[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"solid-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:solid-carcinoma":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,46,83,155,182,206,241,269,300,321,345,366,396,417],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100573826","phase-1-a-study-of-dm002-in-patients-with-advanced-solid-tumors-100573826",false,"NCT06751329","A Study of DM002 in Patients With Advanced Solid Tumors","A Phase I\u002FIIa, Multicenter, Open-label, First-in-Human, Dose Escalation and Expansion Study of DM002 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\nCommon Inclusion Criteria (Part 1 and Part 2)\n\n1. Subjects must have the ability to understand and willingness to sign a written informed consent document.\n2. Subjects must be ≥18 years of age at the time of signing the informed consent form.\n3. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.\n4. Has a life expectancy of ≥3 months.\n5. Participants must meet the following laboratory values within 7 days prior to first dose of study drug:\n\n   Note: Transfusion (red blood cell or platelet) or granulocyte-colony stimulating factor (G-CSF) administration is not allowed within 2 weeks prior to laboratory assessments at Screening.\n   * Absolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL;\n   * Platelet count ≥100 × 10⁹\u002FL;\n   * Hemoglobin ≥9 g\u002FdL;\n   * Calculated creatinine clearance (CrCL) \\>60 mL\u002Fmin (Cockroft-Gault Equation);\n   * Total bilirubin ≤ 1.5 x ULN;\n   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 × upper limit of normal (ULN), if liver metastases are present, ≤5 × ULN;\n   * International normalized ratio (INR)\\\u003C2.0, and prothrombin time and either partial thromboplastin time (PTT) or activated PTT (aPTT) ≤1.5 × ULN, except for participants receiving anti-vitamin K derivative anticoagulant therapy who must have prothrombin time\u002FINR within therapeutic range as deemed appropriate by the Investigator.\n6. Has measurable disease based on RECIST version 1.1.\n7. Participants are required to provide tumor tissue specimens obtained within the previous 3 years for the measurement of MUC1 and\u002For HER3 and other biomarkers. For those subjects who are unable to provide tissue samples will be encouraged (but not mandatory) to undergo biopsy if the risk is manageable. If the biopsy is not possible, it should inform the sponsor for enrolment.\n\nExclusion Criteria:\n\n1. Subjects have another active invasive malignancy within 5 years, with the following exceptions and notes:\n\n   1. History of noninvasive malignancy, such as cervical cancer in situ, in situ melanoma, or ductal carcinoma in situ of the breast that is in complete remission 5 years after treatment with curative intent is allowed.\n   2. Malignancies with a negligible risk of metastasis or death (such as adequately treated basal or squamous cell skin cancer and localized prostate cancer).\n2. Current or history of a hematologic malignancy.\n3. Anticancer therapy (chemotherapy, immunotherapy, hormonal therapy, targeted therapy, biologic therapy, or other anti-cancer therapies, except for hormones for hypothyroidism or estrogen replacement therapy, anti-estrogen analogs, agonists required to suppress serum testosterone levels) within 28 days or 5 half-lives, whichever is shorter, prior to the first study dose. Radiotherapy with a wide field of radiation within 28 days, or radiotherapy with a limited field of radiation for palliation within 14 days of the first study dose. Major surgery, other than diagnostic surgery, within 4 weeks of the first study dose.\n4. Primary central nervous system (CNS) malignancies or CNS metastases. Individuals with brain metastases can be enrolled only if treated, nonprogressive brain metastases and off high-dose steroids (\\>20 mg prednisone or equivalent) for at least 4 weeks.\n5. History of known allergies to ADC, or prior discontinuation of an ADC due to treatment-related toxicities. Has received prior treatment with ADCs that include topoisomerase I (Topo I) payload, and treatment history with any investigational drug within 4 weeks before enrolment in the study.\n6. Has an uncontrolled infection requiring IV injection of antibiotics, antivirals, or antifungals.\n7. Has a pre-existing clinically significant lung diseases (e.g., interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or pre-existing ocular disorders.\n8. Clinically uncontrolled intercurrent illness, including but not limited to an ongoing active infection, active coagulopathy, uncontrolled cardiovascular disease, uncontrolled immune disease, uncontrolled diabetes, uncontrolled pleural and peritoneal effusion, psychiatric illness that would limit compliance with the study requirements and other serious medical illnesses requiring systemic therapies.\n9. Mean resting corrected QT interval corrected by Fridericia's formula (QTcF) \\>470 msec obtained from triplicate 12-lead ECGs at baseline; using concomitant medications that would prolong the QT interval.\n10. Left ventricular ejection fraction \\\u003C50% by either an echocardiogram (ECHO) or a multi-gated acquisition scan within 28 days before first dose of the study drug.\n11. Known active hepatitis B (HBV) or hepatitis C (HCV) infection. Chronic carriers of HBV infection (HBsAg-positive, undetectable HBV DNA or HBV DNA ≤2500 copies\u002Fml or 500 IU\u002Fml) receive prophylactic treatment during the study can be enrolled. Participants with a history of HCV infection have completed curative antiviral treatment and HCV viral load below the limit of quantification and HCV antibody positive but HCV ribonucleic acid (RNA) negative due to prior treatment or natural resolution should be eligible.\n12. Known human immunodeficiency virus (HIV) infection which is not well controlled. Participants should be tested for HIV prior to enrollment if required by local regulations or institutional review board (IRB)\u002Fethics committee. All the following criteria are required to define an HIV infection (positive HIV1\u002F2 antibodies test) that is well controlled: HIV viral load \\\u003C400 copies\u002FmL, CD4+ T- cell counts ≥350 cells\u002FμL, no history of acquired immunodeficiency syndrome-defining opportunistic infection within the past 12 months, and stable viral load for at least 4 weeks on same anti-HIV retroviral medications.\n13. Subjects who are from endemic areas (refer to WHO high tuberculosis burden country list, China is endemic area) will be specifically screened for tuberculosis with any available test. Subjects with active tuberculosis are excluded. Subjects who have received bacille Calmette-Guerin vaccination may have a false positive result of purified-protein derivative (PPD) test. These subjects are eligible if they have a negative result of interferon gamma release assay (IGRA).\n14. Has received a live vaccine within 30 days prior to the first dose of study drug.\n15. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia and anemia) not yet resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, ≤Grade 1 or baseline. Note: Participants may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to \\>Grade 2 for at least 3 months prior to enrolment\u002Frandomization and managed with the standard treatment) that the Investigator deems related to previous anticancer therapy, following discussion with the Sponsor's medical monitor, such as the following: Grade 2 chemotherapy-induced neuropathy, hypothyroidism, hyperglycemia.\n16. Females who are pregnant or lactating or who intend to become pregnant during participation in the study are not eligible to participate.\n17. Participants who are of reproductive potential refuse to use effective methods of birth control during participation of the study and within 7 months for female (and 4 months for male) after the last dose administration.\n18. Participants who took drugs or food which can strongly inhibit or induce the cytochrome P450 (CYP) isoenzyme, CYP3A4\u002F5 within 2 weeks prior to the first dose of DM002 or within 5 half-lives, whichever is longer.","ALL","18 Years",{"count":19,"type":20},280,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The goal of study：\n\nThe study has two parts: Part 1 Dose Escalation and Part 2 Dose Expansion.\n\nIn Part 1, a few participants will receive the lowest dose of study drug. The study team will make sure it is safe and tolerated before enrolling new participants at a higher dose of study drug. There will be up to six or more dose levels of study drug tested (called cohorts). Which dose you receive will depend on how many participants have taken part in the study before you.\n\nThe purpose of Part 1 of the study is to evaluate the safety of the study drug at different dose levels, to understand what your body does to the study drug, and to find the best dose of study drug in people who have advanced solid tumor cancers.\n\nIn Part 2, participants will receive the best dose level that was determined in Part 1 of the study.\n\nThe purpose of Part 2 of the study is to evaluate the safety of the study drug at the dose level determined in Part 1, to understand what your body does to the study drug, and to see how your cancer responds to the study drug.\n\nParticipants will:\n\nParticipants will have 17 or more visits to the study centre. This study has a screening phase of up to 28 days , and a treatment phase with cycles of 21 days each. Participants will also have an End of Treatment (EOT) visit 21 days after the final study drug treatment, and a Follow-up visit 30 days after the EOT visit . Participants will be contacted by telephone every 3 months after the Follow-up visit to check on the wellbeing and record any new anticancer therapy they may have started.",[27,28,29,30,31,32],"Ovarian Neoplasms","Prostatic Neoplasms","Endometrial Neoplasms","Colorectal Neoplasms","Solid Carcinoma","Pancreatic Cancer","RECRUITING","2026-07-01",{"date":36,"type":37},"2026-07-02","ACTUAL",{"date":39,"type":37},"2025-02-17",{"date":41,"type":20},"2028-04-18",{"name":43,"class":44},"Xadcera Biopharmaceutical (Suzhou) Co., Ltd.","INDUSTRY",5,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":69,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100644129","phase-1-imaging-study-of-89zrdfo-ys5-for-cancer-detection-100644129","NCT07664397","Imaging Study of [89Zr]DFO-YS5 for Cancer Detection","A Pilot PET Imaging Study of [89Zr]DFO-YS5 for Detection of Cancer in Patients With Various Malignancies","Inclusion Criteria:\n\n1. Histological or cytological confirmation of malignant peripheral nerve sheath tumor, bladder cancer, or solid tumor neoplasm.\n2. At least one soft tissue lesion measurable at 1 cm or greater in short axis measurement on cross sectional imaging such as Computerized tomography (CT), magnetic resonance imaging (MRI), or Positron Emission Tomography (PET)\u002FCT (scan imaging as documented in the medical record). Exception: For participants with localized bladder cancer (pre-cystectomy), lesions smaller than 1 centimeter (cm) are permitted, provided there is cystoscopic confirmation of a bladder mass.\n3. Clinically able to undergo PET-CT imaging or PET-MRI.\n4. Age ≥ 18 years.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 or Karnofsky ≥ 50% (see Appendix 1).