[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"platinum-resistant-ovarian-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:platinum-resistant-ovarian-cancer":88},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,21,0,[8,45,72,110,133,158,193,223,248,273,295,348,383,424,472,493,530,553,576,600,620],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100570672","phase-2-a-phase-2-open-label-single-arm-study-of-autologous-m-cenk-adoptive-cell-therapy-and-n-803-il-15-superagonist-in-combination-with-gemcitabine-in-participants-with-recurrent-platinum-resistant-high-grade-ovarian-cancer-100570672",false,"NCT06710288","A Phase 2, Open-label, Single-arm Study Of Autologous M-CENK Adoptive Cell Therapy And N-803 (IL-15 Superagonist) In Combination With Gemcitabine In Participants With Recurrent Platinum-Resistant High-Grade Ovarian Cancer","A Phase 2, Open-label, Single-arm Study Of Autologous Memory Cytokine Enriched Natural Killer (M-CENK) Adoptive Cell Therapy And N-803 (IL-15 Superagonist) In Combination With Gemcitabine In Participants With Recurrent Platinum-Resistant High-Grade Ovarian Cancer","Inclusion Criteria:\n\n1. ≥18 years and \\\u003C85 years old.\n2. Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.\n3. Participants must be appropriate for single-agent therapy as the next line of therapy, as determined by the Investigator.\n4. Participants must have received prior treatment with bevacizumab.\n5. Confirmed diagnosis of platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal or fallopian tube. Platinum-resistant is defined as a relapse within 6 months of receiving 1 to 3 platinum-based chemotherapy regimens.\n6. Must have at least one lesion that meets the definition of measurable disease defined by RECIST v1.1 criteria.\n7. Must have received at least one but no more than three prior systemic lines of anticancer therapy and had progressive disease (PD) while receiving or immediately after receiving the previous therapy. Progression will be calculated from the date of the last administered dose of platinum based therapy to the date of radiographic imaging that showed evidence of progression.\n\n   * Participants who had received one line of platinum-based therapy must have received at least four cycles of their initial platinum-containing regimen, had a response (complete or partial), and then had PD between 3 and 6 months after their last dose.\n   * Participants who had previously received two or three lines of platinum-based therapy must have had PD while receiving the therapy or within 6 months after the last dose.\n8. Participants with germline or somatic BRCA1 or BRCA2 mutations must have received prior PARP inhibitor therapy as maintenance or treatment.\n9. Must have adequate peripheral venous access on both arms, or be willing to have temporary vascular access placed for apheresis collection, if deemed necessary by the Investigator.\n10. Must be able to sit or recline with limited movement for approximately 6 hours during apheresis procedure.\n11. Participants must have been previously tested for FRα. If the test result was positive, they must have been offered treatment with mirvetuximab soravtansine-gynx.\n12. Agreement to practice effective contraception for female participants of childbearing potential. Female participants of childbearing potential must agree to use effective contraception for up to 7 months after completion of study treatment. Effective contraception includes surgical sterilization (eg, tubal ligation), orals, injectables, 2 forms of barrier methods (eg, diaphragm), intrauterine devices (IUDs), and hormonal therapy.\n13. Eastern cooperative oncology group (ECOG) performance status of ≤ 1.\n14. Major surgery must be completed and recovered at least 4 weeks prior to the first dose of study treatment.\n15. Participants must meet the following organ and marrow function as defined below:\n\n    * Absolute neutrophil count ≥ 1,000\u002Fmm3\n    * Platelets ≥ 100,000\u002Fmm3\n    * AST(SGOT)\u002FALT(SGPT) ≤ 3 × institutional ULN\n    * Total bilirubin ≤1.5 × institutional upper limit of normal (ULN) (except Gilbert's or disease-related hemolysis, then \\\u003C 3 × ULN)\n    * Albumin ≥ 3.0 g\u002FdL\n    * Serum creatinine ≤ 2.0 mg\u002FdL OR creatinine clearance ≥ 40 mL\u002Fmin\u002F1.73 m2 by Cockcroft-Gault Formula (Appendix C.1)\n    * Oxygen saturation: ≥ 90% on room air\n16. Participants with a prior 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.\n17. Known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association (NYHA) Functional Classification (Appendix B.2). To be eligible for this trial, participants should be class 2B or better.\n18. Expected survival \\> 16 weeks.\n19. Stated willingness to comply with study procedures.\n20. Able to attend required study visits and return for adequate follow-up, as required by this protocol.\n\nAll inclusion criteria must be answered \"yes\" for a participant to participate in the trial.\n\nExclusion Criteria:\n\nIn order to participate in the study, participants must not meet any of the following criteria:\n\n1. Participants with clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low grade or borderline ovarian tumor.\n2. Distant metastasis outside of the abdominopelvic cavity (e.g., central nervous system, pulmonary, osseous, etc.).\n3. Have had anti-tumor chemotherapy or other investigational agents within 2 weeks prior to M-CENK cell infusion, or immunotherapy within 4 weeks prior, or those who have not recovered from adverse events due to agents administered more than two weeks prior. The intent of the language is to ensure that anti-tumor chemotherapy or other investigational agents are not administered to participants within the specified window since they can potentially affect M-CENK cell activity. Therefore, the washout period is defined by time from NK cell infusion and not patient enrollment. During eligibility confirmation from the study team is requested to confirm that according to the planned M-CENK cell dosing schedule, the washout period should be completed, based on each drug class.\n4. Current bowel obstruction, history of bowel obstruction, or high risk for bowel obstruction (in the opinion of the investigator).\n5. Poor oral intake requiring parenteral nutrition or dependence on intravenous fluids.\n6. Presence or history of ascites.\n7. Receiving any other investigational agents.\n8. Solid organ transplant (allograft) recipients.\n9. Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of the first dose of study treatment with the exception of cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, or other non-invasive or indolent malignancy, or cancers from which the patient has been disease-free for \\> 1 year after treatment with curative intent.\n10. Known hypersensitivity or anaphylaxis to sulfa-containing study medication(s).\n11. Known allergy to dimethyl sulfoxide (DMSO).\n12. Prior history of immune-related toxicity during immune therapy that resulted in permanent discontinuation of therapy (as recommended per product label or consensus guidelines) OR any immune-related toxicity requiring intensive or prolonged immunosuppression to manage (with the exception of endocrinopathy that is well-controlled on replacement hormones) are excluded.\n13. Autoimmune disease: history of inflammatory bowel disease, including ulcerative colitis and Crohn's disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis \\[scleroderma\\], systemic lupus erythematosus, autoimmune vasculitis \\[Wegener's granulomatosis\\]) and motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis). participants with Hashimoto thyroiditis are eligible.\n14. Systemic corticosteroid therapy (\\> 10 mg of prednisone or equivalent dose of systemic steroids for at least 4 weeks prior to NK cell infusion). The intent of this language is to ensure that systemic steroids are not administered to participants within the specified window since this can potentially affect NK cell activity. Therefore, the washout period is defined by time from NK cell infusion and not patient enrollment. During eligibility confirmation the study team is requested to confirm that according to the planned NK cell dosing schedule, the washout period should be completed.\n15. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n16. HIV-positive participants are ineligible because of the potential for pharmacokinetic interactions with anti-retroviral agents used in this study. In addition, these participants are at increased risk of lethal infections when treated with marrow-suppressive therapy.\n17. Active uncontrolled hepatitis B or C are ineligible as they are at high-risk of lethal treatment-related hepatotoxicity in the setting of marrow suppression. Known non-infectious pneumonitis or any history of interstitial lung disease.\n18. Receipt of a live vaccine within 30 days of start of study treatment. During eligibility confirmation the study team is requested to confirm that according to the planned NK cell dosing schedule, the washout period should be completed.\n\nAll exclusion criteria must be answered \"no\" for a participant to participate in the trial.","FEMALE","18 Years","85 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is phase 2 single arm study evaluating the safety and preliminary efficacy of M-CENK adoptive cell therapy and fixed dose of N-803 in combination with gemcitabine in participants with platinum-resistant high-grade ovarian cancer (HGOC).Up to 20 participants will receive M-CENK (IV) and N-803 (SC) in combination with gemcitabine (IV).\n\nParticipants will undergo an apheresis procedure for the collection of mononuclear cells (MNCs) at least 1 day prior to Cycle 1 for manufacturing of M-CENK. Starting in Cycle 1, participants will receive gemcitabine and starting in Cycle 2 they will also receive M-CENK and N-803, until no additional M-CENK is available or confirmed PD per iRECIST, unless the participant is potentially deriving benefit per Investigator's assessment.\n\nParticipants who complete the study treatment or discontinue study treatment will be followed for survival\u002Fdisease status every 12 weeks (± 2 weeks) for up to 12 months after the last study treatment or until death, lost to follow-up, or withdrawal of consent.",[27],"Platinum-resistant Ovarian Cancer",[29,30,31],"high grade ovarian cancer","M-CENK","N-803","RECRUITING","2026-06-29",{"date":35,"type":36},"2026-07-01","ACTUAL",{"date":38,"type":36},"2024-11-06",{"date":40,"type":21},"2027-05",{"name":42,"class":43},"ImmunityBio, Inc.","INDUSTRY",2,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":52,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"100630562","phase-1-gb-5267-for-the-treatment-platinum-resistant-ovarian-peritoneal-or-fallopian-tube-cancer-100630562","NCT07489287","GB-5267 for the Treatment Platinum-Resistant Ovarian, Peritoneal, or Fallopian Tube Cancer","A Phase 1, Open-Label, Dose-Escalation Study Evaluating the Safety and Tolerability of GB-5267, an IL-18 Armored CAR T Cell Product Targeting MUC16, in Patients With Platinum-Resistant Ovarian Cancer","Inclusion Criteria:\n\n* At least 18 years of age\n* Patients must have epithelial ovarian, peritoneal, or fallopian tube cancer that is confirmed by histology or cytology, with a histopathological diagnosis of serous, clear cell, endometrioid, mucinous carcinoma, or carcinosarcoma.\n* Must have platinum-resistant disease, defined as:\n\n  1. Progression of disease within 6 months of last platinum-based chemotherapy, OR\n  2. Patients who have an intolerance for further platinum-based therapy.\n* CA125 \\> 2 x ULN as assessed at the local lab by a 501(k) cleared test at Screening.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Must have evaluable disease or measurable disease defined as:\n\n  a. Measurable lesion as per RECIST v1.1 criteria\n* Adequate hematological function, including:\n\n  1. Absolute neutrophil count (ANC) \\> 1,000\u002Fmm3\n  2. Platelet count \\> 50,000\u002Fmm3\n  3. Hemoglobin \\> 8.5 g\u002FdL\n* Adequate renal function, including estimated creatinine clearance \\> 60 mL\u002Fmin (Cockcroft-Gault) or directly measured with a 24-hour urine collection test.\n* Adequate liver function, including:\n\n  1. Total bilirubin \\\u003C 1.5 x ULN, except in subjects with Gilbert's Syndrome who must have a total bilirubin \\\u003C 3 x ULN\n  2. Aspartate and alanine aminotransferase (AST and ALT) \\\u003C 3 x ULN; \\\u003C 5 x ULN if there is liver involvement by the tumor.\n* Life expectancy of at least 3 months without treatment.\n* Participant must be willing to undergo core or excisional biopsy of a tumor lesion\n\n  1. A pretreatment biopsy must be obtained following completion of screening procedures and at least 7 days prior to the cell infusion.\n  2. An on-treatment biopsy must be performed on Day 28 (±5 days) after infusion.\n  3. An end-of-treatment biopsy must be performed within 10 days of disease progression or any other reason for discontinuation.\n* Individuals of child-bearing potential (ICBP), defined as a sexually mature individual who has not undergone a hysterectomy, bilateral oophorectomy, or tubal ligation, or who has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months,\n\n  1. Must have a negative serum beta human chorionic gonadotropin (β-hCG) pregnancy test, as verified by the Investigator, at Screening and Baseline.\n  2. Must agree to abstain from breastfeeding during study participation and for at least 1 year post-GB-5267 infusion.\n  3. Must agree to use effective methods of contraception during sexual contact that has the possibility of resulting in pregnancy without interruption from the time of infusion until at least 1 year post GB-5267 infusion.\n* Ability and willingness to adhere to the study visit schedule and all protocol requirements.\n* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent form prior to receiving any study related procedure\n\nExclusion Criteria:\n\n* Coagulation Abnormalities and Hemorrhage:\n\n  1. Recent significant bleeding, defined as a history of Grade ≥2 hemorrhage within 30 days before Screening.\n  2. Coagulation parameters (assessed at Screening):\n\n     * Activated partial thromboplastin time (aPTT) \\>1.5 × ULN. Exception: Participants on therapeutic heparin may be allowed if aPTT is between 1.5 and 2.5 × ULN.\n     * International Normalized Ratio (INR) \\>1.5. Exception: Participants on warfarin are allowed if INR is between 2.0 and 3.0 on two consecutive measurements taken 1-4 days apart.\n  3. Anticoagulant use: Current use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes is excluded. Prophylactic anticoagulation (e.g., low-molecular-weight heparin \\[LMWH\\] 40 mg\u002Fday) or use of anticoagulants for venous access device patency is permitted if the participant has been on a stable dose for ≥4 weeks without bleeding complications.