A Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors.
Start Date
3/15/2026
Completion Date
2/1/2028
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.
Detailed Description
HWK-016-101 is a Phase 1 study evaluating HWK-016, a mucin-16 (MUC-16) targeted antibody-drug conjugate (ADC) in adult participants with advanced or metastatic solid tumors.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
HWK-016, MUCIN-16-targeted ADC
Bevacizumab
Conditions
Locations
University of Arkansas - Winthrop P. Rockefeller Cancer Institute
Little Rock, Arkansas 72205
United States
START - Los Angeles
Los Angeles, California 90025
United States
SCRI - Florida Cancer Specialists
Sarasota, Florida 34232
United States
St. Francis Medical Center (OSF Healthcare)
Peoria, Illinois 61637
United States
Karmanos Cancer Center
Detroit, Michigan 48201
United States
Start - Ny
Lake Success, New York 11042
United States
Memorial Sloan Kettering Cancer Center
New York, New York 07920
United States
Atrium Health - Wake Forest
Charlotte, North Carolina 282204
United States
Ohio State University Wexner Medical Center
Columbus, Ohio 43210
United States
SCRI - Sydney Kimmel Cancer Center - Jefferson Health
Philadelphia, Pennsylvania 19107
United States
SCRI - Mary Crowley Cancer Research
Dallas, Texas 75230
United States
START Mountain
Salt Lake City, Utah 84119
United States