Actively Recruiting
A Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors.
Led by Whitehawk Therapeutics, Inc. · Updated on 2026-03-13
265
Participants Needed
12
Research Sites
98 weeks
Total Duration
On this page
Sponsors
W
Whitehawk Therapeutics, Inc.
Lead Sponsor
C
Catalyst Pharmaceutical Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have one of the following solid tumor cancers: Endometrial carcinoma or ovarian cancer for monotherapy cohorts
- Have ovarian cancer for combination therapy cohorts with bevacizumab
- Be an adult aged 18 years or older
You will not qualify if you...
- Known or suspected uncontrolled central nervous system metastases
- History of carcinomatous meningitis
- Active uncontrolled bacterial, viral, fungal, or parasitic infection
- Evidence of corneal keratopathy or history of cornea transplant
- Any serious unresolved toxicities from prior therapy
- Significant cardiovascular disease
- Prolonged QT interval corrected for heart rate (QTcF) of 470 milliseconds or more
- History of pneumonitis or interstitial lung disease
- Pregnancy, breastfeeding, or planning to breastfeed during the study or within 30 days after last dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
University of Arkansas - Winthrop P. Rockefeller Cancer Institute
Little Rock, Arkansas, United States, 72205
Not Yet Recruiting
2
START - Los Angeles
Los Angeles, California, United States, 90025
Actively Recruiting
3
SCRI - Florida Cancer Specialists
Sarasota, Florida, United States, 34232
Not Yet Recruiting
4
St. Francis Medical Center (OSF Healthcare)
Peoria, Illinois, United States, 61637
Not Yet Recruiting
5
Karmanos Cancer Center
Detroit, Michigan, United States, 48201
Not Yet Recruiting
6
Start - Ny
Lake Success, New York, United States, 11042
Actively Recruiting
7
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 07920
Not Yet Recruiting
8
Atrium Health - Wake Forest
Charlotte, North Carolina, United States, 282204
Not Yet Recruiting
9
Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Not Yet Recruiting
10
SCRI - Sydney Kimmel Cancer Center - Jefferson Health
Philadelphia, Pennsylvania, United States, 19107
Not Yet Recruiting
11
SCRI - Mary Crowley Cancer Research
Dallas, Texas, United States, 75230
Not Yet Recruiting
12
START Mountain
Salt Lake City, Utah, United States, 84119
Actively Recruiting
Research Team
C
Clinical Trial Manager Lead
CONTACT
C
Central email mailbox - Whitehawk Therapeutics
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
8
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