\n\n     2\\. History or evidence of thrombotic or hemorrhagic disorders within 3 months prior to Screening, including cerebrovascular accident (CVA) \u002F stroke, transient ischemic attack (TIA), or subarachnoid hemorrhage.\n* Known history or presence of clinically relevant CNS pathology (e.g., untreated or active brain metastases, epilepsy requiring ongoing treatment, stroke or subarachnoid hemorrhage within 3 months, severe neurodegenerative disorders, or psychosis).\n* Active or clinically significant autoimmune disease requiring systemic immunosuppression (e.g., \\>10 mg\u002Fday prednisone equivalent or other immunosuppressants) within the past 6 months.\n\nException: Patients with stable, well-controlled autoimmune conditions, including but not limited to:\n\n* Type 1 Diabetes Mellitus on stable insulin therapy\n* Hypothyroidism managed with hormone replacement\n* Vitiligo\n* Resolved childhood asthma\n* Patients on low-dose immunosuppressants (≤10 mg\u002Fday prednisone equivalent) without recent exacerbations\n* Other non-systemic autoimmune conditions deemed low risk at the Principal Investigator's (PI) discretion\n\n  * Any treatment-related immune-mediated AEs from previous immunotherapy that have not resolved to baseline or Grade ≤1 at least 3 months prior to enrollment.\n  * Ongoing systemic bacterial, viral, or fungal infection not improving despite appropriate antimicrobial therapy, or requiring intravenous (IV) antimicrobials at Screening. Participants receiving prophylactic antimicrobials are eligible if there is no active infection.\n  * Any other active malignancy within 2 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ (e.g., cervix, breast).\n  * Need for urgent intervention due to tumor mass effects (e.g., bowel obstruction or major vascular compression) that would preclude protocol compliance.\n  * Cardiac-Related Exclusions:\n\n    1. History of Class III or IV congestive heart failure, non-ischemic cardiomyopathy, unstable or poorly controlled angina, or peripheral arterial disease event within 6 months prior to enrollment.\n    2. Echocardiogram or multigated acquisition (MUGA) scan with left ventricular ejection fraction (LVEF) \\\u003C40%.\n    3. Previous myocardial infarction within 1 year prior to Screening.\n    4. Clinically significant arrhythmia (e.g., second- or third-degree AV block, paroxysmal atrial fibrillation requiring active treatment, or prior pacemaker\u002Fdefibrillator placement).\n    5. Any history of myocarditis.\n    6. Signs or symptoms of active angina, arrhythmia, or heart failure. Moderate-to-severe valvular disease not surgically corrected is also excluded.\n    7. Baseline plasma troponin above institutional ULN. Exception: Minimally elevated troponin-T is permitted if cleared by a cardiologist.\n    8. Inadequately controlled hypertension (systolic blood pressure \\>150 mmHg or diastolic blood pressure \\>100 mmHg).\n    9. Known history of hypertensive crisis or hypertensive encephalopathy.\n    10. Significant vascular disease (e.g., aortic aneurysm requiring surgical repair, recent peripheral arterial thrombosis) within 6 months prior to enrollment.\n    11. Pericardial involvement in the primary ovarian malignancy.\n  * Pulmonary and Third-Space Fluid:\n\n    1. Oxygen saturation \\\u003C92% on room air.\n    2. Known history or evidence of interstitial lung disease (ILD) or active, non-infectious pneumonitis within the past 5 years.\n    3. Clinically significant third-space fluid (pericardial, pleural, or peritoneal) requiring recurrent drainage, or fluid drained for symptom management within 28 days prior to Screening.\n  * Any serious, uncontrolled medical condition (e.g., cirrhotic liver disease, recent significant trauma, or severe psychiatric illness) that, in the opinion of the Investigator, could compromise participant safety or the interpretation of study data.\n  * Prior or Concurrent Therapies:\n\n    1. Treatment with any previous anti-MUC16 therapy.\n    2. Prior allogenic stem cell transplant.\n    3. Receipt of any cellular or gene therapy.\n    4. Prohibited medications relative to leukapheresis or study treatment:\n\n       1. Steroids: Therapeutic doses (\\>10 mg\u002Fday prednisone equivalent) within 72 hours prior to leukapheresis\u002FGB-5267 infusion; physiologic replacement doses and topical\u002Finhaled steroids are allowed.\n       2. Immunosuppressants: Any non-steroidal immunosuppressive medications (e.g., cyclosporine, biologic TNF inhibitors) within 2 weeks prior to leukapheresis.\n       3. Antiproliferative therapies: Within 2 weeks prior to leukapheresis.\n       4. Radiation therapy: Within 2 weeks prior to leukapheresis.\n  * Live Vaccine Administration:\n\n    1. Receipt of a live vaccine within 30 days prior to enrollment.\n\n       * Infectious Disease (HIV, Hepatitis):\n    2. Active or inadequately controlled hepatitis A, B, or C infection:\n\n       1. Hepatitis A: Positive anti-HAV IgM excludes participation; positive anti-HAV IgG alone is allowed.\n       2. Hepatitis B: Vaccinated individuals (positive HBsAb only) are eligible. Past exposure (HBcAb positive) is permitted if the participant has undetectable HBV DNA for ≥6 months and is on or has completed antiviral prophylaxis.\n       3. Hepatitis C: Participants with positive anti-HCV antibody must have undetectable HCV RNA (PCR) for ≥6 months.\n       4. Participants who are hepatitis antibody-positive but DNA\u002FRNA-negative (e.g., due to recent IVIG) may be allowed at Investigator discretion","ALL",{"count":54,"type":21},18,[56],"PHASE1","This phase 1 study evaluates the safety, efficacy, and biological activity of GB-5267 in patients with platinum-resistant ovarian cancer.",[27],[60],"Ovarian Cancer","2026-06-18",{"date":63,"type":36},"2026-06-22",{"date":65,"type":21},"2026-07-15",{"date":67,"type":21},"2030-01-15",{"name":69,"class":70},"Roswell Park Cancer Institute","OTHER",1,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":82,"conditions":83,"keywords":90,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":4},"100644293","phase-1-a-phase-1-study-to-evaluate-the-safety-and-efficacy-of-opb-201-in-recurrent-endometrial-and-platinum-resistant-ovarian-cancer-100644293","NCT07664735","A Phase 1 Study to Evaluate the Safety and Efficacy of OPB-201 in Recurrent Endometrial and Platinum-resistant Ovarian Cancer.","A Phase 1a\u002Fb Study to Evaluate the Safety and Efficacy of OPB 201, an Autologous PReferentially Expressed Antigen of MElanoma (PRAME) T Cell Receptor (TCR) T Cell Therapy in Recurrent Endometrial and Platinum-resistant Ovarian Cancer.","Inclusion Criteria:\n\n1. Age ≥ 18 years of age at the time of signing the informed consent form.\n2. Histologically confirmed diagnosis of endometrial cancer, epithelial ovarian, peritoneal, or fallopian tube cancer based on local histopathological findings.\n3. Received at least 1 prior line of systemic chemotherapy including a platinum-based chemotherapy.\n4. Received prior therapy with a PARP inhibitor if the subject has a known germline or somatic BRCA1\u002F2 mutation.\n5. Measurable disease.\n6. Consent to provide archived tumor tissue sample.\n7. ECOG performance status of 0 or 1.\n8. Adequate organ function.\n9. HLA-A \\*02:01 or HLA-A \\*02:02\n10. PRAME positive tumor\n\nExclusion Criteria:\n\n1. Women of child-bearing potential who are pregnant or breastfeeding.\n2. Uncontrolled bacterial, fungal, or viral infections.\n3. Active infection requiring systemic therapy.\n4. Bleeding or thrombotic disorders or at risk for severe hemorrhage.\n5. Any form of primary immunodeficiency.\n6. Had an allogenic tissue\u002Fsolid organ transplant.\n7. Active autoimmune disease.\n8. Concurrent treatment with systemic high dose corticosteroids.\n9. Unresolved acute effects of any prior therapy.\n10. Other exclusions as stated in the protocol.",{"count":80,"type":21},30,[56],"The goal of this clinical trial is to learn if OPB-201 is safe in recurrent endometrial and platinum resistant ovarian cancer participants and also to find the optimal dose of OPB-201. Participants will have their own T cells modified in a laboratory and given back to them as OPB-201 in this one-time treatment. Participants will be in the hospital when they receive OPB-201 and then be checked at the clinical site frequently for the first few months.",[84,85,86,60,87,88,89],"Endometrial Cancer Recurrent","Endometrial Cancer","Advanced Endometrial Cancer","Ovarian Cancer Recurrent","Platinum Resistant Ovarian Cancer","Endometrial Cancers",[91,92,93,94,95,96,97,98,99],"Outpace","Ovarian cancer","Endometrial cancer","advanced ovarian cancer","advanced endometrial cancer","cell therapy","TCR-T","TCR","PRAME directed TCR","NOT_YET_RECRUITING","2026-06-17",{"date":103,"type":36},"2026-06-24",{"date":105,"type":21},"2026-06-30",{"date":107,"type":21},"2030-09",{"name":109,"class":43},"Outpace Bio, Inc.",{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":52,"minAge":17,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":22,"phases":119,"briefSummary":120,"conditions":121,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":132},"100555709","phase-1-a-phase-1-study-of-ctim-76-in-patients-with-recurring-ovarian-cancer-and-other-advanced-solid-tumors-100555709","NCT06515613","A Phase 1 Study of CTIM-76 in Patients With Recurring Ovarian Cancer and Other Advanced Solid Tumors","A Phase 1, First in Human Study of CTIM-76, a Claudin-6 (CLDN6)-Directed Bispecific Antibody, in Patients With Recurring Ovarian Cancer and Other Advanced Solid Tumors","Inclusion Criteria:\n\n* Participants with CLDN6 positive platinum resistant\u002Frefractory ovarian, advanced testicular or advanced endometrial cancer.\n* Participants with measurable disease per RECIST 1.1.\n* ECOG 0, 1, or 2 and life expectancy of ≥ 12 weeks.\n* Participants with adequate organ function.\n\nExclusion Criteria:\n\n* Evidence of central nervous system metastases, leptomeningeal disease or spinal cord compression.\n* Uncontrolled significant active infection or any medical or other condition that in opinion of the Investigator would preclude the participant's participation in the study.\n* Concurrent participation in another investigational clinical trial.",{"count":118,"type":21},156,[56],"This is a Phase 1a\u002F1b, open-label, dose escalation and expansion study to evaluate the safety and efficacy of CTIM-76 (study drug), a CLDN6-directed T cell-engaging bispecific antibody , in participants with platinum-refractory\u002Fresistant ovarian cancer (PRROC) and other advanced CLDN6-positive solid tumors (i.e., testicular and endometrial).",[27,122,85],"Testicular Cancer","2026-06-15",{"date":125,"type":36},"2026-06-16",{"date":127,"type":36},"2024-07-10",{"date":129,"type":21},"2028-12-31",{"name":131,"class":43},"Context Therapeutics Inc.",14,{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":52,"minAge":17,"maxAge":18,"enrollmentInfo":140,"targetDuration":4,"studyType":22,"phases":141,"briefSummary":142,"conditions":143,"keywords":149,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":151,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":44},"100540795","phase-1-intraperitoneal-cytokine-induced-memory-like-ciml-natural-killer-nk-cells-in-recurrent-ovarian-cancer-100540795","NCT06321484","Intraperitoneal Cytokine-Induced Memory Like (CIML) Natural Killer (NK) Cells in Recurrent Ovarian Cancer","A Phase 1b Study of Cytokine-Induced Memory Like (CIML) Natural Killer (NK) Cell Therapy in Recurrent Ovarian Cancer","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed recurrent epithelial ovarian cancer. Eligible histologies include high grade serous, high grade endometrioid and clear cell ovarian carcinoma.\n* Participants must have measurable cancer defined by RECIST 1.1 criteria.\n* Patients must have received at least 1 lines of prior systemic therapy and be deemed platinum resistant\u002Fintolerant by their treating oncologist. Patients with germline or somatic BRCA1 or BRCA2 mutations must have received prior PARP inhibitor therapy as maintenance or treatment. Prior receipt of immune checkpoint blockade is allowed if grade 3 or higher toxicities were not experienced.\n* Age ≥18 years and \\\u003C85 years old.\n* ECOG performance status of 0 or 1.\n* Participants must meet the following organ and marrow function as defined below:\n\n  * Absolute neutrophil count ≥1,000\u002FmcL\n  * Platelets ≥75,000\u002FmcL\n  * AST(SGOT)\u002FALT(SGPT) ≤3 x institutional ULN\n  * Total bilirubin ≤1.5 x institutional upper limit of normal (ULN) (except Gilbert's or disease-related hemolysis, then \\\u003C 3 x ULN)\n  * Serum creatinine ≤ 2.0 mg\u002FdL OR glomerular filtration rate (GFR) ≥40 mL\u002Fmin\u002F1.73 m2\n  * Oxygen saturation: ≥ 90% on room air\n  * Left ventricular ejection fraction (cardiac function) ≥ 40%\n  * No laboratory evidence of ongoing hemolysis in opinion of investigator\n* Participants 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.\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.\n* Physician assessment indicating the patient would be able to tolerate undergoing a brief procedure for placement of an intraperitoneal port for NK cell infusion.\n* Ability to understand and the willingness to sign a written informed consent document.\n* The effects of CIML NK cells and IL-2 on the developing human fetus are unknown. For this reason and because CIML NK cells and IL-2 may be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.\n\nExclusion Criteria:\n\n* Participants who have had anti-tumor chemotherapy or other investigational agents within two weeks prior to NK cell infusion (6 weeks for nitrosoureas or mitomycin C), or immunotherapy within 6 weeks prior, or those who have not recovered from adverse events due to agents administered more than two weeks prior.\n* Participants with a bowel obstruction within the last 3 months or high risk for bowel obstruction (in the opinion of the investigator) or current need for parenteral nutrition or dependence on intravenous fluids.\n* Participants who are receiving any other investigational agents.\n* Solid organ transplant (allograft) recipients.\n* Participants with known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of the first dose of study treatment with the exception of cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other non-invasive or indolent malignancy, or cancers from which the patient has been disease-free for \\> 1 year after treatment with curative intent.\n* History of severe or anaphylactic allergic reactions attributed to compounds of similar chemical or biologic composition to CIML NK cells or IL-2 or any of the other agents used in study.