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NCT07470853PHASE1Recruiting

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

Whitehawk Therapeutics, Inc.

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

Inclusion Criteria: * Have one of the following solid tumor cancers: 1. Monotherapy escalation, backfill and expansion cohorts: 1. Endometrial Carcinoma 2. Ovarian Cancer 2. Combination Escalation, Backfill and Expansion Cohorts a. Ovarian Cancer Exclusion Criteria: 1. Individual with known or suspected uncontrolled central nervous system (CNS) metastases 2. Individual with history of carcinomatous meningitis 3. Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection 4. Individual with evidence of corneal keratopathy or history of cornea transplant 5. Any serious unresolved toxicities from prior therapy 6. Significant cardiovascular disease 7. Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 milliseconds (ms) 8. History of pneumonitis/interstitial lung disease 9. Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention

Interventions

DRUG

HWK-016, MUCIN-16-targeted ADC

DRUG

Bevacizumab

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Conditions

PROCPlatinum Resistant Ovarian CancerEndometrial Cancer

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