\n6. Adequate organ function as defined below:\n\n   * Total bilirubin: ≤ 1.5 x institutional upper limit of normal (ULN) (unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits).\n   * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase (SGOT)): ≤ 3 x ULN.\n   * Alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase (SGPT)): ≤ 3 x ULN.\n   * Estimated creatinine clearance: ≥ 60 mL\u002Fmin, calculated using the Cockcroft-Gault equation.\n7. Females of reproductive potential (defined below) must be willing to undergo a urine or serum pregnancy test (i.e., human chorionic gonadotropin test) within 72 hours before administration of \\[89Zr\\]DFO-YS5. A female is considered to NOT be of reproductive potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if they meet either of the following two criteria: (1) has reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and\u002For bilateral oophorectomy for removal of uterus and\u002For ovaries). The result of the urine or serum pregnancy test must be negative in order to initiate the \\[89Zr\\]DFO-YS5 administration. If a urine pregnancy test is positive or equivocal, a confirmatory a serum pregnancy test is required. The individual must be excluded from participation if the serum pregnancy result is positive. Pregnant individuals are excluded from this study because there is an unknown but potential risk for adverse effects in the unborn child secondary to treatment of the study participant with \\[89Zr\\]DFO-YS5.\n8. Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or endpoints of this study are eligible.\n9. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Individuals with a contraindication to PET-CT imaging (e.g., severe claustrophobia) or PET-MRI (e.g., implanted devices, metallic objects, or other implants). Participants must be able to undergo either PET-CT or PET-MRI.\n2. Individuals who are pregnant or breastfeeding\u002Fchest-feeding. Pregnant and breastfeeding\u002Fchest-feeding individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn\u002Fnursing child secondary to treatment of the study participant with \\[89Zr\\]DFO-YS5. Females of childbearing potential must have a negative pregnancy test before administration of \\[89Zr\\]DFO-YS5, as outlined in inclusion criterion #7. Breastfeeding\u002Fchest-feeding should be discontinued before administration of \\[89Zr\\]DFO-YS5.\n3. Individuals who do not agree to follow the below contraception requirements:\n\n   Females of reproductive potential (defined below) must agree to use two forms of contraception, consisting of a barrier method (such as condoms) in combination with a secondary complementary method (such as hormonal, Intrauterine device (IUD), etc.), or strict abstinence, for the duration of study participation and for 1 month after administration of \\[89Zr\\]DFO-YS5. A female is considered to NOT be of reproductive potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if they meet either of the following two criteria: (1) has reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and\u002For bilateral oophorectomy for removal of uterus and\u002For ovaries).\n4. Hypersensitivity to \\[89Zr\\]DFO-YS5 or any of its excipients.\n5. Individuals with any condition or social circumstance that, in the opinion of the investigator, would impair the participant's ability to comply with study procedures.",{"count":54,"type":20},40,[23],"This is a single-center, pilot, PET-imaging study of the novel radiotracer 89Zirconium-89 DFO conjugated to the YS5 monoclonal antibody (\\[89Zr\\]DFO-YS5) in participants with nerve sheath tumor, bladder cancer, or advanced solid tumor neoplasms.",[58,59,60,61,62,63,64,65,66,67,68,31],"Bladder Cancer","Nerve Sheath Tumor","Nerve Sheath Tumors","Solid Tumor Malignancies","Solid Tumor Cancer","Solid Tumor Neoplasms","Advanced Solid Tumor","Bladder Neoplasm","Nerve Sheath Neoplasms","Nerve Sheath Tumor, Nos","Solid Tumor, Adult",[70],"Imaging Study","NOT_YET_RECRUITING","2026-06-17",{"date":74,"type":37},"2026-06-24",{"date":76,"type":20},"2026-08-01",{"date":78,"type":20},"2029-09-30",{"name":80,"class":81},"Robert Flavell, MD, PhD","OTHER",1,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":21,"phases":92,"briefSummary":93,"conditions":94,"keywords":126,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":154},"100499720","phase-1-phase-12-trial-of-s241656-in-selected-rasmapk-mutation--positive-malignancies-100499720","NCT05786924","Phase 1\u002F2 Trial of S241656 in Selected RAS\u002FMAPK Mutation- Positive Malignancies","A Phase 1\u002F2, Open-label Study of Oral S241656 (BDTX-4933) as Monotherapy and in Combination With Other Anti-Cancer Therapies in Patients With KRAS, BRAF and Other Selected RAS\u002FMAPK Mutation-Positive Malignancies","Key Inclusion Criteria:\n\n* Life expectancy of ≥ 12 weeks in the opinion of the investigator.\n* Histologically or cytologically confirmed recurrent locally advanced (unresectable) or metastatic solid tumors with documented RAS or RAF mutations or alterations.\n* Adequate bone marrow and organ function.\n* Recovered from toxicity to prior anti-cancer therapy.\n\nPart 1 Dose Escalation cohort ONLY:\n\n* Part 1A: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C, HRAS, NRAS, BRAF or CRAF (RAF1) mutations or alterations\n* Part 1B: Advanced\u002Fmetastatic GI tumors (e.g., PDAC, CRC, and BTC) with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 1C: Advanced\u002Fmetastatic PDAC with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 1D: Colorectal adenocarcinoma with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 1E: Other advanced\u002Fmetastatic non-GI, non-NSCLC solid tumors with KRAS, HRAS, NRAS, BRAF, CRAF (RAF1) mutations or alterations\n\nPart 2 Dose Optimization and Expansion cohorts ONLY:\n\n* Part 2A: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C mutations and\u002For BRAF mutations\n* Part 2A1: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C mutations\n* Part 2A2: Advanced\u002Fmetastatic NSCLC with BRAF mutations\n* Part 2A3: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C or BRAF mutations or alterations and active CNS metastatic disease\n* Part 2A4: Advanced\u002Fmetastatic NSCLC with a KRAS G12C mutation\n* Part 2B1: Advanced\u002Fmetastatic PDAC with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 2B2: Advanced\u002Fmetastatic CRC with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 2B3: Advanced\u002Fmetastatic BTC (adenocarcinoma) with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n\nKey Exclusion Criteria:\n\n* Cancer that has a known MEK1\u002F2 mutation.\n* Known allergy\u002Fhypersensitivity to excipients of S241656 or to any of the registered IMPs administered in combination.\n* Any contra-indication, to use of any of the combination chemotherapy or anti-EGFR therapy partners administered as part of this trial.\n* Major surgery within 4 weeks of study entry or planned during study.\n* Ongoing anticancer therapy.\n* Ongoing radiation therapy.\n* Uncontrolled or active clinically relevant bacterial, fungal, or specific viral infection requiring systemic therapy.\n* Clinically significant cardiovascular disease.\n* Symptomatic spinal cord compression.\n* Evidence of active malignancy (other than study-specific malignancies) requiring systemic therapy within the next 2 years.\n* History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO.\n* Females who are pregnant or breastfeeding.\n* Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study.\n* Prior use of experimental agents that target the KRAS\u002FBRAF\u002FMEK\u002FERK pathway.",{"count":91,"type":20},554,[23,24],"BDTX-4933-101 is a first-in-human, open-label, Phase 1\u002F2 dose escalation, dose optimization and expansion study designed to evaluate the safety and tolerability of S241656 as monotherapy and in combination with other anti-cancer therapies in participants with selected advanced malignancies. The study population for the Dose Escalation part of the study comprises adults with recurrent advanced\u002Fmetastatic non-small cell lung cancer (NSCLC), Gastrointestinal (GI) cancers, and other solid tumors harboring KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (Rapidly Accelerated Fibrosarcoma (RAF1)) mutations or alterations. A dose optimization part in adults with NSCLC may follow the dose escalation phase if the sponsor, in consultation with the safety review committee, decides it is necessary to further characterize the optimal dose. However, the study may also proceed directly to the expansion phase. The study population for the Dose Expansion part of the study comprises adults with advanced\u002Fmetastatic NSCLC with KRAS and\u002For BRAF mutations, and with Pancreatic Ductal AdenoCarcinoma (PDAC), ColoRectal Cancer (CRC), and Biliary Tract Cancer (BTC) with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations and alterations. All patients will self-administer S241656 orally in 28-day cycles until disease progression, toxicity, withdrawal of consent, or termination of the study.",[95,96,97,98,99,100,101,102,103,104,105,106,107,108,31,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125],"Non-small Cell Lung Cancer","Histiocytic Neoplasm","Histiocytosis","BRAF Gene Mutation","BRAF V600E","BRAF V600 Mutation","BRAF Mutation-Related Tumors","BRAF","Metastatic Lung Non-Small Cell Carcinoma","Metastatic Lung Cancer","Recurrent Lung Cancer","Recurrent Lung Non-Small Cell Carcinoma","NSCLC","Solid Tumor","KRAS G12D","KRAS G12V","KRAS Mutation-Related Tumors","NRAS Gene Mutation","Thyroid Cancer","Thyroid Carcinoma","Colorectal Cancer","Colorectal Carcinoma","Recurrent Histiocytic and Dendritic Cell Neoplasm","Brain Metastases","Recurrent NSCLC","KRAS G13C","Acquired Resistance to KRAS G12C Inhibitor","KRAS G12A","KRAS G12F","KRAS G12R","KRAS G13D",[127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145],"BRAF Class I","BRAF Class II","BRAF Class III","KRAS","Intolerant histiocytic neoplasm","BDTX-4933","Phase 1","dose escalation","dose expansion","MAPK","mitogen-activated protein kinase","RAS","RAF","Upstream oncogenic alterations","RAF inhibitor","intracranial disease","CRAF","NRAS","RAF fusions","2026-06-16",{"date":72,"type":37},{"date":149,"type":37},"2023-04-18",{"date":151,"type":20},"2028-06",{"name":153,"class":81},"Institut de Recherches Internationales Servier",27,{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":21,"phases":164,"briefSummary":165,"conditions":166,"keywords":169,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":181},"100642168","phase-1-fortras-a-study-of-msk-tcr5-in-people-with-solid-tumor-cancers-100642168","NCT07638371","FORTRAS: A Study of MSK-TCR5 in People With Solid Tumor Cancers","FORTRAS: Phase I, Investigator Initiated, Dose-escalation Clinical Trial Evaluating a CD8 Alpha\u002FBeta Armored RAS G12D\u002FHLA-A*11:01-specific T-cell Receptor Therapy (MSK-TCR5) in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\nPart A: Prior to cell collection all of the following inclusion criteria must be met:\n\n* Age ≥18 years.