[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"primary-peritoneal-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:primary-peritoneal-cancer":31},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,27,0,25,[9,45,72,93,117,165,196,218,243,269,301,350,370,402,430,477,504,525,549,577,590,615,646,673,755],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100054111","phase-1-catalina-4-a-study-to-investigate-the-safety-and-efficacy-of-torl-1-23-with-chemotherapy-given-before-initial-surgery-in-women-with-advanced-stage-ovarian-cancer-100054111",false,"NCT07322094","CATALINA-4: A Study to Investigate the Safety and Efficacy of TORL-1-23 With Chemotherapy Given Before Initial Surgery in Women With Advanced Stage Ovarian Cancer","CATALINA-4: Phase 1B\u002F2 Study of TORL-1-23 With Neoadjuvant Chemotherapy and Interval Cytoreductive Surgery in Newly Diagnosed Patients With Advanced Stage Ovarian Cancer","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1\n* Histologically or cytologically confirmed diagnosis of epithelial ovarian, primary peritoneal or fallopian tubes cancer\n* FIGO Stage III or IV\n* Positive for claudin 6 (CLDN6) expression\n* Adequate organ function\n\nExclusion Criteria:\n\n* Clear cell, mucinous, sarcomatous, mixed histology, low-grade\u002Fborderline, or non-epithelial ovarian cancers\n* Prior systemic treatment for the disease under study\n* Prior surgery\n* Prior radiation therapy to the abdomen or pelvis\n* Current recipient or receipt within 5-half-lives of C1D1 of any of the following: chemotherapy, biologic\u002Ftargeted therapy, herbal medications or supplements, immunomodulator therapy for any disease indication.\n* History of noninfectious pneumonitis\u002Finterstitial lung disease (ILD) within 6 months of first dose of study drug.\n* Active, progressive, or symptomatic brain metastases\n* Participants considered poor medical risks due to serious, uncontrolled medical conditions, active infections, or nonmalignant systemic diseases\n* Pregnant or breastfeeding women","FEMALE","18 Years","75 Years",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","A Phase 1B\u002F2 Study to Investigate the Safety and Efficacy of TORL-1-23 with Chemotherapy Given Before Initial Surgery in Women with Advanced Stage Ovarian Cancer",[29,30,31],"FIGO Stage III and IV Ovarian Cancer","Fallopian Tube Cancers","Primary Peritoneal Cancer","RECRUITING","2026-07-09",{"date":35,"type":36},"2026-07-13","ACTUAL",{"date":38,"type":36},"2025-12-10",{"date":40,"type":22},"2028-01",{"name":42,"class":43},"TORL Biotherapeutics, LLC","INDUSTRY",7,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":52,"minAge":18,"maxAge":19,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100634882","phase-3-a-study-comparing-bl-m07d1-with-physicians-choice-of-chemotherapy-in-patients-with-her2-expressing-platinum-resistant-recurrent-epithelial-ovarian-cancer-fallopian-tube-cancer-and-primary-peritoneal-cancer-100634882","NCT07545460","A Study Comparing BL-M07D1 With Physician's Choice of Chemotherapy in Patients With HER2-Expressing Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer","A Phase III Randomized Controlled Clinical Study Comparing BL-M07D1 With Physician's Choice of Chemotherapy in Patients With HER2-Expressing Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. Be ≥18 years and ≤75 years old on the day of signing the informed consent form;\n3. Have an expected survival time of ≥3 months;\n4. Have histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer;\n5. Have previously received a platinum-based regimen and have been confirmed to have platinum-resistant recurrence;\n6. Have received a total of ≥1 and ≤3 prior lines of therapy;\n7. If previously confirmed to be folate receptor alpha (FRα)-positive, must have received treatment with mirvetuximab soravtansine;\n8. Agree to provide archived tumor tissue specimens (from primary or metastatic lesions) collected within 3 years, or fresh tissue samples;\n9. Have at least one measurable lesion as defined by RECIST v1.1;\n10. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n11. Have recovered from toxicities of prior anti-tumor therapy to ≤ Grade 1 as defined by NCI-CTCAE v5.0;\n12. Have no severe cardiac dysfunction, with a left ventricular ejection fraction (LVEF) ≥50%;\n13. Meet the required organ function levels;\n14. For premenopausal women of childbearing potential, a serum pregnancy test must be performed within 7 days before starting treatment, with a negative result, and must not be breastfeeding; all enrolled patients must use adequate barrier contraception throughout the entire treatment period and for 6 months after treatment completion.\n\nExclusion Criteria:\n\n1. Received surgical treatment, radical radiotherapy, immunotherapy, etc. within 4 weeks before the first dose;\n2. Previously received ADC therapy with a topoisomerase I inhibitor as the payload, or HER2-ADC therapy;\n3. History of severe cardiovascular or cerebrovascular disease within six months before screening;\n4. Concurrent pulmonary disease resulting in severely impaired lung function;\n5. Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;\n6. Diagnosed with active malignancy within 3 years before study randomization;\n7. Unstable thrombotic event requiring therapeutic intervention within 6 months before screening;\n8. Hypertension inadequately controlled by two antihypertensive medications;\n9. Patients with poorly controlled blood glucose levels;\n10. History of ILD treated with steroids, or current ILD, or Grade ≥2 radiation pneumonitis, etc.;\n11. Patients with active central nervous system (CNS) metastases;\n12. Patients with a history of allergy to recombinant humanized antibodies or to any excipient of BL-M07D1;\n13. Prior receipt of organ transplantation or allogeneic hematopoietic stem cell transplantation;\n14. Positive for human immunodeficiency virus antibody, active hepatitis B virus infection, or hepatitis C virus infection;\n15. Experienced severe infection within 4 weeks before the first dose of study drug;\n16. Presence of large serosal cavity effusions, or symptomatic serosal cavity effusions, etc.;\n17. Receiving long-term systemic corticosteroid therapy (e.g., \\>10 mg\u002Fday prednisone) prior to randomization;\n18. History of severe neurological or psychiatric disorders;\n19. Experienced serious non-healing wound, ulcer, or bone fracture within 4 weeks prior to signing informed consent;\n20. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing informed consent;\n21. Intestinal obstruction, Crohn's disease, ulcerative colitis, or chronic diarrhea, etc.;\n22. Received other unapproved clinical study drugs or treatments within 4 weeks before study randomization;\n23. Subjects who plan to receive or have received a live vaccine within 28 days before the first dose;\n24. Presence of other serious physical conditions, abnormal laboratory findings, or poor compliance that may increase the risk of study participation, interfere with study results, or render the patient unsuitable for this study in the investigator's opinion.","ALL",{"count":54,"type":22},404,[56],"PHASE3","This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with HER2-expressing platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.",[59,60,31],"Epithelial Ovarian Cancer","Fallopian Tube Cancer","NOT_YET_RECRUITING","2026-06-26",{"date":64,"type":36},"2026-06-29",{"date":66,"type":22},"2026-07",{"date":68,"type":22},"2028-12",{"name":70,"class":43},"Sichuan Baili Pharmaceutical Co., Ltd.",2,{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":23,"phases":81,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":85,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":92},"100579451","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-sacituzumab-tirumotecan-mk-2870-maintenance-treatment-versus-standard-of-care-in-participants-with-platinum-sensitive-recurrent-ovarian-cancer-mk-2870-022trofuse-022engot-ov84gog-3103-100579451","NCT06824467","A Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Maintenance Treatment Versus Standard of Care in Participants With Platinum-sensitive Recurrent Ovarian Cancer (MK-2870-022\u002FTroFuse-022\u002FENGOT-ov84\u002FGOG-3103)","A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan Maintenance Treatment With or Without Bevacizumab Versus Standard of Care After Second-line Platinum-based Doublet Chemotherapy in Participants With Platinum-sensitive Recurrent Ovarian Cancer (TroFuse-022\u002FENGOT-ov84\u002FGOG-3103)","Inclusion Criteria:\n\n* Has histologically confirmed Federation of Gynecology and Obstetrics (FIGO) Stage III or IV epithelial ovarian, primary peritoneal, or fallopian tube carcinoma of certain histologies\n* Has received 4 or more cycles of platinum-based doublet chemotherapy in first-line and a total of 6 cycles of carboplatin-based doublet chemotherapy in second-line setting for ovarian cancer (OC)\n* Has platinum-sensitive epithelial OC\n* Has provided tissue of a tumor lesion that was not previously irradiated\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy\n* Participants who are hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation (Part 1) or randomization (Part 2)\n* Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n* Has an ECOG performance status of 0 or 1 assessed within 7 days before allocation (Part 1) or randomization (Part 2)\n\nExclusion Criteria:\n\n* Has nonepithelial cancers (germ cell tumors and sex cord-stromal tumors), low-grade serous tumors, low-grade endometrioid tumors, borderline tumors (low malignant potential), mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor and undifferentiated carcinoma\n* Has platinum-resistant OC or platinum-refractory OC\n* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or severe corneal disease that prevents\u002Fdelays corneal healing\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis, or chronic diarrhea)\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease\n* Has a history of (noninfectious) pneumonitis\u002Finterstitial lung disease (ILD) that required steroids or has current pneumonitis\u002FILD\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has received more than 2 prior lines of systemic therapy for OC\n* Has received prior systemic anticancer therapy within 3 weeks or 5 half-lives (whichever is shorter) before allocation (Part 1) or randomization (Part 2)\n* Has received prior radiotherapy within 2 weeks of allocation (Part 1) or randomization (Part 2), or has radiation related toxicities, requiring corticosteroids\n* Has an additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has active central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n* Has an active infection requiring systemic therapy\n* Has active or ongoing stomatitis",{"count":80,"type":22},770,[56],"The main goals of this study are to learn about the safety of sacituzumab tirumotecan with bevacizumab and if people tolerate it; and if people who take sacituzumab tirumotecan with or without bevacizumab live longer without the cancer getting worse than those who receive standard of care treatment.",[84,60,31],"Ovarian Cancer",{"date":64,"type":36},{"date":87,"type":36},"2025-04-09",{"date":89,"type":22},"2032-11-09",{"name":91,"class":43},"Merck Sharp & Dohme LLC",178,{"id":94,"slug":95,"hasResults":12,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":23,"phases":102,"briefSummary":103,"conditions":104,"keywords":105,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":116},"100576616","phase-2-investigation-of-ubamatamab-combination-therapy-in-adult-participants-with-platinum-resistant-ovarian-cancer-100576616","NCT06787612","Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer","Multi-Arm Phase 2 Platform Study of Ubamatamab (REGN4018; MUC16×CD3 Bispecific Antibody) With or Without Additional Agents in Platinum-Resistant Ovarian Cancer","Key Inclusion Criteria:\n\n1. Participants with histologically or cytologically confirmed diagnosis of advanced serous or endometrioid ovarian (regardless of the grade), primary peritoneal, or fallopian tube cancer (clear cell, mucinous, and carcinosarcoma are excluded)\n2. Must have progression on prior therapy documented radiographically and must have at least 1 measurable lesion (not previously irradiated) that can be accurately measured by RECIST 1.1\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n4. Adequate organ and bone marrow function, as described in the protocol\n5. Platinum-Resistant Ovarian Cancer, as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study intervention(s)\n2. Documented allergic or acute hypersensitivity reaction attributed to antibody treatments or doxorubicin hydrochloride or components of study intervention(s)\n3. Another malignancy that is progressing or requires active treatment, as described in the protocol\n4. Untreated or active Central Nervous System (CNS) metastases, or carcinomatous meningitis, as described in the protocol\n5. Uncontrolled infections including but not limited to human immunodeficiency virus, hepatitis B or hepatitis C infection, or diagnosis of immunodeficiency\n6. Moderate to large or ascites, as described in the protocol\n7. Bowel obstruction within last 3 months or current need for parenteral nutrition\n\nNOTE: Other protocol-defined inclusion\u002Fexclusion criteria apply",{"count":101,"type":22},220,[26],"This study is researching an experimental drug called ubamatamab, also referred to as \"study drug\". The study is focused on patients who have advanced ovarian cancer.\n\nThe aim of the study is to see how safe, tolerable, and effective the study drug is on its own and in combination with other anti-cancer drugs (bevacizumab, cemiplimab, fianlimab and a standard chemotherapy drug, pegylated liposomal doxorubicin \\[PLD\\]), referred to as \"combination drugs'.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug and its experimental combinations\n* How much study drug and fianlimab is in the blood at different times\n* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) and its combinations",[84,60,31],[106],"Platinum Resistance","2026-06-22",{"date":109,"type":36},"2026-06-23",{"date":111,"type":36},"2025-05-28",{"date":113,"type":22},"2028-10-30",{"name":115,"class":43},"Regeneron Pharmaceuticals",53,{"id":118,"slug":119,"hasResults":12,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":125,"targetDuration":127,"studyType":128,"phases":4,"briefSummary":129,"conditions":130,"keywords":138,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":164},"100644252","reirradiation-and-total-ablative-strategies-for-recurrent-gynecologic-cancer-100644252","NCT07667192","Reirradiation and Total Ablative Strategies for Recurrent Gynecologic Cancer","REGYNERA(Dia)TION: An Ambispective International Multicenter Patient Registry of Reirradiation and Total Ablative Strategies for Recurrent Gynecologic Malignancies","Regynera-RT","Inclusion Criteria:\n\n* \\- Age 18 years or older at the time of reirradiation or prospective enrollment.\n* Histologically confirmed gynecologic malignancy, including uterine, cervical, vaginal, vulvar, ovarian, fallopian tube, primary peritoneal, or rare gynecologic primary.\n* Documented prior radiotherapy delivered as part of previous treatment.\n* Recurrent or progressive disease for which reirradiation and\u002For total ablative strategy has been delivered, is ongoing, or is planned according to local multidisciplinary decision-making.\n* Recurrence or progression documented by imaging, clinical examination, pathology, and\u002For multidisciplinary tumor board assessment according to institutional practice.\n* Availability of minimum essential data, including prior radiotherapy information, date of reirradiation or planned reirradiation, disease extent at reirradiation, and at least one follow-up, outcome, or survival-status record for retrospective patients.