[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649985":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":11,"centralContacts":27,"locations":11,"responsibleParty":33,"collaborators":11,"id":35,"slug":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":39,"acronym":11,"eligibilityCriteria":40,"healthyVolunteers":37,"sex":41,"minAge":42,"maxAge":11,"enrollmentInfo":43,"targetDuration":11,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":11,"overallStatus":52,"whyStopped":11,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":11},{"fullName":5,"class":6},"Peking University Third Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Arm","EXPERIMENTAL",null,[13,14],"Drug: Mirvetuximab soravtansine","Drug: Suvemcitug",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Mirvetuximab soravtansine","6 mg\u002Fkg adjusted ideal body weight (AIBW), administered intravenously (IV) once every 3 weeks (Q3W).",[9],[22],"Mirv",{"type":17,"name":24,"description":25,"armGroupLabels":26,"otherNames":11},"Suvemcitug","1.5 mg\u002Fkg, administered intravenously (IV) once every 2 weeks (Q2W).",[9],[28],{"name":29,"role":30,"phone":31,"phoneExt":11,"email":32},"Hongyan Guo, MD","CONTACT","+86-010-82266699","bysyghy@163.com",{"type":34,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100649985","phase-2-mirvetuximab-soravtansine-combined-with-suvemcitug-in-platinum-resistant-recurrent-ovarian-cancer-100649985",false,"NCT07741630","Mirvetuximab Soravtansine Combined With Suvemcitug in Platinum-Resistant Recurrent Ovarian Cancer","Inclusion Criteria:\n\n\\- Voluntary written informed consent signed prior to any study-related procedures.\n\nFemale age ≥ 18 years at the time of signing informed consent.\n\nHistologically confirmed high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer.\n\nDocumented platinum-resistant recurrence, defined as progression within 6 months after completion of the last platinum-based chemotherapy regimen (excluding primary platinum-refractory disease, defined as progression during or within 3 months of first-line platinum-based therapy).\n\nRadiologically confirmed disease progression during or following the most recent line of therapy.\n\nFRα-positive tumor status verified by the Ventana FOLR1 (FOLR-2.1) CDx IHC assay, defined as ≥25% of tumor cells showing ≥2+ membrane staining intensity.\n\nPresence of at least one measurable lesion according to RECIST v1.1 guidelines as evaluated by investigator imaging.\n\nMust have received 1 to 3 prior systemic antineoplastic therapy lines.\n\nMust have received prior treatment with bevacizumab.\n\nEastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n\nAdequate washout period from prior antineoplastic therapy: ≥5 half-lives or ≥4 weeks for systemic therapy (whichever is shorter); ≥2 weeks for localized palliative radiotherapy.\n\nRecovery or stabilization of all toxicities from prior therapies to Grade ≤1 or baseline (NCI CTCAE v5.0).\n\nMajor surgery completed at least 4 weeks prior to initiation of study treatment, with postoperative toxicities recovered or stabilized.\n\nAdequate bone marrow, hepatic, and renal organ functions.\n\nExclusion Criteria:\n\n\\- Non-serous histological subtypes, including endometrioid, clear cell, mucinous, sarcomatous components, mixed histology containing any of these components, or low-grade\u002Fborderline ovarian tumors.\n\nPrimary platinum-refractory disease (failure to achieve CR\u002FPR to first-line platinum therapy or progression within 3 months after last platinum dose).\n\nPrior wide-field radiation therapy involving ≥20% of bone marrow.\n\nBaseline peripheral neuropathy \\> Grade 1 according to CTCAE v5.0.\n\nActive or chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing medication\u002Fmonitoring (e.g., uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic macular edema, macular degeneration, papilledema, and\u002For monocular vision).\n\nHistory of multiple sclerosis, other demyelinating diseases, or Lambert-Eaton myasthenic syndrome.\n\nUncontrolled severe systemic comorbid conditions (e.g., active infection, non-infectious interstitial lung disease, or clinically significant cardiovascular\u002Fcerebrovascular events within 6 months prior to first dose) rendering the patient unsuitable for the study.\n\nHistory of hemorrhagic or ischemic stroke within 6 months prior to randomization\u002Fenrollment.\n\nHistory of hepatic cirrhosis (Child-Pugh Class B or C).\n\nHistory of bowel obstruction (including subileus) related to underlying disease within 6 months prior to study initiation.\n\nPresence of any of the following:\n\nHistory of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess;\n\nPelvic examination or CT scan indicating rectosigmoid\u002Fgastrointestinal involvement, or clinical signs\u002Fsymptoms of intestinal obstruction.\n\nNon-healing wounds, active ulcers, or bone fractures.\n\nHemoptysis (≥0.5 teaspoon \u002F \\~2.5 mL of fresh red blood per episode) within 4 weeks prior to first dose.\n\nHistory of Posterior Reversible Encephalopathy Syndrome (PRES).\n\nClinically significant proteinuria: Urine Protein\u002FCreatinine Ratio (UPC) ≥ 1.0 or dipstick protein ≥ 2+; if UPC ≥ 1.0 or dipstick ≥ 2+, 24-hour urine protein quantification must be ≤ 1.0 g\u002F24h to be eligible.\n\nHistory of pulmonary embolism.\n\nHistory of Grade 4 thromboembolic events.\n\nPrior treatment with mirvetuximab soravtansine, other FRα-targeting agents, or suvemcitug.\n\nUntreated or symptomatic central nervous system (CNS) metastases.\n\nMalignancy within 3 years prior to enrollment, except for localized cancers treated with curative intent with negligible risk of metastasis or death (e.g., adequately treated basal cell\u002Fsquamous cell skin cancer or carcinoma in situ of the cervix\u002Fbreast).\n\nPregnant or breastfeeding females.\n\nKnown hypersensitivity to any of the study intervention drugs or excipients.\n\nAny other condition that, in the opinion of the investigator, makes the patient unsuitable for trial participation.","FEMALE","18 Years",{"count":44,"type":45},20,"ESTIMATED","INTERVENTIONAL",[48],"PHASE2","his is an open-label, single-center, single-arm, prospective Phase II trial evaluating the efficacy and safety of Mirvetuximab Soravtansine (MIRV) combined with Suvemcitug (SV) in patients with folate receptor alpha (FRα)-positive, platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. A total of 20 eligible patients will receive MIRV (6 mg\u002Fkg AIBW IV Q3W) and Suvemcitug (1.5 mg\u002Fkg IV Q2W) until disease progression or intolerable toxicity. The primary endpoint is investigator-assessed Progression-Free Survival (PFS) per RECIST v1.1.",[51],"PROC","NOT_YET_RECRUITING","2026-07-29",{"date":55,"type":56},"2026-08-03","ACTUAL",{"date":58,"type":45},"2026-08-15",{"date":60,"type":45},"2028-04-30",{"name":5,"class":6}]