Study Evaluating the Safety and Efficacy of HWK-007, a PTK7-directed Antibody Drug Conjugate in Participants With Advanced Solid Tumors
NCT07444814 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 226
Last updated 2026-03-27
Summary
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.
Conditions
- Endometrial Cancer
- Ovarian Cancer
- Ovarian Cancer Metastatic
- Ovarian Cancer Metastatic Recurrent
- Non-squamous EGFR Wt NSCLC
- Platinum Resistant Ovarian Cancer
- PROC
Interventions
- DRUG
-
HWK-007
HWK-007 is a PTK7- targeted ADC being developed for the treatment of solid tumors.
Sponsors & Collaborators
-
Whitehawk Therapeutics, Inc.
lead INDUSTRY
Principal Investigators
-
Margaret C Dugan, MD · Whitehawk Therapeutics
-
Edward C Spindler, BS, MBA · Whitehawk Therapeutics
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-12-19
- Primary Completion
- 2028-10-31
- Completion
- 2028-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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