\n* For prospective patients, written informed consent where required by local regulations and ethics approval.\n\nExclusion Criteria:\n\n* No evidence of prior radiotherapy.\n* No reirradiation or clinically meaningful local ablative radiotherapy component delivered or planned.\n* Insufficient minimum data preventing assignment of reirradiation date, disease extent, or survival\u002Ffollow-up status.\n* Exclusively polymetastatic disease with more than 5 active non-regional lesions treated without a meaningful local reirradiation or total ablative component, unless included in an exploratory non-core substudy approved by the steering committee.\n* Prospective refusal of consent when consent is required by local law or ethics approval.",{"count":126,"type":22},500,"5 Years","OBSERVATIONAL","REGYNERA(dia)TION is an international, multicenter, ambispective observational patient registry of adults with recurrent gynecologic malignancies after prior radiotherapy who are treated or planned for reirradiation and\u002For total ablative strategies as part of routine clinical care. The registry does not assign treatment. Radiotherapy technique, dose, systemic therapy, surgery, metastasis-directed therapy, imaging, and follow-up are selected by the treating multidisciplinary team according to local standards and patient-specific factors. The registry will collect harmonized retrospective and prospective data on disease characteristics, prior radiotherapy, recurrence pattern, reirradiation or ablative treatment exposure, response, progression, survival, severe treatment-related morbidity, fistula events, and patient-reported outcomes where available.",[131,132,133,134,135,136,137,31],"Recurrent Gynecologic Cancer","Recurrent Uterine Cancer","Recurrent Cervical Cancer","Recurrent Vaginal Cancer","Recurrent Vulvar Cancer","Recurrent Ovarian Cancer","Recurrent Fallopian Tube Cancer",[139,140,141,142,143,144,145,146,147,148,149,150,151,152,153],"Reirradiation","Radiotherapy","Brachytherapy","External Beam Radiotherapy","Stereotactic Body Radiotherapy","Proton Therapy","Intraoperative Radiotherapy","Total Ablative Strategy","Oligometastatic Recurrence","Metastasis-Directed Therapy","Patient Registry","Radiographic Progression-Free Survival","Treatment-Related Adverse Events","Fistula","Overall survival","2026-06-20",{"date":156,"type":36},"2026-06-24",{"date":158,"type":36},"2026-06-11",{"date":160,"type":22},"2036-12",{"name":162,"class":163},"Affidea Nu-med Center of Oncological DIagnostics and Therapy","OTHER",1,{"id":166,"slug":167,"hasResults":12,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":23,"phases":174,"briefSummary":175,"conditions":176,"keywords":178,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":195},"100584515","phase-2-a-study-to-assess-anti-tumor-activity-of-intravenously-iv-infused-carboplatin-with-mirvetuximab-soravtansine-in-participants-with-newly-diagnosed-folate-receptor-alpha-frexpressing-advanced-stage-serous-epithelial-ovarian-fallopian-tube-or-primary-peritoneal-cancer-100584515","NCT06890338","A Study to Assess Anti-Tumor Activity of Intravenously (IV) Infused Carboplatin With Mirvetuximab Soravtansine in Participants With Newly Diagnosed Folate Receptor Alpha (FRα)Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer.","A Single-Arm, Phase 2 Study of Neoadjuvant Carboplatin and Mirvetuximab Soravtansine in Subjects With FRα-Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.\n* Be judged by the investigator and\u002For treating physician to be an appropriate candidate to receive neoadjuvant chemotherapy.\n* Diagnosis of biopsy-confirmed high-grade, serous epithelial ovarian, fallopian tube or primary peritoneal cancer.\n* Participant meets the following disease criteria:\n\n  * Stage III or IV disease by the Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) staging system, and\n  * Folate Receptor Alpha (FRα) expression positivity as defined by immunohistochemical staining of \\>= 75% of viable tumor cells with moderate \\>= 2+ membrane staining by the Ventana Folate Receptor Alpha (VENTANA FOLR1) assay, FOLR1 Eligibility Testing - Ventana FOLR1 (FOLR1-2.1) RxDx - Commercial or Central, and\n  * Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria.\n\nExclusion Criteria:\n\n* Endometrioid, clear cell, mucinous, or sarcomatous tumor histology; mixed tumors containing any of the above histologies; or low-grade\u002Fborderline ovarian tumor.\n* Previous clinical diagnosis of noninfectious interstitial lung disease, including noninfectious pneumonitis.\n* Previously treated with anticancer therapy including chemotherapy, radiation therapy, immunotherapy, or biologic agent for current cancer, with the exception of one cycle of single agent carboplatin\n* Participants with the following ocular history and\u002For concurrent disorders:\n\n  * History of corneal transplantation;\n  * Undergoing active postoperative management for refractive surgery, cataract surgery, corneal cross-linking, or corneal complications of surgery;\n  * Confluent superficial punctate keratopathy (SPK) not expected to resolve to non-confluence or better within the screening window with standard of care (SOC) intervention;\n  * Active or chronic clinically significant (\\>= Grade 3) corneal dystrophy (e.g., Fuchs dystrophy);\n  * Active ocular conditions requiring ongoing treatment\u002Fmonitoring, such as glaucoma, which is not adequately controlled with medication or surgery, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema or an ocular condition with high risk of retinal detachment;\n  * Monocular vision with visual acuity in the worse eye, worse than 20\u002F200 or visual fields less than 20 degrees (i.e., functional blindness in at least one eye).\n* History of other malignancy within 3 years prior to signing study consent. -- Note: Participants with tumors with a negligible risk for metastasis or death (e.g., adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast) are eligible.",{"count":173,"type":22},140,[26],"Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess the safety and efficacy of neoadjuvant carboplatin and mirvetuximab soravtansine in participants with folate receptor alpha (FRα) -expressing advanced-stage serous epithelial ovarian, fallopian tube or primary peritoneal cancer (EOC).\n\nMirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to cancer cells carrying a protein called folate receptor alpha (FRα). This is a single arm study in adult participants with advanced-stage Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) III-IV FRα-expressing serous EOC. Around 140 participants will be enrolled in the study at approximately 80 sites in the United States.\n\nParticipants will receive intravenous infusion of MIRV in combination with carboplatin on day 1 of each cycle, every 21 days for up to 6 - 9 Cycles. The total study duration will be approximately 3 years .\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.",[59,60,31,177],"Neoadjuvant",[59,60,31,177,179,180,181,182,183,184,185],"Interval Debulking Surgery","Mirvetuximab Soravtansine","MIRV","IMGN853","ELAHERE(R)","Carboplatin","Bevacizumab","2026-06-15",{"date":188,"type":36},"2026-06-16",{"date":190,"type":36},"2025-11-21",{"date":192,"type":22},"2030-02",{"name":194,"class":43},"AbbVie",66,{"id":197,"slug":198,"hasResults":12,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":23,"phases":205,"briefSummary":206,"conditions":207,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":71},"100581914","phase-1-cirtuvivintolaparib-in-breast-cancer-susceptibility-genehomologous-recombination-deficiency-platinum-resistant-ovarian-cancer-100581914","NCT06856499","Cirtuvivint\u002FOlaparib in Breast Cancer Susceptibility Gene\u002FHomologous Recombination Deficiency Platinum Resistant Ovarian Cancer","Phase I Evaluation of Combination CLK\u002FDYRK (Cirtuvivint) Inhibition With PARP Inhibition (Olaparib) in BRCA\u002FHRD Platinum Resistant Ovarian Cancer","Inclusion Criteria:\n\n1. Provision to sign and date the consent form.\n2. Stated willingness to comply with all study procedures and be available for the duration of the study.\n3. Woman aged ≥18 years of age\n4. Patients must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 1 or 2\n5. Patients must have a confirmed diagnosis of high-grade serous or endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer\n6. Patients must have platinum-resistant disease defined as radiographic progression less than 6 months from last dose of most recent platinum therapy\n7. Patients must have measurable disease by defined RECIST 1.1 criteria\n8. Prior anticancer therapy:\n\n   * Patients must have received at least one prior platinum-based chemotherapy regimen\n   * Patients may not have received more than 3 prior lines of systemic therapy\n   * Neoadjuvant +\u002F- adjuvant therapies are considered 1 line of therapy\n   * Maintenance therapy (eg, Bevacizumab, PARP inhibitors) will be considered part of preceding line of therapy (ie, not counted independently)\n   * Therapy changed due to toxicity in the absence of progression will be considered part of the same line (ie, not counted independently)\n   * Hormonal therapy will be counted as a separate line of therapy unless it was given as maintenance\n   * Prior radiation is allowed and is not considered a line of treatment\n9. Patients must have had testing for BRCA mutation (tumor or germline) and tumor HRD testing, and have been positive for one and\u002For the other.\n10. Patients must have received a prior PARP inhibitor as either treatment or maintenance therapy\n11. Patients must have adequate hematologic, liver, and kidney function as defined as:\n\n    * Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL (1500\u002FµL)\n    * Platelet count ≥ 100 x 109\u002FL (100,000 µL)\n    * Hemoglobin ≥ 10.0 g\u002FdL with no blood transfusion in the past 28 days\n    * Serum creatinine ≤ 1.5 x upper limit of normal (ULN)\n    * Patients must have creatinine clearance estimated of ≥51 mL\u002Fmin using the Cockcroft-Gault equation or based on a 24 hour urine test\n    * Aspartate aminotransferase (AST)(Serum Glutamic Oxaloacetic Transaminase (SGOT)) and alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤ 2.5 x ULN unless liver metastases are present in which case they must be ≤ 5x ULN\n    * Serum bilirubin ≤ 1.5 x ULN (patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin \\\u003C 3.0 x ULN)\n    * Serum albumin ≥ 2 g\u002FdL\n12. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n13. Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity (IDMC) who have a legally-authorized representative (LAR) and\u002For family member available will also be eligible.\n\nExclusion Criteria:\n\n1. Patients with clear cell, mucinous, sarcomatous, low grade\u002Fborderline, germ cell, or sex-cord stromal type ovarian tumor\n2. Patients with platinum refractory disease as defined by those who have progressed during or within 4 weeks of receiving platinum-based therapy\n3. Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment\n4. Patients with myelodysplastic syndrome\u002Facute myeloid leukemia or with features suggestive of myelodysplastic syndrome\u002Facute myeloid leukemia.\n5. Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to:\n\n   * Uncontrolled major seizure disorder\n   * Unstable spinal cord compression\n   * Any psychiatric disorder that prohibits obtaining informed consent.\n   * Any other concurrent infectious disease requiring IV antibiotics within 2 weeks prior to the first dose of therapy\n6. Patients with clinically significant cardiac disease including, but not limited to, any of the following\n\n   * Myocardial infarction ≤ 6 months prior to first dose\n   * Uncontrolled ventricular arrhythmia, recent (within 3 months)\n   * Superior vena cava syndrome\n   * Unstable angina pectoris\n   * Uncontrolled congestive heart failure (New York Heart Association \\> class II)\n   * Uncontrolled ≥ Grade 3 hypertension (per CTCAE)\n   * Uncontrolled cardiac arrhythmias\n7. Patients with a history of hemorrhagic or ischemic stroke within 6 months prior to enrollment\n8. Patients with a history of cirrhotic liver disease (Child-Pugh Class B or C)\n9. Persistent toxicities (\\>\u002F= Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia or peripheral sensory neuropathy\n10. Patients with duodenal stent or other GI disorder\u002Fdefect that would interfere with absorption of oral medication\n\n    o Includes patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication\n11. Patients with known untreated or symptomatic central nervous system (CNS) metastases\n12. Prior known hypersensitivity reaction to study drugs and\u002For any of their excipients\n13. Minor or major surgical procedure within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.\n14. Inability to comply with study and follow-up procedures\n15. Patients deemed otherwise clinically unfit for clinical trial per investigators discretion.",{"count":204,"type":22},50,[25],"The purpose of this study is to learn about the safety and tolerability of Cirtuvivint in combination with Olaparib in platinum resistant ovarian cancer. The study also aims to determine the recommended dose of the combination therapy.\n\nIf a participant is a good fit for the study, and they enroll in the study, they will:\n\n* Visit the clinic often at the beginning of the study for physical exams, blood draws, vital signs, and other study and routine care procedures. After the first two months participants will visit the clinic every 28 days.\n* Take the study medications, Cirtuvivint and Olaparib. Participants will take Olaparib every day. Participants will either take Cirtuvivint 5 days per week or 2 days per week.",[208,31,60],"Endometrioid Ovarian Cancer","2026-06-02",{"date":211,"type":36},"2026-06-04",{"date":213,"type":36},"2025-12-08",{"date":215,"type":22},"2029-07",{"name":217,"class":163},"University of Colorado, Denver",{"id":219,"slug":220,"hasResults":12,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":224,"eligibilityCriteria":225,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":226,"targetDuration":4,"studyType":23,"phases":228,"briefSummary":229,"conditions":230,"keywords":231,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":242},"100496112","phase-1-phase-ii-imnn-001-also-known-as-gen-1-on-sll-with-bev-and-nact-newly-diagnosed-advanced-ovarian-fallopian-tube-or-primary-peritoneal-cancer-100496112","NCT05739981","Phase II IMNN-001 (Also Known as GEN-1) on SLL With BEV and NACT, Newly Diagnosed Advanced Ovarian, Fallopian Tube or Primary Peritoneal Cancer","Phase II Study Evaluating the Effect of IMNN-001 on Second Look Laparoscopy (SLL) in Combination With Bevacizumab (BEV) and Neoadjuvant Chemotherapy (NACT) in Newly Diagnosed With Advanced Ovarian, Fallopian Tube or Primary Peritoneal Cancer","MRD","Inclusion Criteria:\n\n1. Subjects with ovarian, fallopian tube, or primary peritoneal carcinoma with high grade serous adenocarcinoma histology are eligible. Poorly differentiated carcinomas consistent with high grade serous histology are eligible. Pathologic diagnosis may be via frozen section or permanent pathology from diagnostic laparoscopy during the screening phase or via pre-enrollment core biopsy (but not cytology).\n2. Subjects must have an International Federation of Gynecology and Obstetrics (FIGO) stage of III or IV who based on standard of care clinical considerations have been recommended to undergo neoadjuvant therapy per standard clinical determination by their oncology provider.\n3. Subjects must have adequate: bone marrow function, renal function, hepatic function, and neurologic function.