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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 226 (estimated)
• Sponsor: Whitehawk Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. In Phase 1a of the study, HWK-007 will initially be administered as an intravenous (IV) infusion every 3 weeks (Q3W).

Conditions

• Endometrial Cancer
• Ovarian Cancer
• Ovarian Cancer Metastatic
• Ovarian Cancer Metastatic Recurrent
• Non-squamous EGFR Wt NSCLC
• Platinum Resistant Ovarian Cancer
• PROC

Interventions

Type	Name	Description
DRUG	HWK-007	HWK-007 is a PTK7- targeted ADC being developed for the treatment of solid tumors.

Timeline

• Start date: 2025-12-19
• Primary completion: 2028-10-01
• Completion: 2028-12-01
• First posted: 2026-03-03
• Last updated: 2026-03-27

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study