[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ovarian-neoplasms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ovarian-neoplasms":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,53,0,25,[9,47,91,116,145,172,211,250,272,301,351,379,408,435,465,497,527,569,596,621,670,725,750,772,806],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"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":20,"type":21},280,"ESTIMATED","INTERVENTIONAL",[24,25],"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.",[28,29,30,31,32,33],"Ovarian Neoplasms","Prostatic Neoplasms","Endometrial Neoplasms","Colorectal Neoplasms","Solid Carcinoma","Pancreatic Cancer","RECRUITING","2026-07-01",{"date":37,"type":38},"2026-07-02","ACTUAL",{"date":40,"type":38},"2025-02-17",{"date":42,"type":21},"2028-04-18",{"name":44,"class":45},"Xadcera Biopharmaceutical (Suzhou) Co., Ltd.","INDUSTRY",5,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":69,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":90},"100431255","phase-1-a-study-of-bms-986340-as-monotherapy-and-as-combination-therapy-in-participants-with-advanced-solid-tumors-100431255","NCT04895709","A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors","A Phase 1\u002F2 Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors","Inclusion Criteria\n\n* Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis.\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable.\n* Eastern Cooperative Oncology Group Performance Status of 0 or 1.\n* Radiographically documented progressive disease on or after the most recent therapy.\n* Received standard-of-care therapies, (except for Part 1C, 2C and 2D, where participants with prior docetaxel use for the advanced\u002Fmetastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated.\n* Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant.\n\nExclusion Criteria\n\n* Women who are pregnant or breastfeeding.\n* Primary central nervous system (CNS) malignancy.\n* Untreated CNS metastases.\n* Leptomeningeal metastases.\n* Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment.\n* Active, known, or suspected autoimmune disease.\n* Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment.\n* Prior organ or tissue allograft.\n* Uncontrolled or significant cardiovascular disease.\n* Major surgery within 4 weeks of study drug administration.\n* History of or with active interstitial lung disease or pulmonary fibrosis.\n* Other protocol-defined inclusion\u002Fexclusion criteria apply.",{"count":55,"type":21},1109,[24,25],"The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab, docetaxel, or Pumitamig in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.",[59,60,61,62,63,64,65,66,67,28,68],"Cervical Cancer","Gastric\u002FGastroesophageal Junction Adenocarcinoma","Microsatellite Stable Colorectal Cancer","Non-Small-Cell Lung Cancer","Squamous Cell Carcinoma of Head and Neck","Carcinoma, Renal Cell","Urothelial Carcinoma","Pancreatic Adenocarcinoma","Melanoma","Triple Negative Breast Neoplasms",[70,59,71,72,73,60,74,61,75,76,62,77,78,63,64,65,66,67,28,68,79,80],"BMS-986340","CRC","First-in-human","GEJ","HNSCC","MSS CRC","Nivolumab","NSCLC","SCCHN","Docetaxel","Pumitamig","2026-06-29",{"date":83,"type":38},"2026-06-30",{"date":85,"type":38},"2021-05-27",{"date":87,"type":21},"2031-08-31",{"name":89,"class":45},"Bristol-Myers Squibb",47,{"id":92,"slug":93,"hasResults":12,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":12,"sex":99,"minAge":18,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":22,"phases":102,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":115},"100617433","phase-3-a-clinical-trial-of-sac-tmt-in-people-with-non-hrd-positive-advanced-ovarian-cancer-mk-2870-021-100617433","NCT07318558","A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021)","A Phase 3, Randomized, Open-label, Multicenter Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care in Participants With Newly Diagnosed Advanced Non-HRD Positive Ovarian Cancer Following First-line Platinum-based Chemotherapy (TroFuse-021\u002FENGOTov85\u002FGOG-3102)","TroFuse-021","The main inclusion criteria include but are not limited to the following:\n\n* Has histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma of certain histologies.\n* Has completed primary debulking surgery or interval debulking surgery.\n* Has completed first-line (1L) platinum-based chemotherapy, with a response of stable disease, partial response, complete response or no evidence of disease per protocol.\n* Has provided tumor tissue that is not previously irradiated.\n* If human immunodeficiency virus (HIV) infected, has well-controlled HIV on antiretroviral therapy.\n* Has undetectable hepatitis B virus (HBV) viral load and received HBV antiviral therapy if hepatitis B surface antigen (HBsAg)-positive.\n* Has undetectable hepatitis C virus (HCV) viral load if has a history of HCV infection.\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has nonepithelial cancers, low-grade serous tumors, low-grade endometrioid tumors, borderline tumors. mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor, and undifferentiated carcinoma.\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n* Has a history of severe eye disease.\n* Has active inflammatory bowel disease requiring immunosuppressive medication or a previous history of inflammatory bowel disease.\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.\n* Has a history of (noninfectious) pneumonitis\u002Finterstitial lung disease (ILD), which required steroids, or has current pneumonitis\u002FILD.\n* Received prior systemic anticancer therapy, with the exception of the first-line platinum-based chemotherapy required by the inclusion criteria.\n* Had a live or live-attenuated vaccine within 30 days of randomization.\n* Has a known additional malignancy that is progressing or required active treatment within the past 3 years.\n* Has active infection requiring systemic therapy.\n* Has concurrent and active HBV and HCV infections.\n* Has HIV infection and a history of Kaposi's sarcoma and\u002For multicentric Castleman's disease.\n* Has not recovered from major surgery or has ongoing surgical complications.\n* Has a homologous recombination deficiency (HRD)-positive, unknown, or inconclusive tumor status as determined by the central laboratory.\n* Has active or ongoing stomatitis of any grade.","FEMALE",{"count":101,"type":21},900,[103],"PHASE3","Researchers are looking for new ways to treat ovarian cancer (OC). Current treatment for OC may start with surgery to remove as much of the cancer as possible. After surgery, people may receive chemotherapy. After chemotherapy, standard care options may include:\n\n* Maintenance treatment, which is used after another therapy to keep the cancer from growing, spreading, or coming back. Bevacizumab is a targeted therapy used as standard maintenance treatment. Targeted therapy works to control how specific types of cancer cells grow and spread.\n* Observation, which is watching to see if cancer grows or worsens\n\nThe study medicine, sacituzumab tirumotecan (also called sac-TMT), is a targeted therapy. The goal of this study is to learn if people who receive sac-TMT maintenance treatment with or without bevacizumab live longer without the cancer getting worse than people who receive standard care.",[28,106],"Ovarian Cancer","2026-06-26",{"date":81,"type":38},{"date":110,"type":38},"2026-02-16",{"date":112,"type":21},"2033-02-25",{"name":114,"class":45},"Merck Sharp & Dohme LLC",115,{"id":117,"slug":118,"hasResults":12,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":12,"sex":99,"minAge":123,"maxAge":4,"enrollmentInfo":124,"targetDuration":126,"studyType":127,"phases":4,"briefSummary":128,"conditions":129,"keywords":131,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":139,"completionDateStruct":140,"leadSponsor":142,"locationsCount":4},"100644487","blood-based-minimal-residual-disease-in-advanced-epithelial-ovarian-cancer-after-1st-line-therapy-100644487","NCT07670962","Blood-Based Minimal Residual Disease in Advanced Epithelial Ovarian Cancer After 1st Line Therapy","The Role of Blood-Based Minimal Residual Disease in Patients With Advanced Epithelial Ovarian Cancer After 1st Line Therapy","Inclusion Criteria:\n\nWomen aged 19 years or older. Pathologically confirmed high-grade serous, endometrioid, clear cell, or mixed type ovarian cancer.\n\nFIGO stage III or IV. Patients who have completed primary debulking surgery (PDS) or interval debulking surgery (IDS) and platinum-based chemotherapy (subsequent maintenance therapy, such as bevacizumab or PARP inhibitors, is allowed).\n\nPatients showing radiological or clinical Complete Response (CR) after the completion of platinum-based chemotherapy.\n\nWritten informed consent for the study.\n\nExclusion Criteria:\n\nRadiological progressive disease during or immediately after treatment. Expected survival of 3 months or less. Immunodeficiency or pathological bleeding tendencies. Unable to undergo blood tests or unwilling to undergo repeated blood sampling. Concurrent other solid tumors or history of malignant tumors within the last 5 years.\n\nRefusal to consent to participate in this study.","19 Years",{"count":125,"type":21},300,"3 Years","OBSERVATIONAL","The purpose of this observational study is to learn if a specialized blood test can help predict whether advanced ovarian cancer will return after a patient's initial treatments are finished.\n\nResearchers are inviting women who have been diagnosed with stage III or IV epithelial ovarian cancer and have recently completed their first-line treatments, which include surgery and platinum-based chemotherapy.\n\nThe study focuses on \"circulating tumor DNA\" (ctDNA), which are tiny fragments of genetic material that cancer cells release into the bloodstream as they break down. Finding these DNA fragments in the blood when a patient appears to be cancer-free on standard tests is known as assessing for minimal residual disease (MRD).\n\nBecause this is an observational study, participants will receive standard medical care as directed by their doctor. For the research portion, participants will provide blood samples at specific times: at the time of diagnosis, shortly after surgery, right after finishing their first-line chemotherapy, and then every 3 months during regular follow-up visits. Researchers will also analyze a sample of the tumor tissue that was already removed during the patient's standard surgery.\n\nBy tracking these participants for up to 3 years, researchers hope to discover if the ctDNA test can accurately identify patients who have a high risk of their cancer returning, and if it can detect this earlier than traditional imaging scans or standard blood tests like CA-125.",[28,130,106],"Carcinoma, Ovarian Epithelial",[132,133,134,135],"ctDNA","Minimal Residual Disease","MRD","Liquid Biopsy","NOT_YET_RECRUITING","2026-06-22",{"date":107,"type":38},{"date":35,"type":21},{"date":141,"type":21},"2028-12-31",{"name":143,"class":144},"Asan Medical Center","OTHER",{"id":146,"slug":147,"hasResults":12,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":22,"phases":154,"briefSummary":155,"conditions":156,"keywords":158,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":7},"100411722","phase-2-a-long-term-treatment-extension-study-of-niraparib-in-participants-who-completed-a-prior-glaxosmithklinetesaro-sponsored-niraparib-study-100411722","NCT04641247","A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline\u002FTESARO-sponsored Niraparib Study","An Open-Label, Multicenter, Long-term Treatment Extension Study in Subjects Who Have Completed a Prior GlaxoSmithKline\u002FTESARO-Sponsored Niraparib Study and Are Judged by the Investigator to Benefit From Continued Treatment With Niraparib","Inclusion Criteria:\n\n* Participant is able to understand the study procedures and agrees to participate in the study by providing written informed consent.\n* Participant is willing and able to comply with scheduled visits, treatment plans, and any other study procedures.\n* Participant is currently receiving treatment with niraparib (as monotherapy or in combination) in a GlaxoSmithKline\u002FTESARO-sponsored study that has fulfilled the requirements for the primary objective.\n* Participant is currently benefiting from treatment with niraparib as assessed by the Investigator according to the parent study protocol requirements.\n* Participants of childbearing potential who are sexually active and their partners must agree to the use of an effective form of contraception throughout their participation during study treatment through 180 days after last dose of study drug.\n\nExclusion Criteria:\n\n* Participant has been permanently discontinued from niraparib treatment in the parent study for any reason.\n* Participant currently has unresolved toxicities for which niraparib dosing has been interrupted in the parent study. Participants meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow niraparib treatment to resume.\n* Participant is pregnant or is expecting to conceive children while receiving study drug or for up to 180 days after the last dose of study drug. Participant is breastfeeding or is expecting to breastfeed within 30 days of receiving the final dose of study drug (women should not breastfeed or store breastmilk for use during niraparib treatment and for 30 days after receiving the final dose of study treatment).",{"count":153,"type":21},37,[25],"This is a global extension study to provide continued access to niraparib and further characterize the long-term safety of niraparib treatment in participants who are currently receiving treatment with niraparib within GlaxoSmithKline\u002FTESARO-sponsored studies (NCT01847274, NCT02354586, NCT01905592, NCT03308942, NCT02657889) that has fulfilled the requirements for the primary objective.",[28,157],"Breast Neoplasms",[159,160,161,162,163],"Adverse events","Open-label extension","Parent study","Niraparib","Safety",{"date":165,"type":38},"2026-06-24",{"date":167,"type":38},"2021-04-16",{"date":169,"type":21},"2026-12-28",{"name":171,"class":45},"GlaxoSmithKline",{"id":173,"slug":174,"hasResults":12,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":22,"phases":181,"briefSummary":182,"conditions":183,"keywords":187,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":210},"100546861","phase-1-a-study-of-ly4170156-in-participants-with-selected-advanced-solid-tumors-100546861","NCT06400472","A Study of LY4170156 in Participants With Selected Advanced Solid Tumors","A First-in-Human, Phase 1a\u002F1b Trial to Assess the Safety, Tolerability and Preliminary Efficacy of LY4170156, an Antibody-Drug Conjugate Targeting Folate Receptor α-Expressing Tumor Cells, in Participants With Selected Advanced Solid Tumors","Inclusion Criteria:\n\n* Have one of the following solid tumor cancers:\n\n  * Dose Escalation: Ovarian (epithelial ovarian, primary peritoneal, and fallopian tube) cancer, endometrial cancer, cervical cancer, non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), pancreatic cancer, or colorectal cancer (CRC)\n  * Dose Optimization: Ovarian (epithelial ovarian, primary peritoneal, and fallopian tube) and endometrial cancer\n  * Dose Expansion: Low grade serous ovarian cancer, cervical cancer, NSCLC, and TNBC\n\nExclusion Criteria:\n\n* Individual with known or suspected uncontrolled central nervous system (CNS) metastases\n* Individual with history of carcinomatous meningitis\n* Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection\n* Individual with evidence of corneal keratopathy or history of corneal transplant\n* Any serious unresolved toxicities from prior therapy\n* Significant cardiovascular disease\n* Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 milliseconds (ms)\n* History of pneumonitis\u002Finterstitial lung disease\n* Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention",{"count":180,"type":21},495,[24],"The purpose of this study is to find out whether the study drug, LY4170156, is safe, tolerable and effective in participants with advanced solid tumors. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.",[28,30,184,185,68,186,31],"Uterine Cervical Neoplasms","Carcinoma, Non-Small-Cell Lung","Pancreatic Neoplasm",[188,77,189,190,191,192,193,194,195,196,197,198,199,200],"Folate receptor alpha","Ovarian cancer","Cervical cancer","Endometrial cancer","Solid tumor","Lung cancer","Breast cancer","Pancreatic cancer","Colorectal cancer","Anti-drug conjugate","Phase I","Chemotherapy","sofe-m","2026-06-17",{"date":203,"type":38},"2026-06-18",{"date":205,"type":38},"2024-05-20",{"date":207,"type":21},"2027-04",{"name":209,"class":45},"Eli Lilly and Company",23,{"id":212,"slug":213,"hasResults":12,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":218,"enrollmentInfo":219,"targetDuration":4,"studyType":22,"phases":221,"briefSummary":222,"conditions":223,"keywords":231,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":249},"100584158","phase-1-anti-mesothelin-tnaivescm-hyp218-tnhyp218-car-t-cells-in-participants-with-mesothelin-expressing-solid-tumors-including-mesothelioma-100584158","NCT06885697","Anti-Mesothelin TNaive\u002FSCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma","Phase 1 Study With Dose Expansion of the Anti-Mesothelin TNaive\u002FSCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria. For this protocol, treatment initiation is defined as the first day of lymphodepleting chemotherapy.\n\n* Participant must have unresectable, locally advanced, or metastatic, or recurrent mesothelioma and other mesothelin expressing solid tumors. For participants with mesothelioma only those with epithelioid or biphasic histology (with \\>80% epithelioid component) will be eligible. The diagnosis will be confirmed by the Laboratory of Pathology, CCR, NCI.\n* Participant must have progressed on at least one FDA-approved systemic therapy considered standard of care for their tumor type. There is no limit on the number of prior treatment regimens. Note: Given the aggressive nature of pancreatic cancer, otherwise eligible individuals with this cancer type can undergo leukapheresis before or while they are getting their frontline treatment as long as they meet all other inclusion criteria. However, TNhYP218 CAR T cells will only be administered after progression on first line standard of care therapy.\n* Participant must have at least 1 measurable lesion by RECIST version 1.1.\n* Tumor must have MSLN positivity of 2+ to 3+ in \\>= 50% cancer cells by immunohistochemistry on freshly collected biopsy or archival tissue.\n* Age \\>= 18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Participants must have adequate organ and marrow function as defined below:\n\nSystem: Laboratory Value\n\nHematological\n\n* Hemoglobi: \\>=9 g\u002FdL(a)\n* absolute neutrophil count: \\>=1,500\u002FmcL\n* platelets: \\>=100,000\u002FmcL\n\nHepatic\n\n* total bilirubin: \\\u003C=2.5 X institutional ULN OR direct bilirubin ULN for participants with total bilirubin levels \\>1.5 X ULN\n* AST and ALT \\\u003C= 2.5 X institutional ULN (\\\u003C= 5 X ULN for participants with liver metastases)\n\nRenal\n\n* Creatinine OR: \\\u003C=1.5 X ULN OR\n* Calculated(b) creatinine clearance (GFR can also be used in place of creatinine or CrCl) \\>= 50 mL\u002Fmin for participant with creatinine levels \\> 1.5 X institutional ULN\n\nCoagulation\n\n* International normalized ratio (INR) OR prothrombin time (PT): \\\u003C=1.5 X ULN unless participant is receiving anticoagulant therapy if PT or aPTT is within therapeutic range of intended use of anticoagulants\n* Activated partial thromboplastin time (aPTT): \\\u003C=1.5 X ULN unless participant is receiving anticoagulant therapy if PT or aPTT is within therapeutic range of intended use of anticoagulants\n\nALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal.\n\n1. Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks.\n2. Creatinine clearance (CrCl) should be calculated per institutional standard.\n\n   * Normal cardiac ejection fraction (\\>= 45% by echocardiogram) and no evidence of hemodynamically significant pericardial effusion as determined by an echocardiogram.\n   * Room air oxygen saturation of 90% or greater.\n   * Treatment-related toxicities from prior treatments must be resolved to \\\u003C= grade 2.\n   * Participants with CNS metastases, leptomeningeal disease or carcinomatous meningitis are eligible if they are asymptomatic, have completed their treatment for CNS disease and have recovered from the acute effects of radiation therapy or surgery prior to study entry. Participants must have radiographically stable CNS disease without associated edema at least three months prior to study entry. Additionally, participants have had to have discontinued corticosteroid treatment or non-prophylactic antiseizure medications for these metastases at least four weeks prior to study entry.\n   * Participants of child-bearing potential and participants who can father children must agree to use highly effective contraception or abstinence.\n   * Participants who are nursing or plan to nurse a child must agree to discontinue\u002Fpostpone nursing for the duration of study therapy and for 12 months after the administration of the cell product or for 4 months from the time no evidence of persistence\u002Fgene modified cells is documented in the participant s blood.\n   * Ability of participant to understand and the willingness to sign a written informed consent document.\n\n   EXCLUSION CRITERIA:\n\n   An individual who meets any of the following criteria will be excluded from participation in this study:\n   * Prior systemic therapy, an investigational therapy, radiation, and\u002For surgery within 14 days prior to leukapheresis and 21 days prior to lymphodepleting chemotherapy.\n   * Prior administration of anti-PD-1 or anti-PD-L1 antibodies or other agents that in the opinion of the PI can stimulate immune activity and interfere with an infusion of CAR-T cells within 8 weeks prior to treatment initiation.\n   * Participants with any form of primary immunodeficiency (e.g. severe combined immunodeficiency).\n   * Participants with active or history of autoimmune or immune mediated disease such as multiple sclerosis, lupus, inflammatory bowel disease, rheumatoid arthritis, or small vessel vasculitis. NOTE: Participants with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible.\n   * History of severe immediate hypersensitivity reaction to cyclophosphamide or fludarabine.\n   * Therapeutic doses of systemic corticosteroid therapy within 14 days prior to treatment initiation. Physiological doses of steroids (up to 5mg\u002Fday of prednisolone or equivalent) are allowed. Corticosteroid creams, ointments, and eye drops are allowed.\n   * Participants with lung fibrosis, inflammatory lung disease or evidence of pneumonitis on baseline imaging studies or medical history of these disorders.\n   * Participant has any other prior or concurrent malignancy with the following exceptions:\n\n     * Adequately treated basal cell or squamous cell carcinoma\n     * In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 12 months prior to initiation of study therapy.\n     * Treated non-melanoma skin cancer.\n     * Stage 0 or 1 melanoma completely resected at least 12 months prior to initiation of study therapy.\n     * Successfully treated organ-confined prostate cancer with no evidence of progressive disease based on PSA levels and are not on active therapy.\n     * A primary malignancy which has been completely resected and in complete remission for \\>= 5 years.\n   * Electrocardiogram showing a QTc interval \\> 450 msec in males and \\> 470 msec in females (\\> 80 msec for participants with bundle branch block). Either Fridericia s or Bazett s formula may be used to correct the QT interval.\n   * Participant has active infection with HIV, hepatitis B virus, HCV, or HTLV as defined below:\n\n     * Positive serology for HIV, HTLV-1, or HTLV-2.\n     * Active hepatitis B infection as demonstrated by test for hepatitis B surface antigen. Participants who are hepatitis B surface antigen negative but are hepatitis B core antibody positive must have undetectable hepatitis B DNA and receive prophylaxis against viral reactivation.\n     * Active hepatitis C infection as demonstrated by hepatitis C RNA test. Participants who are HCV antibody positive will be screened for HCV RNA by any reverse transcription PCR or branched DNA assay. If HCV antibody is positive, eligibility will be determined based on a negative screening RNA value.\n   * Participant is pregnant or intends to be pregnant during the required period of contraception for participants of childbearing potential.\n   * Participants who received live or attenuated vaccine or virus-based vaccine within 30 days before initiation of treatment initiation\n   * Participants with a history of seizure disorder unless due to now treated metastatic lesions.\n   * Ongoing uncontrolled intercurrent illness, including but not limited to ongoing or active infection, that would impact participant safety or limit compliance with study requirements.","120 Years",{"count":220,"type":21},100,[24],"Background:\n\nMesothelioma is an aggressive cancer that grows in the linings of the body; this can include the membranes that line the heart, lungs, and internal organs. Mesothelin (MSLN) is a protein that appears in high numbers in many tumors, including mesothelioma. Researchers are developing a new treatment that collects a person s own immune cells (T cells); the T cells are genetically modified to target and kill tumor cells with high levels of MSLN.\n\nObjective:\n\nTo test a new treatment (TNhYP218 CAR T cells) in people with solid tumors including mesothelioma.\n\nEligibility:\n\nPeople aged 18 and older with solid tumors including mesothelioma that returned or spread after standard treatment.\n\nDesign:\n\nParticipants will be screened. A small piece of tissue will be cut from a tumor (biopsy). The sample will be tested to see if it has enough MSLN.\n\nParticipants will undergo leukapheresis: Blood will be taken from their body through a vein. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a different vein.\n\nParticipant s T cells will be modified in a lab to produce TNhYP218 CAR T cells.\n\nParticipants will enter the hospital. For 7 days, they will receive drugs to prepare their bodies for the study treatment.\n\nTNhYP218 CAR T cells will be administered into a vein. Participants will remain in the hospital for at least 7 more days.\n\nAfter discharge, participants will have follow-up visits for 5 years. These visits may include imaging scans, blood and heart tests, and a new biopsy.\n\nLong-term follow-up will continue another 10 years....",[224,225,226,227,28,228,229,230],"Mesothelioma","Neoplasms","Stomach Neoplasms","Pancreatic Neoplasms","Lung Neoplasms","Thymus Neoplasms","Colonic Neoplasms",[232,233,234,235,236,106,33,237,238,239],"Peritoneal Mesothelioma","Thymic Carcinoma","Colon Cancer","Gastric Cancer","Lung Cancer","mesothelin expressing solid tumors","CAR T cell therapy","Gene Therapy","2026-06-16",{"date":201,"type":38},{"date":243,"type":38},"2025-07-08",{"date":245,"type":21},"2044-06-01",{"name":247,"class":248},"National Cancer Institute (NCI)","NIH",1,{"id":251,"slug":252,"hasResults":12,"nctId":253,"briefTitle":254,"officialTitle":254,"acronym":4,"eligibilityCriteria":255,"healthyVolunteers":12,"sex":99,"minAge":18,"maxAge":4,"enrollmentInfo":256,"targetDuration":4,"studyType":22,"phases":258,"briefSummary":260,"conditions":261,"keywords":263,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":249},"100557855","pilot-randomized-controlled-trial-of-a-collaborative-agenda-setting-intervention-casi-for-patients-with-ovarian-cancer-100557855","NCT06543537","Pilot Randomized Controlled Trial of a Collaborative Agenda-setting Intervention (CASI) for Patients With Ovarian Cancer","Participant Inclusion Criteria:\n\n* At least 18 years old\n* Able to speak, understand, and respond to questions written in English\n* Willing to be audio recorded\n* Have a diagnosis of advanced ovarian cancer (defined as stage III, stage IV, or recurrent disease)\n* Be under the care of a participating clinician dyad\n* Be scheduled for chemotherapy during the recruitment period\n* Be signed up or willing to sign up for Patient Gateway\n\nCaregiver Inclusion Criteria:\n\n* At least 18 years old\n* Able to speak, understand, and respond to questions written in English\n* Willing to be audio recorded\n* Be a family member, partner, or friend of a patient participant with whom the patient participant discusses their cancer care\n\nClinician Inclusion Criteria:\n\n* Be employed at DFCI as an oncologist, nurse practitioner, or physician assistant\n* Take care of at least 4 patients per month with advanced ovarian cancer (defined as stage III, stage IV, or recurrent disease) in the outpatient setting\n\nParticipant Exclusion Criteria:\n\n* Age of \\\u003C18 years\n* Unable to consent",{"count":257,"type":21},112,[259],"NA","This research is being done to test a new communication tool for people with ovarian cancer, caregivers, and clinicians.\n\nThe name of the intervention in this research study is:\n\n-Collaborative Agenda-Setting Intervention (CASI)",[106,28,262],"Ovarian Carcinoma",[106,28,262],"2026-06-15",{"date":201,"type":38},{"date":267,"type":38},"2025-01-17",{"date":269,"type":21},"2027-04-30",{"name":271,"class":144},"Dana-Farber Cancer Institute",{"id":273,"slug":274,"hasResults":12,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":278,"eligibilityCriteria":279,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":280,"targetDuration":4,"studyType":22,"phases":282,"briefSummary":283,"conditions":284,"keywords":288,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":300},"100609378","phase-3-a-three-part-phase-3-study-of-sofetabart-mipitecan-in-participants-with-platinum-resistant-part-a-and-platinum-sensitive-parts-b-and-c-ovarian-cancer-100609378","NCT07213804","A Three-Part Phase 3 Study of Sofetabart Mipitecan in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Parts B and C) Ovarian Cancer","FRAmework-01: A Three-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) Versus Chemotherapy or Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer, and Sofetabart Mipitecan Plus Bevacizumab Versus Platinum-Based Chemotherapy Plus Bevacizumab in Platinum-Sensitive Ovarian Cancer.","FRAmework-01","Inclusion Criteria:\n\nPart A, B, and C:\n\n* Have histologically confirmed high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancer.\n* Have confirmed availability of tumor tissue block or slides\n* Have radiographic progression on or after most recent line of systemic anticancer therapy\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Have measurable disease per RECIST v1.1\n\nPart A:\n\n* Have platinum-resistant disease, defined as radiographic progression less than or equal to (≤)6 months of the last administration of platinum therapy.\n* Have previously received 1 to 3 prior lines of systemic cytotoxic therapy. Up to 4 lines of prior cytotoxic therapy is allowed if one of those lines is mirvetuximab soravtansine.\n* Have received prior bevacizumab treatment, unless documented contraindication or intolerance.\n* Have received treatment with a poly (ADP-ribose) polymerase inhibitor (PARPi) if known to have a somatic or germline breast cancer gene (BRCA) mutation, if clinically indicated, unless documented contraindication or intolerance.\n\nPart B and C:\n\n* Have relapsed after first-line platinum-based chemotherapy and have platinum-sensitive disease defined as radiographic progression greater than (\\>)6 months of their last administration of platinum therapy\n* Have previously received 1 to 2 prior lines of systemic cytotoxic chemotherapy\n\nPart B:\n\n\\- Have previously received a PARPi, per local product label, with progression on, or within 6 months of completion of PARPi treatment.\n\nPart C:\n\n\\- Have not previously received a PARPi treatment.\n\nExclusion Criteria:\n\nParts A, B and C:\n\n\\- Have received prior antibody-drug conjugate (ADC) with a topoisomerase inhibitor payload.\n\nPart A:\n\n* Have primary platinum-refractory disease, defined as radiographic progression ≤ 1 month since the last dose of first-line platinum-containing chemotherapy.