\n* Histologically confirmed advanced or metastatic, unresectable solid tumor\n* Positive for RAS G12D mutation and HLA-A\\*11:01 allele\n* Subject has advanced solid cancer, defined as unresectable, advanced, and\u002For metastatic disease after at least 1 line of systemic standard of care (SOC) treatment regimen and for which there are no available curative treatment options. Subjects with stable disease (SD), or that present lack of clinical benefit from previous therapy (including treatment suspension due to toxicity) may be considered eligible for enrollment. :\n\n  1. For CRC: Patients harboring genomic aberrations such as BRAFV600E mutations, HER2 amplifications, or VEGF expression for which FDA-approved targeted therapies are available must have received prior treatment with applicable FDA-approved targeted therapies, including multi-kinase inhibitors. Patients whose tumors have deficient mismatch repair (dMMR)\u002Fhigh microsatellite instability (MSI-H) must have received an immune checkpoint inhibitor prior to enrolling in this study.\n  2. For NSCLC: Patients harboring genomic aberrations such as non-resistant EGFR mutations, ALK rearrangement, ROS rearrangement, and BRAF V600E mutation for which FDA-approved targeted therapies are available must have received prior treatment with the applicable FDA-approved targeted therapies. Patients with the appropriate PD-L1 expression score must have received treatment with an FDA-approved checkpoint inhibitor with or without chemotherapy consistent with the FDA-approved label.\n  3. Any other solid tumors, including PDAC: Patients harboring genomic aberrations for which FDA-approved targeted therapies are available must have received prior treatment with the applicable FDA-approved targeted therapies. Patients whose tumors have dMMR\u002FMSI-H must have received an immune checkpoint inhibitor prior to enrolling in this study.\n\nPart B: Prior to treatment with MSK-TCR5 all of the following inclusion criteria must be met:\n\n* Measurable disease per RECIST version 1.1. Note: a previously irradiated or locoregionally treated lesion can be considered a target lesion if it progressed post-treatment.\n* ECOG performance status of 0 or 1\n* Adequate organ and bone marrow function based on the following laboratory values:\n\n  1. ANC ≥1000\u002Fmm3 without granulocyte colony-stimulating factor support (filgrastim within 7 days or peg-filgrastim within 14 days of screening)\n  2. Platelets ≥75,000\u002Fmm3 without transfusion within the preceding 7 days of screening.\n  3. Hemoglobin ≥8.0 g\u002FdL (≥80 g\u002FL); blood transfusion permitted within 7 days of screening.\n  4. AST, ALT, and ALP ≤ 3x ULN, or ≤ 5x ULN if liver or bone metastases present.\n  5. Total bilirubin ≤ 1.5x ULN or ≤ 3x ULN in the presence of documented Gilbert's Syndrome\n  6. CrCl ≥50 mL\u002Fmin by Cockcroft-Gualt equation\n\nExclusion Criteria:\n\nPart A: Participant Exclusion Criteria prior to cell collection\n\n* Previous allogeneic stem cell transplantation or prior organ transplantation\n* History of primary immunodeficiency, autoimmune, or inflammatory disease including inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, myasthenia gravis, or Grave's disease that in the past year has required systemic treatment with corticosteroids \\> 10mg\u002Fday of prednisone or equivalent doses of other corticosteroids or immunosuppressive drugs. Note: Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal\u002Fpituitary insufficiency is not considered a form of systemic treatment and allowed)\n* Primary brain tumor\n* Untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression. Patients previously treated for CNS metastases that are radiographically and neurologically stable and off steroids for at least 2 weeks prior to enrollment are eligible.\n* Surgery or catheter-based interventions such as transarterial chemoembolization or percutaneous coronary intervention within 2 weeks.\n* Uncontrolled significant intercurrent or recent illness including, but not limited to the following conditions:\n\n  a. Significant cardiovascular abnormalities as defined by any one of the following: uncontrolled congestive heart failure or hypertension, clinically significant hypotension, symptomatic coronary artery disease, or a documented ejection fraction (EF) of \\\u003C 50% as assessed by echocardiogram or multigated acquisition scan (MUGA).\n* Uncontrolled active bacterial, viral, fungal, or mycobacterial infection not responding to antibiotics, antimycotics, or antifungal agents, as well as long-term oral treatment with any of these agents.\n* Subject has had radiotherapy or systemic anti-cancer therapy within at least 2 weeks or 3 half-lives, whichever is shorter.\n* Pregnant or lactating women; women of childbearing age, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception while receiving study treatment and for at least 12 months after all treatment is finished. Sexually active males, unless they are willing to use a condom during intercourse while receiving study treatment and for at least 12 months after all treatment is finished.\n* Previously identified allergy, hypersensitivity, or known contraindication to cyclophosphamide, fludarabine, or any other agent associated with LDC or MSK-TCR5.\n* Positive serologic test results for HIV.\n* Acute or chronic HBV infection as assessed by serologic (HBVsAg) or PCR results, defined as HBVsAg+, HBVcAb+, HBV PCR+.\n* Acute or chronic HCV infection as assessed by serologic (HCV ab) or PCR results, defined as HCV Ab+ with reflex to positive HCV PCR\n* Patient\u002Fparent\u002FLAR unable to give informed consent\n\nPart B: Participant Exclusion Criteria prior to MSK-TCR5 infusion\n\n* Any exclusion criterion listed in Part A.",{"count":163,"type":20},16,[23],"The purpose of this study is to test the safety of MSK-TCR5 in participants with advance solid tumor cancer that has a KRAS, HRAS, or NRAS G12D mutation.",[108,31,64,167,168],"Unresectable Solid Tumor","Metastatic Solid Tumor",[108,31,64,167,168,170,171,172],"MSK-TCR5","Memorial Sloan Kettering Cancer Center","26-083","2026-06-11",{"date":175,"type":37},"2026-06-15",{"date":177,"type":37},"2026-06-09",{"date":179,"type":20},"2030-06-09",{"name":171,"class":81},7,{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":21,"phases":191,"briefSummary":192,"conditions":193,"keywords":195,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":82},"100584852","phase-1-pet-89zrdfo-starpeg-in-solid-tumors-100584852","NCT06894745","PET [89Zr]DFO-starPEG in Solid Tumors","Positron Emission Tomography (PET) Imaging of the Enhanced Permeability and Retention (EPR) Effect With [89Zr]DFO-starPEG in Patients With Solid Tumors","Inclusion Criteria:\n\n1. Age \\>= 18 years.\n2. Histological or cytological confirmation of solid tumor malignancy.\n3. Any malignancy, with at least one soft tissue lesion measurable at 1 centimeter (cm) or greater in short axis measurement on cross sectional imaging such as Computerized tomography (CT), Magnetic resonance imaging (MRI), or Positron Emission Tomography (PET)\u002FCT, OR at least 1 lesion which is positive (defined as greater than surrounding background) in the bones on standard of care cancer imaging PET exam.\n4. Clinically able to undergo PET\u002FCT imaging.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 or Karnofsky ≥ 50%.\n6. Adequate organ function as defined below within 0-28 days before \\[89Zr\\]DFO-starPEG administration:\n\n   * Total bilirubin: ≤ 1.5 x institutional upper limit of normal (ULN) (unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits) .\n   * Aspartate aminotransferase (AST)\u002F serum glutamic-oxaloacetic transaminase (SGOT) ≤ 3 x ULN.\n   * Alanine aminotransferase (ALT)\u002F serum glutamic-pyruvic transaminase (SGPT) ≤ 3 x ULN.\n   * Estimated creatinine clearance: ≥ 60 mL\u002Fmin, calculated using the Cockcroft-Gault equation or 24 hour urine collection.\n7. Females of reproductive potential (defined below) must be willing to undergo a urine or serum pregnancy test (i.e., human chorionic gonadotropin test) within 72 hours before administration of \\[89Zr\\]DFO-starPEG. A female is considered to NOT be of reproductive potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if they meet either of the following two criteria: (1) has reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and\u002For bilateral oophorectomy for removal of uterus and\u002For ovaries). The result of the urine or serum pregnancy test must be negative in order to initiate the \\[89Zr\\]DFO-starPEG administration. If a urine pregnancy test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the individual must be excluded from participation if the serum pregnancy result is positive. Pregnant individuals are excluded from this study because there is an unknown but potential risk for adverse effects in the unborn child secondary to treatment of the study participant with \\[89Zr\\]DFO-starPEG.\n8. Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or endpoints of this study are eligible.\n9. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Individuals with a contraindication to PET-CT imaging (e.g., severe claustrophobia).\n2. Individuals who are pregnant or breastfeeding\u002Fchestfeeding. Pregnant and breastfeeding\u002Fchestfeeding individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn\u002Fnursing child secondary to treatment of the study participant with \\[89Zr\\]DFO-starPEG. Females of childbearing potential must have a negative pregnancy test before administration of \\[89Zr\\]DFO-starPEG, as outlined in inclusion criterion #7. Breastfeeding\u002Fchestfeeding should be discontinued before administration of \\[89Zr\\]DFO-starPEG.\n3. Individuals who do not agree to follow the below contraception requirements:\n\n   * Females of reproductive potential (defined below) must agree to use two forms of contraception, consisting of a barrier method (such as condoms) in combination with a secondary complementary method (such as hormonal, intrauterine device (IUD), etc.), or strict abstinence, for the duration of study participation and for 1 month after administration of \\[89Zr\\]DFO-starPEG.\n   * A female is considered to NOT be of reproductive potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if they meet either of the following two criteria: (1) has reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and\u002For bilateral oophorectomy for removal of uterus and\u002For ovaries).\n4. Hypersensitivity to \\[89Zr\\]DFO-starPEG or any of its excipients.\n5. Individuals with any condition or social circumstance that, in the opinion of the investigator, would impair the participant's ability to comply with study procedures.",{"count":190,"type":20},13,[23],"This is a first-in-human, pilot study of the novel PET-imaging radiotracer \\[89Zr\\]DFO-starPEG. The study is designed to obtain preliminary data to support future development of this agent as an imaging surrogate to visualize enhanced permeability and retention (EPR)-mediated tracer uptake before administration of EPR-based nanomedicines.",[108,31,194],"Soft Tissue Lesion",[196,197],"Dosimetry","Imaging","2026-06-03",{"date":200,"type":37},"2026-06-05",{"date":202,"type":37},"2025-06-02",{"date":204,"type":20},"2027-12-31",{"name":80,"class":81},{"id":207,"slug":208,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":212,"enrollmentInfo":213,"targetDuration":4,"studyType":21,"phases":215,"briefSummary":217,"conditions":218,"keywords":229,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":82},"100581542","phase-2-trop2-targeted-immunopet-imaging-of-solid-tumors-100581542","NCT06851663","Trop2-targeted immunoPET Imaging of Solid Tumors","Inclusion Criteria:\n\n* Aged 18-75 year-old and of either sex\n* Histologically confirmed diagnosis of solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer) or suspected solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer) by diagnostic imaging;\n* Capable of giving signed informed consent, including compliance with the requirements and restrictions in the informed consent form (ICF) and this protocol.