\n4. Subjects should be free of active infection requiring isolation, parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry. Subjects with diagnosis of COVID-19 infection must be 14 days after positive test or onset of symptoms.\n5. Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to the first treatment. Continuation of hormone replacement therapy is permitted.\n6. Subjects must have a performance status score of 0-1 by Eastern Cooperative Group (ECOG) criteria.\n7. Subjects of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of protocol therapy and agree to practice an effective form of contraception. If applicable, subjects must discontinue breastfeeding prior to study entry.\n8. Subjects must have signed an IRB-approved informed consent.\n9. Subjects must be at least 18 years old.\n\nExclusion Criteria:\n\n1. Subjects who have received prior treatment with IMNN-001.\n2. Subjects who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to IMNN-001 or other drugs used in this study.\n3. Subjects who have received oral or parenteral corticosteroids within 2 weeks of first dose of IMNN-001 (if applicable) or who have a clinical requirement for ongoing systemic immunosuppressive therapy such as chronic steroid (prednisone equivalent of \\> 10 mg\u002Fday) use not related to chemotherapy administration. Steroid prophylaxis for IV contrast allergy is allowed.\n4. Subjects with autoimmune disease requiring immunosuppressive therapy within the last 2 years. Examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.\n5. Subjects with known human immunodeficiency virus (HIV) or human T-lymphotropic virus (HTLV) infections are excluded.\n6. Subjects with other invasive malignancies are excluded if there is any evidence of the invasive malignancy being present within the last three years. Subjects are also excluded if their previous cancer treatment contraindicates this protocol therapy. Subjects with non-invasive malignancies such as non-melanoma skin cancer, melanoma in-situ, etc. are eligible.\n7. Subjects who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, if it was completed more than three years prior to registration, and the subject remains free of recurrent or metastatic disease.\n8. Subjects who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Subjects may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the subject remains free of recurrent or metastatic disease.\n9. Subjects with known active hepatitis.\n10. Subjects with nephrotic syndrome (proteinuria Grade 2 or greater).\n11. Subjects with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the subject to extreme risk or decreased life expectancy.\n12. Subjects with clinically significant cardiovascular disease.\n13. Subjects of childbearing potential, not practicing adequate contraception, subjects who are pregnant, or subjects who are breastfeeding are not eligible for this trial.\n14. Subjects with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study.\n15. Subjects with a history of diverticulitis within the past 6 months. Diverticulosis is not exclusionary.\n16. Subjects having hemoptysis within the last month.\n17. Subjects with any condition\u002Fanomaly that would interfere with the appropriate placement of the IP catheter for study drug administration including abdominal surgery within 4 weeks of study entry (for reasons other than IP port placement), intestinal dysfunction, fistulas, or suspected extensive adhesions from prior history or finding at laparoscopy.",{"count":227,"type":22},30,[25,26],"This is a 1:1 randomized, open label, multi-center phase I\u002FII trial to evaluate the safety, dosing, efficacy, and biological activity of adding IMNN-001 to chemotherapy + BEV compared to chemotherapy + BEV alone.",[84,60,31],[232,233],"IMNN-001","GEN-1","2026-06-01",{"date":209,"type":36},{"date":237,"type":36},"2023-02-10",{"date":239,"type":22},"2028-08-30",{"name":241,"class":43},"Imunon",4,{"id":244,"slug":245,"hasResults":12,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":4,"eligibilityCriteria":249,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":23,"phases":252,"briefSummary":253,"conditions":254,"keywords":256,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":265,"leadSponsor":267,"locationsCount":268},"100568573","phase-2-a-study-to-assess-adverse-events-and-change-in-disease-activity-in-participants-with-platinum-resistant-advanced-high-grade-epithelial-ovarian-primary-peritoneal-or-fallopian-tube-cancers-with-high-folate-receptor-alpha-expression-treated-with-intravenously-iv-infused-mirvetuximab-soravtansine-100568573","NCT06682988","A Study to Assess Adverse Events and Change in Disease Activity in Participants With Platinum-Resistant Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression Treated With Intravenously (IV) Infused Mirvetuximab Soravtansine","A Randomized Phase 2, Open-label Study of Mirvetuximab Soravtansine in Patients With Platinum-resistant Advanced High-grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-alpha Expression Testing 2 Schedules of Administration for Dose Optimization, With a Separate Cohort to Determine Starting Dose in Patients With Moderate Hepatic Impairment","Inclusion Criteria:\n\nBoth Cohorts\n\n* Participants with a confirmed diagnosis of high-grade serous epithelial ovarian cancer (EOC), primary peritoneal cancer, or fallopian tube cancer.\n* Participants with platinum-resistant disease:\n\n  * Participants with 1 prior line of platinum-based therapy who have received ≥ 4 cycles of platinum and had a response (complete response (CR) or partial response (PR)) followed by radiological progressive disease (PD) between \\> 3 months and ≤ 6 months after the date of the last dose of platinum.\n  * Participants with 2 or 3 prior lines of platinum-based therapy who had radiological PD ≤ 6 months after the date of the last dose of platinum.\n* Participants with progression diagnosed radiographically on or after their most recent line of therapy.\n* Participants with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.\n* Participants with ≥ 1 lesion that meets the definition of measurable disease by RECIST v1.1 (radiologically measured by the investigator).\n* Participants with a tumor that is positive for folate receptor alpha (FRα) expression as determined by the Ventana folate receptor 1 (FOLR1) assay (≥ 75% of tumor staining at 2+ intensity).\n\nExclusion Criteria:\n\nBoth Cohorts\n\n* Participants with endometrioid, clear cell, mucinous, or sarcomatous histology; mixed tumors containing any of the above histologies; or low-grade or borderline ovarian tumor.\n* Participants with primary platinum-refractory disease, defined as disease that did not respond (complete response (CR) or partial response (PR)) or that progressed radiographically within 3 months of the last dose of first-line platinum-containing chemotherapy.\n* Participants with serious concurrent illness or clinically relevant active infection as outlined in the protocol\n* Participants with a history of hemorrhagic or ischemic stroke within 6 months prior to randomization.",{"count":251,"type":22},110,[26],"Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess the safety and efficacy of for Mirvetuximab Soravtansine in participants with platinum-resistant advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer (platinum-resistant ovarian cancer) (PROC) whose tumors express a high level of folate receptor alpha (FRα).\n\nMirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to cancer cells carrying a protein called folate receptor alpha (FRα). There are 2 cohorts in this study, the Randomized Phase 2 Cohort and the Hepatic Impairment Cohort. In the Randomized Phase 2 Cohort, participants are placed in 1 of 2 groups, called treatment arms. Each treatment arm receives MIRV on a different schedule (on day 1 every 21 days or on days 1 and 15 every 28 days). The Hepatic Impairment Cohort is designed to determine the starting dose of MIRV in patients with moderately abnormal liver function. Around 110 participants will be enrolled in the study at approximately 75 sites worldwide.\n\nThe total study duration will be approximately 24 months.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.",[255,31,30],"Advanced High-Grade Epithelial Ovarian Cancer",[257,258,30,259,260,180,181,182],"Advanced High-Grade Epithelial Ovarian","Primary Peritoneal","High Folate Receptor-Alpha Expression","Platinum Resistant","2026-05-21",{"date":263,"type":36},"2026-05-26",{"date":111,"type":36},{"date":266,"type":22},"2028-04",{"name":194,"class":43},52,{"id":270,"slug":271,"hasResults":12,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":4,"eligibilityCriteria":275,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":276,"targetDuration":4,"studyType":23,"phases":277,"briefSummary":278,"conditions":279,"keywords":281,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":4},"100638290","phase-2-liposomal-irinotecan-plus-enlonstobart-for-platinum-resistant-recurrent-ovarian-cancer-100638290","NCT07591831","Liposomal Irinotecan Plus Enlonstobart for Platinum-Resistant Recurrent Ovarian Cancer","An Exploratory Clinical Study of Liposomal Irinotecan Combined With Enlonstobart in Patients With Platinum-Resistant Recurrent Ovarian Cancer","Inclusion Criteria:\n\n1. Female participants aged 18 to 75 years, inclusive, at the time of signing informed consent.\n2. Histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, FIGO stage II-IV.\n3. Platinum-resistant recurrent disease, defined as disease progression within 6 months after the last platinum-containing chemotherapy, and not platinum-refractory disease, defined as disease progression within 4 weeks after initial platinum-containing chemotherapy. Participants may have received up to two prior lines of non-platinum systemic therapy. Treatment with a PARP inhibitor or anti-angiogenic therapy after platinum-resistant recurrence will be counted as one line of therapy; maintenance treatment with a PARP inhibitor or anti-angiogenic therapy will not be counted as a treatment line.\n4. Ability to provide sufficient qualified formalin-fixed paraffin-embedded tumor tissue samples or slides for PD-L1 testing. Participants who are unable to provide tumor tissue slides for certain reasons may be enrolled at the investigator's discretion.\n5. At least one measurable lesion at baseline according to RECIST version 1.1. The measurable lesion must not have received prior local therapy such as radiotherapy. A lesion located within a previously irradiated area may be selected as a target lesion if disease progression has been confirmed.\n6. ECOG performance status of 0 or 1.\n7. Expected survival of at least 3 months.\n8. Adequate organ function, meeting all of the following criteria without blood transfusion, hematopoietic stimulating factors, or medication correction of blood cell counts within 14 days before the first dose:\n\n   1. Absolute neutrophil count ≥1.5 × 10\\^9\u002FL;\n   2. Platelet count ≥75 × 10\\^9\u002FL;\n   3. Hemoglobin ≥9 g\u002FdL;\n   4. Serum creatinine ≤1.5 × the upper limit of normal or creatinine clearance ≥50 mL\u002Fmin;\n   5. Total bilirubin ≤1.5 × the upper limit of normal, or ≤3 × the upper limit of normal for participants with Gilbert's syndrome;\n   6. Alanine aminotransferase and aspartate aminotransferase ≤2.5 × the upper limit of normal, or ≤5 × the upper limit of normal for participants with liver metastases;\n   7. Activated partial thromboplastin time and international normalized ratio ≤1.5 × the upper limit of normal, without anticoagulants or other drugs affecting coagulation function within 14 days before the first dose, except for participants requiring long-term anticoagulation due to underlying disease.\n9. Toxicities caused by prior antitumor therapy must have recovered to Grade 1 or lower according to CTCAE version 5.0, except for residual alopecia and fatigue.\n10. Participants must understand the study and voluntarily sign written informed consent before study entry.\n\nExclusion Criteria:\n\n1. History of severe hypersensitivity reaction to monoclonal antibody preparations or uncontrolled allergic asthma.\n2. Known untreated central nervous system metastases, or treated but still symptomatic central nervous system metastases. Participants with residual signs or symptoms related to central nervous system treatment may be eligible if neurological symptoms have been stable or improved for at least 2 weeks before screening.\n3. History of primary immunodeficiency.\n4. Active autoimmune disease or history of autoimmune disease. Participants with well-controlled type 1 diabetes mellitus, well-controlled hypothyroidism requiring only hormone replacement therapy, skin diseases not requiring systemic treatment such as vitiligo, psoriasis, or alopecia, or conditions not expected to recur without external triggers may be eligible for further screening.\n5. Serious arterial or venous thrombotic events within 3 months before screening, such as transient ischemic attack, cerebral hemorrhage, cerebral infarction, deep venous thrombosis, or pulmonary embolism.\n6. History of interstitial lung disease, except localized radiation-induced interstitial pneumonia, or noninfectious pneumonia requiring glucocorticoid therapy.\n7. Prior treatment with any antibody or drug targeting T-cell costimulatory or immune checkpoint pathways, including PD-1, PD-L1, PD-L2, CTLA-4, OX40, or CD137 inhibitors.\n8. Prior immune-related adverse event of CTCAE version 5.0 Grade 3 or higher after immunotherapy.\n9. Major surgery or radical radiotherapy within 28 days before the first dose; palliative radiotherapy within 14 days before the first dose; or use of radiopharmaceuticals such as strontium or samarium within 56 days before the first dose.\n10. Systemic antitumor therapy within 28 days before the first dose, including but not limited to chemotherapy, immunotherapy, macromolecular targeted therapy, or biological therapy such as tumor vaccines, cytokines, or growth factors used to control cancer. Small-molecule targeted therapy or oral fluoropyrimidines within 14 days before the first dose or within 5 half-lives, whichever is longer; or mitomycin C or nitrosoureas within 6 weeks before the first dose.\n11. Receipt of a live attenuated vaccine within 28 days before the first dose or planned receipt of a live attenuated vaccine during the study.\n12. Any active infection requiring systemic treatment by intravenous infusion within 28 days before the first dose.\n13. Treatment within 14 days before the first dose with traditional Chinese patent medicines approved by the NMPA whose package inserts clearly state antitumor indications, or traditional Chinese herbal medicine documented in the medical record as being used for antitumor purposes.\n14. Whole blood or blood component transfusion within 14 days before the first dose.\n15. Treatment with glucocorticoids equivalent to prednisone \\>10 mg\u002Fday or other immunosuppressive agents within 14 days before the first dose.\n16. Participation in another clinical trial and receipt of investigational treatment within 28 days before the first dose, calculated from the date of the last treatment in the previous clinical study, except participation in overall survival follow-up of a study.\n17. Positive human immunodeficiency virus antibody or Treponema pallidum antibody; positive hepatitis B surface antigen and\u002For hepatitis B core antibody with hepatitis B virus DNA above the upper limit of normal of the testing laboratory; or positive hepatitis C antibody with hepatitis C virus RNA above the upper limit of normal of the testing laboratory.\n18. History of active tuberculosis.\n19. Pregnancy or breastfeeding.