MUC16-targeted antibody-drug HWK-016 for advanced ovarian and endometrial cancer
A Phase 1 First-in-Human Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors.
This will test HWK-016, an antibody-drug that targets MUC16, in adults with advanced or metastatic ovarian or endometrial cancer, including platinum-resistant ovarian cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 265 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Whitehawk Therapeutics, Inc. Industry-sponsored |
| Drugs / interventions | bevacizumab |
| Locations | 12 sites (Little Rock, Arkansas and 11 other locations) |
| Trial ID | NCT07470853 on ClinicalTrials.gov |
What this trial studies
This first-in-human, open-label Phase 1 program uses dose escalation followed by dose expansion to define a safe dose and characterize activity of HWK-016, a MUC16-directed antibody-drug conjugate. The trial has two parts: Part A tests HWK-016 alone in ovarian and endometrial cancer cohorts, and Part B tests HWK-016 combined with bevacizumab in ovarian cancer cohorts. There is no randomized control arm; safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity will guide dose decisions and expansion cohort selection. The multicenter design enrolls patients at several U.S. cancer centers.
Who should consider this trial
Good fit: Adults with advanced or metastatic ovarian or endometrial cancer (including platinum-resistant ovarian cancer) who meet the study's safety criteria and do not have uncontrolled CNS disease or major cardiac, pulmonary, or ocular conditions are potential candidates.
Not a fit: Patients with uncontrolled central nervous system metastases, active serious infections, significant cardiovascular disease, corneal keratopathy, a history of pneumonitis/interstitial lung disease, or who are pregnant or breastfeeding are unlikely to be eligible or to benefit from participation.
Why it matters
Potential benefit: If successful, HWK-016 could offer a new treatment option that shrinks tumors or slows progression for patients with MUC16-expressing advanced ovarian or endometrial cancers.
How similar studies have performed: Antibody-drug conjugates and other MUC16-targeted approaches have shown early promise in oncology, but HWK-016 is first-in-human and its safety and efficacy are unproven.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Little Rock, Arkansas and 11 other locations
- University of Arkansas - Winthrop P. Rockefeller Cancer Institute — Little Rock, Arkansas, United States (Not_yet_recruiting)
- START - Los Angeles — Los Angeles, California, United States (Recruiting)
- SCRI - Florida Cancer Specialists — Sarasota, Florida, United States (Not_yet_recruiting)
- St. Francis Medical Center (OSF Healthcare) — Peoria, Illinois, United States (Not_yet_recruiting)
- Karmanos Cancer Center — Detroit, Michigan, United States (Not_yet_recruiting)
- Start - Ny — Lake Success, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Not_yet_recruiting)
- Atrium Health - Wake Forest — Charlotte, North Carolina, United States (Not_yet_recruiting)
- Ohio State University Wexner Medical Center — Columbus, Ohio, United States (Not_yet_recruiting)
- SCRI - Sydney Kimmel Cancer Center - Jefferson Health — Philadelphia, Pennsylvania, United States (Not_yet_recruiting)
- SCRI - Mary Crowley Cancer Research — Dallas, Texas, United States (Not_yet_recruiting)
- START Mountain — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Study coordinator: Clinical Trial Manager Lead
- Email: WHWK-Clinical-Trials@whitehawktx.com
- Phone: 888-392-9025
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.