-risk germline mutation predisposing to breast cancer (including BRCA1, BRCA2, or other identified predisposition genes).\n11. Participation in another interventional clinical trial within 30 days prior to inclusion.\n12. Current pregnancy or breastfeeding.\n13. Cognitive impairment, psychiatric disorder, or social situation preventing valid informed consent or adequate understanding of the protocol, as assessed by the investigator.\n14. Individuals deprived of liberty or under legal protection (guardianship, curatorship, or similar legal status), in accordance with applicable regulations.",{"count":363,"type":21},[240],"This clinical study aims to determine if skipping breast and axillary surgery could provide similar control of local and distant disease, with fewer complications and better quality of life, for triple-negative breast cancer patients in complete response after neoadjuvant chemo-immunotherapy.\n\nPatients will be randomised into 2 groups :\n\n* Control arm will receive the standard treatment, including surgery\n* Experimental arm will receive the standard treatment, except surgery",[30,598],"Non-Metastatic","2026-06-01",{"date":601,"type":38},"2026-06-03",{"date":440,"type":21},{"date":604,"type":21},"2033-07-31",{"name":606,"class":45},"Institut Curie",4,{"id":609,"slug":610,"hasResults":12,"nctId":611,"briefTitle":612,"officialTitle":613,"acronym":614,"eligibilityCriteria":615,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":616,"targetDuration":4,"studyType":22,"phases":618,"briefSummary":619,"conditions":620,"keywords":631,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":599,"lastUpdatePostDateStruct":648,"startDateStruct":649,"completionDateStruct":651,"leadSponsor":653,"locationsCount":655},"100483771","phase-1-rinatabart-sesutecan-rina-s-pro1184-gen1184-for-advanced-solid-tumors-gct1184-01-pro1184-001-100483771","NCT05579366","Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01\u002F PRO1184-001)","Phase 1\u002F2 Study of Rina-S in Patients With Locally Advanced and\u002For Metastatic Solid Tumors","RAINFOL-01","Inclusion Criteria:\n\nPart A and B:\n\n* Histologically or cytologically confirmed metastatic or unresectable solid malignancy including ovarian cancer (must have epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer), endometrial cancer, non-small cell lung cancer (Part A), EGFR-mutated NSCLC (Part B), breast cancer (hormone receptor positive, HER2-negative and triple-negative) (Part A), mesothelioma or cervical cancer (Part B).\n* Previously received therapies known to confer clinical benefit.\n* Measurable disease per RECIST v1.1 for all tumor types other than pleural mesothelioma which will use mRECIST v1.1 at baseline.\n\nPart C, E, and H:\n\nParticipants must have histologically or cytologically confirmed metastatic or unresectable epithelial ovarian cancer as specified below.\n\n* High grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (excluding endometrioid, clear cell carcinomas, mucinous, low grade, and those with a sarcomatous or neuroendocrine element)\n* Participants must have received up to 3 prior lines of therapy. Participants may have had up to to 4 prior lines of therapy are allowed if MIRV is locally approved and was used as the last line of therapy. Participants must have progressed radiographically on or after their most recent line of therapy.\n* Participants must have platinum-resistant ovarian cancer.\n* Participants must have received prior bevacizumab or approved biosimilar.\n* Participants with known or suspected deleterious germline or somatic BRCA mutations (as determined by Food and Drug Administration \\[FDA\\]-approved test in a Clinical Laboratory Improvement Amendments \\[CLIA\\]-certified laboratory; or locally approved equivalent) and who achieved a complete or partial response to platinum-based chemotherapy must have been treated with a poly ADP-ribose polymerase (PARP) inhibitor as maintenance treatment.\n* Measurable disease per the RECIST v1.1 at baseline.