\n\nPart B and C:\n\n\\- Have clinically significant proteinuria\n\nPart C:\n\n\\- Have a known pathogenic BRCA1\u002F2 gene alteration (somatic or germline).",{"count":281,"type":21},1630,[103],"This is a clinical study that has three parts. It is testing a potential new medicine called Sofetabart Mipitecan (Sofe-M) for people with certain types of ovarian, peritoneal, and fallopian tube cancers. Part A enrolls participants with platinum-resistant cancer, meaning their disease progressed during or within six months of platinum-based chemotherapy. Parts B and C enroll participants with platinum-sensitive cancer, whose disease responded and remained controlled for at least six months after completing platinum treatment. The researchers want to find out if Sofe-M works better than the standard treatments that doctors use now and to better understand how safe it is. Each participant's time in the study will depend on how they respond to the treatment.",[28,285,286,287],"Fallopian Tube Neoplasms","Peritoneal Neoplasms","Neoplasm Metastasis",[289,290,291,292],"Folate Receptor Alpha","Antibody-drug Conjugate","Platinum-Resistant","Platinum-Sensitive","2026-06-11",{"date":264,"type":38},{"date":296,"type":38},"2025-10-22",{"date":298,"type":21},"2031-08",{"name":209,"class":45},261,{"id":302,"slug":303,"hasResults":12,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":307,"eligibilityCriteria":308,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":309,"targetDuration":4,"studyType":22,"phases":311,"briefSummary":312,"conditions":313,"keywords":326,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":342,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":350},"100520064","phase-1-a-study-to-evaluate-the-safety-and-efficacy-of-mesothelin-targeting-logic-gated-car-t-in-participants-with-solid-tumors-that-express-msln-and-have-lost-hla-a02-expression-100520064","NCT06051695","A Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Logic-gated CAR T, in Participants With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression","A Seamless Phase 1\u002F2 Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Autologous Logic-gated Tmod™ CAR T Products, in Heterozygous HLA-A*02 Adults With Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression","EVEREST-2","Inclusion Criteria:\n\nKey Inclusion Criteria:\n\n1. Appropriately enrolled in the BASECAMP-1 A2 Biotherapeutics, Inc. study, with tissue demonstrating LOH of HLA-A\\*02 by NGS (whenever possible from the primary site), successful apheresis and PBMC processing, and with sufficient stored cells available for Tmod CAR T-cell therapy\n2. Histologically confirmed recurrent unresectable, locally advanced, or metastatic CRC, NSCLC, PANC, OVCA, MESO, or other solid tumors with MSLN expression. Measurable disease is required with lesions of ≥1.0 cm by CT.\n3. Received previous required therapy for the appropriate solid tumor disease as described in the protocol\n4. Has adequate organ function as described in the protocol\n5. ECOG performance status of 0 to 1\n6. Life expectancy of ≥3 months\n7. Willing to comply with study schedule of assessments including long term safety follow up\n\nKey Exclusion Criteria:\n\n1. Has disease that is suitable for local therapy or able to receive standard of care therapy that is therapeutic and not palliative\n2. Prior allogeneic stem cell transplant\n3. Prior solid organ transplant\n4. MESO with pleural involvement extending into the peritoneum\n5. Cancer therapy within 3 weeks or 3 half lives of infusion\n6. Radiotherapy within 28 days of infusion\n7. Unstable angina, arrhythmia, myocardial infarction, or any other significant cardiac disease within the last 6 months\n8. Any new symptomatic pulmonary embolism (PE) or a deep vein thrombosis (DVT) within 3 months of enrollment. Therapeutic dosing of anticoagulants is allowed for history of PE or DVT if greater than 3 months from time of enrollment, and adequately treated\n9. History of interstitial lung disease including drug-induced interstitial lung disease and radiation pneumonitis that requires treatment with prolonged steroids or other immune suppressive agents within 1 year\n10. Requires supplemental home oxygen\n11. Females of childbearing potential who are pregnant or breastfeeding\n12. Subjects, both male and female, of childbearing potential who are not willing to practice birth control from the time of consent through 6 months post infusion",{"count":310,"type":21},474,[24,25],"The goal of this study is to test autologous logic-gated Tmod™ CAR T-cell products in subjects with solid tumors including colorectal cancer (CRC), pancreatic cancer (PANC), non-small cell lung cancer (NSCLC), ovarian cancer (OVCA), mesothelioma (MESO), and other solid tumors that express mesothelin (MSLN) and have lost HLA-A\\*02 expression.\n\nThe main questions this study aims to answer are:\n\nPhase 1: What is the recommended dose that is safe for patients\n\nPhase 2: Does the recommended dose kill solid tumor cells and protect the patient's healthy cells\n\nParticipants will be required to perform study procedures and assessments, and will also receive the following study treatments:\n\nEnrollment and Apheresis in BASECAMP-1 (NCT04981119)\n\nPreconditioning Lymphodepletion (PCLD) Regimen\n\nTmod CAR T cells at the assigned dose",[314,315,77,316,317,318,319,186,320,71,234,321,322,106,28,224,323,324,236,325],"Solid Tumor, Adult","Colorectal Cancer","Non Small Cell Lung Cancer","NSCLC, Recurrent","Non-Small Cell Squamous Lung Cancer","Pancreas Cancer","Colorectal Adenocarcinoma","Rectal Cancer","Cancer","Mesothelioma, Malignant","Ovary Cancer","MESOM",[327,328,329,330,331,332,333,334,335,336,239,337,322,338,71,315,236,77,339,325,106,224,340],"CAR T Cell","Solid Tumors","Autologous","T Cell","Mesothelin","MSLN","HLA-A2","Solid Tumors expressing MSLN","Pancreatic","Cell Therapy","blocker","PANC","OVCA","Logic-gate","2026-06-10",{"date":343,"type":38},"2026-06-12",{"date":345,"type":38},"2024-04-03",{"date":347,"type":21},"2029-06",{"name":349,"class":45},"A2 Biotherapeutics Inc.",12,{"id":352,"slug":353,"hasResults":12,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":357,"eligibilityCriteria":358,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":359,"targetDuration":4,"studyType":127,"phases":4,"briefSummary":361,"conditions":362,"keywords":364,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":249},"100642313","evaluation-of-interactions-and-group-processes-in-multidisciplinary-tumor-boards-in-gynecologic-oncology-100642313","NCT07645716","Evaluation of Interactions and Group Processes in Multidisciplinary Tumor Boards in Gynecologic Oncology","Group Dynamics Evaluation in ginecOlogic muLtidisciplinary Tumor boarDs","GOLD","Inclusion Criteria:\n\n* Physicians participating in the clinical decision-making process within ovarian and uterine cancer multidisciplinary tumor board meetings.\n* Participation in the full tumor board session.\n* Participation either in person or online.\n* Representation of at least one relevant specialty or role involved in the clinical decision-making process.\n\nExclusion Criteria:\n\n* Partial attendance at the ovarian and uterine cancer multidisciplinary tumor board session.\n* Trainees or other attendees not directly involved in the clinical decision-making process.\n* Physicians whose specialty contribution consists of occasional consultation for less than 50% of the study period.\n* Incomplete survey completion.\n* If more than one member represents the same specialty or role, participants with lower participation in the clinical decision-making process may be excluded.",{"count":360,"type":21},400,"Study Title Group Dynamics Evaluation in Gynecologic Multidisciplinary Tumor Boards - GOLD Study\n\nBackground and Rationale Multidisciplinary Tumor Boards are central to complex oncologic decision-making. In gynecologic oncology, clinical decisions often require the integration of knowledge from different specialties, including surgery, medical oncology, radiology, pathology, radiation oncology, and other relevant disciplines. These teams function not only as groups of specialists but also as collective decision-making systems, where communication, collaboration, information sharing, psychological safety, and group dynamics may influence the quality of clinical discussion and final recommendations.\n\nStudy Objective The GOLD Study aims to investigate the decision-making process and group dynamics within ovarian and uterine cancer Multidisciplinary Tumor Boards. The study will assess how communication patterns, collaboration, minority dissent, team cohesion, team learning, task interdependence, collective information processing, individual information processing, and psychological safety contribute to Tumor Board performance.\n\nStudy Design This is a single-center, prospective, longitudinal observational study involving physicians participating in ovarian and uterine cancer Multidisciplinary Tumor Boards, either in person or online.\n\nMethods At the end of each Tumor Board meeting, participating physicians will complete an online survey using Microsoft Forms. The questionnaire was developed within a scientific collaboration with the Department of Business and Management of LUISS Guido Carli University and includes validated measurement scales derived from the literature. In addition, data on team composition and participation will be collected for each meeting.\n\nStatistical Analysis Survey data and participation data will be analyzed using descriptive statistics, inferential methods, and social network analysis. Network measures such as density and centralization indices will be used to evaluate the structure of interactions and participation over time. Statistical analyses will be performed using Stata, R, and UCINET where appropriate.\n\nTarget Population and Sample Size The target population includes physicians involved in the clinical decision-making process during ovarian and uterine cancer Tumor Boards. A total of approximately 400 questionnaires is planned, based on the rule of thumb of at least 10 respondents per questionnaire variable.\n\nStudy Duration The expected study duration is six months.",[28,363],"Uterine Neoplasms",[28,363,365,366,367,368,369,370],"Multidisciplinary Tumor Board","Clinical Decision Making","Group Dynamics","Team Communication","Social Network Analysis","Surveys and Questionnaires","2026-06-09",{"date":343,"type":38},{"date":374,"type":21},"2026-07-13",{"date":376,"type":21},"2027-03-31",{"name":378,"class":144},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":380,"slug":381,"hasResults":12,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":385,"eligibilityCriteria":386,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":387,"targetDuration":4,"studyType":22,"phases":389,"briefSummary":390,"conditions":391,"keywords":395,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":403,"completionDateStruct":404,"leadSponsor":406,"locationsCount":407},"100609377","phase-1-a-study-of-ly4337713-in-participants-with-fap-positive-solid-tumors-100609377","NCT07213791","A Study of LY4337713 in Participants With FAP-Positive Solid Tumors","A Dose Escalation and Dose Optimization Phase 1a\u002F1b Study to Evaluate Safety, Tolerability and Dosimetry of Radioligand Therapy With LY4337713 in Adults With FAP-Positive Solid Tumors (FiREBOLT)","FiREBOLT","Inclusion Criteria:\n\n* Must have clinical or imaging evidence of fibroblast activation protein (FAP) expression per local assessment\n* Must have histologically or cytologically confirmed diagnosis of one of the following:\n\n  * Adenocarcinoma of the pancreas\n  * Hormone receptor (HR)-positive human epidermal growth factor 2 (HER2)-negative breast cancer\n  * HER2-positive breast cancer\n  * Triple negative breast cancer (TNBC)\n  * Platinum-resistant or refractory ovarian cancer (including ovarian carcinosarcoma)\n  * Other solid tumors\n\n    * Gastric cancer (adenocarcinoma)\n    * Colorectal cancer (CRC)\n    * Esophageal cancer (squamous cell carcinoma or adenocarcinoma)\n    * Cholangiocarcinoma\n* Must have received prior treatments as indicated below:\n\n  * Phase 1a\n\n    * Adenocarcinoma of the pancreas: Participants must have received at least 1, but no more than 2 prior regimens for locally advanced unresectable or metastatic disease.\n    * HR-positive HER2-negative breast cancer: Participants must have received less than or equal to (≤)5 prior lines of treatment for advanced or metastatic disease, which must include a cyclin-dependent kinase 4\u002F6 inhibitor.\n    * HER2-positive breast cancer: Participants must have received at least 2 lines of HER2-targeted therapy, which should include at least 1 antibody-drug conjugate (ADC) for metastatic disease (if locally available).\n    * TNBC: Participants must have received at least 2 lines of therapy for metastatic disease.\n    * Platinum-resistant or refractory ovarian cancer: Participants must have received or after at least 1 platinum-based therapy.\n    * Other solid tumors (gastric cancer, CRC, esophageal and cholangiocarcinoma): Participants must have received greater than or equal to (≥)1 prior line of systemic therapy for advanced or metastatic disease; including prior line(s) in combination with immunotherapy or vascular endothelial growth factor inhibitor.\n  * Phase 1b:\n\n    * Participants must have advanced or metastatic solid tumors and have received ≥1 prior line of therapy.\n* Must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1.\n* Measured creatinine clearance ≥60 milliliters per minute (mL\u002Fmin)\n\nExclusion Criteria:\n\n* Have known active central nervous system (CNS) metastases or carcinomatous meningitis.\n* Have significant cardiovascular disease\n* Have prolongation of the corrected QTcF \\>470 milliseconds (msec) during screening. QTcF is calculated using Fridericia's Formula: QTcF = QT\u002F(RR0.33)\n* Have evidence of ongoing and untreated urinary tract obstruction\n* Had previous hemi- or total-body radiation.\n* Had previous adoptive T-cell therapy (e.g., chimeric antigen receptor T-cell \\[CAR-T therapy, T-cell receptor \\[TCR\\] therapy, etc.)\n* Unable to lie flat during, or otherwise tolerate, single photon emission computed tomography (SPECT), positron emission tomography (PET), computed tomography (CT) or magnetic resonance imaging (MRI).",{"count":388,"type":21},241,[24],"This is a study of LY4337713 in participants with certain types of cancer that is advanced or has spread. Participants must have cancer with high levels of a protein called fibroblast activation protein (FAP). The purpose of this study is to evaluate safety, side effects, and efficacy of LY4337713. In addition, this study will evaluate how much LY4337713 gets into the bloodstream, how it is broken down, and how long it takes the body to get rid of it. For each participant, the study will last about 5 years.",[28,157,392,31,393,226,394],"Pancreatic Intraductal Neoplasms","Esophageal Neoplasms","Cholangiocarcinoma",[396,397,398,399],"Cancer-associated fibroblasts (CAF)","Lutetium-177","LuFAP","Lu-177-FAP","2026-06-03",{"date":402,"type":38},"2026-06-04",{"date":296,"type":38},{"date":405,"type":21},"2033-03",{"name":209,"class":45},30,{"id":409,"slug":410,"hasResults":12,"nctId":411,"briefTitle":412,"officialTitle":412,"acronym":4,"eligibilityCriteria":413,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":414,"targetDuration":4,"studyType":22,"phases":416,"briefSummary":417,"conditions":418,"keywords":424,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":428,"startDateStruct":430,"completionDateStruct":431,"leadSponsor":433,"locationsCount":4},"100643560","phase-2-an-exploratory-study-of-zanidatamab-in-her2-positive-advanced-tumor-after-at-least-one-line-of-standard-therapy-100643560","NCT07631871","An Exploratory Study of Zanidatamab in HER2-positive Advanced Tumor After at Least One Line of Standard Therapy","Inclusion Criteria:\n\n1. Male or female subjects aged ≥ 18 years old.\n2. Subjects with locally advanced, unresectable or metastatic solid tumors who have progressed after ≥1 prior systemic therapy for advanced\u002Fmetastatic disease, or have no available optimal alternative treatments. Qualified tumor types include but are not limited to endometrial carcinoma, urothelial carcinoma, pancreatic cancer, colorectal carcinoma (CRC), head and neck adenocarcinoma (salivary gland adenocarcinoma, lacrimal gland adenocarcinoma, adenocarcinoma of unknown primary of the neck), cervical cancer, ovarian cancer and adenocarcinoma of unknown primary. Biliary tract malignancy, lung cancer and breast cancer are excluded. For CRC patients: documented RAS status (wild-type or mutant) and wild-type BRAF; prior treatment regimen should contain fluoropyrimidine, oxaliplatin and irinotecan unless contraindicated; anti-VEGF therapy when clinically indicated; anti-PD-L1 therapy for MSI-H\u002FdMMR tumors if clinically indicated.\n3. ECOG Performance Status 0, 1 or 2.\n4. Confirmed HER2 positivity defined as IHC 3+, or IHC 2+ with positive FISH amplification (per GC criteria).\n5. Willing and capable of providing adequate tumor specimens for central pathological re-assessment of HER2 status at institutional pathology department. Patients previously treated with HER2-ADC must provide FFPE tumor samples collected after last HER2-ADC administration. Specimens with insufficient tumor cellularity and fine-needle aspiration samples are not acceptable for HER2 testing.