\n\nExclusion Criteria:\n\n* Pregnancy；\n* Severe hepatic and renal insufficiency;\n* Allergic to single-domain antibody radiopharmaceuticals.","75 Years",{"count":214,"type":20},400,[24,216],"PHASE3","This study aims to establish and optimize the trophoblast cell surface antigen 2 (Trop2)-targeted immuno-positron emission tomography\u002Fcomputed tomography (immunoPET\u002FCT) imaging method and its physiological and pathological distribution characteristics, based on which the diagnostic efficacy of the above imaging agents in solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer) will be evaluated.",[108,31,219,58,220,221,222,223,224,225,226,227,113,228],"Uroepithelial Carcinoma","Prostate Cancer","Lung Cancer","Nasopharyngeal Cancer","Liver Cancer","Cholangiocarcinoma","Ovarian Cancer","Cervical Cancer","Endometrial Cancer","Head and Neck Cancer",[230,231,108],"Trophoblast cell surface antigen 2 (Trop2)","ImmunoPET","2026-05-27",{"date":234,"type":37},"2026-05-29",{"date":236,"type":37},"2024-12-23",{"date":238,"type":20},"2027-12",{"name":240,"class":81},"RenJi Hospital",{"id":242,"slug":243,"hasResults":11,"nctId":244,"briefTitle":245,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":11,"sex":16,"minAge":247,"maxAge":4,"enrollmentInfo":248,"targetDuration":4,"studyType":21,"phases":250,"briefSummary":252,"conditions":253,"keywords":254,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":82},"100382849","utilization-of-microbiome-as-biomarkers-and-therapeutics-in-immuno-oncology-100382849","NCT04264975","Utilization of Microbiome as Biomarkers and Therapeutics in Immuno-Oncology","Part 1: development of microbiome biomarkers\n\n\\\u003CInclusion Criteria:\\> 1.Patients with pathologically confirmed solid cancer who are being treated with immunotherapy or are going to receive immunotherapy\n\n1. Age ≥ 19 years old\n2. Eastern Cooperative Oncology Group performance status 0-2\n3. Measurable or evaluable lesion(s) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\n\n\\\u003CExclusion Criteria\\>\n\n1. A history of other cancers requiring treatment within the recent 3 years (excepting treated basal or squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, breast, or stomach)\n2. A history of active primary immunodeficiency\n3. Active infection including tuberculosis or Human Immunodeficiency Virus (HIV)\n4. Autoimmune disease (excepting type 1 diabetes mellitus, hypothyroidism requiring hormone replacement therapy only, skin disease not requiring systemic therapy (such as vitiligo, psoriasis or alopecia)\n5. Patients who are receiving immunosuppressive medications (excepting topical steroids, systemic steroid ≤10 mg\u002Fday prednisone or equivalents, or a brief course of steroids for prophylaxis (e.g., hypersensitivity reaction)\n\n   \\--------------------------------------------------------------------------------------------\n\npart 2: proof-of-concept trial on the fecal microbiota transplantation in patients who are being treated with immunotherapy for solid cancers\n\n\\\u003CInclusion Criteria for donors\\>\n\n1. Patients who have partial or complete response to immunotherapy at the time of stool donation\n2. No history of exposure to HIV or hepatitis virus within the previous 12 months\n3. No history of international travel within previous 6 months to areas of high risk of travelers' diarrhea\n4. No current communicable disease\n5. No household members with active gastrointestinal infection\n6. No history of inflammatory bowel disease\n7. No recent intake of potential allergenic foods that are known to cause hypersensitivity in a recipient (such as peanut)\n\n\\\u003CInclusion criteria for recipients\\>\n\n1. Patients without contraindications for colonoscopy such as suspected bowel perforation, acute diverticulitis, or fulminant colitis\n2. Patients who have disease progression to immunotherapy as one of the following two patterns:\n\n2-1) Patients who have disease progression due to primary resistance to immunotherapy\n\n2-2) Patients who have disease progression following disease stabilization due to secondary resistance to immunotherapy","19 Years",{"count":249,"type":20},60,[251],"NA","This is an open label, single-center, non-randomized clinical trial on utilization of microbiome as biomarkers and therapeutics in immuno-oncology.\n\nThis research consists of two parts:\n\npart 1: development of microbiome biomarkers for immuno-oncology part 2: proof-of-concept trial on the fecal microbiota transplantation in patients who are being treated with immunotherapy for advanced solid tumor",[31],[255,256,257,258,259],"immuno-oncology","immunotherapy","biomarker","fecal microbiota transplantation (FMT)","microbiome","2026-05-20",{"date":262,"type":37},"2026-05-22",{"date":264,"type":37},"2018-06-04",{"date":266,"type":20},"2029-12-31",{"name":268,"class":81},"Asan Medical Center",{"id":270,"slug":271,"hasResults":11,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":275,"eligibilityCriteria":276,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":277,"targetDuration":4,"studyType":21,"phases":279,"briefSummary":280,"conditions":281,"keywords":286,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":299},"100396514","phase-1-an-open-label-study-of-inv-1120-as-a-single-agent-and-in-combination-with-pembrolizumab-in-adult-patients-with-advanced-solid-tumors-100396514","NCT04443088","An Open-Label Study of INV-1120 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Advanced Solid Tumors","A Phase 1a\u002F1b, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Evidence of Antitumor Activity of INV-1120 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Advanced Solid Tumors","KEYNOTE-E12","Inclusion Criteria:\n\n1. Written informed consent, according to local guidelines, signed and dated by the patient prior to the performance of any study-specific procedures, sampling, or analyses;\n2. Patient must be ≥18 years-of-age at the time of signature of the informed consent form (ICF);\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1;\n4. Patients with histologically or cytologically confirmed advanced solid tumors which have progressed on or following standard therapy or for which no standard therapy exists;\n5. Patients with life expectancy ≥3 months;\n6. Patients with at least one measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI), according to RECIST v1.1. Tumor lesions that have been irradiated ≥4 weeks before the start of treatment, and have subsequently had documented progression, may be chosen as target lesions in the absence of measurable lesions that have not been irradiated;\n7. Patients whose laboratory data at screening meet the acceptable criteria for bone marrow, liver function and renal function.\n8. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test during screening. A woman is considered of childbearing potential (fertile) following menarche and until becoming postmenopausal unless permanently sterile. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. Postmenopausal women can be included;\n9. Male patients with female partners of childbearing potential and female patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for 3 months following last dose. Medically acceptable contraception includes:\n\n   * Hormonal methods (Needs to have been instituted at least 1 month prior to the first dose of study drug):\n   * Barrier methods:\n   * Abstinence, defined as refraining from sexual intercourse\n10. Male patients must also refrain from donating sperm from the first dose of study drug until 4 months after the last dose of study drug;\n11. Patients must be able to swallow and retain orally administered medication.\n\nExclusion Criteria:\n\n1. History (≤5 years) or current evidence of cancer that is histologically distinct from the cancer under study, except for cervical carcinoma in situ, superficial non-invasive bladder tumors, or curatively treated Stage I non-melanoma skin cancer. Patients with hepatocellular carcinoma will be excluded from Phase 1b dose escalation;\n2. Known serious allergy to investigational drug or excipients (microcrystalline cellulose);\n3. History of severe autoimmune disease (including significant ongoing immune-related adverse events of prior immune-oncology therapy) or autoimmune disorder that requires chronic systemic corticosteroid treatment at immunosuppressive doses (prednisone \\>10 mg\u002Fday or equivalent);\n4. Known malignant central nervous system disease other than neurologically stable, treated brain metastases - defined as metastases having been treated by surgery, surgery plus radiotherapy or radiotherapy alone, with no evidence of progression or hemorrhage and off any systemic corticosteroids for at least 4 weeks prior to signing the consent;\n5. History (within 4 weeks of starting treatment) or evidence of active infections (Grade ≥2);\n6. Seropositive status for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) at any time before the start of treatment: Testing for seropositive status during screening will be at the discretion of the Investigator in patients without previously reported results;\n7. History or evidence of any severe and\u002For uncontrolled medical conditions or other conditions that, in the opinion of the Investigator and Sponsor, could affect the patient's participation in the study, such as any disorder or surgical procedure that could impact the absorption of study drug from the gastrointestinal tract.\n8. History (≤6 months before the start of treatment) or evidence of any of the following: acute myocardial infarction, unstable angina pectoris, coronary artery bypass graft, cerebrovascular accident, or transient ischemic attack;\n9. Patients who have impaired cardiac function or clinically significant cardiac diseases, including any of the following:\n\n   * Congenital long QT syndrome;\n   * Significant ventricular or supraventricular arrhythmias (patients with sinus arrhythmia or chronic rate-controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible);\n   * LVEF \\\u003C 50% by ECHO or MUGA;\n   * Other clinically significant heart disease such as known congestive heart failure New York Heart Association (NYHA) Class III-IV;\n10. Patients with QT interval ≥470 msec in females and ≥450 msec in males at screening using Fridericia's formula (determined as the mean of 3 QTcF values from the screening triplicate ECG obtained with adequate quality);\n11. Women who are pregnant or breastfeeding.\n12. WOCBP and sexually active fertile men with WOCBP partners who are unwilling or unable to use acceptable contraception method to avoid pregnancy for at least 1 month before the first dose of the study drug, during the study, and for 4 months after the last dose of study drug;\n13. Male patient who plans to father a child while enrolled in this study or within 4 months after the last dose of study drug;\n14. Not recovered from toxicity from prior anticancer therapy to baseline or Grade 1 (except toxicities which are not clinically significant such as alopecia, skin discoloration).