\n\nPart D:\n\nCohort D1:\n\n* Participants must have platinum-sensitive ovarian cancer.\n* Participants must have received 1 to 3 prior lines of therapy.\n\nCohort D2:\n\n* Participants must have primary platinum-refractory, platinum-resistant, or platinum-sensitive ovarian cancer.\n* Participants with primary platinum-refractory ovarian cancer must have received ≤2 prior lines of therapy. Primary platinum-refractory ovarian cancer is defined as a lack of response or by progression within 91 days after completing front-line platinum containing therapy.\n* Participants must have received 1 to 3 prior lines of therapy for platinum-resistant ovarian cancer (PROC), and up to 4 prior lines of therapy for platinum-sensitive ovarian cancer (PSOC). Prior treatments may have included bevacizumab, PARP inhibitor, and MIRV.\n\n  * Participants with PSOC must have disease progression on or after maintenance treatment, or at least 6 months (\\>183 days) or more from the last dose of platinum-based therapy.\n\nCohort D3:\n\n• Endometrial cancer (any subtype excluding sarcoma).\n\nCohort D4:\n\n• Primary advanced or recurrent endometrial cancer (any subtype excluding sarcoma and neuroendocrine tumors).\n\nPart F and G:\n\n* Participants must have histologically or cytologically confirmed EC.\n* Recurrent progressive EC (any subtype excluding neuroendocrine tumors, carcinosarcoma, or endometrial sarcoma) following prior therapy.\n* Participants must have received 1 to 3 prior lines of therapy, and must have progressed radiographically on or after their most recent line of therapy:\n* Participants must have received prior platinum-based chemotherapy and a programmed death-ligand 1 (PD-\\[L\\])1 inhibitor.\n* Participants who progress \\>12 months after completion of prior adjuvant or neoadjuvant platinum-based chemotherapy must receive 1 additional cytotoxic systemic treatment prior to enrollment in this study.\n* Hormonal therapy alone (i.e., without chemotherapy) will not be counted as a separate line of therapy.\n* Measurable disease per the RECIST Version 1.1 at baseline.\n\nPart I:\n\n* Participants must have histologically or cytologically confirmed high grade serous or endometrioid epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer (excluding clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies or low grade\u002Fborderline ovarian tumors).\n* Participants must have platinum sensitive ovarian cancer.\n* Measurable disease per the RECIST Version 1.1 at baseline.\n\nPart J:\n\n* Participants must have high grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer including serous, endometrioid, and clear cell carcinomas, and excluding mucinous, low grade, and those with a sarcomatous or neuroendocrine element.\n* Measurable disease per the RECIST Version 1.1 at baseline.\n\nPart K:\n\n* Participants must have histologically or cytologically confirmed metastatic or unresectable ovarian cancer (must have high grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer including serous, endometrioid, and clear cell carcinomas, and excluding mucinous, low grade, and those with a sarcomatous or neuroendocrine element).\n* Participants must have primary platinum-refractory, platinum-resistant, or platinum-sensitive ovarian cancer.\n* Measurable disease per the RECIST Version 1.1 at baseline.\n\nExclusion Criteria:\n\n* History of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required steroids within the past 2 years, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n* Prior therapy with a topoisomerase 1 inhibitor-based antibody drug conjugate.\n\nNote: Other protocol-defined inclusion\u002Fexclusion may apply.",{"count":617,"type":21},884,[24,106],"This study will test the safety, including side effects, and determine the characteristics of a drug called Rina-S in participants with solid tumors.