[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629146":3},{"organization":4,"armGroups":7,"interventions":42,"overallOfficials":55,"centralContacts":62,"locations":70,"responsibleParty":252,"collaborators":254,"id":257,"slug":258,"hasResults":259,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":54,"eligibilityCriteria":263,"healthyVolunteers":259,"sex":264,"minAge":265,"maxAge":54,"enrollmentInfo":266,"targetDuration":54,"studyType":269,"phases":270,"briefSummary":272,"conditions":273,"keywords":277,"overallStatus":92,"whyStopped":54,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":293},{"fullName":5,"class":6},"Whitehawk Therapeutics, Inc.","INDUSTRY",[8,14,18,22,26,31,34,38],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A - Dose Escalation - 21 Day treatment cycles","EXPERIMENTAL","Escalating doses of HWK-016, a MUCIN-16-targeted ADC administered intravenously (IV)",[13],"Drug: HWK-016, MUCIN-16-targeted ADC",{"label":15,"type":10,"description":16,"interventionNames":17},"Part A - Dose Expansion Group 1 - 21-day treatment cycle - Tumor TBD","Dose Optimization of Recommended dose for expansion 1",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Part A - Dose Expansion Group 2 - 21-day treatment cycle - Tumor TBD","Expanded enrolment at Recommended Dose for Expansion 2 in Ovarian Cancer",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Part A - Dose Expansion Group 3 - 21-day treatment cycle - Tumor TBD","Expansion of enrolment at RDE 1 or 2 in Tumor TBD",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Part B - Dose Escalation - 21 Day treatment cycles of HWK-016 in combination with Bevacizumab","Escalating doses of HWK-016, a MUCIN-16-targeted ADC administered intravenously (IV) combined with Bevacizumab (IV) in Ovarian cancer",[13,30],"Drug: Bevacizumab",{"label":32,"type":10,"description":24,"interventionNames":33},"Part A - Dose Expansion Group 4 - 21-day treatment cycle - Tumor TBD",[13],{"label":35,"type":10,"description":36,"interventionNames":37},"Part B - Dose Expansion Cohort 1- 21 Day cycles of HWK-016 in combination with Bevacizumab","Expanded enrolment at RDE of HWK-016, a MUCIN-16-targeted ADC administered intravenously (IV) combined with Bevacizumab (IV) in Ovarian cancer",[13,30],{"label":39,"type":10,"description":40,"interventionNames":41},"Part B - Dose Expansion Cohort 2 - 21 Day cycles of HWK-016 in combination with Bevacizumab","Expanded enrolment at RDE of HWK-016, a MUCIN-16-targeted ADC administered intravenously (IV) combined with Bevacizumab (IV) in Tumor TBD",[13,30],[43,50],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"DRUG","HWK-016, MUCIN-16-targeted ADC","HWK-016 is a MUCIN-16-targeted Antibody-Drug-Conjugate (ADC) being developed for the treatment of solid tumors.",[9,15,19,23,32,27,35,39],[49],"HWK-016",{"type":44,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"Bevacizumab","Bevacizumab administered according to the USPI in 21-day cycles",[27,35,39],null,[56,60],{"name":57,"affiliation":58,"role":59},"Margaret C Dugan, MD","Whitehawk Therapeutics","STUDY_DIRECTOR",{"name":61,"affiliation":58,"role":59},"Edward Spindler, BS, MBA",[63,68],{"name":64,"role":65,"phone":66,"phoneExt":54,"email":67},"Clinical Trial Manager Lead","CONTACT","888-392-9025","WHWK-Clinical-Trials@whitehawktx.com",{"name":69,"role":65,"phone":54,"phoneExt":54,"email":67},"Central email mailbox - Whitehawk Therapeutics",[71,90,106,121,136,151,165,178,193,208,223,238],{"facility":72,"status":73,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"University of Arkansas - Winthrop P. 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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":267,"type":268},265,"ESTIMATED","INTERVENTIONAL",[271],"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.",[274,275,276],"PROC","Platinum Resistant Ovarian Cancer","Endometrial Cancer",[278,276,274,279,280,281,282,283],"Ovarian Cancer","Ovarian","Endometrial","ADC","Phase 1","Solid tumor","2026-03-09",{"date":286,"type":287},"2026-03-13","ACTUAL",{"date":289,"type":268},"2026-03-15",{"date":291,"type":268},"2028-02",{"name":5,"class":6},12]