\n6. At least one measurable lesion at baseline per RECIST 1.1 criteria.\n7. Adequate bone marrow and organ function confirmed within 14 days prior to enrollment: Hemoglobin ≥ 9 g\u002FdL; Platelet count ≥ 75,000\u002Fmm³; Absolute neutrophil count (ANC) ≥ 1000\u002Fmm³; Serum albumin ≥ 2.5 g\u002FdL; PT, aPTT and INR ≤ 1.5 × ULN; AST\u002FALT ≤ 3 × ULN; ≤5 × ULN for subjects with liver metastasis; Total bilirubin ≤1.5 × ULN (no liver metastasis); ≤3 × ULN (baseline Gilbert syndrome or liver metastasis); Creatinine clearance ≥30 mL\u002Fmin (calculated by Cockcroft-Gault formula)\n8. LVEF ≥50% evaluated via echocardiogram (ECHO) or MUGA scan within 28 days before enrollment.\n\nExclusion Criteria:\n\nSubjects with any of the following conditions are ineligible:\n\n1. Documented spinal cord compression, leptomeningeal disease or clinically active central nervous system (CNS) metastasis.\n2. Active primary immunodeficiency, confirmed HIV infection, active HBV or HCV infection.\n3. History of non-infectious interstitial lung disease (ILD)\u002Fnon-infectious pneumonia requiring steroid therapy, ongoing active ILD\u002Fnon-infectious pneumonia, or suspected ILD\u002Fnon-infectious pneumonia that cannot be ruled out by screening imaging.\n4. History of myocardial infarction, symptomatic congestive heart failure (CHF, NYHA Class II-IV), unstable angina, or any cardiovascular event (including stroke) within 6 months prior to enrollment.\n5. Pulmonary exclusion items: (a) Clinically significant underlying pulmonary disorders, including but not limited to pulmonary embolism within 3 months before screening, severe asthma, severe COPD, restrictive lung disease, recurrent pleural effusion; (b) Confirmed autoimmune, connective tissue or inflammatory diseases (rheumatoid arthritis, Sjögren's syndrome, sarcoidosis etc.), or suspected pulmonary involvement at screening; full disease details shall be recorded in eCRF for enrolled subjects; (c) Previous total pneumonectomy.\n6. Confirmed presence of HER2 gene mutation.",{"count":415,"type":21},10,[25],"The goal of this clinical trial is to learn if Zanidatamab can treat HER2-positive advanced tumors in adults. The main question it aims to answer is: What is the objective response rate of Zanidatamab in adult patients with HER-2 positive advanced solid tumors? Participants will receive Zanidatamab intravenously on Day 1 of each 2-week treatment cycle. The dosage is 20 mg\u002Fkg per cycle.",[225,328,419,420,421,227,31,422,423,28],"HER2 Positive Solid Tumor","Endometrial Neoplasm","Urothelial Carcinoma (UC)","Head and Neck Neoplasms","Cervical Neoplasms",[419,425,426],"Zanidatamab","Basket Study","2026-06-02",{"date":429,"type":38},"2026-06-08",{"date":264,"type":21},{"date":432,"type":21},"2029-12-31",{"name":434,"class":144},"Haihua Yuan",{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":441,"eligibilityCriteria":442,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":443,"targetDuration":4,"studyType":127,"phases":4,"briefSummary":445,"conditions":446,"keywords":451,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":464},"100437810","solid-tumor-analysis-for-hla-loss-of-heterozygosity-loh-and-apheresis-for-car-t--cell-manufacturing-100437810","NCT04981119","Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing","An Observational Study Obtaining Solid Tumor Tissue From Participants and Apheresis for CAR T-Cell Therapy Manufacturing","BASECAMP-1","Key Eligibility Criteria (additional criteria may apply) Part 1 Key Inclusion Criteria\n\n1\\. Pathologically confirmed solid tumors, e.g., Colorectal Cancer (CRC), Non-Small Cell Lung Cancer (NSCLC), or Pancreatic Cancer (PANC), that is metastatic, unresectable locally advanced, or in the Investigator's opinion the subject is high risk for incurable relapse within two years.\n\nPart 1: Key Exclusion Criteria\n\n1. History of any of other malignancy in the past 5 years other than non-melanoma skin carcinoma, low grade localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ (CIS) of the breast, CIS of the Cervix, or Stage I uterine cancer.\n2. Prior allogeneic stem cell transplant.\n3. Prior solid organ transplant.\n\nPart 2 : Key Inclusion Criteria\n\n1. Pathologically confirmed solid tumors, e.g., Colorectal Cancer (CRC), Non-Small Cell Lung Cancer (NSCLC), Pancreatic Cancer (PANC), Mesothelioma, or Ovarian Cancer (OVAC) that is metastatic, unresectable locally advanced, or in the Investigator's opinion the subject is high risk for incurable relapse within two years.\n2. Participants are germline HLA-A\\*02 heterozygous confirmed by HLA typing.\n3. Primary tumor tissue showing LOH of HLA-A\\*02 by NGS testing.\n4. Eastern Cooperative Oncology Group (ECOG) 0 or 1 performance status.\n\nPart 2: Key Exclusion Criteria\n\n1. History of any of other malignancy in the past 5 years other than non-melanoma skin carcinoma, low grade localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ (CIS) of the breast, CIS of the Cervix, or Stage I uterine cancer.\n2. Prior allogeneic stem cell transplant.\n3. Prior solid organ transplant.\n4. Participants who have received any cancer therapy on any investigational therapy for any indication, including but not limited to chemotherapy, small molecules, monoclonal antibodies, or radiotherapy (with bone marrow impact) within 2 weeks of planned apheresis or 3 half-lives, whichever is shorter.\n5. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment necessitating specific treatment, or any major episode of infection requiring treatment with Intravenous (IV) antimicrobials (e.g., IV antibiotics) or hospitalization (relating to completion of antibiotic course).\n6. Has known active central nervous system metastases. Subjects with previously treated brain metastases may participate upon medical monitor agreement.\n7. In the Investigator's judgement, any other condition or reason the subject would not complete the required study visits and procedures, and follow up visits, or comply with the study requirements for participation.",{"count":444,"type":21},200,"Objective:\n\nTo collect information on how often a solid tumor cancer might lose the Human Leukocyte Antigen (HLA) by next generation sequencing and perform apheresis to collect and store an eligible participant's own T cells for future use to make CAR T-Cell therapy for their disease treatment.\n\nDesign:\n\nThis is a non-interventional, observational study to evaluate participants with solid tumors with a high risk of relapse for incurable disease. No interventional therapy will be administered on this study. Some of the information regarding the participant's tumor analysis may be beneficial to management of their disease. Participants that meet all criteria may be enrolled and leukapheresed (blood cells collected). The participant's cells will be processed and stored for potential manufacture of CAR T-cell therapy upon relapse of their cancer.",[314,315,316,33,71,77,319,224,106,28,262,323,447,322,448,449,450],"Mesothelioma; Lung","Triple Negative Breast Cancer (TNBC)","Renal Cell Carcinoma (Kidney Cancer)","Head and Neck Squamous Cell Carcinoma HNSCC",[452,453,454,455,456],"CAR T Cell Therapy","Next Generation Sequencing","Leukapheresis","Apheresis","Immunotherapy","2026-05-29",{"date":427,"type":38},{"date":460,"type":38},"2021-10-29",{"date":462,"type":21},"2029-04",{"name":349,"class":45},16,{"id":466,"slug":467,"hasResults":12,"nctId":468,"briefTitle":469,"officialTitle":470,"acronym":4,"eligibilityCriteria":471,"healthyVolunteers":12,"sex":99,"minAge":18,"maxAge":4,"enrollmentInfo":472,"targetDuration":4,"studyType":22,"phases":474,"briefSummary":475,"conditions":476,"keywords":477,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":493,"completionDateStruct":494,"leadSponsor":496,"locationsCount":4},"100614951","phase-3-a-study-to-investigate-mocertatug-rezetecan-compared-with-standard-of-care-in-participants-with-platinum-resistant-ovarian-cancer-behold-ovarian01-100614951","NCT07286266","A Study to Investigate Mocertatug Rezetecan Compared With Standard of Care in Participants With Platinum-resistant Ovarian Cancer (BEHOLD-Ovarian01)","A Randomized, Open-label, Multicenter, Phase 3 Study to Investigate Mocertatug Rezetecan Compared With Standard of Care in Participants With Platinum-resistant Ovarian Cancer","Inclusion Criteria:\n\n* Is at least 18 years of age and the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the Informed Consent Form (ICF).\n* Has epithelial ovarian cancer, inclusive of primary peritoneal or fallopian-tube cancer with a histologically confirmed diagnosis of high grade serous, high grade endometrioid, or clear cell carcinoma, or carcinosarcoma that is resistant to platinum-based therapy.\n\nPlatinum-resistance is defined as follows:\n\n* Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum therapy, must have had a response (CR, PR, stable disease) and then progressed from \\>3 months to ≤6 months after the last dose of platinum therapy.\n* Participants who have received \\>1 line of platinum therapy must have progressed on or ≤6 months after the date of the last dose of platinum therapy.\n\n  • Has received at least 1 but no more than 4 prior lines of systemic anti-cancer therapy. Prior lines of therapy are defined as follows:\n* Adjuvant ± neoadjuvant are considered one line of therapy.\n* Maintenance therapy (e.g., bevacizumab, \\[poly adenosine diphosphate-ribosylation (ADP) ribose polymerase inhibitor (PARPi)\\] will be considered as part of the preceding line of therapy (i.e., not counted independently).\n* Therapy changed to another agent in the same class due to toxicity in the absence of progression will be considered as part of the same line of therapy (i.e., not counted independently).\n* Unplanned addition or switching to a new drug in a different class is considered a separate line of therapy.\n* Hormonal therapy will be counted as a separate line of therapy unless it was given as maintenance.\n\n  • Must have received prior treatment with the following therapies unless they have a contraindication per label or institutional guidelines as described below:\n* Mirvetuximab soravtansine (MIRV),.\n* The tumor demonstrates positive folate receptor alpha FRα expression (≥ 75% of viable tumor cells with moderate (2+) and\u002For strong (3+) membrane staining) per a test compliant to local regulation, AND\n* Does not have a documented contraindication per label or local institutional guidelines, including but not limited to chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment\u002Fmonitoring, such as uncontrolled glaucoma, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, monocular vision, peripheral neuropathy, interstitial lung disease, or hypersensitivity. AND\n* It is available in the enrolment country. A regimen is considered available if it is approved and reimbursed (covered by national healthcare or private insurance) in the participating country.\n* Bevacizumab, unless the participant has a documented contraindication per label or local institutional guidelines. Contraindications include but are not limited to vascular disorders (uncontrolled hypertension, arterial thromboembolic events), fistula, gastro-intestinal disorders (rectosigmoid involvement, bowel obstruction), delayed wound healing, bleeding diathesis (haemoptysis, epistaxis, pulmonary haemorrhage, acquired coagulopathy), nephrotic syndrome or significant proteinuria, or osteonecrosis of the jaw, or hypersensitivity\n* PARPi, in participants with known or suspected deleterious germline or somatic BRCA mutations and who achieved a complete or partial response to platinum-based chemotherapy must have been treated with a poly ADP-ribose polymerase PARPi as maintenance treatment, if a PARPi is available in the enrolment country, unless the participants is not eligible for treatment with PARPi. A regimen is considered available if it is approved and reimbursed (covered by national healthcare or private insurance) in the participating country.\n\n  * Has at least one Target lesion (TL) per RECIST 1.1, as determined by the investigator. Measurable lesions that have been previously irradiated and have been shown to be progressing following irradiation may be considered as TLs.\n  * Has provided a Formalin fixed, paraffin embedded (FFPE) tumor tissue sample of sufficient quantity and quality for the central assessment of B7 homolog 4 protein (B7-H4) expression, with B7-H4 expression result available prior to date of randomization.\n\nAND\n\n* FR alpha expression\n* In countries where mirvetuximab is available, an FR alpha expression result from a test compliant with local regulation or by central testing is required to determine eligibility.\n* In countries where mirvetuximab is unavailable, an FFPE tumor tissue sample confirmed to be of sufficient quantity and quality must be provided. The FR alpha expression result is not required prior to randomisation or to determine eligibility.\n\nAND\n\n* PD-L1 expression, where a result from a local test is NOT available, an FFPE tumor tissue sample confirmed to be of sufficient quantity and quality must be provided. The PD-L1 expression result is not required prior to randomisation or to determine eligibility.\n\n  * Is eligible to receive 1 of the standard of care interventions if randomized to physician's choice arm.\n  * A female participant is eligible to participate if they are not pregnant or breastfeeding, and one of the following conditions applies:\n* Is a Participant of non-childbearing potential (PONCBP) OR\n* Is a Participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), with low user dependency, 30 days prior to Cycle 1 Day 1 (C1D1) and during the study intervention period and for at least 8 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of study intervention.\n\n  • A POCBP must have a negative, highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention\n* If a urine test is positive or ambiguous and cannot be confirmed as negative, a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.\n\n  * Is capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the ICF and in the study protocol.\n  * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n  * Has adequate organ function\n\nExclusion Criteria:\n\n* Has primary platinum-refractory Ovarian Cancer (OC), defined as disease that did not respond to or has progressed within \\\u003C3 months of the final dose of first line platinum containing chemotherapy.\n* Has a malignancy (except disease under study) that has progressed or required active treatment within 36 months prior to date of randomization, except for basal cell or squamous cell carcinomas of the skin, in-situ carcinomas (e.g., breast, cervix, bladder) that have been resected with no evidence of metastatic disease, or that is otherwise considered cured by the investigator.\n* Has known sensitivity to study intervention components or excipients or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.\n* Has untreated brain or CNS metastases or brain\u002FCNS metastases that have progressed (e.g., evidence of new or enlarging brain metastasis or new neurologic symptoms attributable to brain\u002FCNS metastases). Participants with previously treated and clinically stable brain\u002FCNS metastases and who have completed all corticosteroid therapy for ≥14 days prior to date of C1D1 are not excluded from participation.\n* Has any evidence of current ILD or pneumonitis, or a prior history of ILD or non-infectious pneumonitis.\n* Has ongoing adverse reaction(s) from prior therapy that has (have) not recovered to ≤Grade 1 or to the baseline status preceding prior therapy, excluding e.g., alopecia, hearing loss, vitiligo, endocrinopathy managed with replacement therapy, and Grade 2 neuropathy, or that the investigator, with the agreement of the sponsor, considers to be not clinically relevant for the tolerability of study intervention in the current clinical study.\n* Has any serious and\u002For unstable medical condition (including infection) or any serious and\u002For unstable psychiatric disorder or other condition(s) (including laboratory assessment abnormalities) that could interfere with the participant's safety, obtainment of informed consent, or compliance to the study procedures, including requirements for the Follow-up Period of the study.