A Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors.

HWK-016-101 is a multicenter, open-label, first-in-human (FIH) Phase 1 study evaluating HWK-016, a targeted antibody-drug conjugate (ADC) in adult participants with advanced or metastatic solid tumors. The study employs a dose escalation and dose expansion design without a control group. The study consists of 2 parts (Part A: monotherapy and Part B: combination therapy with bevacizumab); each part has 2 phases, Phase 1a (dose escalation) and Phase 1b (dose expansion). Enrollment to Part A (Phase 1a and Phase 1b) will include ovarian and endometrial cancers. Enrollment to Part B (Phase 1a and Phase 1b) will include ovarian cancer only. A subsequent protocol amendment may evaluate additional tumor types.

NCT Number	NCT07470853
Lead Sponsor	Whitehawk Therapeutics, Inc. Collaborators: Catalyst Pharmaceutical Research
Conditions	PROC, Platinum Resistant Ovarian Cancer, Endometrial Cancer
Enrollment	265 participants
Start Date	2026-03-15
Primary Completion	2028-02 (estimated)
Study Completion	2028-02 (estimated)
Updated on ClinicalTrials.gov	2026-08-06