\n20. Other malignancy that progressed or required treatment within 5 years before screening, except adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or cured carcinoma in situ such as breast carcinoma in situ.\n21. Any other condition that may increase the risk associated with study treatment, interfere with interpretation of study results, affect study compliance, or otherwise make the participant unsuitable for the study in the investigator's judgment.\n22. Any clinically significant gastrointestinal disease, including liver disease, bleeding, inflammation, obstruction, or diarrhea greater than Grade 2.\n23. Current use or use within the past 2 weeks of strong CYP3A enzyme inducers or inhibitors and\u002For strong UGT1A inhibitors.\n24. Prior use of liposomal irinotecan formulation or irinotecan.\n25. Any condition that, in the investigator's judgment, makes the participant unsuitable for this study.",{"count":227,"type":22},[26],"This is a prospective, single-center, single-arm exploratory clinical study designed to evaluate the efficacy and safety of liposomal irinotecan combined with enlonstobart in patients with platinum-resistant recurrent ovarian cancer.\n\nEligible female participants with histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, FIGO stage II-IV, will receive liposomal irinotecan and enlonstobart every 2 weeks. Tumor assessment will be performed every 8 weeks. Participants may discontinue study treatment in the event of disease progression, intolerable toxicity, withdrawal of consent, or other reasons judged by the investigator.",[280,30,59,31],"Platinum-resistant Recurrent Ovarian Cancer",[282,283,284,285,286,287,288,289,290,291,153],"Platinum-resistant ovarian cancer","Recurrent ovarian cancer","Epithelial ovarian cancer","Fallopian tube cancer","Primary peritoneal cancer","Liposomal irinotecan","Enlonstobart","PD-1 inhibitor","Objective response rate","Progression-free survival","2026-05-15",{"date":294,"type":36},"2026-05-18",{"date":296,"type":22},"2026-05-30",{"date":298,"type":22},"2030-05-30",{"name":300,"class":163},"Tianjin Medical University Cancer Institute and Hospital",{"id":302,"slug":303,"hasResults":12,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":307,"eligibilityCriteria":308,"healthyVolunteers":12,"sex":52,"minAge":18,"maxAge":4,"enrollmentInfo":309,"targetDuration":4,"studyType":23,"phases":310,"briefSummary":311,"conditions":312,"keywords":320,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":342,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":164},"100638121","phase-2-romiplostim-n01-plus-atra-for-persistent-isolated-chemotherapy-induced-thrombocytopenia-after-complete-remission-of-gynecologic-breast-or-lung-solid-tumors-100638121","NCT07586826","Romiplostim N01 Plus ATRA for Persistent Isolated Chemotherapy-Induced Thrombocytopenia After Complete Remission of Gynecologic, Breast, or Lung Solid Tumors","A Prospective, Randomized, Open-Label, Controlled Study of Romiplostim N01 Combined With All-Trans Retinoic Acid Versus Romiplostim N01 Alone for Persistent Isolated Chemotherapy-Induced Thrombocytopenia in Patients With Complete Remission of Gynecologic, Breast, or Lung Solid Tumors","N01-A-PICIT-GT","Inclusion Criteria:\n\n1. Age 18 years or older.\n2. Prior diagnosis of a selected gynecologic, breast, or lung solid tumor, including but not limited to non-small cell lung cancer (NSCLC), ovarian cancer, or breast cancer. Other eligible tumor types may include endometrial cancer, cervical cancer, fallopian tube cancer, primary peritoneal cancer, and other lung cancers, if clinically appropriate and if all other eligibility criteria are met.\n3. Complete remission of the underlying tumor after chemotherapy or antitumor treatment, with tumor-related treatment discontinued for at least 12 weeks before enrollment, no evidence of recurrence or progression by specialist assessment, and no current need for additional tumor-directed therapy.\n4. Persistent isolated chemotherapy-induced thrombocytopenia, defined as platelet count \\\u003C30 x 10\\^9\u002FL on two peripheral blood tests at least 7 days apart; or platelet count slightly higher than 30 x 10\\^9\u002FL with dependence on platelet transfusion to maintain a safe platelet level.\n5. Thrombocytopenia has persisted since the last chemotherapy treatment without a clear trend of spontaneous recovery.\n6. Red blood cell count and neutrophil count are generally preserved, without clinically significant anemia or neutropenia.\n7. Bone marrow assessment performed within 1 year after tumor diagnosis and chemotherapy shows no tumor cell infiltration; megakaryocyte count is normal or increased, with or without maturation impairment.\n8. No hepatosplenomegaly, portal hypertension, or other evidence suggesting abnormal platelet redistribution as the main cause of thrombocytopenia.\n9. Prior treatment with at least one thrombopoietin receptor agonist or recombinant human thrombopoietin for PICIT without response, defined as failure of platelet count to rise to a safe level or to at least 2 times baseline after at least 2 weeks of standard-dose treatment.\n10. No prior use of Romiplostim N01.\n11. Other platelet-raising medications have been discontinued before enrollment. No washout period is required for prior thrombopoietin receptor agonists; other investigational drugs or off-label treatments must be discontinued for at least 1 month before enrollment.\n12. Ability to understand and sign the informed consent form and willingness to comply with study visits and procedures.\n13. Participants of reproductive potential must agree to use effective contraception during study treatment. Female participants of childbearing potential must have a negative pregnancy test before enrollment.\n\nExclusion Criteria:\n\n1. Other hematologic diseases that may affect hematopoiesis or cause thrombocytopenia, including but not limited to aplastic anemia, myelodysplastic syndrome, leukemia or other hematologic malignancies, or a clear history of primary immune thrombocytopenia.\n2. Active recurrence or progression of the underlying tumor, or evidence of bone marrow metastasis or tumor cell infiltration on bone marrow examination.\n3. Uncontrolled chronic viral infection, including hepatitis B, hepatitis C, or HIV infection, or active severe infection at screening or within 4 weeks before screening.\n4. Severe cardiac, hepatic, renal, or other organ dysfunction, or any serious organic disease that would make the participant unable to tolerate study treatment.\n5. Pregnancy or breastfeeding.\n6. Known severe hypersensitivity to Romiplostim, Romiplostim N01, ATRA, or any component of the study drugs.\n7. Prior Romiplostim treatment associated with severe adverse reactions or lack of efficacy.\n8. Poor compliance, inability to complete treatment or follow-up, psychiatric or psychological condition that prevents understanding of the study procedures, or any other condition that, in the investigator's judgment, may increase study risk or interfere with interpretation of study results.",{"count":101,"type":22},[26],"This is a prospective, randomized, open-label, active-controlled study to evaluate the efficacy and safety of Romiplostim N01 plus all-trans retinoic acid (ATRA) compared with Romiplostim N01 alone in adults with persistent isolated chemotherapy-induced thrombocytopenia (PICIT) after complete remission of selected gynecologic, breast, or lung solid tumors, including but not limited to non-small cell lung cancer (NSCLC), ovarian cancer, and breast cancer.\n\nEligible participants will be randomized in a 1:1 ratio to receive Romiplostim N01 plus oral ATRA or Romiplostim N01 alone for 12 weeks, with follow-up through Week 24. The primary outcome is the overall platelet response rate at Week 12, defined as platelet count \\>50 x 10\\^9\u002FL in at least 2 of the last 3 scheduled platelet assessments up to Week 12. Secondary outcomes include sustained response during Weeks 13 to 24, complete and partial response rates, duration of response, time to response, platelet count changes, platelet transfusion requirements, bleeding events, and safety.",[313,314,315,84,316,317,318,319,60,31],"Persistent Isolated Chemotherapy-Induced Thrombocytopenia","Chemotherapy-Induced Thrombocytopenia","Gynecologic Cancers","Breast Cancer","Lung Cancer","Non-Small Cell Lung Cancer","Cervical Cancer",[321,322,323,324,325,326,327,328,329,330,331,332,333,334,335,336,337,338,339,340,31,60],"PICIT","Persistent isolated chemotherapy-induced thrombocytopenia","CIT","Chemotherapy-induced thrombocytopenia","Romiplostim N01","ATRA","All-trans retinoic acid","Tretinoin","Thrombopoietin receptor agonist","Gynecologic cancer","Ovarian cancer","Breast cancer","Lung cancer","NSCLC","Non-small cell lung cancer","Endometrial cancer","Cervical cancer","Complete remission","Platelet response","Thrombocytopenia","2026-05-08",{"date":343,"type":36},"2026-05-14",{"date":345,"type":36},"2025-12-22",{"date":347,"type":22},"2027-12-31",{"name":349,"class":163},"Peking University People's Hospital",{"id":351,"slug":352,"hasResults":12,"nctId":353,"briefTitle":354,"officialTitle":355,"acronym":4,"eligibilityCriteria":356,"healthyVolunteers":12,"sex":52,"minAge":18,"maxAge":4,"enrollmentInfo":357,"targetDuration":4,"studyType":23,"phases":359,"briefSummary":360,"conditions":361,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":363,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":164},"100592497","phase-3-a-study-comparing-bl-b01d1-with-the-investigators-choice-of-chemotherapy-in-patients-with-platinum-resistant-recurrent-epithelial-ovarian-cancerpanku-gyn01-100592497","NCT06994195","A Study Comparing BL-B01D1 With the Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Recurrent Epithelial Ovarian Cancer(PANKU-GYN01)","A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With the Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Recurrent Epithelial Ovarian Cancer","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. Age: ≥18 years old;\n3. Expected survival time ≥3 months;\n4. Histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer;\n5. Previously treated with a platinum-based regimen and confirmed to have platinum-resistant recurrence;\n6. Previously received 1-3 lines of systemic anti-tumor therapy, with radiographic evidence of disease progression during or after the last line of treatment or intolerance to the current treatment prior to randomization;\n7. For subjects with documented folate receptor-alpha (FRα) positivity, progression must have occurred after treatment with mirvetuximab soravtansine;\n8. Agree to provide archived tumor tissue specimens or fresh tissue samples from the primary or metastatic lesions within the past 3 years;\n9. Must have at least one measurable lesion as defined by RECIST v1.1;\n10. ECOG performance status score of 0 or 1;\n11. Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;\n12. No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%;\n13. Organ function levels must meet the requirements;\n14. Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5×ULN;\n15. For premenopausal women with childbearing potential, a serum pregnancy test must be performed within 7 days before starting treatment, and the result must be negative; they must not be breastfeeding. All enrolled patients should use adequate barrier contraception throughout the treatment period and for 6 months after treatment ends.\n\nExclusion Criteria:\n\n1. Use of chemotherapy, targeted therapy, biologic therapy, etc., within 4 weeks or 5 half-lives prior to study randomization and palliative radiotherapy, etc., within 2 weeks;\n2. Patients with locally advanced or metastatic platinum-resistant recurrent epithelial ovarian cancer who are eligible for radical locoregional therapy;\n3. Front line received ADCs targeting topoisomerase I inhibitors or EGFR and\u002For HER3;\n4. History of severe heart disease and cerebrovascular disease;\n5. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;\n6. Prolonged QT interval, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;\n7. Diagnosed with active malignancy within 3 years before randomization;\n8. Hypertension poorly controlled by two antihypertensive drugs;\n9. Patients with poor glycemic control;\n10. Patients with grade ≥1 radiation pneumonitis according to the RTOG\u002FEORTC definition; Previous history of ILD;\n11. Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;\n12. Patients with active central nervous system metastases;\n13. Severe infection occurred within 4 weeks before randomization in study 13; Evidence of pulmonary infection or active pulmonary inflammation within 2 weeks before randomization;\n14. Patients with massive or symptomatic effusions or poorly controlled effusions;\n15. Imaging examination showed that the tumor had invaded or enveloped the large blood vessels in the abdomen, chest, neck, and pharynx;\n16. Serious unhealed wound, ulcer or fracture within 4 weeks before signing the informed consent;\n17. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;\n18. Patients with inflammatory bowel disease, extensive bowel resection, immune enteritis, intestinal obstruction or chronic diarrhea;\n19. Patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of BL-B01D1;\n20. Had a history of autologous or allogeneic stem cell transplantation;\n21. Human immunodeficiency virus antibody positive, active hepatitis B virus infection or hepatitis C virus infection;\n22. A history of severe neurological or psychiatric illness;\n23. Received other unmarketed investigational drugs or treatments within 4 weeks before randomization;\n24. Subjects who were scheduled to be vaccinated or received live vaccine within 28 days before study randomization;\n25. Other circumstances in which the investigator considered it inappropriate to participate in the trial because of complications or other circumstances.",{"count":358,"type":22},384,[56],"This trial is a registered, phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with platinum-resistant recurrent epithelial ovarian cancer.",[59,60,31],"2026-04-15",{"date":364,"type":36},"2026-04-20",{"date":366,"type":36},"2025-08-04",{"date":368,"type":22},"2027-12",{"name":70,"class":43},{"id":371,"slug":372,"hasResults":12,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":4,"eligibilityCriteria":376,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":377,"targetDuration":4,"studyType":23,"phases":379,"briefSummary":381,"conditions":382,"keywords":388,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":401},"100570692","revitalize-rct-to-reduce-fatigue-in-adults-with-ovarian-cancer-on-parp-inhibitors-100570692","NCT06710548","REVITALIZE: RCT to Reduce Fatigue in Adults With Ovarian Cancer on PARP Inhibitors","Randomized Trial of REVITALIZE: A Telehealth Intervention to Reduce Fatigue Interference Among Adults With Advanced Ovarian Cancer on PARP Inhibitors","Inclusion Criteria:\n\n* Adult patients (age ≥ 18 years) with ovarian, fallopian tube, or primary peritoneal cancers (hereafter ovarian cancer) who have completed primary therapy (surgery and chemotherapy).\n* Treated with a PARP inhibitor as maintenance therapy for ≥2 months and plan to continue for at least 7 months.\n* English-speaking.\n* Mean fatigue severity level ≥4 on the first three items of the Fatigue Symptom Inventory.\n* ECOG performance status of 0-2.\n* Willing to use a wireless pill bottle for PARP inhibitor medication.\n\nExclusion Criteria:\n\n* Untreated clinical condition or comorbid condition that pre-dates PARP inhibitor use and could explain fatigue, as evaluated by their treating oncologist.\n* Patients with severe psychiatric conditions (e.g. untreated trauma unrelated to cancer, high or imminent suicidality) as evaluated by their treating oncologist, which require more intensive psychiatric treatment than the study can provide.