\n* For participants selected to receive the pembrolizumab-containing regimen as the intended physician's choice only: Has experienced any of the following with prior immunotherapy-any immune-mediated adverse event (imAE) ≥ Grade 3, immune-mediated severe neurologic events of any grade (e.g., myasthenic syndrome\u002Fmyasthenia gravis, encephalitis, Guillain-Barré Syndrome, or transverse myelitis), exfoliative dermatitis of any grade (Stevens-Johnson Syndrome \\[SJS\\], Toxic Epidermal Necrolysis \\[TEN\\], or drug reaction with eosinophilia and systemic symptoms \\[DRESS\\] syndrome), or myocarditis of any grade\n* For participants selected to receive bevacizumab as part of the pembrolizumab + paclitaxel ± bevacizumab intended physician's choice regimen only: Has a history of vascular disorders (uncontrolled hypertension, arterial thromboembolic events), fistula, gastro-intestinal disorders (rectosigmoid involvement, bowel obstruction), delayed wound healing, bleeding diathesis (hemoptysis, epistaxis, pulmonary hemorrhage, acquired coagulopathy), nephrotic syndrome or significant proteinuria, or osteonecrosis of the jaw, or hypersensitivity.\n* Has had any major surgery within 28 days prior to date of C1D1 or received focal radiotherapy within 21 days prior to date of C1D1.\n* Has received treatment with an investigational agent within 30 days prior to date of C1D1.\n* Has received treatment with any cytotoxic chemotherapy drugs or other anti-tumor drugs (including endocrine therapy, molecular targeted therapy, immunotherapy, biotherapy, or investigational agent) within 30 days or 5 half-lives, whichever is shorter, prior to date of C1D1; or need to continue these drugs during study participation.\n* Has ever received prior therapy with topoisomerase I inhibitors (e.g., topotecan) or ADC with a topo1i payload, or B7-H4 targeted therapy.\n* Has received any live vaccine within 30 days prior to date of C1D1.\n* Has received any transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including Granulocyte colony stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 14 days prior to date of C1D1.\n* For participants receiving PLD only: Has baseline Left ventricular ejection fraction (LVEF) \\\u003C50% or lower than institutional lower limits of normal. Intolerance to PLD does not exclude a participant from the study if a different physician's choice option is chosen prior to randomization.",{"count":473,"type":21},450,[103],"This study specifically aims to evaluate how well mocertatug rezetecan (Mo-Rez) works in treating ovarian cancer compared to standard treatments. The study also assesses whether Mo-Rez is safe and tolerated well by participants compared to standard treatments and aims to provide a better understanding of the main side effects of the drug.",[28],[478,479,480,481,482,483,484,485,486,487,488,489],"Platinum-resistant Ovarian Cancer","Mocertatug rezetecan","Mo-Rez","GSK5733584","Paclitaxel","Pembrolizumab","Bevacizumab","Pegylated liposomal doxorubicin (PLD)","Topotecan","Gemcitabine","Antibody-drug conjugate","BEHOLD-Ovarian01","2026-05-22",{"date":492,"type":38},"2026-05-27",{"date":165,"type":21},{"date":495,"type":21},"2030-08-21",{"name":171,"class":45},{"id":498,"slug":499,"hasResults":12,"nctId":500,"briefTitle":501,"officialTitle":502,"acronym":4,"eligibilityCriteria":503,"healthyVolunteers":12,"sex":99,"minAge":4,"maxAge":4,"enrollmentInfo":504,"targetDuration":4,"studyType":127,"phases":4,"briefSummary":506,"conditions":507,"keywords":509,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":520,"startDateStruct":522,"completionDateStruct":523,"leadSponsor":525,"locationsCount":249},"100638338","prospective-sample-collection-study-for-a-blood-based-cfdna-methylation-assay-for-ovarian-cancer-detection-100638338","NCT07593833","Prospective Sample Collection Study for a Blood-Based cfDNA Methylation Assay for Ovarian Cancer Detection","Prospective Clinical Validation Study of a Blood-Based cfDNA Methylation Assay for the Detection of Ovarian Cancer","Inclusion Criteria:\n\n* Female participants.\n* Participants with an ovarian\u002Fadnexal mass who are planned to undergo, for the first time at the current center, surgery or biopsy\u002Fpathologic sampling related to the current lesion, with an expected pathologic diagnosis available as the reference standard.\n* Imaging evaluation during screening suggests a unilateral or bilateral, unilocular or multilocular cystic-solid or solid ovarian\u002Fadnexal mass requiring differential diagnosis.\n* An adequate peripheral blood sample can be collected before the first surgery or before initiation of any systemic anti-tumor treatment for the current ovarian\u002Fadnexal mass, and the sample can be processed and stored within the required time according to the unified study procedures.\n* Clinical data and postoperative pathologic results are expected to be sufficiently complete to provide key information for subsequent analyses.\n* The participant or her legally authorized representative voluntarily signs written informed consent after being fully informed.\n\nExclusion Criteria:\n\n* The participant has already received systemic anti-tumor treatment for the current ovarian\u002Fadnexal lesion under evaluation, such as chemotherapy, targeted therapy, immunotherapy, or radiotherapy, or has already undergone definitive tumor resection or comprehensive staging surgery, and is undergoing surgery only for residual or recurrent lesions.\n* No pathologic diagnosis is ultimately obtained for the current ovarian\u002Fadnexal mass, or no analyzable pathologic conclusion can be established.\n* Imaging findings at screening are highly typical of benign mature cystic teratoma.\n* Ovarian cancer combined with another malignant tumor.\n* There are obvious noncompliances during sample collection, transport, or processing, resulting in severe hemolysis, contamination, or seriously insufficient sample volume, such that the sample cannot meet quality control requirements for cfDNA methylation testing or subsequent analyses.\n* Any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.",{"count":505,"type":21},1000,"The goal of this observational study is to learn whether a blood-based cell-free DNA (cfDNA) methylation assay can help detect ovarian cancer, especially early-stage ovarian cancer, in women undergoing clinical evaluation for ovarian tumors or gynecologic diseases. The main questions it aims to answer are:\n\nHow well can this assay distinguish ovarian cancer from benign gynecologic diseases? How accurately can this assay detect early-stage ovarian cancer and other ovarian tumor subtypes?\n\nResearchers will compare the test results from participants with ovarian cancer and participants with benign gynecologic diseases to evaluate the diagnostic performance of the assay.\n\nParticipants will:\n\nProvide blood samples for cfDNA methylation testing Allow researchers to collect clinical and pathological information related to their diagnosis Be grouped according to their final clinical or pathological diagnosis for analysis",[28,106,508],"Early Detection of Cancer",[106,28,510,511,512,135,513,514,515,516,517,518],"cfDNA Methylation","Cell-Free DNA","DNA Methylation","Blood-Based Assay","Early Detection","Biomarker","Early Diagnosis","Diagnostic Performance","Ovarian Tumor","2026-05-12",{"date":521,"type":38},"2026-05-18",{"date":35,"type":21},{"date":524,"type":21},"2029-12-30",{"name":526,"class":144},"Tongji Hospital",{"id":528,"slug":529,"hasResults":12,"nctId":530,"briefTitle":531,"officialTitle":532,"acronym":4,"eligibilityCriteria":533,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":534,"targetDuration":4,"studyType":22,"phases":536,"briefSummary":537,"conditions":538,"keywords":547,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":560,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":568},"100392410","phase-1-a-study-of-sigvotatug-vedotin-in-advanced-solid-tumors-100392410","NCT04389632","A Study of Sigvotatug Vedotin in Advanced Solid Tumors","A Phase 1 Study of Sigvotatug Vedotin in Advanced Solid Tumors","Inclusion Criteria:\n\n* Disease indication\n\n  * Participants must have histologically or cytologically confirmed metastatic or unresectable solid malignancy within one of the tumor types listed below (dependent on study part).\n\n    * Non-small cell lung cancer (NSCLC)\n    * Head and neck squamous cell cancer (HNSCC)\n    * Advanced HER2-negative breast cancer\n    * Esophageal squamous cell carcinoma (ESCC)\n    * Esophageal\u002FGastro-esophageal junction adenocarcinoma (EAC\u002FGEJ)\n    * Cutaneous squamous cell cancer (cSCC)\n    * Exocrine pancreatic adenocarcinoma\n    * Bladder cancer\n    * Cervical cancer\n    * Gastric cancer\n    * High grade serous ovarian cancer (HGSOC)\n  * Part A only: Participants must have disease that is relapsed or refractory or be intolerant to standard-of-care therapies and should have no appropriate standard-of-care therapeutic options.\n  * Part B only: Participants must have disease that is relapsed or refractory or be intolerant to standard-of-care therapies. Participants must have received platinum-based therapy and a PD-1\u002FPD-(L)1 inhibitor, if applicable and available.\n  * Part C only: For pembrolizumab combination cohorts, participants must be eligible for pembrolizumab per local standard of care. For pembrolizumab with cisplatin or carboplatin, participants must be eligible for both pembrolizumab and the platinum agent per local standard of care. Participants must be treatment naïve for locally advanced or metastatic systemic therapy (prior definitively intended or \\[neo\\]adjuvant therapy is allowed).\n  * Part D only: Participants must be treatment naïve for locally advanced or metastatic systemic therapy.\n* Participants enrolled in the following study parts should have a tumor site accessible for biopsy and agree to biopsy as follows:\n\n  * Disease-specific expansion cohorts (Part B and Part D): A baseline fresh tumor biopsy is required. An archival biopsy collected within 90 days prior to first dose of study drug may be used.\n  * Biology expansion cohort: pretreatment biopsy and on-treatment (Cycle 1) biopsy\n* An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* Measurable disease per the RECIST v1.1 at baseline\n\nExclusion Criteria\n\n* History of another malignancy within 3 years before first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.\n* Known active central nervous system metastases. Participants with previously treated brain metastases may participate provided they:\n\n  * are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment,\n  * have no new or enlarging brain metastases, and\n  * are off of corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to first dose of study drug.\n  * In Part D, participants with untreated, asymptomatic CNS metastases smaller than 1 cm may be enrolled without definitive treatment as long as they have no neurological symptoms, no or minimal surrounding edema, and no requirements for corticosteroids.\n* Carcinomatous meningitis\n* Previous receipt of an MMAE-containing agent or an agent targeting integrin beta-6\n* Pre-existing neuropathy Grade 1 or greater per the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0) for Parts C and D cohorts with cisplatin or carboplatin; Grade 2 or greater per the NCI CTCAE v5.0 for all other cohorts\n* Any uncontrolled Grade 3 or higher (per NCI CTCAE v5.0) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of sigvotatug vedotin.\n\n  * Routine antimicrobial prophylaxis is permitted\n* Grade ≥3 pulmonary disease unrelated to underlying malignancy. This includes clinically severe pulmonary function compromise resulting from clinically significant pulmonary illnesses\n* Part C and D: Prior therapy with a PD-1 inhibitor, anti-PD-(L)1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and was discontinued from that treatment due to a Grade 3 or higher immune-mediated adverse event (IMAE).\n* History of noninfectious interstitial lung disease (ILD) or pneumonitis that required steroids, current ILD or pneumonitis, or suspected ILD or pneumonitis that cannot be ruled out by imaging at screening\n* Known diffusing capacity of the lung for carbon monoxide (DLCO; adjusted for hemoglobin) \\\u003C50% predicted\n* Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.",{"count":535,"type":21},1006,[24],"This trial will look at a drug called sigvotatug vedotin (SGN-B6A) alone and with pembrolizumab, with or without chemotherapy, to find out whether it is safe for people who have solid tumors. It will study sigvotatug vedotin to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether sigvotatug vedotin works to treat solid tumors.\n\nThe study will have four parts.\n\n* Part A of the study will find out how much sigvotatug vedotin should be given to participants.\n* Part B will use the dose found in Part A to find out how safe sigvotatug vedotin is and if it works to treat solid tumors.\n* Part C of the study will find out how safe sigvotatug vedotin is in combination with these other drugs.\n* Part D will include people who have not received treatment. This part of the study will find out how safe sigvotatug vedotin is in combination with these other drugs and if these combinations work to treat solid tumors.\n* In Parts C and D, participants will receive sigvotatug vedotin with either:\n\n  * Pembrolizumab or,\n  * Pembrolizumab and carboplatin, or\n  * Pembrolizumab and cisplatin.",[539,63,540,541,542,543,28,544,545,546,184,226],"Carcinoma, Non-Small Cell Lung","HER2 Negative Breast Neoplasms","Esophageal Squamous Cell Carcinoma","Esophageal Adenocarcinoma","Gastroesophageal Junction Adenocarcinoma","Cutaneous Squamous Cell Cancer","Exocrine Pancreatic Adenocarcinoma","Urinary Bladder Neoplasms",[77,74,548,549,550,73,551,552,553,554,555,556,557,59,235,558],"cSCC","ESCC","EAC","HGSOC","Advanced HER2-Negative Breast Cancer","High Grade Serous Ovarian Cancer","Non-Small Cell Lung Cancer","Head and Neck Squamous Cell Cancer","Esophageal Cancer","Bladder Cancer","Seattle Genetics","2026-05-08",{"date":561,"type":38},"2026-05-11",{"date":563,"type":38},"2020-06-08",{"date":565,"type":21},"2029-03-22",{"name":567,"class":45},"Seagen, a wholly owned subsidiary of Pfizer",159,{"id":570,"slug":571,"hasResults":12,"nctId":572,"briefTitle":573,"officialTitle":574,"acronym":4,"eligibilityCriteria":575,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":576,"targetDuration":4,"studyType":22,"phases":578,"briefSummary":579,"conditions":580,"keywords":584,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":587,"lastUpdatePostDateStruct":588,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":593,"locationsCount":595},"100545354","phase-1-a-phase-iii-trial-of-ucb4594-in-participants-with-advanced-cancer-100545354","NCT06380816","A Phase I\u002FII Trial of UCB4594 in Participants With Advanced Cancer","A Cancer Research UK Phase I\u002FII Trial to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of UCB4594 Alone and in Combination With Anti-cancer Treatments in Participants With Advanced Malignancies","Inclusion Criteria:\n\n1. Written (signed and dated) informed consent and capable of co-operating with investigational medicinal product (IMP) administration and follow-up\n2. Participant population: Histologically or cytologically proven advanced solid tumours (as specified below), refractory to conventional treatment, or for which no conventional therapy is considered appropriate by the Investigator or is declined by the participant. Module A (dose escalation): Tumour types which have shown high levels of human HLA-G expression (as reported in the literature): head and neck squamous cell carcinoma, non-small cell lung cancer, colorectal cancer, triple-negative breast cancer, renal cell cancer (clear cell only), oesophago-gastric cancer (excluding gastrointestinal stromal tumour), cervical cancer, ovarian cancer, pancreatic cancer. N.B. Participants with small cell type cancers on histology\u002Fcytology are excluded. Pre-treatment biopsies are mandatory for all participants. Paired biopsies will be mandatory for participants from doses of 30 mg and higher. Participants must have disease amenable to biopsy (excluding bone metastases) as deemed safe by the Investigator\n3. Measurable disease, according to RECIST v1.1\n4. Life expectancy of at least 12 weeks\n5. Eastern Cooperative Oncology Group performance status of 0 or 1\n6. Haematological and biochemical indices within defined ranges. These measurements should be performed to confirm the patient's eligibility to participate in the trial\n7. Aged 18 years or over at the time consent is given. Participants aged 16-17 