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A Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors.
NCT07470853 · Whitehawk Therapeutics, Inc.
In plain English
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Official title
A Phase 1 First-in-Human Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors.
About this study
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
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
Study design
Enrollment target: 265 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-03-15
Estimated completion: 2028-02
Last updated: 2026-03-13
Interventions
Drug: HWK-016, MUCIN-16-targeted ADCDrug: Bevacizumab
Primary outcomes
- • Determine Maximum Tolerated Dose (MTD) (From Cycle 1, Day 1 Until Cycle 1, Day 21 (21-day cycles))
- • Determine Maximum Administered Dose (MAD) (From Cycle 1, Day 1 to Cycle 1, Day 21 (21-day cycles) until the MTD is reached.)
- • Determine Recommended Dose For Expansion (RDE) (From Cycle 1, Day 1 to Cycle 1, Day 21 (21-day cycle) until MTD is identified.)
Sponsor
Whitehawk Therapeutics, Inc. · industry
With: Catalyst Pharmaceutical Research
Contacts & investigators
ContactClinical Trial Manager Lead · contact · WHWK-Clinical-Trials@whitehawktx.com · 888-392-9025
ContactCentral email mailbox - Whitehawk Therapeutics · contact · WHWK-Clinical-Trials@whitehawktx.com
InvestigatorMargaret C Dugan, MD · study_director, Whitehawk Therapeutics
InvestigatorEdward Spindler, BS, MBA · study_director, Whitehawk Therapeutics
All locations (12)
University of Arkansas - Winthrop P. Rockefeller Cancer InstituteNot Yet Recruiting
Little Rock, Arkansas, United States
START - Los AngelesRecruiting
Los Angeles, California, United States
SCRI - Florida Cancer SpecialistsNot Yet Recruiting
Sarasota, Florida, United States
St. Francis Medical Center (OSF Healthcare)Not Yet Recruiting
Peoria, Illinois, United States
Karmanos Cancer CenterNot Yet Recruiting
Detroit, Michigan, United States
Start - NyRecruiting
Lake Success, New York, United States
Memorial Sloan Kettering Cancer CenterNot Yet Recruiting
New York, New York, United States
Atrium Health - Wake ForestNot Yet Recruiting
Charlotte, North Carolina, United States
Ohio State University Wexner Medical CenterNot Yet Recruiting
Columbus, Ohio, United States
SCRI - Sydney Kimmel Cancer Center - Jefferson HealthNot Yet Recruiting
Philadelphia, Pennsylvania, United States
SCRI - Mary Crowley Cancer ResearchNot Yet Recruiting
Dallas, Texas, United States
START MountainRecruiting
Salt Lake City, Utah, United States