\n* Patients with cognitive conditions (e.g. dementia), determined by their treating oncologist, such that they could not provide informed consent or complete the study procedures.\n* Inability to complete the first questionnaire within one week of consent.",{"count":378,"type":22},240,[380],"NA","The purpose of this study is to see whether a supportive intervention (REVITALIZE) reduces fatigue and its impact on daily life and activities for participants with ovarian cancer taking PARP inhibitors.\n\nThe name of the study groups in this research study are:\n\n1. REVITALIZE\n2. Educational Materials",[84,383,384,31,385,386,387],"Advanced Ovarian Carcinoma","Fallopian Tube Carcinoma","PARP Inhibitor","Fatigue Related to Cancer Treatment","Fatigue in Cancer Survivors",[84,383,389,31,60,390,387,391],"Advanced Ovarian Cancer","Fatigue related to cancer treatment","PARP inhibitor","2026-04-07",{"date":394,"type":36},"2026-04-13",{"date":396,"type":36},"2025-03-17",{"date":398,"type":22},"2029-01-31",{"name":400,"class":163},"Dana-Farber Cancer Institute",6,{"id":403,"slug":404,"hasResults":12,"nctId":405,"briefTitle":406,"officialTitle":406,"acronym":407,"eligibilityCriteria":408,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":23,"phases":411,"briefSummary":412,"conditions":413,"keywords":414,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":4},"100630563","phase-2-benmelstobart-in-combination-with-anlotinib-and-oral-metronomic-cyclophosphamide-in-the-treatment-of-recurrent-epithelial-ovarian-fallopian-tube-or-primary-peritoneal-cancer-100630563","NCT07489300","Benmelstobart in Combination With Anlotinib and Oral Metronomic Cyclophosphamide in the Treatment of Recurrent Epithelial OvariaN, Fallopian Tube, or Primary Peritoneal Cancer","BACON","Inclusion Criteria:\n\n* 1.The age on the day of signing the informed consent form is 18 years or older. 2.Eastern Cooperative Oncology Group performance status of 0-1, with the ability to tolerate chemotherapy.\n\n  3.There is measurable disease according to the RECIST 1.1 or irRECIST criteria. 4.The histological types can be serous, endometrioid, clear cell, mucinous or undifferentialed types of recurrent epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer. The original primary tumor needs to be histologically confirmed through the pathological report.\n\n  5.Participants can be either platinum-sensitive (with a platinum-free interval(PFI) of ≥6 months before the recent recurrence) or platinum-resistant (with a PFI of \\\u003C6 months before the recent recurrence). If the participant has a platinum-sensitive disease, they can only participate in this clinical trial with platinum-based chemotherapy contraindications (such as severe persistent toxicity or a severe hypersensitivity reaction to platinum drugs, or refuse standard treatment).\n\n  6.The participants must be willing to undergo hollow needle biopsy or excisional biopsy of tumor lesion within 4 weeks (28 days) before the start of the treatment and after 3 cycles treatment. For participants who are unable to provide new samples (for example, unable to obtain or there are issues related to the safety of the participants), only with the consent of the principal investigator can archived samples be submitted.\n\nExclusion Criteria:\n\n\\-",{"count":410,"type":22},40,[26],"Efficacy and safety of Benmelstobart combined with Anlotinib and oral metronomic Cyclophosphamide in the treatment of recurrent epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer (BACON study) in China",[84,30,31],[415,416,417,418,419,420],"Benmelstobart","Anlotinib","oral metronomic Cyclophosphamide","epithelial ovarian cancer","fallopian tube cancer","primary peritoneal cancer","2026-03-19",{"date":423,"type":36},"2026-03-24",{"date":425,"type":22},"2026-03-30",{"date":427,"type":22},"2028-01-31",{"name":429,"class":163},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":431,"slug":432,"hasResults":12,"nctId":433,"briefTitle":434,"officialTitle":435,"acronym":4,"eligibilityCriteria":436,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":437,"targetDuration":4,"studyType":23,"phases":439,"briefSummary":440,"conditions":441,"keywords":446,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":468,"startDateStruct":470,"completionDateStruct":472,"leadSponsor":474,"locationsCount":476},"100460887","phase-3-efficacy--safety-of-olvi-vec-and-platinum-doublet--bevacizumab-compared-to-physicians-choice-of-chemotherapy-and-bevacizumab-in-platinum-resistantrefractory-ovarian-cancer-prroc-onprime-gog-3076-100460887","NCT05281471","Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Physician's Choice of Chemotherapy and Bevacizumab in Platinum-Resistant\u002FRefractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076)","A Randomized Phase 3 Study Assessing the Efficacy and Safety of Olvi-Vec Followed by Platinum-doublet Chemotherapy and Bevacizumab Compared With Physician's Choice of Chemotherapy and Bevacizumab in Women With Platinum-Resistant\u002FRefractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076)","Inclusion Criteria:\n\n* Histologically confirmed (from prior treatment) non-resectable ovarian, fallopian tube or primary peritoneal cancer.\n* High-grade serous \\[including malignant mixed Mullerian tumor (MMMT) with metastasis that contains high-grade epithelial carcinoma, FIGO grades 2 \\& 3 allowed\\], endometrioid, or clear-cell ovarian cancer.\n* Performance status ECOG of 0 or 1.\n* Life expectancy of at least 6 months.\n* Received a minimum of 3 prior lines (including the 1st line) of systemic therapy with no maximal limit.\n* Platinum-resistant or -refractory disease based on platinum-free interval (PFI) from the last dose of the most recent. platinum-based line of therapy (must have received a minimum of 2 doses of platinum in that line) to subsequent disease progression based on radiological assessment. Platinum-refractory: PFI of \\\u003C 1 month (including disease progression while on platinum-based therapy). Platinum-resistant: PFI of 1-6 months.\n* Received prior bevacizumab (or biosimilar) treatment.\n* No contraindication to receive carboplatin, cisplatin or bevacizumab (or biosimilar).\n* Have disease progression after last prior line of therapy based on radiological assessment prior to randomization.\n* At least 1 measurable target lesion per RECIST 1.1 based on abdominal\u002Fpelvis imaging scan at screening.\n* Evidence by CT and\u002For PET scans or physical exam of abdominal\u002Fpelvis region likely having disease in the peritoneal cavity (i.e., peritoneal carcinomatosis).\n* Adequate renal, hepatic, bone marrow function, adequate coagulation tests, adequate immune function by lymphocyte count.\n\nExclusion Criteria:\n\n* Tumors of mucinous, low-grade serous, squamous cell, small cell neuroendocrine subtypes, MMMT tumors absent an epithelial component on recent biopsy, or non-epithelial ovarian cancers (e.g., germ cell tumors, Sex-cord tumors).\n* Bowel obstruction within last 3 months prior to screening.\n* Active urinary tract infection, pneumonia, other systemic infections.\n* Active gastrointestinal bleeding.\n* Known current central nervous system (CNS) metastasis.\n* Inflammatory diseases of the bowel.\n* History of HIV infection.\n* Active hepatitis B virus or hepatitis C virus within 4 weeks prior to study.\n* History of thromboembolic event within the prior 3 months.\n* Contraindications for intraperitoneal (IP) catheter placement: Bowel obstruction with distended abdomen, rigid abdomen with bulky anterior wall carcinomatosis, abdominal wall hernia mesh that precludes laparoscopic entry to abdomen.\n* Clinically significant cardiac disease at screening (New York Heart Association Class III\u002FIV).\n* Acute cerebrovascular event(s) such as cerebrovascular accident (CVA) or transient ischemic attack (TIA) in previous 6 months.\n* Oxygen saturation \\\u003C90%.\n* Received prior virus-based gene therapy or therapy with cytolytic virus of any type.\n* Receiving concurrent antiviral agent.\n* Prior malignancy of other histology active within previous 3 years except for locally curable cancers apparently cured such as basal\u002Fsquamous cell skin cancer, superficial bladder cancer, carcinoma in situ of cervix or breast, any other stage I\u002FII local malignancies.\n* Received chemotherapy, radiotherapy, other anti-cancer biologic therapies within 4 weeks prior to planned treatment.\n* Underwent surgery within 4 weeks, or have insufficient recovery from surgical-related trauma or wound healing, prior to first study treatment in either Arm.\n* Receiving immunosuppressive therapy or steroids (except acute concurrent corticosteroid of no more than 20 mg per day for medical management with prednisolone equivalent.\n* Symptomatic malignant ascites or pleural effusions defined as rapidly progressive ascites with abdominal distension and gastrointestinal dysfunction, pleural effusions with respiratory difficulties requiring frequent paracentesis \\> once every 14 days.\n* Known hypersensitivity to gentamicin.",{"count":438,"type":22},186,[56],"The OnPrime study is a multi-center, randomized open-label phase 3 study evaluating the safety and efficacy of Olvi-Vec followed by platinum-doublet chemotherapy and bevacizumab compared to the Active Comparator Arm with Physician's Choice of chemotherapy and bevacizumab in women diagnosed with platinum-resistant\u002Frefractory ovarian cancer (includes fallopian tube cancer and primary peritoneal cancer). This Phase III trial builds on the efficacy and safety data reported in the previous Phase II VIRO-15 trial with promising objective response rate and progression-free survival observed in heavily pre-treated patients with platinum-resistant\u002Frefractory ovarian cancer. The phase II results also showed that the intra-peritoneal route of delivery was efficient in generating tumor cell killing and immune activation, and led to clinical reversal of platinum-resistance or refractoriness in this difficult-to-treat patient population.",[442,443,60,31,444,208,445],"Platinum-resistant Ovarian Cancer","Platinum-refractory Ovarian Cancer","High-grade Serous Ovarian Cancer","Ovarian Clear Cell Carcinoma",[447,448,449,450,451,452,453,454,455,456,457,419,420,458,459,460,461,462,463,464,465,466],"olvimulogene nanivacirepvec","GL-ONC1","GLV-1h68","oncolytic virus","virotherapy","viral therapy","immunotherapy","immunochemotherapy","combination therapy","vaccinia virus","ovarian cancer","platinum resistant","platinum refractory","recurrent ovarian cancer","platinum resensitization","chemoresistance","heavily pre-treated","immune activation","reversal of platinum resistance or refractoriness","resensitize","2026-03-16",{"date":469,"type":36},"2026-03-18",{"date":471,"type":36},"2022-08-31",{"date":473,"type":22},"2026-10",{"name":475,"class":43},"Genelux Corporation",31,{"id":478,"slug":479,"hasResults":12,"nctId":480,"briefTitle":481,"officialTitle":482,"acronym":4,"eligibilityCriteria":483,"healthyVolunteers":12,"sex":52,"minAge":18,"maxAge":4,"enrollmentInfo":484,"targetDuration":4,"studyType":23,"phases":486,"briefSummary":487,"conditions":488,"keywords":495,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":497,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":501,"locationsCount":503},"100412938","phase-1-a-study-of-art0380-for-the-treatment-of-advanced-or-metastatic-solid-tumors-100412938","NCT04657068","A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors","A Phase I\u002FIIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the ATR Kinase Inhibitor ART0380 Administered Orally as Monotherapy and in Combination to Patients With Advanced or Metastatic Solid Tumors","General Inclusion Criteria:\n\n* Signed informed consent\n* Discontinued all previous treatments for cancer for at least 21 days or 5 half-lives, whichever is shorter, and recovered from the acute effects of therapy to CTCAE Grade ≤1. Palliative radiotherapy must have completed 1 week prior to start of study treatment.\n* If patients have a known germline BRCA mutation or a cancer with a somatic BRCA mutations or which is HRD positive and for which there is an approved PARP inhibitor, participants should have received such treatment before participating in the study unless contra-indicated\n* At least 1 radiologically evaluable lesion (measurable and\u002For non-measurable) that can be assessed at baseline and is suitable for repeated radiological evaluation by RECIST v1.1 or Prostate Cancer Working Group-3 Guidelines (PCWG-3)\n* Acceptable hematologic, renal, hepatic, and coagulation functions independent of transfusions and granulocyte colony-stimulating factor\n* Non-irradiated tumor tissue sample (archival or newly obtained core biopsy of a tumor lesion) available for submission for analysis.\n* Female patients of childbearing potential and male patients with female partners of childbearing potential are required to use highly effective contraception plus one barrier method during their participation in the study and for 7 months and 5 months respectively following the last dose. For male and female patients given gemcitabine or irinotecan, highly effective contraception plus one barrier method must be used from study entry until 6 months after the last dose of study treatment. Male patients are required to refrain from donating sperm and female patients are required to refrain from donating eggs, during their participation in the study and for 6 months following last dose.\n* Estimated life expectancy of ≥12 weeks\n* Reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures\n* Performance status of 0-1 on the ECOG Scale\n\nAdditional inclusion criteria for participants in dose escalation (Part A1):\n\n* Advanced or metastatic cancer which is refractory to standard therapies, or for which no standard therapies exist, or for which the investigator feels no other active therapy is required for the duration of the study\n* Performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale\n\nAdditional inclusion criteria for participants in dose escalation (Part A2):\n\n•Advanced or metastatic cancer for which gemcitabine is an appropriate treatment. Prior treatment with gemcitabine is permitted.\n\nAdditional inclusion criteria for participants in dose escalation (Part A3):\n\n* Advanced or metastatic cancer for which irinotecan is an appropriate treatment. Prior treatment with irinotecan is permitted.\n* For food effect cohort only: Patients must be able to eat a high-fat meal within a 30 minute period, as provided by the study site.\n\nAdditional inclusion criteria for participants in dose expansion (Part B1):\n\n* Patients with advanced or metastatic solid tumors with alterations to the ATM gene likely to predict for loss of ATM protein\n* Have at least 1 measurable lesion assessable using standard techniques by RECIST v1.1\n* For France only ART0380 Monotherapy; Patient that is not eligible for curative treatment, for whom all standard of care therapies have failed and no therapies known to provide clinical benefit are available.\n* Combination arms; Patients for which irinotecan is an appropriate treatment. Prior treatment with irinotecan is permitted.\n* For Spain only ART0380 Combination therapy, Patient that is not eligible for curative treatment, for whom standard of care therapies have failed.\n\nAdditional inclusion criteria for participants in dose expansion (Part B2):\n\n* Patients with a known germline BRCA mutation, or a cancer with a known somatic BRCA mutation, or which is known to be HRD positive, and for which there is an approved PARP inhibitor should have received such treatment before participating in the study, unless contra-indicated.