years may be eligible for recruitment to the backfill cohorts in dose escalation once adequate safety and toxicity data have been established in participants aged 18 years or over. All relevant data will be reviewed and a decision on the inclusion of participants aged 16-17 years will be made by the Trial Management Group\n\nExclusion Criteria:\n\n1. Radiotherapy (except palliative), endocrine therapy (unless for non-malignant disease), chemotherapy, targeted therapy or immunotherapy, or any other IMPs during the previous 4 weeks or 5 half-lives (whichever is shorter) before the first dose of IMP\n2. Ongoing toxicity of previous treatments \\>CTCAE Grade 1 (except alopecia of any grade, stable Grade 2 peripheral neuropathy or hormone-replacement therapy (HRT)-managed endocrine disorders)\n3. Patients with rapidly progressing \u002F symptomatically deteriorating brain\u002Fleptomeningeal metastases\u002Funtreated brain metastases are excluded. Patients with previously treated brain metastases are eligible if they haven't had a seizure or a clinically significant change in neurological status or required steroids in the last 2 weeks\n4. Pregnant or breastfeeding female patients (or planning to breastfeed)\n5. Women of childbearing potential. However, those not already pregnant or breastfeeding (or who discontinue breastfeeding) and meet the following are eligible:\n\n   5.1. Have a negative serum pregnancy test within 7 days before enrolment and either:\n\n   5.2.1. Agree to a form of highly effective contraception plus a barrier method, or\n\n   5.2.2. Agree to sexual abstinence\n\n   Effective from the negative pregnancy test, throughout the trial and for 10 months after the last dose of UCB4594\n6. Male patients with partners of childbearing potential. However, patients who meet the following are eligible:\n\n   6.1. Agree to a barrier method of contraception or sexual abstinence\n\n   6.2. Males with pregnant or breastfeeding partners must use barrier method contraception to prevent exposure of the foetus or neonate\n\n   6.3. Non-vasectomised males must also ensure any partner of childbearing potential uses highly effective contraception or agrees to sexual abstinence\n\n   Effective from the date of the first dose of UCB4594, throughout the trial and for 5 months after the last dose of UCB4594 N.B. Males must refrain from donating sperm for the same period\n7. Surgery from which the patient has not yet recovered\n8. High medical risk because of non-malignant systemic disease, including serious or uncontrolled infection (requiring intravenous antibiotics) or unexplained fever \\>38°C within 2 weeks prior to the first dose of UCB4594\n9. Known to be serologically positive for hepatitis B virus, hepatitis C virus or human immunodeficiency virus\n10. Active or suspected autoimmune disease, or any history of autoimmune condition that required systemic corticosteroids or immunosuppressive agents. Patients who have ever had a transplant are excluded. This does not apply to patients with: vitiligo, alopecia, or type I diabetes mellitus, psoriasis not requiring chronic systemic immunosuppressive treatment within the past 2 years, stable autoimmune-mediated hypothyroidism on HRT, and Raynaud's syndrome\n11. Are being treated with escalating or supraphysiologic doses of corticosteroids or immunosuppressive agents. Participants with immunotherapy-related hypophysitis adequately treated with physiologic doses of steroids are not excluded. Use of topical, ophthalmic, inhaled, intermittent steroid injections, and intranasal corticosteroids are permitted\n12. Hypersensitivity to the ingredients\u002Fexcipients (including polysorbate 80) in UCB4594\n13. History of significant toxicities from treatment of immune checkpoint inhibitors (CPIs) that necessitated permanent discontinuation (Patients who started on combination CPI \\[e.g., ipilimumab\u002Fnivolumab\\] and had toxicity requiring discontinuation of one CPI \\[e.g., continued with nivolumab single agent\\] are not excluded)\n14. History of Grade ≥3 infusion-related reaction to monoclonal antibodies or similar drugs\n15. Prior treatment with HLA-G, immunoglobulin-like transcript (ILT)2 or ILT4-targeting drug\n16. Live, attenuated vaccine within 28 days prior to the first dose of IMP\n17. Increased risk due to tumour flare (e.g., an initial increase in tumour size that may lead to obstruction of airways, etc)\n18. Significant active pulmonary disease or condition at screening, including:\n\n    18.1. Lymphangitis carcinomatosa\n\n    18.2. History of interstitial lung disease or pulmonary fibrosis\n\n    18.3. History of pulmonary inflammatory disease\n19. Evidence of bleeding diathesis\n20. Significant cardiovascular disease, defined as a history of: congestive heart failure requiring therapy or left ventricular ejection fraction \\\u003C40%, unstable angina pectoris or myocardial infarction within 6 months prior to entry, or current poorly controlled angina (symptoms weekly or more), clinically significant cardiac arrhythmia within 6 months prior to entry (asymptomatic atrial fibrillation or asymptomatic first-degree heart block permitted), or myocarditis. Presence of symptomatic or severe valvular heart disease. Baseline QT interval corrected by Fridericia \\>450 msec for males and \\>470 msec for females on triplicate electrocardiogram is ineligible\n21. Participant in or plans to join another interventional trial\n22. Other current malignancies. Cancer survivors who have undergone potentially curative therapy for prior malignancy with no evidence of disease for 3+ years are eligible\n23. Any other condition that, in the Investigator's opinion, means the trial is not in the patient's best interest",{"count":577,"type":21},167,[24,25],"This clinical trial is looking at UCB4594. This is the first time the drug is being tested in humans. UCB4594 is a type of drug called a monoclonal antibody. It has been designed to work by targeting a protein called human leucocyte antigen G (HLA-G) that is found in high levels on some cancer cells. By attaching itself to this protein it may help the immune system to attack and kill the cancer cells.\n\nThe four main aims of the clinical trial are to find out:\n\n1. The best dose of UCB4594 that can be given safely to participants in the trial.\n2. What the side effects of UCB4594 are and how they can be managed.\n3. What happens to UCB4594 inside the body and how it affects cancer cells.\n4. Whether UCB4594 can cause cancer to shrink.",[581,63,185,31,68,582,393,583,184,28,227],"Advanced Solid Tumours","Carcinoma, Renal Cell (Clear Cell Only)","Stomach Neoplasms (Excluding Gastrointestinal Stromal Tumors)",[585,586,322],"HLA-G","Monoclonal Antibody","2026-05-05",{"date":559,"type":38},{"date":590,"type":38},"2024-07-09",{"date":592,"type":21},"2029-11",{"name":594,"class":144},"Cancer Research UK",4,{"id":597,"slug":598,"hasResults":12,"nctId":599,"briefTitle":600,"officialTitle":601,"acronym":602,"eligibilityCriteria":603,"healthyVolunteers":12,"sex":99,"minAge":18,"maxAge":4,"enrollmentInfo":604,"targetDuration":4,"studyType":22,"phases":606,"briefSummary":607,"conditions":608,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":612,"lastUpdatePostDateStruct":613,"startDateStruct":615,"completionDateStruct":617,"leadSponsor":618,"locationsCount":620},"100517924","phase-2-a-three-arm-randomized-phase-ii-study-of-dostarlimab-alone-or-with-bevacizumab-versus-nonplatinum-chemotherapy-in-recurrent-gynecological-clear-cell-carcinoma-dove-apgot-ov7-engot-ov80-study-100517924","NCT06023862","A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum Chemotherapy in Recurrent Gynecological Clear Cell Carcinoma: DOVE (APGOT-OV7\u002F ENGOT-ov80 Study)","A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum Chemotherapy in Recurrent Gynecological Clear Cell Carcinoma: DOVE (APGOT-OV07\u002F ENGOT-ov80 Study)","DOVE","Inclusion Criteria:\n\n1. Female patient is at least 18 years of age,\n2. Patient has signed the Informed Consent (ICF) and is able to comply with protocol requirements.\n3. Patient with histologically proven confirmed recurrent or persistent clear cell carcinoma of the ovary, endometrium, cervix, vagina, and vulva\n\n   * Local review by gynecologic pathologist required\n   * ≥50% clear cell histology in case of mixed carcinoma\n   * WT-1 neg (Only in case of ovarian cancer) Note: In the case of including non-ovarian clear cell carcinoma with more than 20 cases, the decision is made through discussion with the SPONSOR.\n4. Patient with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n5. Disease progression within 12 months of completing platinum-based chemotherapy\n6. 1-5 prior lines of therapies\n7. Patient with measurable disease according RECIST 1.1 criteria\n8. Availability of Tumor tissue for translational research . - A formalin-fixed paraffin-embedded (FFPE) tumor block(preferred) or at least 20 slides (unstained, freshly cut, serial sections) must be submitted.\n9. Patients who consent to fresh tumor biopsies\n\n   * Confirmed with at least one lesion with location accessible to safely biopsy per the clinical judgement of the investigator\n   * Note: If mandatory biopsies cannot be performed as per investigator's clinical judgement, discussion and agreement between investigator and Sponsor are required.\n10. Patient has adequate organ function, defined as follows:\n\n    1. Absolute neutrophil count ≥ 1,500 cells\u002FμL\n    2. Platelets ≥ 100,000 cells\u002FμL\n    3. Hemoglobin ≥ 9 g\u002FdL or ≥ 5.6 mmol\u002FL\n    4. Serum creatinine ≤ 1.5× upper limit of normal (ULN) or calculated creatinine clearance ≥ 50 mL\u002Fmin using the Cockcroft-Gault equation for patients with creatinine levels \\> 1.5× institutional ULN\n    5. Total bilirubin ≤ 1.5× ULN (≤ 2.0 x ULN in patients with known Gilbert's syndrome) or direct bilirubin ≤ 1× ULN\n    6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5× ULN unless liver metastases are present, in which case they must be ≤ 5× ULN\n    7. International normalized ratio or prothrombin time (PT) ≤1.5× ULN and activated partial thromboplastin time ≤1.5× ULN.Participants taking anticoagulants may be included on a stable dose with a therapeutic INR \\\u003C3.5. .\n11. Patient must have a negative serum pregnancy test within 72 hours of the first dose of study medication, unless they are of non-childbearing potential. If a negative result cannot be confirmed by a urine test, a serum pregnancy test is required. Non-childbearing potential is defined as follows:\n\n    1. Patient is ≥ 45 years of age and has not had menses for \\> 1 year.\n    2. A follicle-stimulating hormone value in the postmenopausal range upon screening evaluation if amenorrhoeic for \\\u003C 2 years without a hysterectomy and oophorectomy.\n    3. Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation:\n\n       * Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound, MRI, or CT scan.\n       * Tubal ligation must be confirmed with medical records of the actual procedure.\n       * Information must be captured appropriately within the site's source documents.\n12. Patient of childbearing potential must agree to use a highly effective method of contraception with their partners starting from time of consent through 180 days after the last dose of study treatment. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient (Information must be captured appropriately within the site's source documents).\n\nExclusion Criteria:\n\n1. Patient has had ≥ 6 prior lines of chemotherapy. Surgery of the recurrence is allowed.\n2. Patient has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.\n3. Patient has received prior anticancer therapy (chemotherapy, targeted therapies, hormonal therapy, radiotherapy) within 21 days or \\\u003C 5 times the half-life of the most recent therapy prior to Study Day 1, whichever is shorter.\n\n   Note: Palliative radiation therapy to a small field ≥ 1 week prior to Day 1 of study treatment may be allowed after discussion with the SPONSOR.\n4. Patient with contraindication to chemotherapy or immune checkpoint inhibitor treatments or anti-angiogenic inhibitor\n5. Patients with uncontrolled hypertension (defined as systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥100 mmHg) based on an average of ≥ 3 BP readings on ≥ 2 sessions.\n6. Patients with evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)\n7. Patients with current abdominal\u002Fpelvic fistula\n8. Patient has a concomitant malignancy, or patient has a prior non-gynecological malignancy who has been disease-free for \\\u003C 3 years or who received any active treatment in the last 3 years for that malignancy. Non-melanoma skin cancer is allowed.\n9. Patient has known uncontrolled central nervous system metastases, carcinomatosis meningitis, or both. Note: Patients with previously treated brain metastases may participate provided they are stable (without evidence of disease progression by imaging \\[using the identical imaging modality for each assessment, either MRI or CT scan\\] for at least 4 weeks prior to the first dose of study treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and have not been using steroids for at least 7 days prior to study treatment. Carcinomatous meningitis precludes a patient from study participation regardless of clinical stability.\n10. Patient has a known history of human immunodeficiency virus (HIV; HIV ½ antibodies). Participants with known human immunodeficiency virus(HIV) are allowed if they meet all of the following criteria:\n\n    * Cluster of differentiation 4(CD4) ≥350\u002FμL and viral load \\\u003C50 copies\u002FmL.\n    * No history of acquired immunodeficiency syndrome-defining opportunistic infections within 12 months before enrollment.\n    * No history of HIV-associated malignancy for the past 5 years.\n    * Concurrent antiretroviral therapy as per the most current National Institutes of Health (NIH) Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV started \\>4 weeks before study enrollment.\n11. Patient with presence of hepatitis B surface antigen or a positive hepatitis C antibody test result at screening or within 3 months before first dose of dostarlimab treatment.\n\n    * Participants who are hepatitis B surface antigen positive may be enrolled if their HBV-DNA level is below the institutional lower limit.\n    * Participants with chronic hepatitis B virus (HBV) infection who meet the criteria for anti-HBV therapy may be eligible if the participant is on a suppressive antiviral therapy before initiation of cancer therapy.\n    * Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled only if a confirmatory negative hepatitis C RNA polymerase chain reaction is obtained. Hepatitis C participants may be eligible if they both have completed curative therapy and have a hepatitis C viral load \\\u003C!-- Not Allowed Tag Filtered --\\>\\\u003Cquantifiable limit.\n12. Patient has an active autoimmune disease that required systemic treatment in the past 2 years. Replacement therapy is not considered a form of (eg, thyroid hormone or insulin).\n13. diagnosis immunodeficiency receiving steroid any other immunosuppressive within 7 days prior to first dose study treatment. Patients who have received acute and\\>\u002For low-dose systemic immunosuppressive medications (e.g,, a one-time dose of dexamethasone for nausea or chronic use of ≤ 10 mg\u002Fday of prednisone or dose equivalent corticosteroid) may be enrolled in the study after discussion with and approval by the Sponsor. The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) is allowed.\n14. Patient has not recovered (to Grade ≤ 1) from previous anti-cancer therapy-induced adverse events (AEs).\n\n    Note: Patients with Grade ≤ 2 neuropathy, Grade ≤ 2 alopecia, or Grade ≤ 2 fatigue are an exception to this criterion and may qualify for the study.\n15. Patient has not recovered adequately from AEs or complications from any major surgery prior to starting therapy. Major surgical procedures, other than for diagnosis, within 4 weeks prior to initiation of study treatment\n16. Patient has a known hypersensitivity to bevacizumab or dostarlimab components or excipients.\n17. Patient is currently participating and receiving study treatment or has participated in a study of an investigational agent and received study treatment or used an investigational device within 4 weeks of the first dose of treatment.