\n* For patients with prior exposure to check point inhibitor therapy, those with a prior history of immune-related toxicity during immune therapy that resulted in permanent discontinuation of therapy (as recommended per product label or consensus guidelines) OR any immune-related toxicity requiring intensive or prolonged immunosuppression to manage (with the exception of endocrinopathy that is well-controlled on replacement hormones) are excluded.\n* Autoimmune disease: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis \\[scleroderma\\], systemic lupus erythematosus, autoimmune vasculitis \\[Wegener's granulomatosis\\]) and motor neuropathy considered of autoimmune origin (e.g., GuillainBarre syndrome and myasthenia gravis). Patients with Hashimoto thyroiditis are eligible.\n* Systemic corticosteroid therapy (\\> 10 mg of prednisone or equivalent dose of systemic steroids for at least 4 weeks prior to NK cell infusion).\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant women are excluded from this study because of the unknown teratogenic risk of CIML NK cells and IL-2 and with the potential for teratogenic or abortifacient effects by fludarabine\u002Fcyclophosphamide chemotherapy regimen. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CIML NK cells and IL-2, breastfeeding should be discontinued if the mother is treated on this study.\n* HIV-positive participants are ineligible because of the potential for pharmacokinetic interactions with anti-retroviral agents used in this study. In addition, these participants are at increased risk of lethal infections when treated with marrow-suppressive therapy.\n* Individuals with active uncontrolled hepatitis B or C are ineligible as they are at high-risk of lethal treatment-related hepatotoxicity in the setting of marrow suppression. Known non-infectious pneumonitis or any history of interstitial lung disease.\n* Receipt of a live vaccine within 30 days of start of study treatment. During eligibility confirmation the study team is requested to confirm that according to the planned NK cell dosing schedule, the washout period should be completed.\n* Anaphylactic reactions to murine-based antibody therapy or iron dextran as the CIML NK cell product contains similar reagents at end of manufacturing\u002Finfusion.\n* Prior history of Grade 2 or higher hemolytic anemia (\\>\u002F= 2g decrease in hemoglobin plus laboratory evidence of hemolysis) from any cause.",{"count":54,"type":21},[56],"The goal of this research study is to evaluate the safety and effectiveness of the use of cytokine-induced memory-like (CIML) natural killer (NK) cell therapy in recurrent, high grade ovarian cancer (HGOC).\n\nNames of the study therapies involved in this study are:\n\nCIML NK (cellular therapy) Interleukin-2 (IL-2)",[27,144,60,145,146,147,148],"Recurrent Ovary Cancer","Ovarian Carcinoma","Ovarian Carcinoma, Recurrent","Endometroid Ovarian Carcinoma","Clear Cell Ovarian Carcinoma",[150,144,60,145,146,147,148],"Platinum-Resistant Ovarian Cancer",{"date":125,"type":36},{"date":153,"type":36},"2024-10-09",{"date":155,"type":21},"2031-10-31",{"name":157,"class":70},"Dana-Farber Cancer Institute",{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":22,"phases":168,"briefSummary":170,"conditions":171,"keywords":172,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":20},"100639689","phase-3-an-extension-study-to-assess-the-efficacy-of-rina-s-compared-to-treatment-of-investigators-choice-in-participants-with-platinum-resistant-ovarian-cancer-in-china-100639689","NCT07604766","An Extension Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer in China","A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) Versus Treatment of Investigator's Choice (IC) in Patients With Platinum Resistant Ovarian Cancer","RAINFOL-02","Key Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed high grade serous or endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.\n* Participants may be enrolled regardless of FRα expression level.\n* Participants must have received 1 to 4 prior lines of therapy. Participants must have progressed radiographically on or after their most recent line of therapy.\n* Participants must have received prior treatment with the following therapies:\n\n  * Platinum chemotherapy\n  * Prior bevacizumab (or biosimilar) treatment is required, if labeled and available as standard of care per institutional guidelines, unless the participant has a documented contraindication or unless the participant is not eligible for treatment with bevacizumab (or biosimilar) due to precautions\u002Fintolerance\n  * Participants with known or suspected deleterious germline or somatic breast cancer gene (BRCA) mutations and who achieved a complete or partial response to platinum-based chemotherapy must have been treated with a poly ADP-ribose polymerase (PARP) inhibitor as maintenance treatment unless the participant is not eligible for treatment with PARP inhibitor\n* Mirvetuximab soravtansine, if:\n\n  * Mirvetuximab soravtansine is available in the enrollment region, and\n  * The participant is eligible, and\n  * The participant does not have a documented medical exception, including 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* Participants must have platinum-resistant disease:\n\n  * Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum therapy, and must have either had a response (CR or PR) or had non-measurable disease at the start of adjuvant platinum-based therapy, and then progressed between \\> 91 days and ≤ 183 days after the date of the last dose of platinum.\n  * Participants who have received a protocol defined number of lines of platinum-based therapy must have progressed on or within 183 days after the date of the last dose of platinum.\n\nKey Exclusion Criteria:\n\n* Prior therapy with an antibody-drug conjugate containing a topoisomerase 1 inhibitor.\n* Have primary platinum-refractory disease, defined as ovarian cancer that did not respond (CR or PR) to or progressed ≤ 91 days after the last dose of a first-line platinum-containing regimen.\n* History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), including, but not limited to, adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, ductal carcinoma in situ, or Stage I uterine cancer.\n* Known active central nervous system metastases or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment, they have no new or enlarging brain metastases, and are off corticosteroids and anticonvulsants prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study drug. Participants with suspected brain metastases at screening should undergo a computed tomography (CT)\u002Fmagnetic resonance imaging (MRI) of the brain prior to study entry.\n* Hospitalization or clinical symptoms due to gastrointestinal obstruction within the past 91 days or radiographic evidence of gastrointestinal obstruction at the time of screening. Enrollment of participants who currently require parenteral nutrition must be discussed with the study medical monitor to determine eligibility.\n* Participant has clinically significant ascites\u002Fpleural effusion. Enrollment of participants with an indwelling catheter flush\u002Fdrain is not allowed. Note: Clinically significant is defined as (1) symptomatic, or (2) requires therapeutic paracentesis\u002Fthoracentesis within 8 weeks of the first dose, or (3) recurrent ascites\u002Fpleural effusion that necessitates multiple paracentesis\u002Fthoracocentesis procedures more often than approximately every 4 weeks.\n\nNOTE: Other protocol-defined Inclusion\u002FExclusion criteria may apply.",{"count":167,"type":21},82,[169],"PHASE3","The purpose of this Chinese extension study is to compare how well Rina-S works against platinum-resistant ovarian cancer compared to chemotherapy drugs that are already approved and used for platinum-resistant ovarian cancer.\n\nTreatment in this study could be Rina-S or it could be 1 of 4 indicated chemotherapy agents that are considered standard medical care. There is an equal (50:50) chance of getting Rina-S or an approved chemotherapy agent as treatment in this study. No one will know what treatment they are assigned to until the first dose.\n\nAll participants will receive active drug; no one will be given placebo.\n\nThis study is an extension study of the protocol GCT1184-02 (NCT06619236).",[27],[173,174,175,176,177,178,179,180,181,182,183],"antibody-drug conjugate","folate receptor alpha (FRα)","ovarian cancer","fallopian tube cancer","primary peritoneal cancer","folate receptor","platinum-resistant ovarian cancer (PROC)","rinatabart sesutecan","Topoisomerase 1 inhibitor","PRO1184","GEN1184","2026-06-01",{"date":186,"type":36},"2026-06-02",{"date":188,"type":21},"2026-06",{"date":190,"type":21},"2028-12",{"name":192,"class":43},"Genmab",{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":22,"phases":202,"briefSummary":203,"conditions":204,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":222},"100572213","phase-2-a-study-of-lorigerlimab-in-participants-with-advanced-solid-tumors-100572213","NCT06730347","A Study of Lorigerlimab in Participants With Advanced Solid Tumors","A Phase 2 Multicohort Study to Evaluate Lorigerlimab in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Histologically confirmed high-grade serous epithelial ovarian cancer, including primary peritoneal, or fallopian tube cancer, resistant to platinum based chemotherapy. OR\n* Histologically confirmed clear cell carcinoma of the ovary (including primary peritoneal and fallopian tube), endometrium, vagina, vulva, or cervix.\n* Persistent or recurrent disease with documented disease progression.\n* Participants with PROC must have received at least 1 but not more than 3 prior lines of therapy for PROC.\n* Participants with CCGC must have received at least 1 prior line of therapy for CCGC.\n* Participants with a known breast cancer (BRCA) mutation (germline or somatic) must have received a Poly ADP-ribose polymerase (PARP) inhibitor, if locally approved and available, and experienced disease progression or intolerance on the PARP inhibitor.\n* Participants must have at least one lesion that meets the definition of measurable disease by RECIST v1.1.\n* Participants must have an available archival or formalin-fixed paraffin-embedded tumor tissue, or be willing to undergo a biopsy procedure to obtain a fresh tumor sample.\n* Participants have acceptable physical condition and laboratory values.\n* Participants of childbearing potential must agree to use highly effective methods of birth control.\n* Participants must not be pregnant, planning to be pregnant, or breastfeeding.\n\nExclusion Criteria:\n\n* Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.\n* Primary platinum-refractory disease, defined as disease that did not respond to (CR or PR) or has progressed within 3 months of the last dose of first-line platinum- containing chemotherapy.\n* Prior treatment with a checkpoint inhibitor (e.g., anti-PD-1\u002FPD-L1, anti-PD-L2, anti-CTLA-4). Prior use of immune checkpoint inhibitors (e.g., anti-PD-1, anti-PD-L1, anti-CTLA-4) is allowed for clear cell endometrial and clear cell cervical cancer.\n* Active brain metastases or leptomeningeal metastases.\n* Prior stem cell, tissue, or solid organ transplant.\n* Paracentesis (removal of fluid from the abdomen) within 4 weeks prior to initiation of study treatment.\n* Another hematologic or solid tumor ≥ stage 1 malignancy that completed surgery, last dose of radiotherapy, or last dose of systemic anti-cancer therapy ≤ 3 years from first dose of study treatment. Participants with another tumor that has a negligible risk for metastasis or death such as, adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast are eligible.",{"count":201,"type":21},80,[24],"Study CP-MGD019-03 is an open-label study of lorigerlimab in participants with platinum-resistant ovarian cancer (PROC) or clear cell gynecologic cancer (CCGC). Approximately 80 participants will be enrolled. The study will assess the efficacy and safety of lorigerlimab in participants with PROC or CCGC.\n\nParticipants will receive lorigerlimab by intravenous (IV) infusion on Day 1 of every 21-day treatment cycle. Treatment cycles will continue until progression of cancer, unacceptable side effects, withdrawal of consent by the participant, or the study ends.\n\nParticipants will be monitored closely for side effects by physical exam and routine laboratory tests every cycle. Tumor status will be checked approximately every 9 weeks for the first year, then every 12 weeks for the duration of treatment. Participants will have a safety followup performed within 30 days after treatment discontinuation. Participants who discontinue study treatment for reasons other than progression of cancer, will continue CA-125 and tumor assessments every 12 weeks. Participants who discontinue study treatment for progression of cancer will enter the 6-month survival follow up portion of the study.",[27,205,206,207,208,209,210,211,212,213,85],"Platinum-Resistant Fallopian Tube Carcinoma","Platinum-Resistant Primary Peritoneal Carcinoma","Clear Cell Adenocarcinoma of Ovary","Clear Cell Adenocarcinoma of Vulva","Clear Cell Adenocarcinoma of Vagina","Clear Cell Adenocarcinoma of Cervix","Clear Cell Adenocarcinoma of Uterus","Clear Cell Adenocarcinoma of Fallopian Tube","Clear Cell Adenocarcinoma of Peritoneum","2026-05-29",{"date":186,"type":36},{"date":217,"type":36},"2025-05-01",{"date":219,"type":21},"2027-12",{"name":221,"class":43},"MacroGenics",16,{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":22,"phases":232,"briefSummary":233,"conditions":234,"keywords":235,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":247},"100610349","phase-1-a-first-in-human-study-of-men2501-in-participants-with-platinum-resistant-ovarian-cancer-100610349","NCT07226427","A First-in-Human Study of MEN2501 in Participants With Platinum-Resistant Ovarian Cancer","A Phase 1, First-in-Human Study of MEN2501, a KIF18A Inhibitor, as Monotherapy in Participants With Platinum-Resistant Ovarian Cancer","Key Inclusion Criteria:\n\n* Participants must have a histopathologically confirmed diagnosis of high-grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.\n\nKey Exclusion Criteria:\n\n* Participants with primary platinum-refractory disease.\n\nNote: Other protocol-defined inclusion\u002Fexclusion criteria may apply.",{"count":231,"type":21},100,[56],"This is a first-in-human, open-label, dose-escalation, dose-optimization trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of MEN2501 monotherapy in adult participants with platinum-resistant ovarian cancer.",[27],[236,237,60],"MEN2501","First-in-Human","2026-05-20",{"date":240,"type":36},"2026-05-26",{"date":242,"type":36},"2026-01-10",{"date":244,"type":21},"2028-06-02",{"name":246,"class":43},"Stemline Therapeutics, Inc.",6,{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":22,"phases":257,"briefSummary":258,"conditions":259,"keywords":260,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":71},"100613373","phase-2-losartan-and-paclitaxel-in-platinum-resistant-ovarian-cancer-100613373","NCT07265739","Losartan and Paclitaxel in Platinum Resistant Ovarian Cancer","A Phase 2 Study of Losartan in Combination With Weekly Paclitaxel in Platinum Resistant Ovarian Cancer","Inclusion Criteria:\n\n* The subject must be 18 years of age.