\n* Females with histologically-confirmed diagnosis of high grade serous carcinoma of the ovary, fallopian tube or primary peritoneum that is not amenable to curative therapy\n* Platinum-resistant disease. Patients must not have had primary platinum-refractory disease (disease that progressed during first-line platinum-based therapy).\n* No more than one prior regimen in the platinum-resistant setting. Hormonal therapies and antiangiogenic therapies (as single agents) and PARP inhibitors used as maintenance therapy are not considered as separate lines of therapy. Patients should have previously received bevacizumab and chemotherapy unless contra-indicated.\n* Have not received prior treatment with gemcitabine unless administered in combination with a platinum with no disease progression within 12 months after completion of that regimen\n* Have at least 1 measurable lesion assessable using standard techniques by RECIST v1.1\n\nInclusion criteria specific to Part B3\n\n* Persistent or recurrent endometrial cancer with biological selection.:\n* Patients should have received taxane\u002Fplatinum chemotherapy, unless contraindicated.\n* Measurable disease.\n\nInclusion criteria specific to Part B4\n\n* Advanced or metastatic solid cancers of any histology with biological selection\n* If a PD-1\u002FPDL-1 inhibitor (eg, pembrolizumab) is approved and available for the patient's cancer, the patient should have received such treatment before participating in this study.\n* Radiologically evaluable disease\n* Performance status of 0-1 on the ECOG scale\n\nInclusion criteria specific to Part B5\n\n* Metastatic CRC with alterations to the ATM gene\n* Participants should have previously received appropriate prior lines of therapy in this setting.\n* Have at least 1 measurable lesion assessable using standard techniques by RECIST v1.1.\n* Patients have received a maximum of 2 prior chemotherapy regimens for the treatment of CRC and have demonstrated progressive disease or intolerance to their last regimen.\n\nInclusion criteria specific to Part B6:\n\n* Metastatic or locally advanced PDAC or acinar cell carcinoma with alterations to the ATM gene\n* Participants must have received a maximum of 1 prior chemotherapy regimen for the treatment of the advanced disease and have demonstrated progressive disease or intolerance to this regimen OR have received neoadjuvant\u002Fadjuvant therapy with recurring occurring \\\u003C6 months following completion of this treatment.\n* Have at least 1 measurable lesion assessable using standard techniques by RECIST v1.1. Previously irradiated lesions may not be considered target lesions.\n* Serum albumin ≥3g\u002FdL within 7 days prior to first dose.\n\nGeneral Exclusion Criteria:\n\n* Women who are pregnant, breast feeding, or who plan to become pregnant while in the study or within 7 months after the last administration of study treatment\n* Men who plan to father a child while in the study or within5 months after the last administration of study treatment\n* Serious concomitant systemic disorder that would compromise the participants ability to adhere to the protocol including: one or more opportunistic HIV\u002FAIDs-related infections within the past 12 months, a known hepatitis B virus, or known hepatitis C virus; documented active or chronic tuberculosis infection; malignancy prior to the one currently being treated that is not in remission\n* Have ongoing interstitial lung disease or pneumonitis (whether symptomatic or asymptomatic).\n* Moderate or severe cardiovascular disease\n* Valvulopathy that is severe, moderate, or deemed clinically significant\n* Documented major electrocardiogram (ECG) abnormalities which are clinically significant\n* Symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment\n* Received a live vaccine within 30 days before the first dose of study treatment\n* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate\n* Recent major surgery within 4 weeks prior to entry into the study or minor surgery within 1 week of entry into the study\n* Drainage for ascites, pleural effusion or pericardial fluid within 4 weeks before the first dose of study treatment.\n* A significant bleeding disorder or vasculitis or had a Grade ≥3 bleeding episode within 12 weeks prior to enrollment\n* Currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study\n\nAdditional exclusion criteria for participants in dose escalation (Part A3, B1, B5, and B6 in combination with irinotecan):\n\n* Patients who have symptoms or signs of clinically unacceptable deterioration of the primary disease at the time of screening.\n* Patients who are known to be homozygous for both UGT1A1 \\*6 and \\*28 (UGT1A1 7\u002F7 genotype), or simultaneously heterozygous for both UGT1A1 \\*6 and \\*28.\n* Patients receiving strong inhibitors of UGT1A1 within 2 weeks before the first dose of study treatment\n* Part A3 Fed-fasted cohort only: Patients receiving acid reducing agents within 1 week before the first dose of study treatment will be excluded\n* Part B6: Neuroendocrine (carcinoid, islet cell) or adenosquamous carcinoma pancreatic cancer",{"count":485,"type":22},442,[25,26],"This clinical trial is evaluating a drug called ART0380 in participants with advanced or metastatic solid tumors. The main goals of this study are to:\n\n* Find the recommended dose of ART0380 that can be given safely to participants alone and in combination with gemcitabine or irinotecan\n* Learn more about the side effects of ART0380 alone and in combination with gemcitabine or irinotecan\n* Learn more about the effectiveness of ART0380 alone and in combination with gemcitabine or irinotecan",[489,490,84,31,60,491,492,493,494],"Advanced Cancer","Metastatic Cancer","Endometrial Cancer","Metastatic Colorectal Cancer","Pancreatic Ductal Adenocarcinoma","Acinar Cell Carcinoma",[496],"Loss of Ataxia Telangiectasia Mutated (ATM) protein",{"date":469,"type":36},{"date":499,"type":36},"2021-01-27",{"date":368,"type":22},{"name":502,"class":43},"Artios Pharma Ltd",79,{"id":505,"slug":506,"hasResults":12,"nctId":507,"briefTitle":508,"officialTitle":509,"acronym":4,"eligibilityCriteria":510,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":511,"targetDuration":4,"studyType":23,"phases":513,"briefSummary":514,"conditions":515,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":517,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":522,"locationsCount":164},"100629243","phase-2-parp-poly-adp-ribose-polymerase-inhibitor-with-or-without-angiogenesis-inhibitor-in-homologous-recombination-deficient-primary-ovarian-cancer-fallopian-tube-cancer-or-primary-peritoneal-cancer-100629243","NCT07472140","PARP (Poly (ADP-ribose) Polymerase) Inhibitor With or Without Angiogenesis Inhibitor in Homologous Recombination Deficient Primary Ovarian Cancer, Fallopian-Tube Cancer, or Primary Peritoneal Cancer","To Develop and Implement The Scope of Medical Care for Homologous Recombination Deficient Ovarian Cancer, Fallopian-Tube Cancer, or Primary Peritoneal Cancer of the III-IV Stages Using Maintenance Therapy With PARP Inhibitor Combined With Angiogenesis Inhibitor.","Inclusion Criteria:\n\n* Age ≥18-≤75 years.\n* Histologically confirmed diagnosis of serous or endometrioid high-grade ovarian cancer, fallopian-tube cancer or primary peritoneal cancer.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Possibility of performing diagnostic laparoscopy or cytoreductive surgery.\n* Presence of homologous recombination deficiency (HRD).\n* No contraindications to chemotherapy, or bevacizumab.\n* Signed informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Presence of another active malignant invasive neoplasm.\n* Pregnancy or lactation period.\n* Disease progression during treatment.",{"count":512,"type":22},120,[26,56],"This is a randomized trial evaluating the results of using of PARP inhibitor combined with angiogenesis inhibitor. in patients with homologous recombination deficient primary ovarian cancer, fallopian-tube cancer, or primary peritoneal cancer of the III-IV stages.",[84,30,31],"2026-03-11",{"date":467,"type":36},{"date":519,"type":36},"2025-07-01",{"date":521,"type":22},"2033-06-30",{"name":523,"class":524},"N.N. Alexandrov National Cancer Centre","OTHER_GOV",{"id":526,"slug":527,"hasResults":12,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":531,"eligibilityCriteria":532,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":533,"enrollmentInfo":534,"targetDuration":127,"studyType":128,"phases":4,"briefSummary":536,"conditions":537,"keywords":538,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":164},"100483410","characterization-of-epithelial-ovarian-cancer-patients-in-terms-of-homologous-recombination-phenotype-100483410","NCT05574673","Characterization of Epithelial Ovarian Cancer Patients in Terms of Homologous Recombination Phenotype","Characterization of Epithelial Ovarian Cancer Patients in Terms of Homologous Recombination Phenotype - A Prospective Observational Study","HERO","Patients are eligible to be included in the study, if all the following inclusion criteria are met:\n\n* Patients with newly diagnosed histologically confirmed epithelial ovarian cancer:\n\n  * FIGO stage I-II with a known BRCA1\u002F2 mutation (germline\u002FgBRCA or somatic\u002FtBRCA)\n  * FIGO stage III-IV of any histology\n* Women aged ≥18 years of age at the time of diagnosis\n* Patients intended for platinum-based chemotherapy treatment\n* Patients capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol\n* Patients consent to provide archival tumor tissue sample\n\nPatients are ineligible to be included in the study, if any of the exclusion criteria are met:\n\n* Non-epithelial ovarian cancer, borderline tumors, or mucinous histology\n* Patients with FIGO stage I-II, BRCAwt ovarian cancer","100 Years",{"count":535,"type":22},1000,"This is a prospective observational multi-country, multi-center study of a large real-world cohort of first line (1L) epithelial ovarian cancer patients, exposed to standard of care (SOC) treatment stratified according to BRCA1\u002F2 and HRD status.",[84,31,60],[539],"Ovarian cancer, observational study, HRD","2026-02-24",{"date":542,"type":36},"2026-02-27",{"date":544,"type":36},"2022-12-01",{"date":546,"type":22},"2032-07-01",{"name":548,"class":163},"Nordic Society of Gynaecological Oncology - Clinical Trials Unit",{"id":550,"slug":551,"hasResults":12,"nctId":552,"briefTitle":553,"officialTitle":554,"acronym":4,"eligibilityCriteria":555,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":556,"targetDuration":4,"studyType":23,"phases":558,"briefSummary":559,"conditions":560,"keywords":562,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":568,"lastUpdatePostDateStruct":569,"startDateStruct":571,"completionDateStruct":573,"leadSponsor":575,"locationsCount":4},"100626204","phase-2-neoadjuvant-aitua-pd-1ctla-4-bispecific-plus-nab-paclitaxel-and-carboplatin-for-advanced-high-grade-serous-ovarian-cancer-100626204","NCT07432594","Neoadjuvant Aitua (PD-1\u002FCTLA-4 Bispecific) Plus Nab-Paclitaxel and Carboplatin for Advanced High-Grade Serous Ovarian Cancer","A Prospective, Randomized, Controlled Phase II Clinical Study of Albumin-Bound Paclitaxel\u002FCarboplatin Combined With Aitua Combination Antibody (PD-1\u002FCTLA-4 Bispecific Antibody) for the Neoadjuvant Treatment of Advanced High-Grade Serous Ovarian Cancer With Unsatisfactory Debulking","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Histologically confirmed high-grade serous ovarian cancer (HGSC), fallopian tube cancer, or primary peritoneal cancer.\n* International Federation of Gynecology and Obstetrics (FIGO) stage IIIC-IV.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Assessed by a multidisciplinary team (MDT) based on imaging (± laparoscopic exploration) as initially unable to achieve satisfactory tumor debulking (R0 resection).\n* At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.\n* Major organ function is basically normal.\n* Willing to provide tumor tissue, peripheral blood, and ascites samples for translational research.\n\nExclusion Criteria:\n\n* Pathological types other than high-grade serous carcinoma (HGSC).\n* Prior receipt of any form of anti-tumor therapy.\n* History of autoimmune disease or requiring immunosuppressive therapy.\n* Known allergy to study drug components.\n* Pregnant or lactating women.",{"count":557,"type":22},82,[26],"This is a prospective, randomized, controlled Phase II clinical study designed to evaluate the efficacy and safety of adding Aitua Combination Antibody (a PD-1\u002FCTLA-4 bispecific antibody) to standard neoadjuvant chemotherapy for patients with advanced high-grade serous ovarian cancer.\n\nThe study focuses on patients who are newly diagnosed with Stage IIIC-IV ovarian, fallopian tube, or primary peritoneal cancer and are assessed as unable to achieve satisfactory tumor debulking (R0 resection) initially.\n\nParticipants will be randomized in a 1:1 ratio into two groups:\n\nExperimental Group: Receives Nab-paclitaxel and Carboplatin combined with Aitua Combination Antibody.\n\nControl Group: Receives Nab-paclitaxel and Carboplatin alone.\n\nBoth groups will receive 3 cycles of neoadjuvant treatment followed by Interval Debulking Surgery (IDS). The primary goal is to compare the R0 resection rate (complete removal of macroscopic tumor) between the two groups during surgery. Secondary goals include assessing pathological complete response (pCR), objective response rate, progression-free survival, and safety. The study also aims to explore how this combination therapy affects the tumor immune microenvironment.",[561,30,31],"High-grade Serous Ovarian Cancer (HGSOC)",[563,179,564,565,566,184,567],"Neoadjuvant Chemotherapy","PD-1\u002FCTLA-4 Bispecific Antibody","Aitua Combination Antibody","Nab-paclitaxel","Immunotherapy","2026-02-21",{"date":570,"type":36},"2026-02-25",{"date":572,"type":22},"2026-03-01",{"date":574,"type":22},"2027-06-30",{"name":576,"class":163},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":578,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":579,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":580,"enrollmentInfo":581,"targetDuration":4,"studyType":23,"phases":582,"briefSummary":27,"conditions":583,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":584,"lastUpdatePostDateStruct":585,"startDateStruct":587,"completionDateStruct":588,"leadSponsor":589,"locationsCount":164},"100617705","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.\n* Histologically or cytologically confirmed diagnosis of epithelial ovarian, primary peritoneal or fallopian tubes cancer\n* FIGO Stage III or IV\n* Positive for claudin 6 (CLDN6) expression\n* Adequate organ function\n\nExclusion Criteria:\n\n* Clear cell, mucinous, sarcomatous, mixed histology, low-grade\u002Fborderline, or non-epithelial ovarian cancers\n* Prior systemic treatment for the disease under study\n* Prior surgery\n* Prior radiation therapy to the abdomen or pelvis\n* Current recipient or receipt within 5-half-lives of C1D1 of chemotherapy, biologic\u002Ftargeted therapy, immunomodulator therapy for any disease indication\n* Active, progressive, or symptomatic brain metastases\n* Participants considered poor medical risks due to serious, uncontrolled medical conditions, active infections, or nonmalignant systemic diseases\n* Pregnant or breastfeeding women","70 Years",{"count":21,"type":22},[25,26],[29,30,31],"2026-01-05",{"date":586,"type":36},"2026-01-07",{"date":38,"type":36},{"date":40,"type":22},{"name":42,"class":43},{"id":591,"slug":592,"hasResults":12,"nctId":593,"briefTitle":594,"officialTitle":595,"acronym":4,"eligibilityCriteria":596,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":597,"targetDuration":4,"studyType":23,"phases":599,"briefSummary":600,"conditions":601,"keywords":602,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":607,"lastUpdatePostDateStruct":608,"startDateStruct":609,"completionDateStruct":611,"leadSponsor":613,"locationsCount":614},"100407815","phase-1-a-study-to-find-out-how-safe-regn5668-is-and-how-well-it-works-in-adult-women-when-given-with-either-cemiplimab-or-cemiplimab--fianlimab-or-ubamatamab-100407815","NCT04590326","A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamatamab","A Phase 1\u002F2 Study of REGN5668 (MUC16xCD28, a Costimulatory Bispecific Antibody) Administered in Combination With Other Agents in MUC16 + Malignancies","Key Inclusion Criteria:\n\n1. Ovarian Cancer Cohorts Only: Has histologically or cytologically confirmed diagnosis of advanced epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian tube cancer that has received at least 1 line of platinum-based systemic therapy as defined in the protocol\n2. Expansion cohorts only: Has at least 1 lesion that is measurable by RECIST 1.1 as described in the protocol.