\n18. Patient is considered a poor medical condition due to a serious, uncontrolled medical disorder, non-malignant systemic disease, or active infection requiring systemic therapy. Specific examples include, but are not limited to, active, non-infectious pneumonitis; uncontrolled ventricular arrhythmia; recent (within 90 days) myocardial infarction; uncontrolled major seizure disorder; unstable spinal cord compression; superior vena cava syndrome; or any psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study (including obtaining informed consent).\n19. Patients with known history of non-infectious pneumonitis that required steroids or has current pneumonitis.\n20. Use of any of the following immunomodulatory agents within 28 days prior to the first dose of study drug:\n\n    * Interferons\n    * Interleukins\n    * Live vaccine Note: Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster, yellow fever, rabies, BCG, and typhoid vaccine. mRNA and adenoviral-based COVID-19 vaccines are considered non-live and are not exclusionary. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed as other killed vaccines, if done at least 2 weeks prior the first dose of study drug; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.\n21. Patient who are pregnant or lactating, or plan to become pregnant or lactate during the expected duration of the study, from screening through 180 days after the last dose of study drug.",{"count":605,"type":21},198,[25],"Multicenter, randomized, open-label, phase II clinical study comparing Dostarlimab +\u002F- Bevacizumab with standard chemotherapy in patients with gynecological clear cell carcinoma.\n\n198 subjects will be enrolled in this study and will be assigned to three groups in a 1:1:1 ratio.\n\n1. Group A: Dostarlimab monotherapy\n\n   * First 3 cycles: Dostalimab 500mg every 3 weeks, IV\n   * 4 cycles \\~ up to 24 months: Dostalimab 1000mg every 6 weeks, IV\n2. Group B: Dostarlimab + Bevacizumab combination therapy\n\n   * First 3 cycles: Dostalimab 500mg every 3 weeks, IV\n   * 4 cycles \\~ up to 24 months: Dostalimab 1000mg every 6 weeks, IV\n   * Bevacizumab administered IV at 15 mg\u002Fkg every 3 weeks until disease progression or unacceptable toxicity\n3. Group C: General chemotherapy (one of Pegylated liposomal doxorubicin, Doxorubicin, Paclitaxel, and Gemcitabine)",[28,30,184,609,610,611],"Vulvar Cancer","Vagina Neoplasm","Clear Cell Carcinoma","2026-04-30",{"date":614,"type":38},"2026-05-06",{"date":616,"type":38},"2024-01-22",{"date":432,"type":21},{"name":619,"class":144},"Yonsei University",27,{"id":622,"slug":623,"hasResults":12,"nctId":624,"briefTitle":625,"officialTitle":626,"acronym":4,"eligibilityCriteria":627,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":628,"targetDuration":4,"studyType":22,"phases":630,"briefSummary":631,"conditions":632,"keywords":653,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":660,"lastUpdatePostDateStruct":661,"startDateStruct":663,"completionDateStruct":665,"leadSponsor":667,"locationsCount":669},"100561192","phase-1-a-study-with-nkt3964-for-adults-with-advancedmetastatic-solid-tumors-100561192","NCT06586957","A Study With NKT3964 for Adults With Advanced\u002FMetastatic Solid Tumors","A Phase 1, First-in-human, Open-label Study to Evaluate the Safety, Tolerability, PK, and Preliminary Anti-tumor Activity of the Novel Oral CDK2 Degrader NKT3964 in Adults With Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n\\- Must have a pathologically confirmed advanced and unresectable or metastatic solid tumor listed below with documented disease progression on last standard treatment. Part 1 only: subjects must be refractory to, or intolerant of existing therapy(ies) known to provide clinical benefit for their condition.\n\nDose Escalation:\n\n1. Ovarian cancer\n2. Endometrial cancer (only endometrioid subtype will require CCNE1 amplification)\n3. Gastric, gastroesophageal junction (GEJ) or esophageal adenocarcinoma with CCNE1 amplification\n4. Small cell lung cancer (SCLC)\n5. Triple-negative breast cancer (TNBC; HER2, estrogen receptor and progesterone receptor negative)\n6. HR+ (includes estrogen-receptor or progesterone-receptor) and HER2- breast cancer (must have progressed following treatment with a CDK4\u002F6 inhibitor, and is not suitable for endocrine therapy \\[ET\\])\n7. Other solid tumors with CCNE1 amplification\n\nDose Expansion:\n\nPart 2A: HR+ and HER2- breast cancer that is locally advanced and unresectable (Stage III) or metastatic (Stage IV); previously treated with ≥1 line of standard of care (SOC) including CDK4\u002F6 inhibitor plus ET and not suitable for further ET. Subjects must have progressed after receiving therapy for ≥3 months in the metastatic setting or for ≥6 months in the adjuvant setting. Subjects must have received ≤2 lines of systemic cytotoxic therapy (chemotherapy or cytotoxic antibody drug conjugate \\[ADC\\]) in the metastatic setting..\n\nPart 2B: Advanced platinum-based-chemotherapy resistant or refractory epithelial ovarian\u002Ffallopian\u002Fprimary peritoneal carcinoma or clear cell ovarian cancer (defined as recurrence ≤6 months after completing platinum-based regimen) with progression on at least one platinum containing therapy and previously treated with ≤4 prior lines of systemic therapy administered for advanced\u002Fmetastatic disease and with CCNE1 amplification.\n\nPart 2C: Advanced unresectable or metastatic gastric, GEJ or esophageal adenocarcinoma with progression on at least one systemic therapy and previously treated with ≤3 prior lines of systemic therapy administered for advanced\u002Fmetastatic disease, with CCNE1 amplification as determined by NGS by local liquid or tissue test.\n\nPart 2D: Advanced endometrial adenocarcinoma or uterine papillary serous carcinoma previously treated with ≤4 prior lines of systemic therapy administered for advanced\u002Fmetastatic disease with CCNE1 amplification.\n\nPart 2E: Advanced\u002Frecurrent uterine carcinosarcoma previously treated with 1 prior platinum-based chemotherapy regimen and ≤3 prior lines of systemic therapy. Prior bevacizumab or PARP inhibitors are allowed and must be at least 3 weeks prior to the start of study drug.\n\n* Have adequate organ function\n* Subjects with female reproductive organs must be surgically sterile, post-menopausal, or must be willing to use highly effective method(s) of contraception\n* Ability to swallow oral medications.\n* Consent to provide archived tumor tissues and paired tumor biopsy at pretreatment\n\nExclusion Criteria:\n\n* Locally advanced solid tumor that is a candidate for curative treatment through radical surgery and\u002For radiotherapy, or chemotherapy.\n* History of another malignancy with exceptions\n* History of lymphohistiocytic or lymphoid hyperplasia; hemophagocytic lymphohistiocytosis.\n* Failed to recover from effects of prior anticancer treatment therapy to baseline or Grade ≤ 1 severity (per CTCAE)\n* Clinically significant cardiovascular event within 6 months prior to start of NKT3964 treatment\n* Known active CNS metastases and\u002For carcinomatous meningitis\n* Active interstitial lung disease currently requiring treatment\n* History of uveitis, retinopathy or other clinically significant retinal disease\n* Active or chronic corneal disorders, other active ocular conditions requiring ongoing therapy, or any clinically significant corneal disease\n* Active wound healing from major surgery within 1 month or minor surgery within 10 days before the first dose of NKT3964.\n* Known human immunodeficiency virus (HIV), active hepatitis B or C infection\n* Prior investigative treatment with a selective or nonselective CDK2 inhibitor or degrader\n* Childs-Pugh class B or C cirrhosis or any other clinically significant liver disorder\n* Palliative radiation therapy within 14 days or other radiation therapy within 4 weeks prior to C1D1",{"count":629,"type":21},150,[24],"The goal of the Dose Escalation phase of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity to determine the preliminary recommended dose for expansion (RDE) of NKT3964 in adults with advanced or metastatic solid tumors. The goal of the Expansion phase of the study is to evaluate the preliminary anti-tumor activity of NKT3964 at the RDE based on objective response rate (ORR) and determine the preliminary recommended Phase 2 dose (RP2D).",[633,634,314,635,106,28,262,636,30,637,638,639,640,641,642,235,643,644,645,646,647,68,478,648,649,650,651,652],"Solid Tumor","Advanced Solid Tumor","Metastatic Tumor","Metastatic Ovarian Carcinoma","Endometrial Diseases","Metastatic Endometrial Cancer","Triple Negative Breast Cancer","Metastatic Endometrial Carcinoma","Advanced Endometrial Carcinoma","Advanced Ovarian Carcinoma","Advanced Gastric Carcinoma","Metastatic Gastric Cancer","Metastatic Gastric Carcinoma","Small Cell Lung Cancer","Small Cell Lung Carcinoma","Platinum-refractory Ovarian Carcinoma","CCNE1 Amplification","Hormone Receptor Negative Breast Carcinoma","Human Epidermal Growth Factor 2 Negative Carcinoma of Breast","Progesterone-receptor-positive Breast Cancer",[654,655,656,657,658,659],"CDK 2 Inhibitor","CDK 4 Inhibitor","CDK 6 Inhibitor","CDK2 Degrader","Protein Degrader","PROTAC","2026-04-16",{"date":662,"type":38},"2026-04-21",{"date":664,"type":38},"2024-09-19",{"date":666,"type":21},"2029-05",{"name":668,"class":45},"NiKang Therapeutics, Inc.",19,{"id":671,"slug":672,"hasResults":12,"nctId":673,"briefTitle":674,"officialTitle":675,"acronym":676,"eligibilityCriteria":677,"healthyVolunteers":12,"sex":17,"minAge":678,"maxAge":4,"enrollmentInfo":679,"targetDuration":4,"studyType":22,"phases":680,"briefSummary":681,"conditions":682,"keywords":699,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":717,"lastUpdatePostDateStruct":718,"startDateStruct":720,"completionDateStruct":722,"leadSponsor":724,"locationsCount":620},"100626796","phase-2-determine-trial-treatment-arm-07-dabrafenib-in-combination-with-trametinib-in-adult-paediatric-and-teenageyoung-adult-patients-with-braf-v600-mutation-positive-cancers-100626796","NCT07440290","DETERMINE Trial Treatment Arm 07: Dabrafenib in Combination With Trametinib in Adult, Paediatric and Teenage\u002FYoung Adult Patients With BRAF V600 Mutation-Positive Cancers.","DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage\u002FYoung Adult (TYA) Cancers With Actionable Genomic Alterations, Including Common Cancers With Rare Actionable Alterations. Treatment Arm 07: Dabrafenib in Combination With Trametinib in Adult, Paediatric and TYA Patients With BRAF V600 Mutation-Positive Cancers.","DETERMINE","THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA WITHIN THE DETERMINE MASTER PROTOCOL (NCT05722886) AND WITHIN THE TREATMENT ARM 07 (DABRAFENIB AND TRAMETINIB) OUTLINED BELOW\\* \\*When dabrafenib- and trametinib-specific inclusion\u002Fexclusion criteria or precautions below differ from those specified in the Master Protocol, the dabrafenib- and trametinib-specific criteria will take precedence.\n\nInclusion criteria:\n\nA. Confirmed diagnosis of a malignancy harbouring an oncogenic alteration in BRAF V600, including Langerhans cell histiocytosis, using an analytically validated next-generation sequencing method.\n\nB. Patients ≥1 year old and ≥8 kg in body weight.\n\nC. Women of childbearing potential are eligible provided that they meet the following criteria:\n\n• Have a negative serum or urine pregnancy test before enrolment and;\n\n• Agree to use one form of a non-hormonal highly effective contraception method (a method that can achieve a failure rate of \\\u003C1% when used consistently and correctly; the requirement for non-hormonal method is because dabrafenib may decrease the efficacy of oral or any systemic hormonal contraceptives), such as: i. intrauterine device (IUD), ii. bilateral tubal occlusion, bilateral tubal ligation (at least six weeks before taking trial treatment), iii. vasectomised partner, iv. total sexual abstinence. Effective from the first administration of dabrafenib and trametinib (whichever is first), throughout the trial and for two weeks following discontinuation of dabrafenib and for 16 weeks following discontinuation of trametinib (whichever is later).\n\nPatients who are breastfeeding must be willing to discontinue breastfeeding from the start of treatment, throughout the trial and for two weeks following discontinuation of dabrafenib and for 16 weeks following discontinuation of trametinib (whichever is later).\n\nD. Male patients with partners who are women of childbearing potential are eligible provided that they agree to the following, from the first administration of dabrafenib and trametinib (whichever is first), throughout the trial and for two weeks after the last administration of dabrafenib and 16 weeks after the last administration of trametinib (whichever is later):\n\n* Agree to take measures not to father children by using a barrier method of contraception (male condom plus spermicide) or to sexual abstinence.\n* Non-vasectomised male partners with partners who are women of childbearing potential should also be advised of the benefit for their partner of using a highly effective method of contraception, such as:\n\n  i. combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation \\[oral, intravaginal or transdermal\\]), ii. progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), iii. IUD, iv. intrauterine hormone-releasing system (IUS), v. bilateral tubal occlusion, vi. total sexual abstinence.\n* Male patients with pregnant or breastfeeding partners must be advised to use barrier method contraception (male condom) to prevent drug exposure of the foetus or neonate, even if vasectomised.\n* Male patients must refrain from donating sperm for the same period.\n\nE. Patients must be able and willing to undergo a fresh tissue biopsy at baseline and blood samples for translational research. Note that for patients with haematological malignancies or neuroblastomas, blood, bone marrow aspiration and\u002For trephine or lymph node biopsy samples may be taken.\n\nF. Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility\n\nExclusion criteria:\n\nA. Diagnosis of one of the following BRAF V600E mutation-positive cancers:\n\n* Colorectal cancer in adult (≥18 years) patients;\n* Unresectable or metastatic melanoma in adult (≥18 years) patients;\n* Advanced non-small cell lung cancer in adult (≥18 years) patients;\n* Gliomas harbouring a BRAF V600E mutation in paediatric (1 to \\\u003C16 years) or TYA (16 to \\\u003C18 years) patients.\n\nB. Previous treatment with dabrafenib and trametinib in combination (or other BRAF and MEK inhibitors in combination) for the current indication.\n\nC. Female patients who are pregnant, breastfeeding or planning to become pregnant during the trial or for two weeks following their last dose of dabrafenib or 16 weeks following their last dose of trametinib, whichever is later.\n\nD. Known hypersensitivity to dabrafenib or trametinib or any of the excipients. See the current relevant SmPCs (UK) for the full lists.\n\nE. Patients with a history of retinal vein occlusion.\n\nF. Any impairment of gastrointestinal (GI) function of uncontrolled GI disease that may significantly alter the administration or absorption of dabrafenib and\u002For trametinib (e.g. history of diverticulitis, metastases to the GI tract, uncontrolled Crohn's disease, uncontrolled ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome or short gut syndrome).\n\nG. Clinically significant cardiac or cerebrovascular disease as defined by:\n\n* Unstable angina within three months prior to screening;\n* Myocardial infarction within three months prior to screening;\n* History of documented congestive heart failure (New York Heart Association functional classification III\u002FIV) etc.\n\nPatients with a cerebrovascular event (including stroke or transient ischaemic attack \\[TIA\\]) within three months prior to screening.\n\n• Patients with primary central nervous system (CNS) tumours may be considered unless intratumoural bleeding has occurred within two weeks prior to the first dose of dabrafenib and trametinib, and patients with punctate CNS haemorrhages \\\u003C3 mm may be considered.\n\nH. Patients who were administered a live, attenuated vaccine within 28 days prior to initiation of treatment, or anticipation of need for such a vaccine during investigational medicinal product (IMP) treatment or within six months after the final dose of dabrafenib and trametinib.