[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"proc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:proc":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,87],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100629146","phase-1-a-study-of-muc16-directed-antibody-drug-conjugate-hwk-016-in-participants-with-advanced-solid-tumors-100629146",false,"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","ALL","18 Years",{"count":19,"type":20},265,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","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.",[26,27,28],"PROC","Platinum Resistant Ovarian Cancer","Endometrial Cancer",[30,28,26,31,32,33,34,35],"Ovarian Cancer","Ovarian","Endometrial","ADC","Phase 1","Solid tumor","RECRUITING","2026-08-17",{"date":39,"type":40},"2026-08-18","ACTUAL",{"date":42,"type":40},"2026-03-15",{"date":44,"type":20},"2028-02",{"name":46,"class":47},"Whitehawk Therapeutics, Inc.","INDUSTRY",12,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":48},"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":57,"type":20},226,[23],"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.",[28,30,61,62,63,27,26],"Ovarian Cancer Metastatic","Ovarian Cancer Metastatic Recurrent","Non-squamous EGFR Wt NSCLC",[65,66,67,68,69,70,33,71,35,34,72,73,74,75,76,77,27,78],"PTK7","Ovarian cancer","Endometrial cancer","NSCLC","Lung cancer","Chemotherapy","Antibody-Drug-Conjugate","Ovarian neoplasms","Endometrial neoplasms","Carcinoma, Non Small Cell Lung","Lung neoplasms","Gynecologic cancer","EGFR Wt NSCLC","DNA Topoisomerase I","2026-08-03",{"date":81,"type":40},"2026-08-05",{"date":83,"type":40},"2025-12-19",{"date":85,"type":20},"2028-12",{"name":46,"class":47},{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":93,"minAge":17,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":21,"phases":96,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":4},"100649985","phase-2-mirvetuximab-soravtansine-combined-with-suvemcitug-in-platinum-resistant-recurrent-ovarian-cancer-100649985","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",{"count":95,"type":20},20,[97],"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.",[26],"NOT_YET_RECRUITING","2026-07-29",{"date":79,"type":40},{"date":104,"type":20},"2026-08-15",{"date":106,"type":20},"2028-04-30",{"name":108,"class":109},"Peking University Third Hospital","OTHER"]