\n15. History of an allogeneic bone marrow or solid organ transplant;\n16. Use of systemic anti-cancer agent (except luteinizing hormone-releasing hormone (LHRH) agonists, bisphosphonates and denosumab) or investigational drug ≤28 days or five half-lives whichever is shorter prior to the first dose of study treatment;\n17. Radiation therapy ≤28 days prior to the first dose of study treatment, or likely to require radiation therapy at any time until the 30 days after the last dose of study treatment, except for palliative radiation therapy limited to non-target bone lesions;\n18. Major surgery within 4 weeks before enrollment or surgery with ongoing post-operative complications);\n19. History of transfusion of platelets ≤2 weeks before the start of treatment;\n20. Patients who start erythropoietin or granulocyte-colony stimulating factor (G-CSF), pegfilgrastim, or filgrastim ≤3 weeks before screening;\n21. Patients taking medications known to have a significant risk of causing Torsades de Pointes. Patients who have discontinued any of these medications must have a wash-out period of at least 7 days or at least 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug.\n22. History of use of H2 blockers (\\\u003C24 hours before the first dose of study treatment and during the study) and proton pump inhibitors (\\\u003C5 days before the first dose of study treatment and during the study).\n23. Patients with recent (within past 12 months) history, or are currently being treated for gastroesophageal ulcer.\n\n    The following additional exclusion criteria will apply to patients enrolling in Phase 1b:\n24. Have been discontinued treatment due to a Grade 3 or higher immune-related (irAE) from prior anti-PD-1 or anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX40, CD137) (only for dose expansion).\n25. Patient is currently participating or has participated in a study of an investigational agent or using an investigational device within 30 days of administration of investigational products.\n26. Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention. Note: Administration of killed vaccines are allowed.\n27. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n28. Has a history of (non-infectious) pneumonitis \u002F interstitial lung disease that required steroids or has current pneumonitis \u002F interstitial lung disease or radiation pneumonitis.",{"count":278,"type":20},78,[23],"Phase 1, open-label dose-escalation study to determine the MTD of INV-1120 and RP2D, and to assess the DLT of INV-1120 as a single agent or in the combination with pembrolizumab. The safety, tolerability, and PK of INV-1120 as a single agent or in the combination with pembrolizumab will be assessed in adult patients with advanced solid tumors.",[282,68,283,31,284,285],"Cancer","Cancer Metastatic","Solid Tumor, Unspecified, Adult","Tumor, Solid",[287,288,282,289],"Ionova","Ionova Bio","Oncology","2026-03-16",{"date":292,"type":37},"2026-03-18",{"date":294,"type":37},"2020-06-26",{"date":296,"type":20},"2026-12-31",{"name":298,"class":44},"Shenzhen Ionova Life Sciences Co., Ltd.",3,{"id":301,"slug":302,"hasResults":11,"nctId":303,"briefTitle":304,"officialTitle":304,"acronym":305,"eligibilityCriteria":306,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":307,"targetDuration":4,"studyType":21,"phases":309,"briefSummary":310,"conditions":311,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":82},"100520027","thrombin-generation-and-prediction-of-thromboembolic-events-in-oncology-patients-at-risk-100520027","NCT06051214","Thrombin Generation and Prediction of Thromboembolic Events in Oncology Patients at Risk","THROMBIN","Inclusion Criteria:\n\n1. Patient aged \\> 18 years,\n2. Patient with a solid cancer at high risk of thrombosis, whether metastatic or not (lung, pancreatic, gastric or glioblastoma cancers)1,\n3. Patients who have not received any systemic treatment for their cancer,\n4. An informed patient who does not object to the use of data for research purposes and who has consented to the collection, use and storage of biological samples.\n\nExclusion Criteria:\n\n1. Patient who has had a VTE in the 12 months preceding the diagnosis of cancer,\n2. Patient on low molecular weight heparins, standard unfractionated heparins and anti-vitamin K2,\n3. Women who are pregnant, likely to become pregnant or who are breast-feeding,\n4. Persons deprived of their liberty, under court protection, under curators or under the authority of a guardian,\n5. Unable to undergo medical monitoring of the trial for geographical, social or psychological reasons.",{"count":308,"type":20},200,[251],"Coagulation is a complex system which, through the action of thrombin, leads to the formation of fibrin, which stabilises the platelet clot. Any disturbance in the balance between procoagulant and anticoagulant factors can tip the physiological process either towards a state of hypercoagulability leading to thrombosis or hypocoagulability responsible for bleeding.\n\nDue to a number of factors, cancer is associated with a state of hypercoagulability, leading to thrombosis. The incidence of venous thromboembolism (VTE) in cancer patients varies from 15 to 20% depending on the type of cancer, the stage of the disease and the associated treatments (ONCORIF data, November 2021). The risk of venous thromboembolism (VTE) is greatly increased in cancer patients (RR x 3 to 6) and doubled in the case of associated chemotherapy (1). VTE is a poor prognostic factor, occurs mainly in the first 6 months after diagnosis and is the second leading cause of death in cancer patients.\n\nAt present, haemostasis tests performed in medical laboratories independently explore the different coagulation pathways but do not allow the overall haemostatic profile of a hyper- or hypocoagulable patient to be assess.\n\nBased on this knowledge base, the aim of our study will be to monitor thrombogram profiles during the management of patients with tumours at high risk of thromboembolism (lung, pancreas, stomach, glioblastoma) and to correlate these profiles with the risk of a thromboembolic event occurring in these patients. The aim of the project is to validate a simple predictive test (suitable for clinical use) for the risk of thromboembolism in these patients. These analyses will also make it possible to monitor the impact of chemotherapy on changes in the thrombin generation test in patients.",[31],"2026-02-12",{"date":314,"type":37},"2026-02-17",{"date":316,"type":37},"2023-09-12",{"date":318,"type":20},"2028-09",{"name":320,"class":81},"Institut Cancerologie de l'Ouest",{"id":322,"slug":323,"hasResults":11,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":4,"eligibilityCriteria":327,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":328,"targetDuration":4,"studyType":21,"phases":330,"briefSummary":331,"conditions":332,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":344},"100555738","phase-1-a-study-of-dm005-in-patients-with-advanced-solid-tumors-100555738","NCT06515990","A Study of DM005 in Patients With Advanced Solid Tumors","A Phase 1, Multicenter, Open-label, First-in-human, Dose Escalation and Expansion Study of DM005 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Common inclusion criteria for both Parts\n\n  1. Participants must have the ability to understand and willingness to sign a written informed consent document.\n  2. Participants who have pathologically or cytologically documented metastatic\u002Fadvanced NSCLC, gastroesophageal cancer, CRC, HCC, pancreatic cancer, or HNSCC, not curable with standard local therapies (i.e., surgery and\u002For radiation) and have progressed on standard therapy, or intolerant to standard therapy.\n  3. Participants must be ≥18 years of age on the day of signing the informed consent form (ICF).\n  4. Participants must have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 2.\n  5. Has a life expectancy ≥3 months.\n  6. Has measurable disease based on response evaluation criteria in solid tumors (RECIST) version 1.1.\n\nExclusion Criteria:\n\n* Participants are excluded from the study if any of the following criteria apply:\n\n  1. Participants have another active invasive malignancy within 5 years, with the following exceptions and notes:\n\n     * History of noninvasive malignancy, such as cervical cancer in situ, in situ melanoma, or ductal carcinoma in situ of the breast that is in complete remission years after treatment with curative intent is allowed.\n     * Malignancies with a negligible risk of metastasis or death (such as adequately treated basal or squamous cell skin cancer and localized prostate cancer).\n  2. Current or history of hematologic malignancy.\n  3. Anticancer therapy (chemotherapy, immunotherapy, hormonal therapy, targeted therapy, biologic therapy, or other anti-cancer therapies, except for hormones for hypothyroidism or estrogen replacement therapy, anti-estrogen analogs, agonists required to suppress serum testosterone levels) within 28 days or 5 half-lives, whichever is shorter, prior to the first study dose. Radiotherapy with a wide field of radiation within 28 days, or radiotherapy with a limited field of radiation for palliation within 14 days of the first study dose. Major surgery, other than diagnostic surgery, within 4 weeks of the first study dose.\n  4. Primary central nervous system (CNS) malignancies or CNS metastases. Individuals with brain metastases can be enrolled only if treated, non-progressive brain metastases and off high-dose steroids (\\>20 mg prednisone or equivalent) for at least 4 weeks.\n  5. Presence of bulky disease (defined as any single mass \\>7 cm in its greatest dimension). Individuals with a mass \\>7 cm, but otherwise eligible, may be considered for enrollment after discussion and approval with the medical monitor.\n  6. Has an uncontrolled infection requiring IV injection of antibiotics, antivirals, or antifungals.\n  7. Has clinically significant corneal disease.\n  8. Has a corrected QT interval (QTcF) prolongation to \\>470 ms (for both genders) based on average of the Screening triplicate 12-lead ECG determinations; no concomitant medications that would prolong the QT interval; no known family history of long QT syndrome.\n  9. Left ventricular ejection fraction (LVEF) \\\u003C50% by either an echocardiogram (ECHO) or a multigated acquisition (MUGA) scan within 28 days before first dose of the study drug.\n  10. Known active hepatitis B (HBV) or hepatitis C (HCV) infection. Chronic carriers of HBV infection (HBsAg-positive, undetectable HBV DNA or HBV DNA ≤2500 copies\u002Fml or 500 IU\u002Fml) receive prophylactic treatment during the study can be enrolled. Participants with a history of HCV infection have completed curative antiviral treatment and HCV viral load below the limit of quantification and HCV antibody positive but HCV ribonucleic acid (RNA) negative due to prior treatment or natural resolution should be eligible.\n  11. Known human immunodeficiency virus (HIV) infection which is not well controlled. participants should be tested for HIV prior to enrollment if required by local regulations or institutional review board (IRB)\u002Fethics committee. All the following criteria are required to define an HIV infection (positive HIV1\u002F2 antibodies test) that is well controlled: HIV viral load \\\u003C400 copies\u002FmL, CD4+ T-cell counts ≥350 cells\u002FμL, no history of acquired immunodeficiency syndrome \\[AIDS\\])-defining opportunistic infection within the past 12 months, and stable viral load for at least 4 weeks on same anti-HIV retroviral medications.