\n* Subjects with histologically\u002Fcytologically confirmed advanced epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. Subjects with mucinous carcinoma and low-grade serous carcinoma are not eligible.\n* Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam.\n* Subject is able to provide written, informed consent before initiation of any study related procedures, and is able, in the opinion of the investigator, to comply with all the requirements of the study.\n* Subject has Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n* Subject has adequate organ function at screening:\n\n  i) absolute neutrophil count (ANC) ≥ 1000\u002Fmm3 without the use of hematopoietic growth factors.\n\nii) platelet count ≥ 75,000\u002Fmm3. iii) hemoglobin ≥ 8.0 g\u002FdL (must be at least 1 weeks post-red blood cell transfusion and not receiving erythropoietic-stimulating agents).\n\niv) total bilirubin ≤ 1.5 × the upper limit of normal (ULN). For subjects with documented Gilbert's disease, total bilirubin ≤ 3.0 mg\u002FdL is allowed.\n\nv) serum albumin ≥ 2.5 g\u002FdL vi) serum creatinine clearance (CrCl) ≥ 40 mL\u002Fmin, using Cockcroft and Gault vii) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN in the absence of documented liver metastases; ≤ 5 x ULN in the presence of liver metastases.\n\n* Prior to study Day 1 (first study treatment administration), subject must be:\n\n  i) at least 4 weeks after the most recent biologic (antibody-based) or immunotherapy ii) at least 2 weeks after any prior chemotherapy or targeted small molecule therapy\n* Subjects must have platinum resistant ovarian cancer defined as disease recurrence \\\u003C 6 months after completion of a platinum-containing regimen. Patients with primary platinum refractory disease are eligible. Primary platinum refractory disease is defined as progression of disease prior to completion of 1st line platinum therapy or immediately following (≤ 3 months following last date of chemotherapy).\n* Subjects will have received ≤4 prior lines for platinum resistant ovarian cancer (PROC); maintenance bevacizumab or poly adenosine diphosphate-ribose polymerase (PARP) are not included as a line of therapy.\n* Subjects who are eligible for bevacizumab, mirvetuximab, or PARP inhibitor therapy must have received these treatments. For patients who are ineligible for these treatments or those who decline, this must be documented in the records.\n\nExclusion Criteria:\n\n* Has adverse events (AEs) from prior anti-cancer therapy that have not resolved to Grade ≤ 1, except alopecia.\n* Subjects with asymptomatic central nervous system (CNS) metastases are eligible provided they have been clinically stable and not requiring steroid for at least 4 weeks.\n* Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator), such as significant cardiac or pulmonary morbidity e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 3 months.\n* Impaired cardiac function or clinically significant cardiac disease.\n* Active infection requiring therapy or has a known history of positive Hepatitis B surface antigen (HBsAg) or positive Hepatitis C antibody with detected Hepatitis C virus (HCV) RNA. No testing for Hepatitis B or Hepatitis C is required.\n* Received a live vaccine within 30 days of planned start of study treatment or requiring a live vaccine during the study.\n* Females who are pregnant or breastfeeding.\n* History of severe allergic, anaphylactic, or other hypersensitivity reactions to paclitaxel.\n* Grade 2 peripheral neuropathy at baseline or screening.\n* Essential hypertension or any other condition currently being treated with an angiotensin-converting enzyme (ACE)\u002Fangiotensin II receptor blockers (ARB) inhibitor, calcium channel blocker, diuretic or any other antihypertensive agent.\n* Subjects with a history of orthostasis or syncope.\n* Subjects with a history of hypersensitivity, allergy or intolerance to ACE\u002FARB inhibitors.\n* Subjects with baseline systolic blood pressure ≤ 95 or diastolic blood pressure ≤ 60 obtained on two separate days prior to study enrollment.\n* Subjects with uncontrolled hypertension at baseline defined as systolic blood pressure ≥ 180 or diastolic blood pressure ≥ 110 on two readings obtained on two separate days prior to study enrollment.\n* Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical trial (e.g., substance abuse; psychiatric disturbance; or uncontrolled intercurrent illness including active infection, arterial thrombosis, and symptomatic pulmonary embolism).\n* Presence of any other condition that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the opinion of the investigator, would make the subject inappropriate for entry into the study.",{"count":256,"type":21},27,[24],"The purpose of this Phase II study is to measure the effects of a combination of study drugs, losartan and paclitaxel, on platinum resistant ovarian cancer.",[88],[88,261,262,263],"epithelial ovarian carcinoma","fallopian tube carcinoma","primary peritoneal carcinoma","2026-05-05",{"date":266,"type":36},"2026-05-06",{"date":268,"type":21},"2026-08",{"date":270,"type":21},"2028-12-30",{"name":272,"class":70},"Massachusetts General Hospital",{"id":274,"slug":275,"hasResults":11,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":4,"eligibilityCriteria":279,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":280,"targetDuration":4,"studyType":22,"phases":282,"briefSummary":283,"conditions":284,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":294},"100481630","phase-1-in10018-in-combination-with-standard-chemotherapy-in-high-grade-serous-epithelial-ovarian-cancer-100481630","NCT05551507","IN10018 in Combination With Standard Chemotherapy in High-grade Serous Epithelial Ovarian Cancer","A Phase Ib\u002FII, Open-label Clinical Study to Evaluate the Safety, Tolerability and Antitumor Activities of IN10018 in Combination With Standard Chemotherapy in Subjects With High-grade Serous Epithelial Ovarian Cancer","Inclusion Criteria:\n\n1. Ability to understand and willingness to sign informed consent(s). Signed informed consent must be obtained before any study specific procedures, except those procedures used as institutional standard of care falling into the protocol specified window and fulfilling study specific requirements such as tumor imaging.\n2. Female subjects ≥ 18 years at the time of signing informed consent.\n3. Histologically confirmed epithelia ovarian cancer, fallopian tube cancer or primary peritoneum cancer with the subtype limited to high-grade serous carcinoma (HGSC) only.\n4. Subjects with platinum-resistant disease, defined as having relapsed or progressed between 1- 6 months after completion of prior platinum-based therapy (at least 4 cycles).\n5. Have maximum total of 5 prior lines of systemic therapy and maximum 2 prior lines of systemic therapy following diagnosis of platinum-resistance.\n6. At least one measurable lesion can be accurately measured per RECIST 1.1 as assessed by investigator.\n7. ECOG performance status of 0 or 1.\n8. Life expectancy of at least 3 months as assessed by investigator.\n9. Availability of archival or fresh (newly obtained) tumor tissue sample during Screening Phase: Fresh tumor tissue sample obtained after most recent relapse or progression is preferred; if no sample or not sufficient number of slides can be provided or collected, a joint decision between Sponsor and investigator is needed for the enrollment of this subject.\n10. Must have recovered from all AEs due to previous therapies to ≤ Grade 1 (CTCAE 5.0) or stable status as assessed by investigator.\n11. Adequate bone marrow, liver, renal, and coagulation function within 5 days prior to first dose of study treatment.\n12. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:\n\n    * Not a woman of childbearing potential (WOCBP) . OR\n    * A WOCBP who agrees to follow the contraceptive guidance during the treatment period and through 3 months after the last dose of study treatment.\n\nExclusion Criteria:\n\n1. Has had major surgery or significant traumatic injury within 28 days prior to first dose of study treatment, or diagnostic biopsies within 14 days prior to first dose of study treatment.\n2. Has received prior systemic anticancer therapy including investigational agents, such as within 14 days or less than 5 half-lives (whichever is shorter) of chemotherapy or targeted therapy, or within 28 days of immunotherapy, prior to first dose of study treatment.\n3. Has received prior radiotherapy within 14 days prior to first dose of study treatment.\n4. Has received prior treatment of any FAK inhibitor or prior treatment of PLD.\n5. Has a known previous or concurrent cancer that is distinct in primary site or histology from current ovarian cancer within 3 years prior to first dose of study treatment, except for curatively treated cancers such as cervical carcinoma in situ.\n6. Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n7. Has a history of major cardiovascular, cerebrovascular or thromboembolic diseases (e.g., congestive heart failure, acute myocardial infarction, unstable angina, stroke, transient ischemic attack, deep vein thrombosis or pulmonary embolism) within 6 months before first dose of study treatment, or has any of the following abnormality:\n\n   * QTc interval \\> 480 msec;\n   * Left ventricular ejection fraction (LVEF) \\\u003C 50%;\n   * New York Heart Association (NYHA) functional classification ≥ Grade 2；\n   * Clinically significant arrhythmia;\n   * Uncontrolled hypertension;\n   * Other clinically significant heart diseases.\n8. Has known uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage. Note: A small amount of ascites that can only be detected by imaging examination is allowed.\n9. Has malabsorption syndrome or inability to take oral drugs.\n10. Has clinically significant gastrointestinal abnormalities including uncontrolled gastrointestinal inflammatory lesions (Crohn's disease, or ulcerative colitis in active) or uncontrolled gastrointestinal bleeding.\n11. Has an active infection requiring systemic therapy within 14 days prior to the first dose of study treatment.\n12. Has known human immunodeficiency virus (HIV) infection. Note: No HIV testing is required unless mandated by local health authority and\u002For site.\n13. Has known active Hepatitis B or Hepatitis C virus infection. Note: No testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority and\u002For site.\n14. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n15. Has a known psychiatric or substance abuse disorder that would interfere with the subject's ability to cooperate with the requirements of the study.\n16. Known allergy or hypersensitivity to IN10018 or PLD, or their ingredients.\n17. Has received prior cumulative anthracycline dose of 550 mg\u002Fm2 or more.\n18. Has received systemic treatment of CYP3A4, CYP2D6 or P-gp strong inhibitors\u002Finducers within 14 days prior to the first dose of study treatment, or anticipation of the systemic treatment of these drugs during Treatment Phase.",{"count":281,"type":21},150,[56,24],"This is a phase Ib\u002FII, open label clinical study to evaluate the safety, tolerability and antitumor activities of IN10018 in combination with standard chemotherapy in subjects with high-grade serous ovarian cancer (including fallopian tube cancer and primary peritoneum cancer, collectively defined as ovarian cancer).",[27],"2026-05-01",{"date":287,"type":36},"2026-05-04",{"date":289,"type":36},"2020-07-27",{"date":291,"type":21},"2026-09-30",{"name":293,"class":43},"InxMed (Shanghai) Co., Ltd.",7,{"id":296,"slug":297,"hasResults":11,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":4,"eligibilityCriteria":301,"healthyVolunteers":11,"sex":52,"minAge":17,"maxAge":4,"enrollmentInfo":302,"targetDuration":4,"studyType":22,"phases":303,"briefSummary":304,"conditions":305,"keywords":331,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":339,"startDateStruct":341,"completionDateStruct":343,"leadSponsor":345,"locationsCount":347},"100561192","phase-1-a-study-with-nkt3964-for-adults-with-advancedmetastatic-solid-tumors-100561192","NCT06586957","A Study With NKT3964 for Adults With Advanced\u002FMetastatic Solid Tumors","A Phase 1, First-in-human, Open-label Study to Evaluate the Safety, Tolerability, PK, and Preliminary Anti-tumor Activity of the Novel Oral CDK2 Degrader NKT3964 in Adults With Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n\\- Must have a pathologically confirmed advanced and unresectable or metastatic solid tumor listed below with documented disease progression on last standard treatment. Part 1 only: subjects must be refractory to, or intolerant of existing therapy(ies) known to provide clinical benefit for their condition.\n\nDose Escalation:\n\n1. Ovarian cancer\n2. Endometrial cancer (only endometrioid subtype will require CCNE1 amplification)\n3. Gastric, gastroesophageal junction (GEJ) or esophageal adenocarcinoma with CCNE1 amplification\n4. Small cell lung cancer (SCLC)\n5. Triple-negative breast cancer (TNBC; HER2, estrogen receptor and progesterone receptor negative)\n6. HR+ (includes estrogen-receptor or progesterone-receptor) and HER2- breast cancer (must have progressed following treatment with a CDK4\u002F6 inhibitor, and is not suitable for endocrine therapy \\[ET\\])\n7. Other solid tumors with CCNE1 amplification\n\nDose Expansion:\n\nPart 2A: HR+ and HER2- breast cancer that is locally advanced and unresectable (Stage III) or metastatic (Stage IV); previously treated with ≥1 line of standard of care (SOC) including CDK4\u002F6 inhibitor plus ET and not suitable for further ET. Subjects must have progressed after receiving therapy for ≥3 months in the metastatic setting or for ≥6 months in the adjuvant setting. Subjects must have received ≤2 lines of systemic cytotoxic therapy (chemotherapy or cytotoxic antibody drug conjugate \\[ADC\\]) in the metastatic setting..\n\nPart 2B: Advanced platinum-based-chemotherapy resistant or refractory epithelial ovarian\u002Ffallopian\u002Fprimary peritoneal carcinoma or clear cell ovarian cancer (defined as recurrence ≤6 months after completing platinum-based regimen) with progression on at least one platinum containing therapy and previously treated with ≤4 prior lines of systemic therapy administered for advanced\u002Fmetastatic disease and with CCNE1 amplification.