[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07444814":3,"trial-entities:NCT07444814":332,"trial-summary:NCT07444814":340},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":26,"study_type":44,"primary_purpose":45,"phases":46,"enrollment_info":48,"interventions":51,"primary_outcomes":64,"secondary_outcomes":77,"sex":127,"minimum_age":128,"maximum_age":129,"healthy_volunteers":130,"eligibility_criteria":131,"std_ages":135,"locations":138,"central_contacts":316,"overall_officials":323,"references":330,"see_also_links":331},"NCT07444814","HWK-007-101","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","RECRUITING","2028-12","2026-08","2026-08-05","2025-12-19","Whitehawk Therapeutics, Inc.","INDUSTRY",true,"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.","The study consists of 2 phases, Phase 1a (dose escalation) and Phase 1b (dose expansion). In Phase 1a, participants with non-squamous Endothelial Growth Factor Receptor Wild type (EGFR Wt) NSCLC, platinum resistant ovarian cancer (PROC), and endometrial cancer will be enrolled. In Phase 1b, non-squamous EGFR Wt NSCLC expansion cohort(s) will be opened, based on the safety, tolerability, PK, and preliminary antitumor data in Phase 1a.\n\nIn Phase 1a of the study, HWK-007 will initially be administered as an intravenous (IV) infusion every 3 weeks (Q3W).",[19,20,21,22,23,24,25],"Endometrial Cancer","Ovarian Cancer","Ovarian Cancer Metastatic","Ovarian Cancer Metastatic Recurrent","Non-squamous EGFR Wt NSCLC","Platinum Resistant Ovarian Cancer","PROC",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,24,43],"PTK7","Ovarian cancer","Endometrial cancer","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","INTERVENTIONAL","TREATMENT",[47],"PHASE1",{"count":49,"type":50},226,"ESTIMATED",[52],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":62},"DRUG","HWK-007","HWK-007 is a PTK7- targeted ADC being developed for the treatment of solid tumors.",[57,58,59,60,61],"Dose Escalation - 21 Day treatment cycle","Dose Expansion Group 1- 21-day treatment cycle - non-squamous EGFR-WT NSCLC","Dose Expansion Group 2 - 21-day treatment cycle - Tumor TBD","Dose Expansion Group 3 - 21-day treatment cycle - Tumor TBD","Dose Expansion Group 4 - 21-day treatment cycle - Tumor TBD",[63],"HWK-007 anti-PTK7 targeted ADC",[65,69,73],{"measure":66,"description":67,"timeFrame":68},"Determine Maximum Tolerated Dose (MTD)","Determine the highest dose of HWK-007 that can be administered without signs of toxicity measured at the end of Cycle 1 (21 day cycle) by: Incidence and severity of Adverse Events (AE). Incidence of Dose-Limiting Toxicities (DLT). Incidence of Serious Adverse Events (SAE).","From Cycle 1, Day 1 until Cycle 1, Day 21 (21-day cycles)",{"measure":70,"description":71,"timeFrame":72},"Determine Maximum Administered Dose (MAD)","Determine the highest dose administered during the dose escalation part of the study measured at the end of Cycle 1 (21 day cycle) by: Incidence and severity of Adverse Events (AE). Incidence of Dose-Limiting Toxicities (DLT). Incidence of Serious Adverse Events (SAE).","From Cycle 1, Day 1 to Cycle 1, Day 21 (21-day cycles) until the MTD is reached.",{"measure":74,"description":75,"timeFrame":76},"Determine the Recommended Dose for Expansion (RDE)","Determine the dose that will be recommended for further study within the tumor types studied in this clinical trial measured at the end of Cycle 1 (21 day cycle) by: Incidence and severity of Adverse Events (AE). Incidence of