\n  12. Participants from endemic area will be specifically screened for tuberculosis. Participants with active tuberculosis are excluded. Participants who have received bacille Calmette-Guerin (BCG) vaccination may have a false positive result in the purified protein derivative (PPD) skin test. These participants are eligible if they have a negative Interferon Gamma Release Assay (IGRA).\n  13. Has received a live vaccine within 30 days prior to the first dose of study drug.\n  14. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia and anemia) not yet resolved to NCI-CTCAE version 5.0, ≤Grade 1 or baseline. Note: Participants may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to \\>Grade 2 for at least 3 months prior to enrollment\u002Frandomization and managed with the standard treatment) that the Investigator deems related to previous anticancer therapy, following discussion with the Sponsor's medical monitor, such as the following: Grade 2 chemotherapy-induced neuropathy, hypothyroidism, hyperglycemia.\n  15. Females who are pregnant or lactating or who intend to become pregnant during participation in the study.\n  16. Participants who are of reproductive potential refuse to use effective methods of birth control during participation of the study and within 7 months for female (and 4 months for male) after the last dose administration.",{"count":329,"type":20},136,[23],"The goal of this clinical trial is to find out about the safety, efficacy, and tolerability of DM005 for patients with the advanced solid tumors. DM005 is an experimental drug which is not approved by health authorities for the treatment of advanced solid tumors. For each participant, there will be a screening period of up to 28 days, a treatment period consisting of 21-day cycles, an end of treatment (EOT) Visit (+7 days), and a Follow-up Visit at 30 days (±7 days) after the EOT Visit.\n\nParticipants with advanced solid malignant tumors will be treated with DM005 on Day 1 of each cycle (every 3 weeks, Q3W). An initial dose of DM005 will be infused intravenously (IV) into each participant for approximately 60 minutes (±10) on Cycle1 Day 1. If there is no infusion-related reaction (IRR) during or after the initial dose, with the Investigator's confirmation and supervision, the subsequent dosing of DM005 in the following cycles maybe infused IV for approximately 30 minutes ( ±5). A 21-day observation period (Cycle 1) will then occur, at the end of which all relevant safety data will be reviewed.",[333,334,31],"Carcinoma, Non-Small-Cell Lung","Squamous Cell Carcinoma of Head and Neck","2026-01-13",{"date":337,"type":37},"2026-01-15",{"date":339,"type":37},"2024-10-31",{"date":341,"type":20},"2027-03",{"name":343,"class":44},"Doma Biopharmaceutical（Suzhou）Co., Ltd.",6,{"id":346,"slug":347,"hasResults":11,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":351,"eligibilityCriteria":352,"healthyVolunteers":11,"sex":16,"minAge":247,"maxAge":4,"enrollmentInfo":353,"targetDuration":4,"studyType":21,"phases":355,"briefSummary":356,"conditions":357,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":359,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":365,"locationsCount":82},"100480284","fmt-with-nivolumab-in-patients-with-advanced-solid-cancers-who-have-progressed-during-anti-pd-l1-therapy-100480284","NCT05533983","FMT With Nivolumab in Patients With Advanced Solid Cancers Who Have Progressed During Anti-PD-(L)1 Therapy","A Phase II Study of Fecal Microbiota Transplantation With Nivolumab in Patients With Advanced Solid Cancers Who Have Progressed During Anti-PD-(L)1 Therapy","NIVO-FMT","Donor inclusion criteria Having provided written consent before participation in the study, all donor candidates must fulfil all of the following criteria to be eligible for a donor in this study.\n\n1. Sex: Male or female\n2. Age (at the time of informed consent): 19 years and older\n3. Subjects with histologically- or cytologically-confirmed solid cancer In case of hepatocellular carcinoma, clinically confirmed diagnosis as per the American Association for the Study of Liver Diseases (AASLD) is allowed.1\n4. Patients who currently maintain a CR, PR or SD per RECIST v1.12 for at least 6 months with anti-PD-(L)1 monotherapy for solid cancer\n\nDonor exclusion criteria The subject who meets any of the following criteria will be excluded from a donor candidate. If an enrolled donor candidate is found to meet any of the following criteria anytime during the study, the donated stool obtained when those exclusion criteria are met will not be used for FMT.\n\n1. Having taken antimicrobials (antibiotics, antivirals antifungals) in the 4 weeks prior to donation\n2. Positive result for any pathogen tests during the screening period (Table 3)\n3. Current gastrointestinal symptoms including diarrhea, nausea, or vomiting\n4. History of chronic gastrointestinal disease including inflammatory bowel disease, celiac disease, or irritable bowel syndrome\n5. History of systemic autoimmune disease (e.g., multiple sclerosis, connective tissue disorder, type I diabetes mellitus)\n6. History of significant neurological (except for chemotherapy-induced neuropathy), neurodegenerative, neurodevelopmental, or psychiatric disorders\n7. History or risk behaviors for infectious disease:\n\n   * History of HIV, syphilis, human T-lymphotropic virus I and II\n   * Current systemic infection\n   * Enteric pathogen infection in the last 8 weeks\n   * Vaccination with a live attenuated virus in the last 8 weeks\n   * Previous tissue\u002Forgan transplant\n   * Recent travel (3 months) to tropical countries, countries with endemic diarrheal diseases or high risk of traveler's diarrhea (Africa, Southeast Asia, Mexico, Central America, South America, Caribbean)\n\nRecipient Main Inclusion criteria\n\nHaving provided written consent before participation in the study, patients must fulfill all of the following criteria to be eligible for this study:\n\n1. Sex: Male or female\n2. Age (at the time of informed consent)L 19 years and older\n3. Patients with histologically- or cytologically-confirmed solid cancer In case of hepatocellular carcinoma, clinically confirmed diagnosis as per the American Association for the Study of Liver Diseases (AASLD) is allowed.1\n4. Patients who do not have standard treatment, are no longer effective, are not drug resistant to standard treatment, or are unable to use standard treatment, and have previously performed anti-PD-1 or anti-PD-L1-based treatment (as monotherapy or combination therapy)\n5. Patients who did not experience any of the following immune-related adverse events (irAEs) during prior immunotherapy:\n\n   * A previous irAE corresponding to treatment discontinuation criteria for nivolumab as described in Section 8.2.2.3\n   * Unresolved irAEs prior to study entry (alopecia, Grade ≤2 sensory neuropathy, or other Grade ≤2 AEs not constituting a safety risk based on Investigator's judgment are acceptable)\n6. Patients who have at least 1 measurable lesion per the RECIST v1.12 as confirmed by imaging within 28 days before study enrollment. The following requirements should also be satisfied:\n\n   ˙If patients only have lesions that were previously treated with radiation, the lesion should be limited to one with confirmed aggravation by imaging after radiation.\n7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2\n8. Patients with a life expectancy of at least 3 months\n9. Patients whose latest laboratory data meet the below criteria within 7 days before the initiation of study treatment. If the date of the laboratory tests at the time of study entry is not within 7 days before the initiation of study treatment, testing must be repeated within 7 days before the initiation of study treatment, and these latest laboratory tests must meet the following criteria. Of note, laboratory data will not be valid if the patient has received a granulocyte colony-stimulating factor (G-CSF) within 7 days before testing.\n\n   * White blood cells ≥2,000\u002Fmm3 and neutrophils ≥1,500\u002Fmm3\n   * Platelets ≥100,000\u002Fmm3\n   * Hemoglobin ≥9.0 g\u002FdL\n   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x the upper limit of normal (ULN) of the study site (or ≤ 5.0 x ULN of the study site in patients with liver metastases)\n   * Total bilirubin ≤ 1.5 x ULN of the study site\n   * Creatinine ≤ 1.5 x ULN of the study site or creatinine clearance (either the measured or estimated value using the Cockcroft-Gault equation) \\> 45 mL\u002Fmin\n10. Women of childbearing potential (including women with chemical menopause or no menstruation for other medical reasons)#1 must agree to use contraception#2 from the time of informed consent until 5 months or more after the last dose of the study treatment. Also, women must agree not to breastfeed from the time of informed consent until 5 months or more after the last dose of the study treatment.\n11. Men must agree to use contraception#2 from the start of study treatment until 7 months or more after the last dose of the study treatment.\n\n    * 1\\. Women of childbearing potential are defined as all women after the onset of menstruation who are not postmenopausal and have not been surgically sterilized (e.g., hysterectomy, bilateral tubal ligation, bilateral oophorectomy). Postmenopause is defined as amenorrhea for ≥12 consecutive months without specific reasons. Women using oral contraceptives, intrauterine devices, or mechanical contraception such as contraceptive barriers are regarded as having childbearing potential.\n    * 2\\. The subject must consent to use any two of the following methods of contraception: vasectomy or condom for patients who are male or female subject's partner and tubal ligation, contraceptive diaphragm, intrauterine device, spermicide, or oral contraceptive for patients who are female or male subject's partner.\n12. Patients must be willing to provide blood and fecal samples at baseline, on-treatment, and\u002For disease progression for biomarker analyses.\n13. Patients who have biopsiable lesion(s) must consent to undergo fresh tumor biopsies of accessible lesion(s).\n\nRecipient Main Exclusion criteria Patients who meet any of the following criteria at the time of assessment for study entry will be excluded. If an enrolled subject is found to meet any of the following criteria before the initiation of study treatment, the subject will not be started on study treatment and will be withdrawn from the study.\n\n1. Patients with active malignancy within the previous 2 years before study entry (with the exception of completely resected non-melanoma skin cancer, curatively treated carcinoma in situ or intramucosal carcinoma, superficial bladder cancer treated with curative intent, localized prostate cancer treated with curative intent or other cancers that are less likely to influence on their prognosis such as localized thyroid papillary carcinoma)\n2. Patients with residual adverse effects of prior therapy or effects of surgery that would affect the safety evaluation of the study treatment in the opinion of the investigator or sub-investigator.