\n\nPart 2C: Advanced unresectable or metastatic gastric, GEJ or esophageal adenocarcinoma with progression on at least one systemic therapy and previously treated with ≤3 prior lines of systemic therapy administered for advanced\u002Fmetastatic disease, with CCNE1 amplification as determined by NGS by local liquid or tissue test.\n\nPart 2D: Advanced endometrial adenocarcinoma or uterine papillary serous carcinoma previously treated with ≤4 prior lines of systemic therapy administered for advanced\u002Fmetastatic disease with CCNE1 amplification.\n\nPart 2E: Advanced\u002Frecurrent uterine carcinosarcoma previously treated with 1 prior platinum-based chemotherapy regimen and ≤3 prior lines of systemic therapy. Prior bevacizumab or PARP inhibitors are allowed and must be at least 3 weeks prior to the start of study drug.\n\n* Have adequate organ function\n* Subjects with female reproductive organs must be surgically sterile, post-menopausal, or must be willing to use highly effective method(s) of contraception\n* Ability to swallow oral medications.\n* Consent to provide archived tumor tissues and paired tumor biopsy at pretreatment\n\nExclusion Criteria:\n\n* Locally advanced solid tumor that is a candidate for curative treatment through radical surgery and\u002For radiotherapy, or chemotherapy.\n* History of another malignancy with exceptions\n* History of lymphohistiocytic or lymphoid hyperplasia; hemophagocytic lymphohistiocytosis.\n* Failed to recover from effects of prior anticancer treatment therapy to baseline or Grade ≤ 1 severity (per CTCAE)\n* Clinically significant cardiovascular event within 6 months prior to start of NKT3964 treatment\n* Known active CNS metastases and\u002For carcinomatous meningitis\n* Active interstitial lung disease currently requiring treatment\n* History of uveitis, retinopathy or other clinically significant retinal disease\n* Active or chronic corneal disorders, other active ocular conditions requiring ongoing therapy, or any clinically significant corneal disease\n* Active wound healing from major surgery within 1 month or minor surgery within 10 days before the first dose of NKT3964.\n* Known human immunodeficiency virus (HIV), active hepatitis B or C infection\n* Prior investigative treatment with a selective or nonselective CDK2 inhibitor or degrader\n* Childs-Pugh class B or C cirrhosis or any other clinically significant liver disorder\n* Palliative radiation therapy within 14 days or other radiation therapy within 4 weeks prior to C1D1",{"count":281,"type":21},[56],"The goal of the Dose Escalation phase of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity to determine the preliminary recommended dose for expansion (RDE) of NKT3964 in adults with advanced or metastatic solid tumors. The goal of the Expansion phase of the study is to evaluate the preliminary anti-tumor activity of NKT3964 at the RDE based on objective response rate (ORR) and determine the preliminary recommended Phase 2 dose (RP2D).",[306,307,308,309,60,310,145,311,312,313,314,315,316,317,318,319,320,321,322,323,324,325,27,326,327,328,329,330],"Solid Tumor","Advanced Solid Tumor","Solid Tumor, Adult","Metastatic Tumor","Ovarian Neoplasms","Metastatic Ovarian Carcinoma","Endometrial Neoplasms","Endometrial Diseases","Metastatic Endometrial Cancer","Triple Negative Breast Cancer","Metastatic Endometrial Carcinoma","Advanced Endometrial Carcinoma","Advanced Ovarian Carcinoma","Gastric Cancer","Advanced Gastric Carcinoma","Metastatic Gastric Cancer","Metastatic Gastric Carcinoma","Small Cell Lung Cancer","Small Cell Lung Carcinoma","Triple Negative Breast Neoplasms","Platinum-refractory Ovarian Carcinoma","CCNE1 Amplification","Hormone Receptor Negative Breast Carcinoma","Human Epidermal Growth Factor 2 Negative Carcinoma of Breast","Progesterone-receptor-positive Breast Cancer",[332,333,334,335,336,337],"CDK 2 Inhibitor","CDK 4 Inhibitor","CDK 6 Inhibitor","CDK2 Degrader","Protein Degrader","PROTAC","2026-04-16",{"date":340,"type":36},"2026-04-21",{"date":342,"type":36},"2024-09-19",{"date":344,"type":21},"2029-05",{"name":346,"class":43},"NiKang Therapeutics, Inc.",19,{"id":349,"slug":350,"hasResults":11,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":4,"eligibilityCriteria":354,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":355,"targetDuration":4,"studyType":22,"phases":357,"briefSummary":358,"conditions":359,"keywords":363,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":294},"100558186","phase-1-a-study-of-mov18-ige-in-patients-with-solid-tumours-that-express-folate-receptor-alpha-100558186","NCT06547840","A Study of MOv18 IgE in Patients With Solid Tumours That Express Folate Receptor Alpha","A Phase Ib, Open-Label Trial of MOv18 IgE in Patients With Solid Tumours That Overexpress Folate Receptor Alpha","Inclusion criteria:\n\nPatients must meet all of the following criteria:\n\n1. Female ≥18 years of age.\n2. Written (signed and dated) informed consent.\n3. Histologically or cytologically confirmed advanced, recurrent or metastatic ovarian cancer, endometrial cancer, triple-negative breast cancer i. Ovarian cancer: must have epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer with high-grade serous or endometrioid features or a predominantly serous\u002Fendometrioid component ii. Endometrial cancer: must have advanced, recurrent or metastatic, endometrial cancer (any subtype excluding endometrial sarcoma) iii. Triple Negative Breast cancer: must have advanced, recurrent or metastatic triple-negative breast cancer (based on the most recently analyzed biopsy from locally recurrent or metastatic site, local laboratory) meeting the following criteria:\n\n   * HER2-negative in situ hybridization test or an immunohistochemistry (IHC) status of 0 or 1+\n   * ER and PgR expressions \\\u003C10% as determined locally by IHC assay as per most recent ASCO\u002FCAP guidelines\n4. Tumour tissue expressing FRα on at least 5% of tumour cells, as determined by immunohistochemistry using either (i) the BN3.2 antibody (Leica Biosystems) or (ii) the FOLR1 (FOLR1-2.1) antibody (Ventana) Note: All patients must be willing to provide an archival tumour tissue block, or undergo a procedure to obtain a new biopsy, using a low risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα positivity using BN3.2 antibody (Leica Biosystems).\n\n   Note: Pre-screening for FRα positivity, using BN3.2 antibody (Leica Biosystems), may be performed at any point in advance of the first administration of MOv18 IgE i. Leica Biosystems BN3.2 antibody 1+ 2+ 3+ staining ii. Ventana FOLR1 antibody criteria 2+ 3+ membrane staining Note: Patients with a medical history confirming tumour tissue expression of FRα, as confirmed by the Ventana FOLR1 antibody, will be considered as meeting inclusion Criteria #4 and will not require a confirmation via Leica Biosystems assay prior to receiving MOv18 IgE. However, in all instances, confirmation of FRα expression using the BN3.2 antibody (Leica Biosystems), will be required to be tested during the trial. Confirmation is not required prior to C1D1.\n\n   Note: Discordant results between the two systems will not result in patient removal from the trial unless deemed appropriate by the treating Investigator.\n5. Negative basophil activation test (BAT) prior to the first administration of MOv18 IgE.\n\n   Note: this test will be performed at a reference laboratory.\n6. Ovarian cancer: platinum-free interval since last dose of platinum, of less than 6 months (182 days).\n7. Prior therapies:\n\n   Ovarian cancer: progressed following ≤2 prior regimens of anti-cancer therapy for platinum resistant ovarian cancer, and, at the time, no other authorised therapy is considered appropriate by the treating investigator.\n\n   i. Patients who received hyperthermic intraperitoneal chemotherapy (HIPEC) or other IP therapies are eligible.\n\n   Endometrial cancer: progressed after any prior line of systemic therapy, and, at the time, no other authorised therapy is considered appropriate by the treating investigator.\n\n   Breast cancer: progressed after any prior line of systemic therapy, and, at the time, no other authorised therapy is considered appropriate by the treating investigator.\n8. Has measurable disease as defined by RECIST v1.1 on CT or MRI scan i. Note: Baseline scans must be performed ≤28 days before the first administration of MOv18 IgE, after discontinuation of the prior regimen.\n\n   ii. Note: Lesions previously embolised, perfused, or irradiated without objective evidence of progression before the first administration of MOv18 IgE are not allowed to be considered for response assessment.\n9. No evidence of bowel obstruction.\n10. ECOG Performance Status Score 0-1 prior to the first administration of MOv18 IgE.\n11. Estimated life expectancy of \\>3 months, in the opinion of the Investigator.\n12. Adequate haematological function, including all of the following:\n\n    i. Absolute neutrophil count (ANC) ≥1.5 × 109\u002FL (\\>1,500\u002Fmm3). G-CSF or GM-CSF may not be used to achieve this level.\n\n    ii. Platelets ≥100 × 109\u002FL (\\>100,000 per mm3) iii. Haemoglobin level \\>9 g\u002FdL obtained within 14 days before the first administration of MOv18 IgE. Packed red blood cell transfusion is acceptable, if the patient has a stable result of ≥9 g\u002FdL for at least 1 week post-transfusion. Erythropoietin should not be used to achieve this level.\n\n    iv. Adequate coagulation function at screening as determined by prothrombin time (PT) ≤1.5 × upper limit of normal (ULN) or international normalised ratio (INR) \\\u003C1.5 and activated partial thromboplastin time (aPTT) ≤1.5 × ULN. Does not apply to patients on an anti coagulant with a stable dose within 28 days prior to first dose.\n\n    v. Lymphocyte count ≥1000 cells\u002Fmm3, (1.0x10\\*9\u002FL)\n13. Intact immune system as demonstrated by CD4 count ≥500 cells\u002Fmm3 and CD8 count ≥150 cells\u002Fmm3.\n14. Adequate renal function as demonstrated by either estimated glomerular filtration rate \\[eGFR\\] or calculated creatinine clearance \\>45 mL\u002Fmin (Cockcroft Gault equation: creatinine clearance: (140-age \\[years\\]) × weight (kg)\u002F(serum creatinine \\[mg\u002FdL\\] × 72) × 0.85 ≤1.5 × ULN, or ≥60 mL\u002Fmin for a patient with creatinine levels \\>1.5 × institutional ULN.\n15. Adequate hepatic function:\n\n    i. Serum total bilirubin ≤1.5 × ULN or direct bilirubin ≤ ULN for a patient with total bilirubin levels \\>1.5 × ULN.\n\n    ii. AST (SGOT) and ALT (SGPT) ≤2.5 × ULN or ≤5 × ULN for a patient with liver metastases.\n\n    iii. Albumin ≥3.0 g\u002FdL.\n16. Recovered from all chemotherapy-related toxicities to Grade ≤1 according to CTCAE v5.0, excluding alopecia (any grade) and peripheral neuropathy (Grade ≤2).\n17. No history of significant cardiac or pulmonary dysfunction, including but not limited to interstitial pulmonary disease and chronic obstructive pulmonary disease.\n18. No active or history of autoimmune disease, (with exception of vitiligo, type I DM, residual hypothyroidism due to autoimmune condition only requiring hormone replacement) and\u002For no history of autoimmune disease that required treatment with steroids or immunosuppressive medication within 6 months of the first administration of MOv18 IgE.\n19. Negative serum or urine pregnancy test.\n20. Women of childbearing potential must have 2 negative pregnancy tests during Screening, the second within 24 hours prior to the first administration of MOv18 IgE. This criterion does not apply to patients who have had a previous hysterectomy or bilateral oophorectomy.\n21. Female patients of child bearing potential must agree to practice true abstinence or to use two forms of contraception, one of which must be highly effective. These forms of contraception must be used from the time of signing consent, throughout the treatment period, and for 6 months, (182 days), following the last dose of any study medication. Oral or injectable contraceptive agents cannot be the sole method of contraception.\n22. Willing and able to comply with all protocol-specified assessments and the trial visit schedule.\n23. Patient has been advised to take measures to avoid or minimise exposure of the skin to UV light, including sunbathing and solarium use for the duration of the trial and for 4 weeks following last administration of MOv18 IgE.\n\nExclusion criteria:\n\nPatients must not meet any of the following criteria:\n\n1. Non-epithelial tumour of the ovary, the fallopian tube, or the peritoneum (including germ cell tumours and sarcomas).\n2. Presence of ascites\u002Fpleural effusion requiring drainage within 28 days of first dose MOv18 IgE or persistent ongoing malignant ascites or pleural effusion requiring an in-dwelling drain.\n3. Taking beta-blockers (at PI discretion) and unable to interrupt beta-blockade (which may counteract the therapeutic effects of adrenaline), or full dose tricyclic anti-depressants\u002FMAOIs (which can dangerously augment the effects of adrenaline). These agents should be discontinued at least 4 half-lives before administration of the first dose of MOv18 IgE. Treatment may be reintroduced 48 hours post dose administration.\n\n   i. Note: Beta blockers may continue if, in the opinion of the Investigator, it would not pose additional risk to the patient ii. Note: Only applies to full dose tricyclic anti-depressants. Low dose tricyclic anti-depressants to support conditions such as peripheral neuropathy, chronic pain, or insomnia, may be permitted at PI discretion\n4. History of laryngeal oedema, uncontrolled or high-risk asthma, or anaphylaxis. Patients with a history of hypersensitivity to carboplatin, taxanes, or contrast media may enter the trial at the Investigator's discretion.\n5. History of parasitic infections, such as helminthiasis within 5 years of the first administration of MOv18 IgE.\n6. Baseline elevation in serum tryptase (indicating possible mastocytosis) or a positive BAT. Tryptase normal range is 2-15 ng\u002FmL.\n7. Receiving systemic anti-cancer therapy, including immunostimulatory agents (e.g., cytokine-based modality, antigen-specific peptide immunotherapy, immune checkpoint blockade, co-stimulatory agonists) within 28 days of the first administration of MOv18 IgE.\n8. Administration of other simultaneous chemotherapy drugs, anti-cancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period (hormonal replacement therapy and denosumab is permitted).\n9. Receiving radiation therapy within 14 days prior to the first administration of MOv18 IgE. Local palliative radiotherapy is permitted; however, if the radiotherapy is to a target lesion, that lesion must be excluded from tumour response assessments.\n10. Chronic treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone (\\>10 mg), cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF agents) within 14 days prior to the first administration of MOv18 IgE, or anticipated requirement for systemic immunosuppressive medications during the trial.