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A Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors.
Sponsor: Whitehawk Therapeutics, Inc.
Summary
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.
Official title: A Phase 1 First-in-Human Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
265
Start Date
2026-03-15
Completion Date
2028-02
Last Updated
2026-03-13
Healthy Volunteers
No
Interventions
HWK-016, MUCIN-16-targeted ADC
HWK-016 is a MUCIN-16-targeted Antibody-Drug-Conjugate (ADC) being developed for the treatment of solid tumors.
Bevacizumab
Bevacizumab administered according to the USPI in 21-day cycles
Locations (12)
University of Arkansas - Winthrop P. Rockefeller Cancer Institute
Little Rock, Arkansas, United States
START - Los Angeles
Los Angeles, California, United States
SCRI - Florida Cancer Specialists
Sarasota, Florida, United States
St. Francis Medical Center (OSF Healthcare)
Peoria, Illinois, United States
Karmanos Cancer Center
Detroit, Michigan, United States
Start - Ny
Lake Success, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Atrium Health - Wake Forest
Charlotte, North Carolina, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, United States
SCRI - Sydney Kimmel Cancer Center - Jefferson Health
Philadelphia, Pennsylvania, United States
SCRI - Mary Crowley Cancer Research
Dallas, Texas, United States
START Mountain
Salt Lake City, Utah, United States