\n\nParticipants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).",[621,368,622,111,109,330,623,624,625,30,626,627,628,629,630],"High Grade Epithelial Ovarian Cancer","Primary Peritoneal Carcinoma","Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer (NSCLC)","Mesothelioma","Breast Adenocarcinoma","Hormone Receptor-positive\u002FHer2 Negative Breast Cancer","Platinum-resistant Ovarian Cancer (PROC)","Platinum Sensitive Ovarian Cancer (PSOC)","Primary Refractory Ovarian Cancer","Uterine Cancer",[632,633,634,635,636,637,638,639,640,641,642,643,644,645,646,647],"antibody-drug conjugate","folate receptor alpha","folate receptor","solid tumor","ovarian cancer","primary peritoneal carcinoma","fallopian tube cancer","endometrial cancer","non-small cell lung cancer","mesothelioma","breast cancer","triple negative breast cancer","hormone receptor-positive (HR+)\u002Fhuman epidermal growth factor receptor 2 negative (HER2-) breast cancer","topoisomerase I inhibitor","PROC","epidermal growth factor receptor (EGFR)-mutated NSCLC",{"date":601,"type":38},{"date":650,"type":38},"2022-12-07",{"date":652,"type":21},"2027-10",{"name":654,"class":70},"Genmab",66,{"id":657,"slug":658,"hasResults":12,"nctId":659,"briefTitle":660,"officialTitle":661,"acronym":4,"eligibilityCriteria":662,"healthyVolunteers":12,"sex":79,"minAge":18,"maxAge":80,"enrollmentInfo":663,"targetDuration":4,"studyType":22,"phases":665,"briefSummary":667,"conditions":668,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":669,"lastUpdatePostDateStruct":670,"startDateStruct":672,"completionDateStruct":674,"leadSponsor":676,"locationsCount":46},"100428593","early-phase-1-monitoring-breast-cancer-immunotherapy-treatment-with-advanced-positron-emission-tomography-magnetic-resonance-imaging-petmri-100428593","NCT04861077","Monitoring Breast Cancer Immunotherapy Treatment With Advanced Positron Emission Tomography Magnetic Resonance Imaging (PET\u002FMRI)","Monitoring Breast Cancer Immunotherapy Treatment With Advanced PET\u002FMRI: A Pilot Study","Inclusion Criteria:\n\n1. Patients must be ≥ 18 years old and ≤ 75 years old\n2. Triple negative breast cancer (TNBC) patients (biopsy-proven) stage II-IV eligible\n3. \\>50%Programmed death-ligand 1 (PD-L1) positive\n4. Eligible for immunotherapy who are naïve to beginning any immunotherapy treatment\n5. May not be pregnant or breastfeeding\n6. Subjects must be willing to sign consent\n7. Adequate creatinine clearance per institutional guidelines and within 30 days\n8. Estimated life expectancy of greater than one year\n9. Patients must have one lesion with RECIST measurable disease (greater than 1 cm in diameter, measured from diagnostic breast MRI or staging CT)\n\nExclusion Criteria:\n\n1. Inability to provide informed consent\n2. Weight over 350 lbs., due to the scanner bore size\n3. Lactating, known or suspected pregnancy. Women with child-bearing potential must a have a negative serum Human chorionic gonadotropin (β-hCG) pregnancy test within 48 hours or a negative urine β-hCG pregnancy test within 24 hours of each PET imaging study.\n4. Contraindication for MRI study (e.g. non-removable metal implants or certain tattoos)\n5. Unable to lie still on the imaging table for one (1) hour\n6. contraindication for gadolinium-based contrast agent, ProHance (gadoteridol)\n7. Have received immunotherapy in the neoadjuvant or adjuvant setting",{"count":664,"type":21},20,[666],"EARLY_PHASE1","This clinical study will investigate the utility of Fludeoxyglucose (18F) fluoromisonidazole (FMISO), in patients diagnosed with triple negative breast cancer (stage II-IV disease), to monitor and predict the effect of immunotherapy. This is a parallel imaging study to current treatment strategies and no clinical decisions or outcomes will be based on the imaging. If promising, this data will be used to design larger trials. A total of 20 patients will be recruited for this study. This trial will not designate the participant's treatment plan; they will be eligible based on their treatment plan designated from their