\n11. Administration of a live, attenuated vaccine within 28 days prior to Day 1 or anticipation that such a live attenuated vaccine will be required during the trial or within 5 months, (152 days), after the last dose of MOv18 IgE. Influenza vaccination should be given during influenza season only. Patients must not receive live, attenuated influenza vaccination. COVID vaccination is permitted as necessitated.\n12. Previous allogeneic bone marrow transplant or previous solid organ transplantation.\n13. Historical positive serology test for human immunodeficiency virus (HIV).\n14. History of interstitial lung disease or active pneumonitis.\n15. Has a known hypersensitivity to a component of protocol therapy, MOv18 IgE or its vehicle (sodium citrate, L-arginine, sucrose and polysorbate 20).\n16. Positive serology for hepatitis B or C.\n17. Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness.\n18. Has a history within last 12 months or ongoing clinically significant cardiovascular disease such as unstable angina, myocardial infarction, or acute coronary syndrome, symptomatic or uncontrolled arrhythmia, left ventricular failure, congestive heart failure, baseline ECG abnormalities that, in the Investigator's opinion, would be likely to interfere with their participation in the study, or with the interpretation of the results, including, but not limited to, QTc prolongation to greater than 470 ms (as determined by the Fridericia formula), or any Class III or IV cardiac disease as defined by the New York Heart Association Functional Classification.\n19. Concomitant use of drugs known to prolong QT\u002FQTc interval (Appendix 1).\n20. Has a fever ≥38oC within 3 days before the first dose of MOv18 IgE.\n21. No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, surgically treated Stage I or II cancer from which the patient is currently in complete remission (at least to 5 years), or any other non-metastatic cancer controlled by surgery alone or surgery plus radiotherapy from which the patient has been disease-free for 5 years.\n22. Presence of CNS metastases (including spinal metastases) or CNS primary tumour, e.g., glioblastoma.\n23. Clinically significant illness or major surgery within 4 weeks before the administration of MOv18 IgE.\n24. Currently breastfeeding.\n25. Any condition which could interfere with, or the treatment for which might interfere with, the conduct of the trial, or which would, in the opinion of the Investigator, unacceptably increase the patient's risk by participating in the trial\n26. Patient is under legal custodianship.\n27. First-degree relatives of the Investigator, trial staff or Sponsor employees.",{"count":356,"type":21},45,[56],"EPS101-10-02 is a Phase Ib open label, multicentre clinical trial comprising of a Dose Escalation phase (Part 1) followed by a Dose Expansion phase (Part 2) of MOv18 IgE in patients with folate receptor alpha-expressing (5% or higher) platinum resistant ovarian cancer\n\nThe dose escalation part of the study will primarily assess the safety and tolerability of MOv18 IgE in ascending dose cohorts, until the determination of the maximum tolerated dose (MTD) or maximum administered dose (MAD).\n\nPart 2 (dose expansion) will further assess the safety, tolerability and anti-tumour activity of MOv18 IgE.",[360,27,361,362,85,86],"Advanced Ovarian Cancer","Triple Negative Breast Cancer (TNBC)","Triple -Negative Breast Cancer",[364,365,366,367,368,369,370,371,372,373],"Ovarian","Cancer","Resistant","IgE","Advanced","Platinum","Folate Receptor alpha","Antibody","Endometrial","Triple Negative Breast","2026-03-31",{"date":376,"type":36},"2026-04-06",{"date":378,"type":36},"2024-09-03",{"date":380,"type":21},"2027-03",{"name":382,"class":43},"Epsilogen Ltd",{"id":384,"slug":385,"hasResults":11,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":4,"eligibilityCriteria":389,"healthyVolunteers":11,"sex":52,"minAge":17,"maxAge":4,"enrollmentInfo":390,"targetDuration":4,"studyType":22,"phases":392,"briefSummary":393,"conditions":394,"keywords":399,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":421,"locationsCount":423},"100627144","phase-1-study-evaluating-the-safety-and-efficacy-of-hwk-007-a-ptk7-directed-antibody-drug-conjugate-in-participants-with-advanced-solid-tumors-100627144","NCT07444814","Study Evaluating the Safety and Efficacy of HWK-007, a PTK7-directed Antibody Drug Conjugate in Participants With Advanced Solid Tumors","A Phase 1 First-in-Human Study of PTK7-Directed Antibody Drug Conjugate HWK-007 in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\nHave one of the following solid tumor cancers:\n\n1. Monotherapy escalation and backfill cohorts:\n\n   1. non-squamous EGFR-Wt NSCLC\n   2. Endometrial carcinoma\n   3. Platinum Resistant Ovarian Cancer\n2. Monotherapy expansion cohorts:\n\n   1. Non-squamous EGFR-Wt NSCLC\n   2. Additional tumor indications to be defined in a future amendment\n\nExclusion Criteria:\n\n1. Individual with known or suspected uncontrolled central nervous system (CNS) metastases\n2. Individual with history of carcinomatous meningitis\n3. Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection\n4. Individual with evidence of corneal keratopathy or history of cornea transplant\n5. Any serious unresolved toxicities from prior therapy\n6. Significant cardiovascular disease\n7. Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 milliseconds (ms)\n8. History of pneumonitis\u002Finterstitial lung disease\n9. Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention",{"count":391,"type":21},226,[56],"HWK-007-101 is a multicenter, open-label, first-in-human (FIH) Phase 1 study evaluating HWK-007, a protein tyrosine kinase 7 (PTK7)-targeted antibody drug conjugate (ADC), in adult participants with advanced or metastatic solid tumors known to be expressing PTK7. The study employs a sequential dose escalation and dose expansion design without a control group.",[85,60,395,396,397,88,398],"Ovarian Cancer Metastatic","Ovarian Cancer Metastatic Recurrent","Non-squamous EGFR Wt NSCLC","PROC",[400,92,93,401,402,403,404,405,406,407,408,409,410,411,412,413,88,414],"PTK7","NSCLC","Lung cancer","Chemotherapy","ADC","Antibody-Drug-Conjugate","Solid tumor","Phase 1","Ovarian neoplasms","Endometrial neoplasms","Carcinoma, Non Small Cell Lung","Lung neoplasms","Gynecologic cancer","EGFR Wt NSCLC","DNA Topoisomerase I","2026-03-26",{"date":417,"type":36},"2026-03-27",{"date":419,"type":36},"2025-12-19",{"date":190,"type":21},{"name":422,"class":43},"Whitehawk Therapeutics, Inc.",12,{"id":425,"slug":426,"hasResults":11,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":4,"eligibilityCriteria":430,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":431,"targetDuration":4,"studyType":22,"phases":433,"briefSummary":434,"conditions":435,"keywords":442,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":463,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":469,"locationsCount":471},"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":432,"type":21},186,[169],"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.",[27,436,437,438,439,440,441],"Platinum-refractory Ovarian Cancer","Fallopian Tube Cancer","Primary Peritoneal Cancer","High-grade Serous Ovarian Cancer","Endometrioid Ovarian Cancer","Ovarian Clear Cell Carcinoma",[443,444,445,446,447,448,449,450,451,452,175,176,177,453,454,455,456,457,458,459,460,461],"olvimulogene nanivacirepvec","GL-ONC1","GLV-1h68","oncolytic virus","virotherapy","viral therapy","immunotherapy","immunochemotherapy","combination therapy","vaccinia virus","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":464,"type":36},"2026-03-18",{"date":466,"type":36},"2022-08-31",{"date":468,"type":21},"2026-10",{"name":470,"class":43},"Genelux Corporation",31,{"id":473,"slug":474,"hasResults":11,"nctId":475,"briefTitle":476,"officialTitle":477,"acronym":4,"eligibilityCriteria":478,"healthyVolunteers":11,"sex":52,"minAge":17,"maxAge":4,"enrollmentInfo":479,"targetDuration":4,"studyType":22,"phases":481,"briefSummary":482,"conditions":483,"keywords":484,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":485,"lastUpdatePostDateStruct":486,"startDateStruct":488,"completionDateStruct":490,"leadSponsor":492,"locationsCount":423},"100629146","phase-1-a-study-of-muc16-directed-antibody-drug-conjugate-hwk-016-in-participants-with-advanced-solid-tumors-100629146","NCT07470853","A Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors.","A Phase 1 First-in-Human Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors.","Inclusion Criteria:\n\n* Have one of the following solid tumor cancers:\n\n  1. Monotherapy escalation, backfill and expansion cohorts:\n\n     1. Endometrial Carcinoma\n     2. Ovarian Cancer\n  2. Combination Escalation, Backfill and Expansion Cohorts a. Ovarian Cancer\n\nExclusion Criteria:\n\n1. Individual with known or suspected uncontrolled central nervous system (CNS) metastases\n2. Individual with history of carcinomatous meningitis\n3. Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection\n4. Individual with evidence of corneal keratopathy or history of cornea transplant\n5. Any serious unresolved toxicities from prior therapy\n6. Significant cardiovascular disease\n7. Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 milliseconds (ms)\n8. History of pneumonitis\u002Finterstitial lung disease\n9. Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention",{"count":480,"type":21},265,[56],"HWK-016-101 is a multicenter, open-label, first-in-human (FIH) Phase 1 study evaluating HWK-016, a targeted antibody-drug conjugate (ADC) in adult participants with advanced or metastatic solid tumors. The study employs a dose escalation and dose expansion design without a control group.\n\nThe study consists of 2 parts (Part A: monotherapy and Part B: combination therapy with bevacizumab); each part has 2 phases, Phase 1a (dose escalation) and Phase 1b (dose expansion). Enrollment to Part A (Phase 1a and Phase 1b) will include ovarian and endometrial cancers. Enrollment to Part B (Phase 1a and Phase 1b) will include ovarian cancer only. A subsequent protocol amendment may evaluate additional tumor types.",[398,88,85],[60,85,398,364,372,404,407,406],"2026-03-09",{"date":487,"type":36},"2026-03-13",{"date":489,"type":21},"2026-03-15",{"date":491,"type":21},"2028-02",{"name":422,"class":43},{"id":494,"slug":495,"hasResults":11,"nctId":496,"briefTitle":497,"officialTitle":498,"acronym":4,"eligibilityCriteria":499,"healthyVolunteers":11,"sex":52,"minAge":17,"maxAge":4,"enrollmentInfo":500,"targetDuration":4,"studyType":22,"phases":502,"briefSummary":503,"conditions":504,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":523,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":423},"100534718","phase-1-a-study-of-mgc026-in-participants-with-advanced-solid-tumors-100534718","NCT06242470","A Study of MGC026 in Participants With Advanced Solid Tumors","A Phase 1\u002F1b First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Adults ≥ 18 years old, able to provide informed consent\n* Adequate performance and laboratory parameters\n* Availability of archival or formalin-fixed paraffin-embedded tumor tissue sample. Participants may undergo a fresh tumor biopsy to obtain a specimen for testing if an archival tumor sample is not available. Participants with no available archival tissue sample who cannot safely undergo a fresh biopsy as determined by consultation between the sponsor and investigator are eligible\n* Unresectable, locally advanced or metastatic solid tumors including: squamous cell cancer (SCC) of the head and neck, esophageal SCC, squamous and non-squamous non-small cell lung cancer, small cell lung cancer, bladder cancer, sarcoma, endometrial cancer, melanoma, castration resistant prostate cancer, breast cancer, ovarian cancer, cervical cancer, colorectal cancer gastric or gastroesophageal cancer, pancreatic carcinoma, clear cell renal cell cancer or hepatocellular cancer.\n* Measurable disease per RECIST v1.1. Participants with metastatic CRPC without measurable disease are eligible.\n* Must be willing to use highly effective methods of birth control from the time of consent through 7 months after discontinuation of MGC026.\n* Not pregnant or breastfeeding.\n\nExclusion Criteria:\n\n* Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.\n* Another cancer that required treatment within the past 2 years, with the exception of those with low risk of cancer spreading or death such as adequately treated non melanomatous skin cancer, localized prostate cancer (Gleason Score \\\u003C 6), or carcinoma in situ.\n* Patients with history of prior central nervous system (CNS) metastasis must have been treated, be asymptomatic, and not have concurrent treatment for CNS disease, progression of CNS metastases on magnetic resonance imaging, computed tomography or positron emission tomography, or history of leptomeningeal disease or cord compression at the time of enrollment.\n* Treatment with surgery, systemic cancer therapy, immunotherapy, chimeric antigen receptor-T therapy, or anti-hormonal within protocol specified intervals.\n* Prior treatment with any B7-H3 targeted agent for cancer or any ADC with a topoisomerase payload.\n* Prior autologous or allogeneic stem cell or solid organ transplant.\n* Clinically significant cardiovascular, pulmonary, or gastrointestinal disorders.\n* Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 1 week of first study drug administration.\n* Known history of hepatitis B or C infection or known positive test for hepatitis B surface antigen or core antigen, or hepatitis C polymerase chain reaction.\n* Known positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome.\n* History of primary immunodeficiency.\n* Major trauma or major surgery within 4 weeks of first study drug administration.\n* Known hypersensitivity to recombinant proteins.",{"count":501,"type":21},250,[56],"The study is designed to understand the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of MGC026 in participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors The study has a dose escalation portion and a cohort expansion portion of the study.