\n3. Patients with current or past history of severe hypersensitivity to any other antibody products\n4. Patients with active autoimmune disease with systematic treatment (i.e., immunomodulator, corticosteroid, or immunosuppressant) required within the past 2 years before study entry.\n\n   * Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement therapy due to dysfunction of adrenal gland or pituitary gland, etc.) is not regarded as a form of systematic treatment and would be allowed.\n   * Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., no psoriatic arthritis) may be eligible provided that they meet the following conditions:\n\n     * Rash must cover less than 10% of the body surface area.\n     * Disease is well controlled at baseline and only requires low potency topical steroids.\n5. Patients with a current or past history of interstitial lung disease or pulmonary fibrosis diagnosed based on imaging or clinical findings. Patients with radiation pneumonitis may be enrolled if the radiation pneumonitis has been confirmed as stable (beyond acute phase) without any concerns about recurrence.\n6. Patients with concurrent diverticulitis or symptomatic gastrointestinal ulcerative or inflammatory disease (e.g., Crohn´s disease or ulcerative colitis)\n7. Patients with any metastasis in the brain or meninx that is symptomatic or requires treatment. Patients may be enrolled if the metastasis is asymptomatic and requires no treatment.\n8. Patients with uncontrollable pericardial fluid, pleural effusion, or ascites requiring frequent drainage (recurrence within 2 weeks of intervention)\n9. Patients with uncontrollable, tumor-related pain\n10. Patients who have experienced a transient ischemic attack or cerebrovascular accident within 180 days before study entry\n11. Patients with a history of uncontrollable or significant cardiovascular disease meeting any of the following criteria:\n\n    * Myocardial infarction within 180 days before study entry\n    * Uncontrollable angina pectoris within 180 days before study entry\n    * New York Heart Association (NYHA) Class III or IV congestive heart failure\n    * Uncontrollable hypertension despite appropriate treatment (e.g., systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥ 90 mmHg lasting 24 hours or more)\n    * Clinically significant cardiac arrhythmia not controlled by adequate medication\n12. Patients receiving or requiring anticoagulation therapy for a disease. Patients receiving antiplatelet therapy including low-dose aspirin may e enrolled.\n13. Patients with uncontrollable diabetes mellitus\n14. Patients with systemic infections requiring treatment within 14 days before starting the study treatment\n15. Patients who have a condition requiring systemic corticosteroids (\\> 10 mg daily prednisone or equivalents) (except for temporary use, e.g., for examination or prophylaxis of allergic reactions) or other immunosuppressants within 28 days before study entry\n\n    ˙Patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption)\n16. Patients who have a history of organ transplant, including stem cell allograft\n17. Patients who have received antineoplastic drugs (e.g., chemotherapy agents, molecular-targeted therapy agents, or immunotherapy agents) within 28 days before starting the study treatment, except for anti-PD-(L)1 inhibitor such as nivolumab, pembrolizumab, atezolizumab, avelumab, or durvalumab, for which its regular cycle interval is required before starting the study.\n18. Patients who have undergone surgical adhesion of the pleura or pericardium within 28 days before starting the study treatment\n19. Patients who have undergone major surgery under general anesthesia within 28 days before starting the study treatment\n20. Patients who have received radiotherapy within 28 days before starting the study treatment or radiotherapy to bone metastases within 14 days before starting the study treatment\n21. Patients who have received any radiopharmaceuticals (except for examination or diagnostic use of radiopharmaceuticals) within 42 days before the study treatment\n22. Patients with known history of Human Immunodeficiency Virus (HIV) infection\n23. Patients with active HBV (detectable HBs antigen or HBV DNA) or HCV infection (detectable HCV RNA):\n\n    * For the subject receiving antiviral agents for HBV at screening, if the subject has been treated for \\> 2 weeks and HBV DNA is \\\u003C500 IU\u002FmL (or 2,500 copies\u002FmL) prior to study entry, the subject will be allowed to be enrolled in the study. Antiviral agent should be continued for 6 months after study treatment discontinuation.\n    * For hepatocellular carcinoma, patients with past or ongoing HCV infection will be eligible for the study.\n24. Women who are pregnant or breastfeeding, or possibly pregnant\n25. Patients who have received any other unapproved drug (e.g., investigational use of drugs, unapproved combined formulations, or unapproved dosage forms) within 28 days before starting the study treatment\n26. Patients who have received a live vaccine within 4 weeks before starting the study treatment\n27. Patients judged to be incapable of providing consent for reasons such as concurrent dementia\n28. Other patients judged by the investigator or sub-investigator to be inappropriate as subjects of this study",{"count":354,"type":20},50,[251],"This is a single-center, open-label, Phase 2 study to evaluate the efficacy and safety of FMT with nivolumab in patients with advanced, unresectable, or metastatic solid cancer who have progressed during anti-PD-(L)1 therapy.",[31],"2025-11-26",{"date":360,"type":37},"2025-12-03",{"date":362,"type":37},"2023-03-08",{"date":364,"type":20},"2026-08-19",{"name":268,"class":81},{"id":367,"slug":368,"hasResults":11,"nctId":369,"briefTitle":370,"officialTitle":370,"acronym":4,"eligibilityCriteria":371,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":372,"targetDuration":4,"studyType":21,"phases":374,"briefSummary":375,"conditions":376,"keywords":385,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":82},"100588492","phase-1-imaging-of-solid-tumors-using-18f-trx-100588492","NCT06942104","Imaging of Solid Tumors Using 18F-TRX","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Advanced solid tumor malignancy in one of the following cohorts:\n\n  * Cohort 1 (n = 6): Any solid tumor malignancy with at least 3 metastatic lesions on conventional imaging\n  * Cohort 2 (n = 50):\n\n    * WHO grade 3 or 4 glioma - patients with known (by integrated molecular and histopathologic diagnosis) or presumed (by imaging; e.g., enhancing necrotic and\u002For hypervascular intrinsic brain tumor) high grade (WHO grade 3 or 4) glioma (n = 10), Locally advanced or metastatic clear cell renal cell carcinoma with at least three metastatic lesions on conventional imaging (n = 10).\n    * Metastatic castration-resistant prostate cancer with at least one metastatic lesion on conventional imaging including cross-sectional imaging of the chest, abdomen and pelvis and whole body bone scan or prostate-specific membrane antigen (PSMA) PET scan (n = 30).\n* Ability to understand and the willingness to sign a written informed consent document.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Negative serum or urine pregnancy test (women of childbearing potential only) within 72 hours of baseline procedures.\n* Absolute neutrophil count \\> 1.5 x 10\\^6\u002FL.\n* Platelets \\> 75,000 x 10\\^6\u002FL.\n* Hemoglobin \\> 8 g\u002FdL.\n* Total bilirubin \\\u003C 1.5 x upper limit of normal.\n* Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase (SGOT)) \\\u003C 2.5 x upper limit of normal (\\\u003C 5 x upper limit of normal in patients with liver metastases on conventional imaging).\n* Alanine aminotransferase (ALT)(serum glutamic-pyruvic transaminase (SGPT)) \\\u003C 2.5 x upper limit of normal (\\\u003C 5 x upper limit of normal in patients with liver metastases on conventional imaging).\n* Creatinine clearance \\> 50 ml\u002Fmin, calculated using the Cockcroft-Gault equation.\n\nExclusion Criteria:\n\n* Individuals with any condition or social circumstance that, in the opinion of the investigator, would impair the participant's ability to comply with study procedures.\n* Individuals receiving strong inhibitors or inducers of CYP3A4.\n* Uncontrolled active infection or other medical condition that would preclude safe participation in the study as judged by the Investigator.\n* Individuals who are pregnant.\n\n  * Individuals of childbearing potential (defined below) must agree to undergo a urine pregnancy test prior to participating in the study scans. Pregnant individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn child secondary to administration of 18F-TRX to the study participant.\n  * A female is considered to not be of childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if the participant meets either of the following two criteria: (1) has reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and\u002For bilateral oophorectomy for removal of uterus and\u002For ovaries).\n* Individuals who are breastfeeding\u002Fchestfeeding.\n\n  * Breastfeeding\u002Fchestfeeding individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn\u002Fnursing child secondary to administration of 18F-TRX to the study participant.\n  * Breastfeeding\u002Fchestfeeding should be discontinued before administration of 18F-TRX.",{"count":373,"type":20},56,[23],"This phase I trial tests the safety and effectiveness of 18F-TRX in detecting tumors (cancer) patients with solid tumors. 18F-TRX is an imaging tracer that is used to visualize tumors using a PET scan. It specifically targets and detects labile (unstable) iron levels within tissues, including tumors. Diagnostic procedures, such as 18F-TRX PET\u002FCT or PET\u002FMRI, may help detect tumors in patients with solid tumors",[108,31,377,378,379,380,381,382,383,384],"Castration-Resistant Prostate Carcinoma","Locally Advanced Clear Cell Renal Cell Carcinoma","Metastatic Clear Cell Renal Cell Carcinoma","Metastatic Malignant Solid Neoplasm","Stage III Renal Cell Cancer AJCC v8","Stage IV Renal Cell Cancer AJCC v8","Stage IVB Prostate Cancer AJCC v8","Glioma, Malignant",[386],"Imaging Studies","2025-07-17",{"date":389,"type":37},"2025-07-18",{"date":391,"type":37},"2025-07-03",{"date":393,"type":20},"2026-09-30",{"name":395,"class":81},"Rahul Aggarwal",{"id":397,"slug":398,"hasResults":11,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":4,"eligibilityCriteria":402,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":403,"targetDuration":4,"studyType":21,"phases":405,"briefSummary":406,"conditions":407,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":45},"100552657","phase-1-a-study-of-dm001-in-patients-with-advanced-solid-tumors-100552657","NCT06475937","A Study of DM001 in Patients With Advanced Solid Tumors","A Phase I, Multicenter, Open-label, First-in-Human, Dose Escalation and Expansion Study of DM001 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Subjects must have the ability to understand and willingness to sign a written informed consent document.\n2. Subjects who have pathologically or cytologically confirmed documented metastatic\u002Fadvanced breast cancer, EGFRmut or EGFRwt NSCLC, gastric cancer, gastroesophageal cancer or CRC, and have progressed on standard therapy, or intolerant to standard therapy, or no standard therapy accessible to the subjects due to any reason.