\n3. Has a serum CA-125 level ≥2x ULN (in screening, not applicable to endometrial cohorts)\n4. Has adequate organ and bone marrow function as defined in the protocol\n5. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Has a life expectancy of at least 3 months\n7. Endometrial Cancer Cohorts Only: histologically confirmed endometrial cancer that has progressed or recurrent after prior anti-PD-1 therapy and platinum-based chemotherapy as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Current or recent (as defined in the protocol) treatment with an investigational agent, systemic biologic therapy, or anti-cancer immunotherapy\n2. Has had another malignancy within the last 5 years that is progressing, requires active treatment, or has a high likelihood of recurrence as defined in the protocol\n3. Prior treatment with a Mucin 16 (MUC16)-targeted therapy\n4. Ovarian Expansion cohorts only: More than 5 prior lines of systemic therapy\n5. Has any condition that requires ongoing\u002Fcontinuous corticosteroid therapy as defined in the protocol within 1 week prior to the first dose of study drug\n6. Has ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments as defined in the protocol\n7. Has untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression as defined in the protocol\n8. Has history of clinically significant cardiovascular disease as defined in the protocol\n9. Has known allergy or hypersensitivity to cemiplimab and\u002For components of study drug(s).\n\nNote: Other protocol-defined Inclusion\u002FExclusion criteria apply",{"count":598,"type":22},612,[25,26],"This study is researching an investigational drug called REGN5668 :\n\n* alone or,\n* combined with cemiplimab (also known as REGN2810) or,\n* combined with both cemiplimab and fianlimab (also known as REGN3767), or\n* combined with ubamatamab (also known as REGN4018), with or without sarilumab.\n\nThe main purposes of this study are to:\n\n* Learn about the safety and profile of any side effects from the study drugs and to determine the highest, safe dose that can be given to participants with ovarian cancer or cancer of the uterus\n* Look for signs that the study drugs can treat ovarian cancer or cancer of the uterus\n\nThis study has 2 parts. The purpose of Part 1 (Escalation) is to find the highest, safe dose of the study drug(s). The purpose of Part 2 (Expansion) is to use the doses chosen in Part 1. Participants with cancer of the uterus will only participate in Part 2.\n\nThe study is looking at several other research questions, including:\n\n* Side effects that may be experienced by participants taking REGN5668 alone and\u002For in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab\n* How REGN5668 works in the body either alone and\u002For in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab\n* How much of the study drugs (REGN5668, cemiplimab, fianlimab, ubamatamab) are in the blood\n* To see if REGN5668 in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab works to treat cancer",[84,60,31,491],[603,604,605,606],"Progressive","Recurrent","Refractory","Serum CA-125 levels >= 2x ULN","2025-11-20",{"date":190,"type":36},{"date":610,"type":36},"2020-12-08",{"date":612,"type":22},"2027-11-30",{"name":115,"class":43},24,{"id":616,"slug":617,"hasResults":12,"nctId":618,"briefTitle":619,"officialTitle":620,"acronym":4,"eligibilityCriteria":621,"healthyVolunteers":12,"sex":52,"minAge":18,"maxAge":4,"enrollmentInfo":622,"targetDuration":4,"studyType":23,"phases":624,"briefSummary":625,"conditions":626,"keywords":632,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":636,"lastUpdatePostDateStruct":637,"startDateStruct":639,"completionDateStruct":641,"leadSponsor":643,"locationsCount":645},"100505889","phase-1-study-of-avzo-021-in-patients-with-advanced-solid-tumors-100505889","NCT05867251","Study of AVZO-021 in Patients With Advanced Solid Tumors","A Phase 1\u002F2, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-021 as a Single Agent and in Combination Therapy in Patients With Advanced Solid Tumors","Key Inclusion Criteria:\n\n1. Male or female aged ≥18 years old at screening with Eastern Cooperative Oncology Group (ECOG) 0-1.\n2. Disease-related inclusion criteria by study phase and part:\n\n   i) Phase 1a Monotherapy Dose Escalation: Patients with locally advanced or metastatic HR+\u002FHER2- breast cancer, CCNE1-amplified tumors that are either epithelial ovarian cancer, primary peritoneal cancer, fallopian tube cancer, endometrial cancer or TNBC, with no other oncogenic driver mutations that are treatable and standard therapies are no longer effective, appropriate, or safe in the opinion of the investigator and medical monitor. Patients with any additional tumor type with CCNE1 amplification can be enrolled only if clinical data is supportive and approved by medical monitor (Cohort 1A).\n\n   ii) Phase 1b Combination Dose Escalation: histologically or cytologically confirmed diagnosis of locally advanced or metastatic HR+ HER2- (HER2-low may be allowed if failed standard of care therapy) breast cancer, who have been previously treated with inhibitor of CDK4\u002F6 and endocrine therapy(Cohorts 1B1, 1B2, 1B3, 1B4, and 1B5); or histologically or cytologically confirmed diagnosis of CCNE1- amplified, locally advanced or metastatic, platinum-refractory or platinum-resistant EOC, primary peritoneal, or fallopian tube cancer (Cohort 1C).\n\n   iii) Phase 2a Monotherapy dose expansion: Histologically or cytologically confirmed diagnosis of locally advanced or metastatic CCNE1 amplified epithelial ovarian cancer, primary peritoneal cancer, fallopian tube cancer, endometrial cancer or TNBC, with no other oncogenic driver mutations that are treatable and standard therapies are no longer effective, appropriate, or safe in the opinion of the investigator and medical monitor (Cohort 2A).\n\n   iv) Phase 2b Combination dose expansion: Histologically or cytologically confirmed diagnosis of locally advanced or metastatic HR+\u002FHER2- (HER2-low may be allowed if failed standard of care therapy) breast cancer who have been previously treated with no more than 1 prior CDK4\u002F6 inhibitor and endocrine therapy (Cohorts 2B1, 2B2, 2B3, 2B4, and 2B5); or Histologically or cytologically confirmed diagnosis of locally advanced or metastatic, CCNE1-amplified, platinum-refractory or platinum-resistant EOC, primary peritoneal cancer, or fallopian tube cancer (Cohort 2C).\n3. No more than 2 prior cytotoxic chemotherapy regimens for locally advanced\u002Fmetastatic disease (excepting patients treated with an antibody-drug conjugate, with ovarian cancer if there disease is platinum resistant or refractory, having progressed beyond all SOC care; and patients who have received prior chemotherapy in the adjuvant or neoadjuvant setting \\>12 months prior to starting AVZO-021 treatment).\n4. Measurable disease as determined by RECIST version 1.1.\n5. Adequate bone marrow and organ function.\n6. Ability to swallow capsules or tablets.\n\nKey Exclusion Criteria:\n\n1. Received an investigational agent or anticancer therapy within 2 weeks, or 5 half-lives of the drug, whichever is shorter, prior to planned start of AVZO-021.\n2. Received any CDK2 inhibitor, protein kinase membrane associated tyrosine\u002Fthreonine 1 (PKMYT1) inhibitor, or WEE1 inhibitor anticancer therapy. For cohort B5, prior therapy with topoisomerase inhibitors is not permitted.\n3. Undergone major surgery within 4 weeks prior to planned start of AVZO-021.\n4. Received radiotherapy for palliation within 7 days of the first dose of study treatment, unless specified otherwise in the protocol.\n5. Active CNS metastases or confirmed leptomeningeal disease are not eligible.\n6. Unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade \\>1 at the time of starting study treatment.\n7. Clinically unstable cardiac function as described in the protocol.\n8. Any active or chronic infection\u002Fdisease that compromises the immune system.\n9. Current treatment with strong or moderate cytochrome P450 (CYP)3A4 inhibitors or inducers.\n10. Active second malignancy unless in remission with life expectancy \\> 2 years and with documented sponsor approval.\n11. Pregnancy, lactation, or plans to breastfeed during the study or within 6 months of the last dose of study intervention.",{"count":623,"type":22},430,[25,26],"This study, the first clinical trial of AVZO-021, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and anti-tumor effects of AVZO-021 in patients with advanced solid tumors. AVZO-021 is an oral medication that inhibits cyclin-dependent kinase 2 (CDK 2).",[627,628,629,630,59,31,60,491,631],"Advanced Solid Tumor","HR+\u002FHER2- Breast Cancer","HR+, HER2-, Advanced Breast Cancer","CCNE1 Amplification","TNBC - Triple-Negative Breast Cancer",[633,628,316,634,630,59,31,60,491,635],"Advanced solid tumor","Advanced Breast Cancer","Triple Negative Breast Cancer","2025-11-17",{"date":638,"type":36},"2025-11-19",{"date":640,"type":36},"2023-08-30",{"date":642,"type":22},"2030-01-31",{"name":644,"class":43},"Avenzo Therapeutics, Inc.",13,{"id":647,"slug":648,"hasResults":12,"nctId":649,"briefTitle":650,"officialTitle":651,"acronym":4,"eligibilityCriteria":652,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":653,"targetDuration":4,"studyType":23,"phases":655,"briefSummary":656,"conditions":657,"keywords":659,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":663,"lastUpdatePostDateStruct":664,"startDateStruct":666,"completionDateStruct":668,"leadSponsor":670,"locationsCount":672},"100409086","phase-2-study-of-carboplatin-and-mirvetuximab-soravtansine-in-first-line-treatment-of-patients-receiving-neoadjuvant-chemotherapy-with-advanced-stage-ovarian-fallopian-tube-or-primary-peritoneal-cancer-100409086","NCT04606914","Study of Carboplatin and Mirvetuximab Soravtansine in First-Line Treatment of Patients Receiving Neoadjuvant Chemotherapy With Advanced-Stage Ovarian, Fallopian Tube or Primary Peritoneal Cancer","Single-Arm Phase II Study of Carboplatin and Mirvetuximab Soravtansine in First-Line Treatment of Patients Receiving Neoadjuvant Chemotherapy With Advanced-Stage Ovarian, Fallopian Tube or Primary Peritoneal Cancer Who Are Folate Receptor α Positive","Inclusion Criteria:\n\n* Patients must have biopsy-confirmed high grade serous epithelial ovarian cancer.\n* Patients must present with stage III or IV disease and be appropriate to receive neoadjuvant chemotherapy\n* Patients must be willing to provide an archival tumor tissue block or slides, or undergo procedure to obtain a new biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα positivity\n* Patients must have a performance status of 0 or 1.\n* Patient's tumor must be positive for FRα expression as defined by a score of PS2+ intensity in \\>75% of cells\n* Patients must have adequate hematologic, liver and kidney functions defined as:\n* Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL (1,500\u002FμL)\n* Platelet count ≥ 100 x 109\u002FL (100,000\u002FμL) without platelet transfusion in the prior 10 days\n* Hemoglobin ≥ 9.0 g\u002FdL\n* Serum creatinine ≤ 1.5 x upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN\n* Serum bilirubin ≤ 1.5 x ULN (patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin \\\u003C 3.0 x ULN)\n* Serum albumin ≥ 2 g\u002FdL\n* Patients must be willing and able to sign the informed consent form (ICF) and to adhere to the protocol requirements\n* Women of childbearing potential (WCBP) must agree to use highly effective contraceptive method(s) (as defined in Section 5.8.6 while on MIRV and for at least 4 months after the last dose\n* WCBP must have a negative pregnancy test within the 4 days prior to the first dose of MIRV\n\nExclusion Criteria:\n\n* Patients who have previously been treated with a systemic anti-cancer therapy\n* Patients with low-grade serous, endometrioid, clear cell, or mucinous histology\n* Patients with active or chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment\u002Fmonitoring, such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and \u002For monocular vision\n* Patients with serious concurrent illness or clinically relevant active infection, including, but not limited to the following:\n* History of hepatitis B or C infection (whether or not on active antiviral therapy)\n* History of human immunodeficiency virus (HIV) infection\n* Any other concurrent infectious disease requiring IV antibiotics within 2 weeks prior to the first dose of MIRV\n* Patients with a history of multiple sclerosis (MS) or other demyelinating disease and\u002For Lambert-Eaton syndrome (paraneoplastic syndrome)\n* Patients with clinically significant cardiac disease including, but not limited to, any of the following:\n* Myocardial infarction ≤ 6 months prior to first dose\n* Unstable angina pectoris\n* Uncontrolled congestive heart failure (New York Heart Association \\> class II)\n* Uncontrolled ≥ Grade 3 hypertension (per CTCAE)\n* Uncontrolled cardiac arrhythmias\n* Patients with a history of hemorrhagic or ischemic stroke within 6 months prior to enrollment\n* Patients with a history of cirrhotic liver disease (Child-Pugh Class B or C)\n* Patients with a previous clinical diagnosis of noninfectious interstitial lung disease (ILD), including noninfectious pneumonitis\n* Patients requiring use of folate-containing supplements (eg, folate deficiency)\n* Patients with prior hypersensitivity to monoclonal antibodies (mAb)\n* Women who are pregnant or breastfeeding\n* Patients who received prior treatment with MIRV or other FRα-targeting agents\n* Patients with untreated or symptomatic central nervous system (CNS) metastases\n* Patients with a history of other malignancy within 3 years prior to enrollment Note: patients with tumors with a negligible risk for metastasis or death (eg, adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast) are eligible",{"count":654,"type":22},70,[26],"The proposed study design is a single arm Phase II trial to document the feasibility of carboplatin-mirvetuximab - in patients with advanced-stage EOC. Patients with biopsy confirmed, newly diagnosed, advanced-stage serous EOC deemed appropriate for NACT will have their tumors evaluated for FRα receptor over-expression via a centralized immunohistochemical assay (IHC) and identified as appropriate for study participation if IHC staining is PS2+ in \\>75% of cells (40% of all serous patients). Eligible patients will receive NACT with one cycle of carboplatin, followed by mirvetuximab + carboplatin (if FRα +) every 21 days for three cycles prior to interval cytoreductive surgery (iCRS). A total of 70 will be included in the study. Following completion of 4 cycles total of NACT and after allowing for appropriate recovery of cycle # 4, patients eligible for surgery, will undergo an iCRS. Patients will then complete 3 more cycles of mirvetuximab + carboplatin for a total of 7 intended cycles of treatment. It is up to the treating physician if they want to add bevacizumab to the last 2 cycles or use any type of maintenance therapy. The decision to add bevacizumab or use maintenance therapy does not need to be made upfront. Patients will sign a screening consent form prior to tissue biopsy. If a patient is found to be FRα negative, their treating physician can select the treatment they deem appropriate and the patient will be declared a screen failure. Patients with BRCA mutations are not excluded from this trial and are allowed to receive standard of care maintenance therapy including bevacizumab and\u002For PARP inhibitors.",[84,658,31],"Fallopian Tube",[660,661,662,182],"First line treatment","Advanced epithelial ovarian cancer","mirvetuximab soravtansine","2025-09-01",{"date":665,"type":36},"2025-09-08",{"date":667,"type":36},"2021-05-27",{"date":669,"type":22},"2028-05-31",{"name":671,"class":163},"University of Alabama at Birmingham",9,{"id":674,"slug":675,"hasResults":12,"nctId":676,"briefTitle":677,"officialTitle":678,"acronym":679,"eligibilityCriteria":680,"healthyVolunteers":12,"sex":52,"minAge":18,"maxAge":4,"enrollmentInfo":681,"targetDuration":4,"studyType":23,"phases":683,"briefSummary":684,"conditions":685,"keywords":716,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":746,"lastUpdatePostDateStruct":747,"startDateStruct":749,"completionDateStruct":751,"leadSponsor":753,"locationsCount":5},"100445919","phase-1-a-beta-only-il-2-immunotherapy-study-100445919","NCT05086692","A Beta-only IL-2 ImmunoTherapY Study","A Phase 1\u002F2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors","ABILITY-1","Key Inclusion Criteria:\n\n1. Aged at least 18 years (inclusive at the time of informed consent).