\n\nParticipants will receive MGC026 by intravenous (IV) infusion. The dose of MGC026 will be assigned at the time of enrollment. Participants may receive up to 35 treatments if there are no severe side effects and as long as the cancer does not get worse. Participants will be monitored for side effects, and progression of cancer, have blood samples collected for routing laboratory work, and blood samples collected for research purposes.",[307,505,506,507,508,509,510,511,85,512,513,514,515,319,516,517,518,519,27,520,60,521],"Advanced Cancer","Metastatic Cancer","Squamous Cell Carcinoma of Head and Neck","Non Small Cell Lung Cancer","Small-cell Lung Cancer","Bladder Cancer","Sarcoma","Melanoma","Castration Resistant Prostatic Cancer","Cervical Cancer","Colorectal Cancer","Gastro-esophageal Cancer","Pancreas Cancer","Clear Cell Renal Cell Carcinoma","Hepatocellular Carcinoma","Breast Cancer","Esophageal Squamous Cell Cancer (SCC)","2026-02-03",{"date":524,"type":36},"2026-02-05",{"date":526,"type":36},"2024-03-06",{"date":528,"type":21},"2028-10",{"name":221,"class":43},{"id":531,"slug":532,"hasResults":11,"nctId":533,"briefTitle":534,"officialTitle":535,"acronym":4,"eligibilityCriteria":536,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":537,"targetDuration":4,"studyType":22,"phases":538,"briefSummary":539,"conditions":540,"keywords":541,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":544,"lastUpdatePostDateStruct":545,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":552},"100595319","phase-1-a-study-to-evaluate-the-safety-and-efficacy-of-opb-101-in-platinum-resistant-ovarian-cancer-100595319","NCT07030907","A Study to Evaluate the Safety and Efficacy of OPB-101 in Platinum-resistant Ovarian Cancer","A Phase 1a\u002Fb Study to Evaluate the Safety and Efficacy of OPB-101, an Autologous Mesothelin (MSLN) CAR T Cell Therapy With Antigen-dependent Expression of OUTSMART™ Designed IL-2 Cytokine in Platinum-resistant Ovarian Cancer","Inclusion Criteria:\n\n1. Age ≥ 18 years of age at the time of signing the informed consent form.\n2. Histologically confirmed diagnosis of high grade serous epithelial ovarian, peritoneal, or fallopian tube cancer based on local histopathological findings.\n3. Recurrent platinum-resistant disease defined as: Disease that has recurred within 6 months of the last receipt of platinum-based therapy.\n4. Received at least 2 prior lines of systemic chemotherapy including a platinum-based chemotherapy.\n5. Received prior therapy with a PARP inhibitor if the subject has a known germline or somatic BRCA1\u002F2 mutation.\n6. Measurable disease.\n7. Consent to provide archived tumor tissue sample.\n8. ECOG performance status of 0 or 1.\n9. Adequate organ function.\n10. Alkaline phosphatase ≤ 2.5 x ULN\n11. ≤ Grade 1 dyspnea and oxygen saturation levels (SpO2) \\> 92% on room air.\n12. LVEF ≥ 50%\n13. Life expectancy of ≥ 3 months\n14. Adequate venous access.\n15. Negative screen for infectious disease markers.\n16. Negative serum pregnancy test.\n17. Abstain from heterosexual activity or to use 2 forms of effective methods of contraception.\n\nNote: Other protocol defined inclusion criteria could apply\n\nExclusion Criteria:\n\n1. Women of child-bearing potential who are pregnant or breastfeeding.\n2. Uncontrolled bacterial, fungal, or viral infections.\n3. Active infection requiring systemic therapy.\n4. Bleeding or thrombotic disorders or at risk for severe hemorrhage.\n5. Any form of primary immunodeficiency.\n6. Had an allogenic tissue\u002Fsolid organ transplant.\n7. Active autoimmune disease.\n8. Concurrent treatment with systemic high dose corticosteroids.\n9. Unresolved acute effects of any prior therapy.\n10. Active invasive cancer other than the cancer under study.\n11. Significant lung disease.\n12. Clinically significant pericardial effusion.\n13. Prior radiotherapy within 2 weeks of start of study intervention.\n14. No major surgery within 28 days prior to enrollment.\n15. Received investigational agents or tumor vaccines.\n16. Received chemotherapy within the previous 3 weeks.\n17. History of grade ≥ 3 ascites.\n18. Active CNS involvement.\n19. Received a live vaccine within 30 days prior to study treatment.\n20. Received prior CAR T cell therapy.\n21. Received prior mesothelin targeted therapy.\n22. Dependent on intravenous hydration or total parenteral nutrition. Note: Other protocol defined exclusion criteria could apply",{"count":80,"type":21},[56],"The goal of this clinical trial is to learn if OPB-101 is safe in platinum resistant ovarian cancer participants and also to find the optimal dose of OPB-101.\n\nParticipants will have their own T cells modified in a laboratory and given back to them as OPB-101 in this one-time treatment. Participants will be in the hospital when they receive OPB-101 and then be checked at the clinical site frequently for the first few months.",[87,60,88],[91,92,542,96,543],"Advanced ovarian cancer","CAR T","2025-12-11",{"date":546,"type":36},"2025-12-18",{"date":548,"type":36},"2025-06-16",{"date":550,"type":21},"2030-05-15",{"name":109,"class":43},4,{"id":554,"slug":555,"hasResults":11,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":4,"eligibilityCriteria":559,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":560,"targetDuration":4,"studyType":22,"phases":562,"briefSummary":563,"conditions":564,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":566,"lastUpdatePostDateStruct":567,"startDateStruct":569,"completionDateStruct":571,"leadSponsor":573,"locationsCount":575},"100540334","phase-2-a-study-of-cbx-12-in-subjects-with-platinum-resistant-or-refractory-ovarian-cancer-100540334","NCT06315491","A Study of CBX 12 in Subjects With Platinum Resistant or Refractory Ovarian Cancer","A Randomized Phase 2 Study of CBX 12 in Subjects With Platinum Resistant or Refractory Ovarian Cancer","Inclusion Criteria:\n\n* Subjects must have histologically- or cytologically-diagnosed epithelial high-grade serous cancer of the ovary, fallopian tube cancer or primary peritoneum cancer that is refractory to prior therapy and must have platinum-resistant disease defined as:\n\n  * Subjects who have received only 1 platinum-based chemotherapy regimen for at least 4 cycles of platinum must have disease progression on treatment or occurring ≤ 26 weeks after their last dose of platinum.\n  * Patients who have progressed following a second course of a platinum based regimen.\n  * Subjects may have up to 2 additional systemic regimens for advanced or metastatic disease. Maintenance regimens (e.g., with a PARP inhibitor or bevacizumab) are not considered separate regimens.\n* Age greater than or equal to 18 years at the time of signing the informed consent form (ICF).\n* Has measurable disease per RECIST 1.1.\n* Has provided written informed consent.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Adequate liver, renal, hematologic, pulmonary and coagulation function.\n\nExclusion Criteria:\n\n* Cytotoxic chemotherapy, biologic agent, investigational agent, or radiation therapy within 3 weeks prior to the first dose of CBX-12.\n* Subjects who are currently receiving any other anticancer or investigational agent(s).\n* Clinically significant intercurrent disease.\n* Active human immunodeficiency virus (HIV) infection.\n* Active hepatitis B or C infection.",{"count":561,"type":21},40,[24],"The purpose of this study is to assess the safety, tolerability, and efficacy of CBX-12 in female subjects with platinum resistant or refractory ovarian cancer at 2 doses; 125 mg\u002Fm2 every 21 days or 100 mg\u002Fm2 every 21 days.",[27,565],"Refractory Ovarian Carcinoma","2025-10-02",{"date":568,"type":36},"2025-10-06",{"date":570,"type":36},"2024-09-25",{"date":572,"type":21},"2025-10",{"name":574,"class":43},"Cybrexa Therapeutics",17,{"id":577,"slug":578,"hasResults":11,"nctId":579,"briefTitle":580,"officialTitle":581,"acronym":4,"eligibilityCriteria":582,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":583,"enrollmentInfo":584,"targetDuration":4,"studyType":22,"phases":586,"briefSummary":587,"conditions":588,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":591,"lastUpdatePostDateStruct":592,"startDateStruct":594,"completionDateStruct":596,"leadSponsor":598,"locationsCount":71},"100602005","phase-2-etoposide-capsules-combined-with-bevacizumab-and-iparomlimab-and-tuvonralimab-in-the-treatment-of-platinum-resistant-or-platinum-refractory-ovarian-cancer-100602005","NCT07117877","Etoposide Capsules Combined With Bevacizumab and Iparomlimab and Tuvonralimab in the Treatment of Platinum Resistant or Platinum Refractory Ovarian Cancer","Etoposide Capsules Combined With Bevacizumab and Iparomlimab and Tuvonralimab in the Treatment of Platinum Resistant or Platinum Refractory Ovarian Cancer: a Single Arm, Open, Single Center, Phase II Clinical Study","Inclusion Criteria:\n\n1. Age: 18-75, female;\n2. According to RECIST 1.1 criteria, there are measurable lesions at baseline;\n3. ECOG PS： 0-1；\n4. Epithelial ovarian, fallopian tube, and primary peritoneal cancer with platinum resistance or platinum refractory recurrence; Provide 10 white films for pathological type confirmation and efficacy marker exploration, and meet all of the following conditions.\n\n   ① Received systemic treatment with ≥ 1 line and ≤ 6 lines, among which only received systemic treatment with ≤ 4 lines after platinum resistance relapse.\n\n   ② Previous treatments should include at least one platinum based chemotherapy regimen. There are two specific situations:\n   1. For patients who have only received 1-line platinum based chemotherapy in the past, disease remission (CR or PR) must be achieved, and disease progression must occur within a period of ≥ 4 weeks and\\\u003C6 months after the last platinum based chemotherapy.\n   2. For patients who have received systemic treatment from line 2 to line 5 in the past, it is required that disease progression must occur within a period of less than 6 months after the last platinum based chemotherapy.\n\n   Note: When determining the number of lines, the following requirements should be noted:\n\n   The overall count of neoadjuvant ± adjuvant systemic therapy is one line. Maintenance treatment does not calculate the number of lines separately. Simple endocrine therapy is counted as a baseline, but the use of endocrine therapy due to non disease progression (such as only elevated CA-125) is not counted as a baseline.\n\n   Changing the treatment plan due to intolerance without disease progression is not considered as changing the line.\n\n   The subject needs to experience disease progression after the final systemic treatment.\n5. The main organ functions well and meets the following criteria:\n\n   1. Blood routine examination (without blood transfusion or correction with hematopoietic stimulating factor drugs within 14 days): hemoglobin (Hb) ≥ 90g\u002FL; Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL; platelet count (PLT) ≥ 90 × 109\u002FL;\n   2. Biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN for tumor liver metastases); Serum total bilirubin (TBIL) ≤ 1.5 × ULN (Gilbert syndrome subjects, ≤ 3 × ULN); Serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance rate ≥ 60mL\u002Fmin;\n   3. Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5 × ULN;\n   4. Urine routine examination shows urinary protein\\\u003C2+; If urinary protein is ≥ 2+, 24-hour urinary protein quantification should be\\\u003C1 g;\n   5. Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ 50%.\n6. Non surgical sterilization or female patients of childbearing age are required to use two medically approved contraceptive measures (such as intrauterine devices, birth control pills, or condoms) during the study treatment period and within 3 months after the end of the study treatment period; Female patients of childbearing age who undergo non-surgical sterilization must have a negative serum HCG test within 72 hours before their first medication and must be non lactating; For male patients whose partners are women of childbearing age, two effective methods of contraception should be used during the study treatment period and within 3 months after the end of the study treatment period.\n7. The subjects voluntarily joined this study, signed informed consent forms, had good compliance, and cooperated with follow-up.\n\nExclusion Criteria:\n\n1. Patients who participate in other clinical trials simultaneously;\n2. Allergic constitution, including a history of severe drug allergies or drug allergic reactions; Known to be allergic or intolerant to the investigational drug;\n3. No measurable lesions or lesions that cannot be evaluated;\n4. Patients with untreated central nervous system metastases, who have previously received systemic or curative treatment for brain or meningeal metastases (radiotherapy or surgery), have been confirmed stable for at least one month by imaging, and have stopped systemic hormone therapy (dose\\>10mg\u002Fday prednisone or other therapeutic hormones) for more than two weeks without clinical symptoms can be included;\n5. Those who are unable to swallow pills normally or have gastrointestinal dysfunction, as determined by researchers, may affect drug absorption;\n6. Individuals who have experienced intestinal obstruction within the past 3 months;\n7. At present, there are uncontrollable malignant pleural effusion, ascites, or pericardial effusion (defined as those that cannot be effectively controlled by diuretics or puncture methods as determined by researchers);\n8. Suffering from uncontrolled comorbidities, including but not limited to: active HBV or HCV infection; Known history of HIV infection or AIDS; Active syphilis; Active tuberculosis; Active infection; Uncontrolled hypertension and symptomatic heart failure; Active bleeding;\n9. History of myelodysplastic syndrome (MDS)\u002Facute myeloid leukemia (AML) or other malignant tumors within 5 years prior to the initial administration of the study (excluding completely relieved carcinoma in situ and malignant tumors with slow progression determined by the investigator)\n10. Other incurable malignant tumors in the past (within 5 years) or at the same time, except for cured skin basal cell carcinoma, cervical carcinoma in situ and breast cancer with no recurrence after radical surgery\\>3 years;\n11. Pregnant or lactating women;\n12. According to the researchers' assessment, there may be other factors that could lead to the forced termination of this study, such as other serious illnesses (including mental illnesses) requiring concurrent treatment, serious laboratory abnormalities, and family or social factors that could affect the safety of the subjects or the collection of data and samples.","75 Years",{"count":585,"type":21},33,[24],"This study is a Prospective, Single-arm, Phase II clinical trial. The purpose of this study is to find out if taking Etoposide Capsules combined With Bevacizumab and Iparomlimab and Tuvonralimab is safe and works well for people with platinum-resistant or platinum refractory ovarian cancer . Researchers will look at the Progression-Free Survival, Objective Response Rate, Overall Survival, safety, and any side effects.",[88,589,590],"Platinum Refractory Epithelial Ovarian Cancer","Ovarian Cancer (OvCa)","2025-08-22",{"date":593,"type":36},"2025-08-28",{"date":595,"type":21},"2025-09-15",{"date":597,"type":21},"2027-08-31",{"name":599,"class":70},"Fudan University",{"id":601,"slug":602,"hasResults":11,"nctId":603,"briefTitle":604,"officialTitle":605,"acronym":4,"eligibilityCriteria":606,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":583,"enrollmentInfo":607,"targetDuration":4,"studyType":22,"phases":609,"briefSummary":610,"conditions":611,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":612,"lastUpdatePostDateStruct":613,"startDateStruct":615,"completionDateStruct":617,"leadSponsor":619,"locationsCount":71},"100590899","phase-2-phase-ii-study-of-utidelone-plus-fruquintinib-combination-therapy-for-platinum-resistant-recurrent-ovarian-cancer-100590899","NCT06973421","Phase II Study of Utidelone Plus Fruquintinib Combination Therapy for Platinum-Resistant Recurrent Ovarian Cancer","Preliminary Phase II Clinical Study on the Efficacy and Safety of the Combination of Utidelone Capsules and Fruquintinib Capsules in the Treatment of Platinum Resistant Recurrent Ovarian Cancer","Inclusion Criteria:\n\n1. The subjects were fully informed, voluntarily signed the informed consent, and were willing and able to follow the planned visit, research treatment plan, laboratory examination and other research procedures.