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

Recruiting now · Phase 1

Conditions studied: PROC, Platinum Resistant Ovarian Cancer, Endometrial Cancer

In brief

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.

Key facts

Study ID

NCT07470853

Run by

Whitehawk Therapeutics, Inc.

People needed

265

Starts

2026-03-15

Expected to finish

2028-02-01

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have one of the following solid tumor cancers:
• Monotherapy escalation, backfill and expansion cohorts:
• Endometrial Carcinoma
• Ovarian Cancer
• Combination Escalation, Backfill and Expansion Cohorts a. Ovarian Cancer

You may not qualify if…

• Individual with known or suspected uncontrolled central nervous system (CNS) metastases
• Individual with history of carcinomatous meningitis
• Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
• Individual with evidence of corneal keratopathy or history of cornea transplant
• Any serious unresolved toxicities from prior therapy
• Significant cardiovascular disease
• Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 milliseconds (ms)
• History of pneumonitis/interstitial lung disease
• Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention

Where it is running

• University of Arkansas - Winthrop P. Rockefeller Cancer Institute — Little Rock, Arkansas, United States (enrolling)
• START - Los Angeles — Los Angeles, California, United States (enrolling)
• SCRI - Florida Cancer Specialists — Sarasota, Florida, United States (enrolling)
• St. Francis Medical Center (OSF Healthcare) — Peoria, Illinois, United States (enrolling)
• SCRI - Sydney Kimmel Cancer Center - Jefferson Health — Philadelphia, Pennsylvania, United States (enrolling)
• SCRI - Mary Crowley Cancer Research — Dallas, Texas, United States (enrolling)
• START Mountain — Salt Lake City, Utah, United States (enrolling)
• Start - Ny — Lake Success, New York, United States (enrolling)
• Ohio State University Wexner Medical Center — Columbus, Ohio, United States (enrolling)
• Karmanos Cancer Center — Detroit, Michigan, United States
• Atrium Health - Wake Forest — Charlotte, North Carolina, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.