\n\nI. Known active infections (bacterial, fungal or viral) that would interfere with the assessment of safety or efficacy of dabrafenib and trametinib including human immunodeficiency virus (HIV) positivity. Patients with history of testing positive for HIV infection are eligible provided that each of the following conditions are met:\n\n* CD4 count ≥350\u002FµL;\n* Undetectable viral load;\n* Receiving antiretroviral therapy (ART) that does not interact with IMP (patients should be on established ART for at least four weeks); and\n* No HIV\u002Facquired immune deficiency syndrome associated opportunistic infection in the last 12 months.\n\nJ. Any clinically significant concomitant disease or condition (or its treatment) that could interfere with the conduct of the trial (including absorption of oral medications) that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this trial.","1 Year",{"count":407,"type":21},[25,103],"This clinical trial is looking at two drugs called dabrafenib and trametinib. Dabrafenib and trametinib are approved as standard of care treatment for adult patients with melanoma (a type of skin cancer) or lung cancer and in children with glioma (a type of brain tumour). This means they have gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Dabrafenib and trametinib work in patients with a particular mutation in their cancer known as BRAF V600.\n\nInvestigators now wish to find out if they will be useful in treating patients with other cancer types which have the same mutation. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future.\n\nThis trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.",[683,684,685,686,687,688,689,690,322,691,692,28,31,693,694,695,696,697,698],"Haematological Malignancy","Malignant Neoplasm","Lymphoproliferative Disorders","Neoplasms by Histologic Type","Neoplasms by Site","Gastrointestinal Cancer","Non-Melanoma Skin Cancer (NMSC)","Langerhans Cell Histiocytosis (LCH)","Erdheim-Chester Disease","Thyroid Carcinoma, Papillary","Laryngeal Neoplasms","Carcinoma, Non-Small Cell-Lung","Glioma","Multiple Myeloma","Thyroid Carcinoma, Anaplastic","Solid Tumour",[700,701,322,702,703,704,705,706,707,708,687,709,710,711,712,713,714,715,716],"Adult","Antineoplastic Agents","Child","Dabrafenib","Malignancy","Malignant Neoplasms","Molecular Targeted Therapy","Mutation","Neoplasms by Histologic Site","Paediatric","Precision Medicine","Proto-Oncogene Proteins B-raf","Protein Kinase Inhibitors","Rare","Trametinib","Tumour-Agnostic","Young adult","2026-02-23",{"date":719,"type":38},"2026-02-27",{"date":721,"type":21},"2026-02",{"date":723,"type":21},"2029-10",{"name":594,"class":144},{"id":726,"slug":727,"hasResults":12,"nctId":728,"briefTitle":729,"officialTitle":730,"acronym":4,"eligibilityCriteria":731,"healthyVolunteers":12,"sex":99,"minAge":18,"maxAge":4,"enrollmentInfo":732,"targetDuration":4,"studyType":22,"phases":734,"briefSummary":735,"conditions":736,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":741,"lastUpdatePostDateStruct":742,"startDateStruct":744,"completionDateStruct":746,"leadSponsor":748,"locationsCount":249},"100614493","ultrasound-microvessel-imaging-for-the-evaluation-of-ovarian-and-adnexal-lesions-100614493","NCT07280312","Ultrasound Microvessel Imaging for the Evaluation of Ovarian and Adnexal Lesions","Ultrasound Imaging of Ovarian and Adnexal Lesions","Inclusion Criteria:\n\n* Female patients aged ≥ 18 years\n* Scheduled for surgery for ovarian or adnexal lesions\n\nExclusion Criteria:\n\n* Prior surgical removal of ovarian or adnexal lesions\n* Undergoing neoadjuvant chemotherapy or targeted systemic therapy\n* Vulnerable populations, including prisoners, adults lacking capacity to consent, and pregnant women (our study coordinator will ask participants if they are pregnant; if uncertain, a urine pregnancy test will be offered at no cost).",{"count":733,"type":21},40,[259],"This clinical trial studies how well ultrasound microvessel imaging (UMI) works in evaluating ovarian and adnexal lesions in patients who are scheduled to have surgical treatment for their ovarian or adnexal lesions as part of their clinical care. Ovarian cancer is the most lethal gynecologic malignancy, often diagnosed at an advanced stage. Current diagnostic tools include a blood test (serum cancer antigen 125 \\[CA125\\]) and transvaginal ultrasound. However, CA125 has limited diagnostic accuracy and is Food and Drug Administration-approved only for monitoring the return of cancer (recurrence), not for preoperative diagnosis. A key measurement in calculating ovarian and adnexal cancer risk is by looking at increased blood flow, which may suggest a higher risk of cancer developing. However, current ultrasound techniques have limited ability to assess blood flow. A new ultrasound technique, UMI, may have higher sensitivity for detecting small blood vessels compared to traditional ultrasound imaging.",[737,262,738,28,739,740],"Female Reproductive System Adnexal Neoplasm","Female Reproductive System Neoplasm","Adnexal Lesion","Ovarian Lesion","2026-01-30",{"date":743,"type":38},"2026-02-03",{"date":745,"type":38},"2026-01-22",{"date":747,"type":21},"2029-12-17",{"name":749,"class":144},"Mayo Clinic",{"id":751,"slug":752,"hasResults":12,"nctId":753,"briefTitle":754,"officialTitle":754,"acronym":755,"eligibilityCriteria":756,"healthyVolunteers":12,"sex":99,"minAge":18,"maxAge":4,"enrollmentInfo":757,"targetDuration":4,"studyType":22,"phases":758,"briefSummary":759,"conditions":760,"keywords":761,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":763,"lastUpdatePostDateStruct":764,"startDateStruct":766,"completionDateStruct":768,"leadSponsor":770,"locationsCount":249},"100590119","phase-3-validation-of-the-sentinel-lymph-node-technique-in-early-stage-ovarian-cancer-sentov-ii-100590119","NCT06963268","Validation of the Sentinel Lymph Node Technique in Early-stage Ovarian Cancer (SENTOV II)","SENTOV II","Inclusion Criteria:\n\n* Signed informed consent prior to the performance of any procedure related to the clinical trial.\n* Female, 18 years of age or older at the time of inclusion.\n* Patients with a histopathological diagnosis of malignant ovarian tumor in a deferred study (any epithelial histology), in apparent early stage FIGO I-II, proposed for staging surgery, or patients with suspected malignant ovarian tumor in apparent early stage FIGO I-II, who will undergo exploratory laparotomy and operative biopsy, and if positive, will undergo staging surgery.\n\nExclusion Criteria:\n\n* Failure to obtain informed consent or revocation of informed consent.\n* Under 18 years of age at the time of inclusion.\n* Previous history of vascular surgery on the aorta, vena cava, or pelvic vessels.\n* Previous pelvic or paraaortic lymphatic surgery.\n* Previous lymphoma.\n* Previous abdomino-pelvic tumor.\n* Previous allergy to Tc99 or ICG.\n* Pregnancy\u002FBreastfeeding.\n\nPatients who have signed informed consent but do not meet all inclusion criteria and none of the exclusion criteria will be considered as selection failures.",{"count":444,"type":21},[103],"This clinical trial investigates the sentinel lymph node (SLN) technique as a less invasive alternative to conventional lymphadenectomy in patients with early-stage ovarian cancer. The primary objective is to evaluate the effectiveness, safety, and diagnostic accuracy of the SLN approach in detecting lymphatic metastases. By assessing its negative predictive value, the study aims to determine whether the SLN technique can reliably replace systematic pelvic and paraaortic lymphadenectomy. If successful, this technique could minimize surgical morbidity, shorten hospitalization stays, and lower complication rates, ultimately improving patient outcomes.",[28],[762],"Sentinel Node Technique","2025-12-12",{"date":765,"type":38},"2025-12-19",{"date":767,"type":38},"2025-11-10",{"date":769,"type":21},"2028-06",{"name":771,"class":144},"Instituto de Investigacion Sanitaria La Fe",{"id":773,"slug":774,"hasResults":12,"nctId":775,"briefTitle":776,"officialTitle":776,"acronym":777,"eligibilityCriteria":778,"healthyVolunteers":779,"sex":99,"minAge":18,"maxAge":4,"enrollmentInfo":780,"targetDuration":4,"studyType":22,"phases":782,"briefSummary":783,"conditions":784,"keywords":787,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":798,"lastUpdatePostDateStruct":799,"startDateStruct":800,"completionDateStruct":802,"leadSponsor":804,"locationsCount":249},"100563046","overcoming-immunosuppression-and-rebalancing-the-immune-response-in-ovarian-cancer-study-100563046","NCT06611072","OveRcoming immunosupprEssion aNd rebAlancing the Immune reSponSe in ovAriaN CancEr Study","RENAISSANCE","Inclusion Criteria:\n\n* Subjects should be at least 18 years old and mentally competent;\n* Newly diagnosed patients with OC who go for primary debulking surgery or patients with OC who are scheduled for interval debulking;\n* Controls: women who undergo surgery for benign gynaecological conditions under general anaesthesia.\n\nExclusion Criteria:\n\n* Mentally incompetent;\n* Pregnant or breastfeeding;\n* Known inflammatory of infectious diseases or an immunosuppressive status;\n* Using medication interfering with the immune system;\n* Severe comorbidities: other active malignancy (except for basal cell carcinoma and other in situ carcinomas);\n* Serious psychiatric pathology;\n* A self reported alcohol consumption of \\>21 units per week.",true,{"count":781,"type":21},90,[259],"Ovarian cancer (OC) is one of the most lethal cancers in the world due to late-stage disease at diagnosis. Standard therapy consists of debulking surgery and chemotherapy. However, despite this aggressive treatment, recurrent disease almost invariably occurs resulting in a five-year survival rate of approximately 30%.\n\nImmunotherapy could be a way to increase survival in OC patients. However, a major barrier to a successful deployment of cancer immunotherapy for ovarian cancer patients is the immunosuppressive tumor microenvironment.\n\nEnvisioned solution\u002Fresearch direction\n\nTumor-related inflammation is one of the hallmarks of cancers in general. Innate immunity specifically is a common denominator that is involved in the pathogenesis of OC. To improve the patient's outcome and identify novel therapeutic targets, one needs a deeper understanding of the tumor-induced changes in the bone marrow myeloid progenitor cells. Furthermore, treatment of these cells by nanoparticles or other agents that induce a program of 'trained immunity' may be a novel way to re- educate myeloid cells and their bone marrow progenitors in OC patients.\n\nHypothesis\n\nWe hypothesize that by exposing myeloid cells or their progenitors to various agents that induce trained immunity (e.g. trained immunity-inducing agents: BCG, heat-killed Candida,), these immune cells will undergo functional reprogramming to induce a tumor-suppressive phenotype. In the future, this could be explored as a novel immunotherapy for tumors that are refractory to conventional treatment.\n\nObjective\n\nTo characterize and phenotype the immune state of OC patients compared to controls without cancer with a focus on the hematopoietic organs and the immune cells originating from these organs. In addition, the effect of established trained immunity-inducing agents on these cells will be evaluated in vitro, potentially providing new therapies.\n\nThis will be executed by assessing the transcriptional, epigenetic, and functional reprogramming of circulating monocytes and myeloid progenitor cells in OC and by assessing the in vitro effect of trained immunity inducers on the reprogramming of circulating monocytes and myeloid progenitor cells.\n\nStudy design: investigator-initiated, multi-center explorative cross-sectional study at the Catharina hospital Eindhoven, Radboud University Medical Center and Eindhoven University of Technology.",[28,106,262,785,786],"Immune Suppression","Immune System Suppression",[189,788,789,790,456,791,792,793,794,795,796,797],"Immune system","Immune suppression","Immune system suppression","Monocytes","Myeloid cells","Vena punction","Bone marrow aspiration","Spleen biopsy","Peritoneal fluid","Tumor biopsy","2025-12-05",{"date":763,"type":38},{"date":801,"type":38},"2025-01-01",{"date":803,"type":21},"2027-12",{"name":805,"class":144},"Gynaecologisch Oncologisch Centrum Zuid",{"id":807,"slug":808,"hasResults":12,"nctId":809,"briefTitle":810,"officialTitle":811,"acronym":4,"eligibilityCriteria":812,"healthyVolunteers":12,"sex":99,"minAge":123,"maxAge":813,"enrollmentInfo":814,"targetDuration":4,"studyType":22,"phases":815,"briefSummary":816,"conditions":817,"keywords":818,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":823,"lastUpdatePostDateStruct":824,"startDateStruct":826,"completionDateStruct":828,"leadSponsor":830,"locationsCount":4},"100613961","phase-1-tolerance-safety-efficacy-and-pharmacokinetics-of-pressurized-intraperitoneal-aerosol-chemotherapy-pipac-using-paclitaxel-for-platinum-resistant-recurrent-ovarian-cancer-100613961","NCT07273396","Tolerance, Safety, Efficacy, and Pharmacokinetics of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Using Paclitaxel for Platinum-resistant Recurrent Ovarian Cancer","A Phase 1\u002F2a Study to Evaluate the Tolerance, Safety, Efficacy, and Pharmacokinetics of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Using Paclitaxel for Platinum-resistant Recurrent Ovarian Cancer With Peritoneal Metastasis (PIPAC-OVPAC 1\u002F2a)","Inclusion Criteria:\n\n1. Age: Women aged 19-85 years.\n2. Diagnosis: Histologically confirmed ovarian, fallopian tube, or peritoneal cancer.\n3. Platinum Status:\n\n   * Refractory: Disease progression during platinum-based chemotherapy.\n   * Resistant: Progression within 6 months (24 weeks) post-platinum therapy.\n4. Prior Therapies: ≥2 prior intravenous chemotherapies (may include paclitaxel).\n5. Treatment Options: Unresponsive to\u002Fineligible for standard therapies (e.g., intolerance, hypersensitivity) and ineligible for surgical resection.\n6. Measurable Disease: ≥1 measurable\u002Fevaluable peritoneal lesion per RECIST 1.1.\n7. Metastasis: ≤1 asymptomatic distant metastasis (excluding retroperitoneal lymph nodes, pleural effusion, localized skin metastases).\n8. Imaging Confirmation: Peritoneal carcinomatosis confirmed by PET-CT\u002FCT.\n9. Performance Status: ECOG 0-2.\n10. Pregnancy\u002FContraception:\n\n    * Non-pregnant\u002Fnon-lactating.\n    * Contraception: Effective methods (IUD, sterilization) for 6 months post-PIPAC (childbearing potential only).\n11. Organ Function:\n\n    * Bone Marrow: ANC \\>1,500\u002Fmm³, platelets \\>100,000\u002Fmm³, hemoglobin \\>8.0 g\u002FdL.\n    * Liver: Bilirubin ≤1.5×ULN, AST\u002FALT ≤1.5×ULN.\n    * Kidney: Creatinine ≤1.5×ULN, creatinine clearance \\>60 mL\u002Fmin.\n    * Lungs: FVC\u002FFEV1 ≥70% predicted.\n    * Coagulation: INR ≤1.5, aPTT ≤1.5×ULN.\n12. Consent: Signed informed consent.\n\nExclusion Criteria:\n\n1. ≥2 distant metastases (excluding retroperitoneal lymph nodes, pleural effusion, and localized skin metastases).\n2. Contraindications to paclitaxel per approved domestic labeling.\n3. Hypersensitivity history to paclitaxel or PIPAC devices.\n4. Uncontrolled comorbidities per investigator judgment:\n\n   * NYHA Class ≥II heart failure\n   * Clinically significant cardiovascular disease (e.g., arrhythmia, myocardial infarction)\n   * Immunosuppressive conditions (AIDS, autoimmune diseases, immunosuppressive therapy)\n   * Active HBV\u002FHCV infection\n   * Uncontrolled hypertension (systolic \\>160 mmHg or diastolic \\>100 mmHg)\n   * Uncontrolled diabetes (HbA1c \\>8%)\n   * Radiographic\u002Fclinical bowel obstruction.\n5. IV chemotherapy within 4 weeks prior to Cycle 1 PIPAC.\n6. Life expectancy \\\u003C3 months.\n7. Prior PIPAC therapy.\n8. Medically unfit for general anesthesia or laparoscopic surgery.\n9. Refusal of contraception:\n\n   \\- Medically acceptable methods:\n   * Intrauterine device (failure rate \\\u003C1%)\n   * Surgical sterilization (tubal ligation, hysterectomy, vasectomy; failure rate \\\u003C0.5%).\n10. Participation in another clinical trial within 1 month of screening.\n11. Other exclusionary factors per investigator discretion.","85 Years",{"count":5,"type":21},[24,25],"The purpose of this study is to evaluate the tolerance, safety, efficacy, and pharmacokinetics of pressurized intraperitoneal aerosol chemotherapy (PIPAC) with paclitaxel in patients with platinum-resistant recurrent ovarian cancer and peritoneal carcinomatosis.",[28,286],[819,820,821,822],"Pressurized intraperitoneal aerosol chemotherapy","platinum-resistant recurrent","ovarian cancer","paclitaxel","2025-11-27",{"date":825,"type":38},"2025-12-09",{"date":827,"type":21},"2026-01-01",{"date":829,"type":21},"2030-08-31",{"name":831,"class":144},"Seoul National University Hospital"]