oncologist.",[30],"2026-05-30",{"date":671,"type":38},"2026-06-02",{"date":673,"type":21},"2026-06",{"date":675,"type":21},"2028-08",{"name":677,"class":45},"University of Alabama at Birmingham",{"id":679,"slug":680,"hasResults":12,"nctId":681,"briefTitle":682,"officialTitle":683,"acronym":4,"eligibilityCriteria":684,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":80,"enrollmentInfo":685,"targetDuration":4,"studyType":22,"phases":687,"briefSummary":688,"conditions":689,"keywords":694,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":699,"lastUpdatePostDateStruct":700,"startDateStruct":701,"completionDateStruct":702,"leadSponsor":703,"locationsCount":4},"100639777","phase-1-a-first-in-human-study-of-hh160-in-patients-with-advanced-solid-tumors-100639777","NCT07623369","A First-in-Human Study of HH160 in Patients With Advanced Solid Tumors","An Open-Label, Multicenter, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Preliminary Antitumor Activity of HH160 in Patients With Advanced Solid Tumors","Key Inclusion Criteria\n\n1. Adults aged 18 to 75 years with signed informed consent.\n2. Histologically or cytologically confirmed advanced solid tumors meeting phase-specific disease requirements.\n3. At least 1 measurable lesion per RECIST v1.1.\n4. Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status of 0 or 1 with life expectancy ≥ 12 weeks.\n5. Adequate organ function based on protocol-specified laboratory criteria.\n\nKey Exclusion Criteria\n\n1. Active leptomeningeal disease or uncontrolled\u002Funtreated brain metastases.\n2. History of severe hypersensitivity reactions to monoclonal antibodies, bispecific antibodies, trispecific antibodies, or study drug components.\n3. Other malignancy within 3 years prior to first dose, except specified curatively treated cancers.\n4. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage.\n5. Significant bleeding risk, severe coagulopathy, gastrointestinal hemorrhage, or recent pulmonary hemorrhage\u002Fhemoptysis.\n\nNOTE: Other eligibility criteria may apply.",{"count":686,"type":21},56,[24],"This study is evaluating the safety, side effects, how the body processes HH160, and its early anticancer activity when given alone or with other cancer treatments in participants with advanced solid tumors. The study will also identify the recommended dose for future studies. The trial includes two phases and is expected to last about 4 years, with treatment and follow-up lasting approximately 6-12 months each.",[509,330,690,142,288,458,109,331,691,30,692,693],"Hepatocellular Carcinoma","Small-cell Lung Cancer","Urothelial Carcinoma","Gastroesophageal Adenocarcinoma",[695,696,330,150,690,697,142,375,301,288,458,698,109,331,691,30,154,692,693,110],"HH160","PD-1×CTLA-4×VEGF-A Antibody","HCC","RCC","2026-05-29",{"date":601,"type":38},{"date":673,"type":21},{"date":675,"type":21},{"name":704,"class":70},"Huahui Health",{"id":706,"slug":707,"hasResults":12,"nctId":708,"briefTitle":709,"officialTitle":710,"acronym":711,"eligibilityCriteria":712,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":713,"targetDuration":4,"studyType":22,"phases":715,"briefSummary":716,"conditions":717,"keywords":721,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":699,"lastUpdatePostDateStruct":722,"startDateStruct":723,"completionDateStruct":725,"leadSponsor":727,"locationsCount":729},"100380170","phase-2-sacituzumab-govitecan-in-tnbc-100380170","NCT04230109","Sacituzumab Govitecan In TNBC","A Phase 2 Study of Response-guided Neoadjuvant Sacituzumab Govitecan (IMMU-132) in Patients With Localized Triple-Negative Breast Cancer (NeoSTAR)","NeoSTAR","Inclusion Criteria:\n\n* Female or male patients ≥ 18 years of age.\n* Histologically confirmed diagnosis of invasive breast cancer, previously untreated.