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RECRUITING
NCT07470853
PHASE1

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

Sponsor: Whitehawk Therapeutics, Inc.

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

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