\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.\n3. Must be able and willing to provide written informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures.\n4. Histologically or cytologically confirmed locally advanced or metastatic solid tumor (see tumor types listed under conditions)\n5. Demonstrated adequate organ function\n6. Measurable disease as per Response Evaluation Criteria in Solid Tumors, (RECIST v1.1) and documented by CT and\u002For MRI.\n7. Life expectancy of ≥ 12 weeks.\n8. Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and within 72 hours before the first dose of study drug(s). Women must not be breastfeeding.\n9. Agree to use highly effective contraception methods. WOCBP must agree to use highly effective birth control.\n\nKey Exclusion Criteria:\n\n1. Last administration of prior antitumor therapy:\n\n   * Prior systemic anti-cancer therapy including investigational agents within 4 weeks (could consider shorter interval for kinase inhibitors or other short half-life drugs) prior to start of treatment.\n   * Prior radiotherapy within 2 weeks prior to start of treatment or has had a history of radiation pneumonitis. A 1-week washout is required for palliative radiation (\\\u003C2 weeks of radiotherapy) to non-CNS disease.\n   * Radiation therapy to the lung that is \\> 30Gy within 6 months prior to start of treatment.\n   * Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to start of treatment. Concomitant participation in an observational study must be discussed on a case-by-case basis with the MM for approval.\n2. Has known active CNS metastases and\u002For carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to start of treatment, subject to discussion with MM.\n3. Active malignancy (other than the disease under treatment in the study) within the previous 3 years except for curable cancers.\n4. Condition requiring long-term systemic treatment with either corticosteroids \\> 10 mg daily prednisone equivalent or any other form of immunosuppressive therapy within 7 days prior to start of treatment.\n5. Clinically significant active, known or suspected autoimmune disease, or diseases that can be exacerbated with immunotherapy.\n6. Severe pulmonary, cardiac or other systemic disease.\n7. Known hepatitis B or C virus infection.\n8. Females who are pregnant or lactating or planning to become pregnant during the study.\n9. Has had an allogeneic tissue\u002Fsolid organ transplant.\n10. Active infection requiring systemic therapy.\n11. Any medical, emotional or psychiatric condition that interfere with the patient's ability to adhere to the protocol\n12. Any other underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug(s) unsafe or obscure the interpretation of toxicity determination or adverse events.\n13. Known severe hypersensitivity to any component of study drug(s).\n14. Inability to comply with study and follow up procedures as judged by the Investigator.",{"count":682,"type":22},115,[25,26],"This is a Phase 1\u002F2, multi-center, open-label, dose-escalation and expansion study to evaluate safety and tolerability, PK, pharmacodynamic, and early signal of anti-tumor activity of MDNA11 alone or in combination with a checkpoint inhibitor in patients with advanced solid tumors.",[627,686,687,635,688,689,690,691,319,692,693,694,695,696,697,698,699,700,701,702,703,704,31,705,706,707,708,709,60,84,710,711,712,713,714,715,491],"Unresectable Solid Tumor","Clear Cell Renal Cell Carcinoma","Non-Small Cell Lung Cancer Squamous","Non-Small Cell Lung Cancer Non-squamous","Colorectal Cancer (MSI-H)","Gastric Cancer","Basal Cell Carcinoma","Bladder Cancer","Merkel Cell Carcinoma","Squamous Cell Carcinoma of Head and Neck","Cutaneous Squamous Cell Carcinoma","Pleural Mesothelioma","Esophageal Cancer","Endometrial Carcinoma","Solid Tumor","Solid Tumor, Adult","MSI-H Solid Malignant Tumor","Cancer With A High Tumor Mutational Burden","Epithelial Ovarian Carcinoma","Gastroesophageal Junction (GEJ) Cancer","Acral Melanoma","Mucosal Melanoma","Cutaneous Melanoma","DMMR Solid Malignant Tumor","MSI-H Cancer","DMMR Cancer","Pancreas Adenocarcinoma (MSI-H)","Skin Cancer","Viral Cancer","Cervical Cancers",[717,718,719,720,721,722,723,334,724,725,726,727,728,729,730,731,732,733,734,735,736,737,738,453,739,740,741,742,743,744,745],"IL-2","IL2","Interleukin-2","cancer","metastatic","ccRCC","TNBC","CRC","GEJ","intrahepatic","extrahepatic","MCC","SCCHN","CSCC","Gastroesophageal Junction","advanced","unresectable","MSI-H","dMMR","Microsatellite Instability-High","Mismatch Repair Deficient","PD-1","anti-PD-1","BCC","RCC","HCC","Tumor Mutation Burden High","TMB-H","PDAC","2025-07-03",{"date":748,"type":36},"2025-07-09",{"date":750,"type":36},"2021-08-27",{"date":752,"type":22},"2026-12-30",{"name":754,"class":43},"Medicenna Therapeutics, Inc.",{"id":756,"slug":757,"hasResults":12,"nctId":758,"briefTitle":759,"officialTitle":759,"acronym":4,"eligibilityCriteria":760,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":761,"targetDuration":4,"studyType":23,"phases":763,"briefSummary":764,"conditions":765,"keywords":766,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":769,"lastUpdatePostDateStruct":770,"startDateStruct":772,"completionDateStruct":774,"leadSponsor":776,"locationsCount":4},"100596353","phase-2-phase-ii-clinical-study-of-utidelone-capsule-utd2-in-patients-with-advanced-epithelial-ovarian-fallopian-tube-or-primary-peritoneal-cancer-100596353","NCT07044349","Phase II Clinical Study of Utidelone Capsule (UTD2) in Patients With Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer","Inclusion Criteria:\n\n1. Participants who voluntarily sign the informed consent form, are willing and able to comply with the scheduled visits, study treatment plan, laboratory tests, and other study procedures.\n2. Female participants aged ≥ 18 years when signing the informed consent form.\n3. Pathologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal cancer.\n4. Participants with at least one measurable lesion as defined per RECIST v1.1.\n5. Participants must meet the criteria for platinum-resistant recurrence, which is defined as disease progression during platinum-based therapy or disease progression or recurrence within 6 months after the last platinum-based therapy. Note: Participants must have radiographically confirmed disease progression during or after the most recent line of systemic therapy. Biochemical progression is not considered disease progression in this study.\n6. Participants must meet the requirements of failure or intolerance to the existing standard of treatment or no standard of treatment. Prior use of at least 1 but ≤ 3 lines of systemic antitumor treatment (neoadjuvant and adjuvant treatment are not considered prior systemic treatment, unless disease progression occurred during treatment or within 6 months after the last dose of treatment). Maintenance therapy (e.g., bevacizumab, poly-ADP ribose polymerase \\[PARP\\] inhibitors, hormonal therapy) is considered part of the prior line of treatment. Treatment changes due to toxicity without progression will be considered part of the prior line of treatment (i.e., not counted separately).\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n8. Hematology test within 7 days prior to enrollment (based on the laboratory normal range at each site), and no use of recombinant human granulocyte colony-stimulating factor (rhG-CSF) or blood products \u002Ferythropoietin (EPO) within 14 days prior to the laboratory test during the screening period.\n\n   Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL; Platelet count (PLT) ≥ 100 × 109\u002FL; Hemoglobin ≥ 9.0 g\u002FdL.\n9. Blood chemistry test within 7 days prior to enrollment (based on the laboratory normal range at each site); Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); ALT ≤ 3 × ULN (≤ 5 × ULN for participants with liver metastases); AST ≤ 3 × ULN (≤ 5 × ULN for participants with liver metastasis); Creatinine clearance (Ccr) ≥ 60 mL\u002Fmin (calculated by Cockcroft-Gault formula).\n10. Life expectancy ≥ 12 weeks.\n11. Female participants of childbearing potential must agree to use highly effective contraceptive methods and not to donate eggs during the study and for 8 weeks after the last dose of study treatment. Female patients of childbearing potential must have a negative blood or urine pregnancy test result at screening and be willing to undergo additional pregnancy tests as needed throughout the study. See Appendix 1 for details.\n\nExclusion Criteria:\n\n1. The best overall response during the first-line platinum-based treatment is disease progression, or disease recurrence or progression within 3 months after the end of the platinum-based treatment.\n2. History of other malignancies within 5 years prior to enrollment, excluding cured skin basal cell carcinoma, cervical carcinoma in situ, or papillary thyroid carcinoma.\n3. Anti-tumor therapy, including chemotherapy, radiotherapy, target therapy, immunotherapy, etc. within 4 weeks prior to the first dose of the investigational drug, except for the following items;\n\n   1. Received nitrosourea or mitomycin C within 6 weeks prior to the first dose of the investigational drug;\n   2. Oral fluorouracil, small molecule targeted drugs, or endocrine therapy within 2 weeks or within 5 half-lives of the drug prior to the first dose of the investigational drug, whichever is shorter;\n   3. Use of traditional Chinese medicine with anti-tumor indications or endocrine therapy within 2 weeks prior to the first dose of the investigational drug.\n4. Participants who have undergone major surgery (craniotomy, thoracotomy, or laparotomy, or as defined by the investigator) or have experienced significant trauma within 4 weeks prior to the first dose of the investigational product, or those who require elective surgery during the study.\n5. Participants with adverse reactions due to previous antitumor therapy that have not recovered to Grade ≤1 (based on CTCAE 5.0), except toxicities without safety risks as judged by the investigator, such as alopecia.\n6. Participants with gastrointestinal perforation, gastrointestinal fistula, or intra-abdominal abscess, or patients with gastrointestinal hemorrhage, gastrointestinal obstruction (including paralytic ileus), or imaging\u002Fclinical symptoms suggestive of bowel obstruction within 3 months prior to the first use of the investigational product;\n7. Participants who are unable to take oral medications, or with other factors that interfere with the oral administration and absorption of the drug, or those who require total parenteral nutrition.\n8. Participants who need concomitant use of strong CYP3A4 inhibitors or inducers, or medications that prolong the QT interval, within 14 days prior to the first use of the investigational product or during the study.\n9. Participants with symptomatic or uncontrolled central nervous system (CNS) metastases or meningeal metastases, i.e., patients with brain metastasis disease progression confirmed by examination within 2 months after radiotherapy or other local treatments, or patients who are judged by the investigator to be unsuitable for enrollment.\n10. Uncontrolled bone metastases, i.e., patients who have experienced fracture or have the risk of fracture in recent days, patients who need surgery or localized radiotherapy in recent days, or those with other critical conditions as determined by the investigator.\n11. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once per month or more frequently).\n12. History of severe cardiovascular and cerebrovascular diseases, including but not limited to:\n\n    Patients with acute myocardial infarction, severe\u002Funcontrolled angina, or coronary artery bypass surgery within 6 months prior to the first dose of the investigational product; congestive heart failure with a New York Heart Association (NYHA) classification ≥ 2; left ventricular ejection fraction (LVEF) \\\u003C 50%; Fridericia corrected QT interval \\> 470 ms (average of three measurements); or a history of myocarditis (including patients with a past history of myocarditis that recovered after treatment) or other Grade ≥ 3 cardiovascular events.\n\n    Stroke and\u002For transient ischemic attack within 6 months prior to the first dose of the investigational product; Uncontrolled hypertension despite standard treatment; Other heart diseases at high risk, as judged by the investigator.\n13. Participants with uncontrolled diabetes mellitus.\n14. Participants with active hepatitis B and\u002For hepatitis C, i.e., HBsAg positive and HBV DNA positive; anti-HCV positive and HCV RNA positive; positive for human immunodeficiency virus (HIV) antibody; positive for treponema pallidum specific antibody.\n15. Participants who had active infection prior to screening and initial use of the investigational drug and required systemic anti-infective therapy.\n16. Pregnant or breastfeeding women, or women who plan to become pregnant during the study.\n17. Participants with mental disorder or poor compliance.\n18. Participants with prior use of utidelone.\n19. Participants with known hypersensitivity to the investigational product or any of the excipients.\n20. Participants who simultaneously participate in another interventional clinical trial or use other investigational therapies.\n21. Participants who, in the opinion of the investigator, are not suitable to participate in this study due to history of severe systemic diseases or other reasons.",{"count":762,"type":22},72,[26],"This is an open, multicenter, phase II clinical study enrolling patients with platinum-resistant advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer to evaluate the safety and efficacy of Utidelone Capsules. Approximately 72 patients will be included in this study.",[84,60,31],[767,768],"UTD2","Utidelone Capsule","2025-06-23",{"date":771,"type":36},"2025-06-30",{"date":773,"type":22},"2025-09",{"date":775,"type":22},"2027-03",{"name":777,"class":43},"Beijing Biostar Pharmaceuticals Co., Ltd."]