Dose-Limiting Toxicities (DLT). Incidence of Serious Adverse Events (SAE).","From Cycle 1, Day 1 to Cycle 1, Day 21 (21-day cycles) until MTD is identified.",[78,82,86,90,94,98,102,106,109,112,116,120,123],{"measure":79,"description":80,"timeFrame":81},"Characterize the Volume of Distribution (Vd) of HWK-007 (ADC, total antibody, CPT116, and CPT119)","Pharmacokinetic analysis of HWK-007 in human subjects","Cycle 1 and Cycle 4 (21-day cycles)",{"measure":83,"description":84,"timeFrame":85},"Assess ADA (Anti drug antibody) against HWK-007","Using a blood test, determine the risk of developing anti-drug antibodies against HWK-007 following infusion in human patients.","Every cycle from Cycle 1, Day 1 (21-day cycles) until 30 days past the last dose of study drug for up to 24 months.",{"measure":87,"description":88,"timeFrame":89},"Evaluate the Overall Response Rate (ORR)","Measure the response rate to the study drug by CT-scans evaluated using RECIST1.1","From Cycle 1, Day 1 (21-day cycles), every 6-weeks for the first 4 assessments and then every 6 weeks for up to 24 months until disease progression or 24 months, whichever comes first.",{"measure":91,"description":92,"timeFrame":93},"Evaluate Overall Survival (OS).","Measure how long patient lives following treatment with HWK-007","From Cycle 1, Day 1 (21-day cycles) until death or 24 months, whichever comes first.",{"measure":95,"description":96,"timeFrame":97},"Maximum Concentration - Cmax of HWK-007 (ADC, total antibody, CPT116, and CPT119)","Maximum amount of study drug and drug components in blood following infusion.","At Cycle 1 and Cycle 4 - (21-day cycles)",{"measure":99,"description":100,"timeFrame":101},"Time to Maximum Concentration (Tmax) of HWK-007 (ADC, total antibody, CPT116, and CPT119)","Time to reach maximum concentration of drug and drug components in blood following infusion.","At Cycle 1 and Cycle 4 (21-day cycles).",{"measure":103,"description":104,"timeFrame":105},"Area Under the Concentration Time Curve (AUC) for HWK-007 (ADC, total antibody, CPT116, and CPT119)","The total area under the concentration time curve of study drug and drug components following infusion.","Cycle 1 and Cycle 4 - (21-day cycles)",{"measure":107,"description":108,"timeFrame":81},"T1\u002F2 - Half-life of HWK-007 (ADC, total antibody, CPT116, and CPT119)","Time for 1\u002F2 of the infused drug to be eliminated\u002Fmetabolized",{"measure":110,"description":111,"timeFrame":81},"Clearance (CL)","Measured rate at which HWK-007 is cleared from the blood following infusion.",{"measure":113,"description":114,"timeFrame":115},"Evaluate the Duration of Response (DoR) to HWK-007","Measure the time from evidence of response by CT-scan until evidence of progression of cancer.","From Cycle 1, Day 1 (21-day cycles) until disease progression or 24 months, whichever comes first.",{"measure":117,"description":118,"timeFrame":119},"Evaluate Progression-free Survival (PFS)","Measure the time from the first infusion of HWK-007 until evidence of cancer progression is detected.","From Cycle 1, Day 1 (21-day cycles) infusion to End of Study (up to 24 months)",{"measure":121,"description":122,"timeFrame":115},"Evaluate Disease control Rate (DCR)","Measure the time from Cycle 1, Day 1 that cancer does not worsen by RECIST1.1 criteria.",{"measure":124,"description":125,"timeFrame":126},"Time to Response (TTR)","Time from Cycle 1, Day 1 infusion of HWK-007 until evidence of response via CT scan according to RECIST1.1 criteria.","From Cycle 1, Day 