\n3. Subjects must be ≥18 years of age at the time of signing the informed consent form.\n4. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n5. Has a life expectancy of ≥3 months.\n6. Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n\nExclusion Criteria:\n\n1. Subjects have another active invasive malignancy within 5 years.\n2. Current or history of a hematologic malignancy.\n3. Primary central nervous system (CNS) malignancies or CNS metastases. Individuals with brain metastases can be enrolled only if treated, nonprogressive brain metastases and off high-dose steroids (\\>20 mg prednisone or equivalent) for at least 4 weeks.\n4. Individuals with Gilbert's disease with ≥3 × ULN.\n5. Has an uncontrolled infection requiring intravenous (IV) injection of antibiotics, antivirals, or antifungals.\n6. Has a medical history of clinically significant lung diseases or is suspected to have these diseases by imaging at the screening period.\n7. Clinically uncontrolled intercurrent illness, including but not limit to an ongoing active infection, active coagulopathy, uncontrolled cardiovascular disease, uncontrolled immune disease, uncontrolled diabetes, uncontrolled pleural and peritoneal effusion, psychiatric illness that would limit compliance with the study requirements and other serious medical illnesses requiring systemic therapies.\n8. Mean resting corrected QT interval corrected by Fridericia's formula (QTcF, QTcF=QT\u002F\\[RR\\]1\u002F3) \\>470 msec obtained from triplicate 12-lead ECGs at baseline; no concomitant medications that would prolong the QT internal; no family history of long QT syndrome.\n9. Known human immunodeficiency virus infection, or active hepatitis B virus (HBV), or hepatitis C virus (HCV) infection. Chronic carriers of HBV infection (hepatitis B surface antigen-positive, undetectable, or low HBV DNA) who receive prophylactic treatment during the study can be enrolled. Subjects with a history of HCV infection have completed curative antiviral treatment and HCV viral load below the limit of quantification and HCV antibody positive but HCV RNA negative due to prior treatment or natural resolution should be eligible.\n10. Females who are pregnant or lactating or who intend to become pregnant during participation in the study are not eligible to participate.\n11. Subjects who are of reproductive potential refuse to use effective methods of birth control during the course of participation in the study and within 120 days for both women and men of the last dose are ineligible to participate in the study.",{"count":404,"type":20},128,[23],"The goal of this clinical trial is to find out about the safety, efficacy, and tolerability of DM001 for patients with the advanced solid tumors. DM001 is an experimental drug which is not approved by health authorities for the treatment of advanced solid tumors.\n\nParticipants will have up to 17 visits during the study.There will be up to a 4-week Screening Period followed by a treatment period that will be divided into 3-week cycles\u002F Participants will have 5 study visits during Cycle 1, 3 visits during Cycles 2 and 3, and 1 visit during subsequent cycles. Participants will have an End of Treatment visit 21 days (+ 7 days) after last dose of study drug and then a follow-up visit 30 days (± 7 days) after the End of Treatment visit.",[408,333,31],"Breast Neoplasms","2025-04-15",{"date":411,"type":37},"2025-04-17",{"date":413,"type":37},"2024-10-24",{"date":415,"type":20},"2027-02-13",{"name":43,"class":44},{"id":418,"slug":419,"hasResults":11,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":423,"eligibilityCriteria":424,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":425,"targetDuration":4,"studyType":21,"phases":427,"briefSummary":428,"conditions":429,"keywords":448,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":484,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":490,"locationsCount":181},"100505964","phase-1-pre-i-spy-phase-iib-oncology-platform-program-100505964","NCT05868226","PRE-I-SPY Phase I\u002FIb Oncology Platform Program","PRE-Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis: A Phase I\u002FIb Platform Trial","PRE-I-SPY-PI","General Inclusion Criteria (GIC):\n\n* GIC1: The participant must have ability to understand and willingness to provide signed written informed consent prior to any study related assessments and procedures and for collection of archival FFPE blocks (freshly cut 14 unstained tumor slides would be acceptable).\n* GIC2: Age ≥ 18 years at the time of signing the informed consent\n* GIC3: Gender: Male or female (premenopausal and postmenopausal)\n* GIC4: ECOG performance status Grade 0-2\n* GIC5: Estimated life expectancy \\> 12 weeks at the start of investigational medicinal product (IMP) treatment.\n* GIC6: Adequate organ function, evidenced by the following laboratory results within 30 days of the start of IMP:\n\n  * Absolute neutrophil count ≥ 1,500\u002Fmm3\n  * Platelet count ≥ 100,000\u002Fmm3\n  * Hemoglobin ≥ 9.0 g\u002FdL with no blood transfusion in the past 28 days\n  * Total bilirubin ≤ 1.5 x the upper limit of normal (ULN)\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN\n  * Estimated Creatinine clearance (using Cockcroft-Gault formula) ≥ 60 mL\u002Fmin for small molecules and \\>30 mL\u002Fmin for monoclonal antibodies unless otherwise specified in the Arm Specific Eligibility.\n\nThese cut-off values may be modified with supporting data for specific drug regimens.\n\n* GIC7: Non-Pregnant: Serum or urine pregnancy test must be negative within 14 days of IMP treatment start in women of childbearing potential. Pregnancy testing does not need to be pursued in patients who are judged as postmenopausal before enrollment, or who have undergone bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation. If male, they must agree to refrain from donating sperm during treatment.\n* GIC8: Contraception: Women of childbearing potential and men must be willing to use adequate contraception for the duration of protocol treatment. Additional information regarding contraception for the specific treatment arm will be added to the drug arm description. Adequate contraception is defined as one highly effective form (i.e., abstinence, (fe)male sterilization) OR two effective forms (e.g., non-hormonal IUD and condom \u002F occlusive cap with spermicidal foam \u002F gel \u002F film \u002F cream \u002F suppository).\n* GIC9: Prior therapy effects: Resolution of all acute toxic effects of prior therapy, including radiotherapy, to grade ≤1 and neuropathy to grade ≤2 (except toxicities not considered a safety risk for the patient) and recovery from surgical procedures.\n* GIC10: Participant compliance: Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n* Additional arm specific inclusion criteria as needed by drug arm regimen\n\nGeneral Exclusion Criteria (GEC):\n\n* GEC1: Wash out periods: No other anticancer therapy within the following periods:\n\n  * chemotherapy or investigational agents, 3 weeks\n  * mitomycin C and nitrosoureas, 6 weeks\n  * radiotherapy, 3 weeks\n  * targeted therapy, 2 weeks\n  * MAbs, ADCs, and immunotherapy, 3 weeks\n  * endocrine therapy, no washout needed\n* GEC2: Concurrent therapy with other Investigational Products.\n* GEC3: Prior history of drug\u002Fregimen hypersensitivity: History of infusion-related reactions and\u002For hypersensitivity to IMP or excipients of the study drug\u002Fdrugs which led to permanent discontinuation of the treatment.\n* GEC4: Uncontrolled intercurrent illness including (active infection, diabetes, pulmonary embolism in the past 6 months, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements).\n* GEC5: Cardiovascular disease: History (within 6 months prior to start IMP) of clinically significant cardiovascular disease such as unstable angina, congestive heart failure (CHF), myocardial infarction, uncontrolled hypertension, cardiac arrhythmia requiring medication, or baseline corrected QT by Fridericia's formula (QTcF) length \\> 470 msec for men and women. The QTcF cut-off value may be modified with supporting data for specific drug regimens.\n* GEC6: CNS tumoral spread: Active uncontrolled\u002Fsymptomatic central nervous system cancer\u002Fspinal cord compression. Previously treated and clinically stable lesions, as per Investigator's judgment, are permitted. Newly discovered asymptomatic lesions that are not life threatening and do not require urgent local treatment to ensure patient safety, after consultation with study regimen chaperones, may be permitted.\n* GEC7: Liver disease: Patients with clinically significant history of liver disease, including viral or other known hepatitis, current alcohol abuse, or cirrhosis.\n* GEC8: Recent major surgery within 4 weeks prior to start IMP treatment\n* GEC9: Pregnancy or breastfeeding\n* GEC10: Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized.\n* GEC11: Other conditions, which in the opinion of the investigator, would compromise the safety of the patient or the patient's ability to complete the study.\n* GEC12: Concomitant malignancies: A diagnosis of a malignancy in the 2 years prior to starting study treatment other than the disease under study. Exceptions include indolent or definitively treated malignancy not expected to require treatment during the study, affect the safety of subjects, or affect the endpoints of the trial.\n* Additional arm specific exclusion criteria as needed by drug arm regimen",{"count":426,"type":20},124,[23],"I-SPY Phase I\u002FIb (I-SPY-P1) is an open-label, multisite platform study designed to evaluate single agents or combinations in a metastatic treatment setting that may be relevant for breast cancer patients with the overall goal of moving promising drug regimens into the I-SPY 2 SMART Design Trial (NCT01042379) and\u002For other oncology-based trials in a timely manner.",[430,431,432,433,434,435,436,437,438,439,440,441,442,443,108,68,31,444,445,446,447],"HER2-positive Breast Cancer","Metastatic Cancer","Metastatic Breast Cancer","Metastatic","HER2-positive Metastatic Breast Cancer","HER2 Mutation-Related Tumors","HER-2 Protein Overexpression","HER2-negative Breast Cancer","Triple Negative Breast Cancer","HR Positive","Hormone Receptor-positive Breast Cancer","Estrogen Receptor Positive Tumor","Progesterone Receptor-positive Breast Cancer","Hormone Receptor Negative Breast Carcinoma","HER2 Low Breast Cancer","HER2 Low Breast Carcinoma","ER Positive Breast Cancer","PR-positive Breast Cancer",[449,450,451,452,453,454,455,456,457,458,459,460,461,462,463,464,465,466,467,468,469,470,471,472,473,474,475,476,477,478,479,480,481,482],"I-SPY Trials","Quantum Leap Healthcare Collaborative","QLHC","I-SPY","I-SPY2","I-SPY1","PRE-ISPY","PRE-I-SPY","I-SPY Phase 1","I-SPY Phase 1b","I-SPY-P1","ISPY","ISPYP1","I-SPY Phase 1 Platform","ISPY2","ISPY1","Phase 1 Platform","Phase 1 Oncology Platform","T-DXd naive","PRE1","PRE2","PRE3","PRE","PRE-I-SPY Phase 1","PRE-I-SPY Phase 1b","ALX148","T-DXd","Enhertu","Zanidatamab","Tucatinib","Ziihera","Tukysa","Evorpacept","QL","2025-04-01",{"date":485,"type":37},"2025-04-04",{"date":487,"type":37},"2023-02-15",{"date":489,"type":20},"2029-12-30",{"name":491,"class":81},"QuantumLeap Healthcare Collaborative"]