\n* Participants must have biopsy proven ER negative (ER-), PR negative (PR-), HER2 negative (HER2-), invasive breast cancer. ER, PR, and HER2 positivity would be determined per ASCO\u002FCAP guidelines by institutional (local) assessment. Patients with multi-focal and multicentric disease are eligible provided all histologically examined lesions are ER-\u002FPR-\u002FHER2- (local assessment). The need to biopsy additional lesions is at the discretion of the treating physician. Patients with bilateral invasive breast cancer are eligible provided all histologically examined lesions are ER-\u002FPR-\u002FHER2- (local assessment).\n* Primary tumor (at least one lesion) 1 cm or greater measured by radiological imaging. Regional lymph node AJCC (v7) TNM stages N0-N2. If node positive, any primary tumor size is permissible. Absence of distant metastatic disease (AJCC TNM stage M0). Staging scans are not required and are per discretion of the treating physician.\n* Pre- and postmenopausal women are eligible.\n* ECOG performance status = 0, 1 (Karnofsky ≥60%, see Appendix A)\n* Ability to understand and the willingness to sign a written informed consent form (ICF). Patient has signed the ICF prior to any screening procedures being performed and is able to comply with protocol requirements, including research biopsy.\n* Patient has adequate bone marrow and organ function as defined by the following laboratory values at screening:\n* Absolute neutrophil count (ANC) ≥ 1,500 per mm3\n* Platelets ≥ 100,000 per mm3\n* Hemoglobin ≥9.0 g\u002FdL\n* INR ≤1.5\n* Serum creatinine \\\u003C1.5 mg\u002FdL or creatinine clearance ≥50 mL\u002Fmin\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C2.5 x ULN.\n* Total bilirubin ≤1.5 x ULN or in patients with well-documented Gilbert's Syndrome direct bilirubin ≤1.5 x ULN.\n\nExclusion Criteria:\n\n* Inflammatory breast cancer, or locally recurrent breast cancer\n* Participants currently receiving systemic therapy for any other malignancy or having received systemic therapy for a malignancy in the preceding 3 years.\n* Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia,or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Clinically significant, uncontrolled heart disease and\u002For cardiac reppolarization abnormality including any of the following:\n\n  * History of angina pectoris, symptomatic pericarditis, coronary artery bypass graft (CABG) or myocardial infarction within 6 months prior to study entry.\n  * History of cardiac failure, known cardiomyopathy (LVEF \\\u003C 50%; new LVEF assessment is not specifically required for this trial), significant\u002Fsymptomatic bradycardia, Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome or any of the following:\n* Known risk to prolong the QT interval or induce Torsade's de Pointes.\n* Uncorrected hypomagnesemia or hypokalemia.\n* Systolic Blood Pressure (SBP) \\>160 mmHg or \\\u003C90 mmHg.\n* Bradycardia (heart rate \\\u003C50 at rest), by ECG or pulse. On screening, inability to determine the QTcF interval on the ECG (i.e.: unreadable or not interpretable) or QTcF \\>470 screening ECG\n* Pregnant or breast-feeding women are excluded from this study because the safety of study medications is not established.\n* Known HIV-positive participants on combination antiretroviral therapy are ineligible.\n* These participants are at increased risk of lethal infections when treated with marrow-suppressive therapy. Separate HIV testing for this trial is not required. Similarly, separate Hepatitis B or C testing for this trial is not required, but patients with known (or history) of hepatitis B positive, or hepatitis C positive infection will be excluded",{"count":714,"type":21},260,[106],"This research study is studying to evaluate sacituzumab govitecan for individuals with localized triple negative breast cancer (TNBC)\n\nThe names of the study drugs involved in this study is:\n\n* Sacituzumab govitecan (SG)\n* Pembrolizumab (combination therapy with SG)",[718,30,719,720,160],"Invasive Breast Cancer","ER-Negative Breast Cancer","PR-Negative Breast Cancer",[718,30,719,720,160],{"date":671,"type":38},{"date":724,"type":38},"2020-07-14",{"date":726,"type":21},"2029-10",{"name":728,"class":45},"Massachusetts General Hospital",5]