NCT07444814 – A Phase 1 First-in-Human Study of PTK7-Directed Antibody-Drug Conjugate HWK-007 in Participants with Advanced Solid Tumors
This is a first-in-human Phase 1 trial evaluating HWK-007, an antibody-drug conjugate that targets PTK7 (protein tyrosine kinase 7), a protein found on the surface of several tumor types. The study is sponsored by Whitehawk Therapeutics and enrolls patients with advanced solid tumors, including endometrial cancer, ovarian cancer (including platinum resistant and recurrent metastatic disease), and non-squamous, EGFR wild-type non-small cell lung cancer. The trial has two parts: a dose escalation phase (1a) to establish safety, the maximum tolerated dose, and the recommended dose for expansion, followed by a dose expansion phase (1b) to further evaluate safety and objective response rate. Secondary goals include characterizing the drug’s pharmacokinetics and early signs of anti-tumor activity. Planned enrollment is up to 226 patients, and the study is currently recruiting.