\n2. Female subjects aged ≥ 18 and ≤ 70 at the time of signing the informed consent.\n3. Malignant epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer were confirmed by histology or pathology.\n4. Subjects had at least one measurable lesion defined by RECIST v1.1.\n5. The number of lines of previous systematic anti-tumor treatment ≤ 3 (neoadjuvant and adjuvant chemotherapy are not considered as previous systematic treatment, unless disease progression occurs during its chemotherapy or within 6 months after the last chemotherapy).\n6. ECoG physical status score was 0 or 1.\n7. The baseline examination confirmed that there was sufficient bone marrow and organ function, and no relevant supportive treatment, such as gcs-f, EPO or blood transfusion, was used within 14 days before the laboratory examination in the screening period. (see the table on the next page for specific indicators)\n8. The expected survival time was more than 12 weeks.\n9. Fertile patients must agree to use reliable contraceptive methods (hormone or barrier method or abstinence) with their partners during the trial and at least 3 months after the last medication; The blood or urine pregnancy test of female patients of childbearing age must be negative before enrollment.\n\nExclusion Criteria:\n\n1. It has clear cell, mucinous or sarcomatous histology, contains mixed tumors of any histological type, or low-grade\u002Fborderline ovarian cancer.\n2. In platinum refractory ovarian cancer subjects, platinum refractory was defined as the best response during the first platinum containing regimen treatment as disease progression or recurrence, or disease recurrence or progress within 4 weeks after the end of platinum containing regimen treatment.\n3. Other malignant tumors within 5 years, excluding cured basal cell carcinoma of the skin, carcinoma in situ of the cervix and papillary carcinoma of the thyroid.\n4. Received nitrosourea or mitomycin C within 6 weeks before the first use of the study drug; received anti-tumor treatment within 4 weeks or 5 half lives (whichever is shorter) before the first use of the study drug, including chemotherapy, radiotherapy, biological targeted therapy, immunotherapy, etc; Oral fluorouracil, small molecule targeted drugs and endocrine therapy were used 2 weeks before the first use of the study drug or within 5 half lives of the drug (whichever is shorter); Traditional Chinese medicine or Chinese patent medicine with anti-tumor indications were used within 2 weeks before the first use of the study drug.\n5. Major surgical operations (craniotomy, thoracotomy or laparotomy or other operations defined by the investigator) or significant trauma were performed within 60 days before the first use of the study drug, or elective surgery was required during the trial.\n6. There were patients with clinically significant skin wounds, surgical sites, wound sites, severe mucosal ulcers or fractures that were not completely healed as assessed by the researchers.\n7. Patients with peripheral neuropathy with CTCAE 5.0 rating ≥ 2.\n8. The adverse reactions of previous anti-tumor treatment have not recovered to CTCAE 5.0 grade evaluation ≤ 1 (except for the toxicity without safety risk judged by researchers such as hair loss).\n9. Patients who have previously received eutidylon or antiangiogenic drugs (except bevacizumab).\n10. Urine protein detection 2+or more, or 24-hour urine protein quantitation ≥ 1.0g\u002F24h.\n11. There were symptoms or thyroid dysfunction requiring treatment at the time of screening.\n12. Patients with obvious evidence of bleeding tendency or medical history within 2 months before the first use of the study drug, such as black stool, hematemesis, hemoptysis, occult blood in stool++, etc.\n13. Subjects with active central nervous system metastasis.\n14. Cancerous ascites with clinical symptoms requiring puncture and drainage; Or those who received drainage for the purpose of treatment within 30 days before the first use of the study drug.\n15. During screening, it was found that the tumor invaded the structure of large blood vessels, such as pulmonary artery, superior vena cava or inferior vena cava, and the researchers judged that there was a high risk of bleeding; Or there is a history of previously known aneurysms.\n16. There was a history of arterial thrombosis or deep venous thrombosis within 6 months before the first use of the study drug; Thrombosis caused by implantable venous infusion pump or catheter, or superficial venous thrombosis, except those with stable thrombosis after regular anticoagulation therapy.\n17. Patients with coagulation disorders, bleeding tendency, or undergoing anticoagulation therapy 2 months before the first use of the study drug.\n18. Have a history of serious cardiovascular and cerebrovascular diseases, including but not limited to:\n\n    Acute myocardial infarction, severe\u002Funstable angina pectoris or coronary artery bypass grafting within 6 months before the first use of the study drug; The New York Heart Association (NYHA) classification of congestive heart failure was ≥ 2; LVEF\\\u003C50%； Or there is a history of myocarditis (including patients who have been cured after treatment of previous myocarditis) or other grade 3 or above cardiovascular events; Stroke events and\u002For transient cerebral ischemia occurred within 12 months before the first use of the study drug; Patients with uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg) were given standard treatment; Other researchers judged that there was a high risk of heart disease.\n19. Uncontrolled diabetic patients within 3 months before the first use of the study drug.\n20. Patients with active hepatitis B and\u002For C, i.e. HBsAg positive and\u002For HBcAb positive, detected HBV DNA positive and\u002For anti HCV positive and HCV RNA positive at the same time; Human immunodeficiency virus (HIV) antibody was positive; Treponema pallidum specific antibody was positive.\n21. active infection or fever of unknown origin (body temperature\\>38.5 ℃) before screening and first use of the study drug.\n22. patients with active autoimmune diseases need systemic treatment (i.e. disease regulators, corticosteroids or immunosuppressive drugs) within 2 years before enrollment. Replacement therapy (such as thyroxine, insulin or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered as a systemic treatment.\n23. women who are pregnant or nursing or plan to be pregnant during the study period.\n24. patients with mental disorders or poor compliance.\n25. known allergic to the study drug or any of its excipients.\n26. participate in another intervention clinical trial or use other research treatment at the same time.\n27. the researcher believes that the subject has a serious history of systemic diseases or other reasons and is not suitable to participate in the trial.",{"count":608,"type":21},35,[24],"This study is a Prospective, Single-arm, Phase 2 clinical trial. The purpose of this study is to find out if taking Utidelone Capsules together with Fruquintinib Capsules is safe and works well for people with platinum-resistant ovarian cancer . Researchers will look at the Objective Response Rate, Progression-Free Survival, Overall Survival, safety, and any side effects.",[88],"2025-05-07",{"date":614,"type":36},"2025-05-15",{"date":616,"type":21},"2025-07-01",{"date":618,"type":21},"2028-06-30",{"name":599,"class":70},{"id":621,"slug":622,"hasResults":11,"nctId":623,"briefTitle":624,"officialTitle":625,"acronym":4,"eligibilityCriteria":626,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":627,"targetDuration":4,"studyType":22,"phases":629,"briefSummary":630,"conditions":631,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":632,"lastUpdatePostDateStruct":633,"startDateStruct":635,"completionDateStruct":637,"leadSponsor":639,"locationsCount":44},"100422934","phase-2-a-comparison-of-2-standard-doses-of-bevacizumab-in-combination-with-chemotherapy-in-epithelial-ovarian-cancer-100422934","NCT04787289","A Comparison of 2 Standard Doses of Bevacizumab in Combination With Chemotherapy in Epithelial Ovarian Cancer","A Comparison of 2 Standard Doses of Bevacizumab in Combination With Chemotherapy in Epithelial Ovarian Cancer - a Pragmatic Trial","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of epithelial ovarian cancer, primary peritoneal, or fallopian tube carcinoma according to WHO Classification of tumours that is advanced\u002Fmetastatic\u002Frecurrent or unresectable and for which no curative therapy exists.\n* Platinum resistant disease (progression within six months of completing a platinum-containing protocol). In this case, progression from the last line of therapy would be defined as radiologic progression by RECIST 1.1 criteria on CT or MR.\n* Presence of clinically and\u002For radiologically documented disease. All radiology studies must be performed within 28 days of randomization.\n* All patients must have measurable disease as defined by RECIST 1.1. The criteria for defining measurable disease are as follows:\n\n  * Chest x-ray \\> 20 mm\n  * CT scan (with slice thickness of 5 mm) \\> 10 mm longest diameter\n  * Physical exam (using calipers) \\> 10 mm Lymph nodes by CT scan \\> 15 mm measured in short axis\n* Patients must be \\>= 18 years of age.\n* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.\n* Any number of prior lines of treatment is permitted. However, all patients must have received at least one prior regimen of chemotherapy including platinum. All patients may have received other therapies including immunotherapy, hormone therapy, or PARP inhibitors.\n* Patients must have never received an anti-angiogenesis inhibitor including bevacizumab.\n* A BC Cancer \"Compassionate Access Program\" (CAP) request must be approved prior to treatment\n* Radiation: prior external beam radiation is permitted provided a minimum of 28 days (4 weeks) have elapsed between the last dose of radiation and date of treatment initiation. Exceptions may be made for low-dose, non-myelosuppressive radiotherapy after consultation with sponsor.\n* Surgery: Previous surgery is permitted provided that a minimum of 28 days (4 weeks) have elapsed between any major surgery and date of randomization\u002Fregistration, and that wound healing has occurred.\n* Women of childbearing potential must have agreed to use a highly effective contraceptive method during the study and for up to 5 months after the last dose of chemotherapy\u002Fbevacizumab. A woman is considered to be of \"childbearing potential\" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, \"effective contraception\" also includes heterosexual celibacy and surgical sterility defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation, or vasectomy\u002Fvasectomized partner.\n* Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to any study specific procedures (see Section 6.0) to document their willingness to participate.\n\nPatients who cannot give informed consent (i.e. mentally incompetent patients, or those physically incapacitated such as comatose patients) are not to be recruited into the study. Patients competent but physically unable to sign the consent form may have the document signed by their Legally Acceptable Representative (LAR) or legal guardian. Each patient will be provided with a full explanation of the study before consent is requested.\n\n* Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits. Investigators must assure themselves the patients registered on this trial will be available for complete documentation of the treatment, response assessment, adverse events, and follow-up.\n\nExclusion Criteria:\n\n* Patients with a history of other active or current malignancies that require active treatment.\n* Patients with serious illness or medical conditions that might be aggravated by treatment or limit compliance including, but not limited to:\n\n  * History of significant neurologic or psychiatric disorder which would impair the ability to obtain consent or limit compliance with study requirements.\n  * Uncontrolled hypertension\n  * Active uncontrolled or serious infection (viral, bacterial or fungal)\n  * Other medical conditions that might be aggravated by study treatment\n* Patients receiving concurrent treatment with other anti-cancer therapy or investigational agents.\n* Neutrophils less than 1 x 10\\^9 \u002FL\n* Pregnancy or breastfeeding\n* Bleeding diathesis\n* History of bowel obstruction or unresolved bowel obstruction (refer to the BC Cancer protocols above)\n* Uncontrolled arterial or venous thromboembolism (note: once controlled, patient may still be eligible).\n* Myocardial infarction (MI) or cerebrovascular accident (CVA) within 4 months.\n* Untreated or uncontrolled central nervous system (CNS) metastatic disease.\n* Open, non-healing wounds or known fistulas that have not healed.",{"count":628,"type":21},244,[24],"A pragmatic, two armed, study comparing 2 standard doses of an anti-cancer drug called bevacizumab, given in combination with Chemotherapy. The study will be offered to ovarian cancer patients whose disease is platinum chemotherapy resistant . Higher doses of anti-cancer based drugs are not always better than lower doses and can cause more side effects without improvement of cancer. These patients will be randomly assigned either 7.5 mg\u002Fkg or 15mg\u002Fkg of bevacizumab combined with chemotherapy . Comparing these two doses will determine if the lower dose-level is non-inferior, and could lead to practice changes.",[60,27],"2024-08-06",{"date":634,"type":36},"2024-08-07",{"date":636,"type":36},"2021-09-10",{"date":638,"type":21},"2025-01-31",{"name":640,"class":70},"British Columbia Cancer Agency"]