1 (21-day cycles) until End of Study or 24 months, whichever comes first.","ALL","18 Years",null,false,{"inclusion":132,"exclusion":133,"raw_text":134},[],[],"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",[136,137],"ADULT","OLDER_ADULT",[139,156,171,186,201,216,231,248,261,274,286,300],{"facility":140,"status":8,"city":141,"state":142,"zip":143,"country":144,"contacts":145,"geoPoint":153},"University of Arkansas","Little Rock","Arkansas","72205-7199","United States",[146,151],{"name":147,"role":148,"phoneExt":149,"email":150},"Michael Birrer, MD","CONTACT","501-686-8274","MJbirrer@uams.edu",{"name":147,"role":152},"PRINCIPAL_INVESTIGATOR",{"lat":154,"lon":155},34.74648,-92.28959,{"facility":157,"status":158,"city":159,"state":160,"zip":161,"country":144,"contacts":162,"geoPoint":168},"UCLA - Hematology\u002FOncology Clinical Research Unit","NOT_YET_RECRUITING","Los Angeles","California","90095",[163,167],{"name":164,"role":148,"phone":165,"email":166},"Aaron Lisberg, MD","310-352-8252","alisberg@mednet.ucla.edu",{"name":164,"role":152},{"lat":169,"lon":170},34.05223,-118.24368,{"facility":172,"status":8,"city":173,"state":174,"zip":175,"country":144,"contacts":176,"geoPoint":183},"St. Francis Medical Center (OSF Healthcare)","Peoria","Illinois","61637",[177,181],{"name":178,"role":148,"phone":179,"email":180},"Michelle C Rowland, MD","309-308-3350","michelle.rowland@osfhealthcare.org",{"name":182,"role":152},"Michelle Rowland, MD",{"lat":184,"lon":185},40.69365,-89.58899,{"facility":187,"status":8,"city":188,"state":189,"zip":190,"country":144,"contacts":191,"geoPoint":198},"START - Midwest","Grand Rapids","Michigan","49546",[192,196],{"name":193,"role":148,"phone":194,"email":195},"Manish Sharma, MD","616-954-5554","manish.sharma@startresearch.com",{"name":197,"role":152},"Manish Sharma",{"lat":199,"lon":200},42.96336,-85.66809,{"facility":202,"status":8,"city":203,"state":204,"zip":205,"country":144,"contacts":206,"geoPoint":213},"Hackensack University Medical Center - John Theurer Cancer Center","Hackensack","New Jersey","07601",[207,211],{"name":208,"role":148,"phone":209,"email":210},"Oncology Clinical Research Referral Office","551-996-1777","oncologyresearchreferral@hmhn.org",{"name":212,"role":152},"Miguel Gonzalez, MD",{"lat":214,"lon":215},40.88593,-74.04347,{"facility":217,"status":8,"city":218,"state":219,"zip":220,"country":144,"contacts":221,"geoPoint":228},"Roswell Park Comprehensive Care Center","Buffalo","New York","14263",[222,227],{"name":223,"role":148,"phone":224,"phoneExt":225,"email":226},"Bailey Fitzgerald, MD","716-845-2300","8338","bailey.fitzgerald@roswellpark.org",{"name":223,"role":152},{"lat":229,"lon":230},42.88645,-78.87837,{"facility":232,"status":8,"city":233,"state":234,"zip":235,"country":144,"contacts":236,"geoPoint":245},"University Hospital - Cleveland Medical Center","Cleveland","Ohio","44106",[237,241,243],{"name":238,"role":148,"phone":239,"email":240},"Matthew C Mirsky, MD","301-980-8969","Matthew.Mirsky2@UHhospitals.org",{"name":242,"role":148},"C",{"name":244,"role":152},"Matthew MIrsky, MD",{"lat":246,"lon":247},41.4995,-81.69541,{"facility":249,"status":8,"city":250,"state":251,"zip":252,"country":144,"contacts":253,"geoPoint":258},"NEXT Oncology - Austin","Austin","Texas","78758",[254],{"name":255,"role":148,"phone":256,"email":257},"Sheena Sahota, MD","737-610-5200","ssahota@nextoncology.com",{"lat":259,"lon":260},30.26715,-97.74306,{"facility":262,"status":8,"city":263,"state":251,"zip":264,"country":144,"contacts":265,"geoPoint":271},"NEXT - Oncology - Houston","Houston","77054",[266,270],{"name":267,"role":148,"phone":268,"email":269},"Jennifer Segar, MD","832-384-7900","jsegar@nextoncology.com",{"name":267,"role":152},{"lat":272,"lon":273},29.76328,-95.36327,{"facility":275,"status":8,"city":276,"state":251,"zip":277,"country":144,"contacts":278,"geoPoint":283},"START - San Antonio","San Antonio","78229",[279],{"name":280,"role":148,"phone":281,"email":282},"Drew Rasco, MD","210-593-5258","drew.rasco@startresearch.com",{"lat":284,"lon":285},29.42412,-98.49363,{"facility":287,"status":8,"city":288,"state":289,"zip":290,"country":144,"contacts":291,"geoPoint":297},"NEXT Oncology - Virginia Cancer Specialists","Fairfax","Virginia","22031",[292,296],{"name":293,"role":148,"phone":294,"email":295},"Alexander Spira, MD, PhD","571-350-8400","aspira@nextoncology.com",{"name":293,"role":152},{"lat":298,"lon":299},38.84622,-77.30637,{"facility":301,"status":158,"city":302,"state":303,"zip":304,"country":144,"contacts":305,"geoPoint":313},"Fred Hutchinson Cancer Center","Seattle","Washington","98109",[306,310,311],{"name":307,"role":148,"phone":308,"email":309},"Lei C Deng, MD","206-606-4801","ldeng1@fredhutch.org",{"name":242,"role":148},{"name":312,"role":152},"Lei Deng, MD",{"lat":314,"lon":315},47.60621,-122.33207,[317,321],{"name":318,"role":148,"phone":319,"email":320},"Clinical Trial Manager Lead","866-742-9495","WHWK-Clinical-Trials@whitehawktx.com",{"name":322,"role":148,"email":320},"Central email mailbox - Whitehawk Therapeutics",[324,328],{"name":325,"affiliation":326,"role":327},"Margaret C Dugan, MD","Whitehawk Therapeutics","STUDY_DIRECTOR",{"name":329,"affiliation":326,"role":327},"Allison Upalawanna",[],[],{"nct_id":4,"conditions":333,"biomarkers":338},[334,335,336,337],"Endometrial Carcinoma","Lung Non-Small Cell Carcinoma","Malignant Ovarian Neoplasm","Solid Neoplasm",[339],"Inactive Tyrosine-Protein Kinase 7",{"nct_id":4,"found":15,"summary":341,"prompt_version":351},{"design":342,"status":343,"heading":344,"summary":345,"follow_up":346,"word_count":347,"commitments":348,"compensation":349,"drugs_mentioned":350},"This is an open-label, first-in-human study with an estimated 226 participants. It has two phases: dose escalation to find the right dose, and dose expansion to further evaluate that dose.","completed","Study of HWK-007 for Advanced Solid Tumors","This study is testing a new drug called HWK-007 for adults with advanced solid tumors, including certain types of endometrial cancer, ovarian cancer, and non-squamous non-small cell lung cancer (NSCLC) that is EGFR wild-type (meaning it doesn't have a specific gene change). HWK-007 is an antibody drug conjugate (ADC), which means it's designed to deliver a drug directly to cancer cells that have a protein called PTK7. The main goals of this study are to find the safest and most effective dose of HWK-007. To join, you must have one of the specific cancers mentioned and be at least 18 years old. This is a first-in-human study, meaning it's one of the first times this drug is being tested in people.","The primary endpoints for determining the maximum tolerated dose and recommended dose are measured during 21-day cycles until the dose is identified. The total follow-up duration is not specified.",121,"HWK-007 will be given as an intravenous (IV) infusion every three weeks. The study will measure safety and dose-related information during these 21-day cycles.","Not stated in the trial record.",[54],"v2"]