Study Evaluating the Safety and Efficacy of HWK-007, a PTK7-directed Antibody Drug Conjugate in Participants With Advanced Solid Tumors
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.
Checked against the public recordLast updated Aug 5, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Whitehawk Therapeutics, Inc.
- Interventions being studied
- Drug: HWK-007
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: Have one of the following solid tumor cancers: 1. Monotherapy escalation and backfill cohorts: 1. non-squamous EGFR-Wt NSCLC 2. Endometrial carcinoma 3. Platinum Resistant Ovarian Cancer 2. Monotherapy expansion cohorts: 1. Non-squamous EGFR-Wt NSCLC 2. Additional tumor indications to be defined in a future amendment Exclusion Criteria: 1. Individual with known or suspected uncontrolled central nervous system (CNS) metastases 2. Individual with history of carcinomatous meningitis 3. Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection 4. Individual with evidence of corneal keratopathy or history of cornea transplant 5. Any serious unresolved toxicities from prior therapy 6. Significant cardiovascular disease 7. Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 milliseconds (ms) 8. History of pneumonitis/interstitial lung disease 9. Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of ArkansasLittle Rock, Arkansas
- UCLA - Hematology/Oncology Clinical Research UnitLos Angeles, California
- St. Francis Medical Center (OSF Healthcare)Peoria, Illinois
- START - MidwestGrand Rapids, Michigan
- Hackensack University Medical Center - John Theurer Cancer CenterHackensack, New Jersey
- Roswell Park Comprehensive Care CenterBuffalo, New York
- University Hospital - Cleveland Medical CenterCleveland, Ohio
- NEXT Oncology - AustinAustin, Texas
- NEXT - Oncology - HoustonHouston, Texas
- START - San AntonioSan Antonio, Texas
- NEXT Oncology - Virginia Cancer SpecialistsFairfax, Virginia
- Fred Hutchinson Cancer CenterSeattle, Washington
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 5, 2026. Always confirm current availability with the study team.