RecruitingPhase 1NCT07470853

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

A Phase 1 First-in-Human Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors.


Sponsor

Whitehawk Therapeutics, Inc.

Enrollment

265 participants

Start Date

Mar 15, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new antibody-drug conjugate (ADC) called HWK-016 — a targeted treatment that delivers chemotherapy directly to cancer cells carrying the protein MUC16 (also known as CA-125) — in patients with advanced endometrial (uterine) or ovarian cancer. **You may be eligible if...** - You have been diagnosed with advanced endometrial cancer or ovarian cancer - For the combination therapy portion: you must have ovarian cancer **You may NOT be eligible if...** - You have uncontrolled cancer spread to the brain or spinal fluid - You have a history of cancer spreading to the lining around the brain (carcinomatous meningitis) - You have an active, uncontrolled serious infection - You have corneal eye disease or have had a cornea transplant - You have unresolved significant side effects from previous treatments - You have significant heart disease or abnormal heart rhythms on ECG - You have a history of lung inflammation (pneumonitis or interstitial lung disease) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHWK-016, MUCIN-16-targeted ADC

HWK-016 is a MUCIN-16-targeted Antibody-Drug-Conjugate (ADC) being developed for the treatment of solid tumors.

DRUGBevacizumab

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

View Full Details on ClinicalTrials.gov

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NCT07470853


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