MUC16-targeted antibody-drug HWK-016 for advanced ovarian and endometrial cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Arkansas - Winthrop P. Rockefeller Cancer Institute
  Little Rock, Arkansas, United States Recruiting
• START - Los Angeles
  Los Angeles, California, United States Recruiting
• SCRI - Florida Cancer Specialists
  Sarasota, Florida, United States Recruiting
• St. Francis Medical Center (OSF Healthcare)
  Peoria, Illinois, United States Recruiting
• Start - Ny
  Long Island City, New York, United States Recruiting
• Ohio State University Wexner Medical Center
  Columbus, Ohio, United States Recruiting

Study contacts

• Study coordinator: Clinical Trial Manager Lead
• Email: WHWK-Clinical-Trials@whitehawktx.com
• Phone: 866-742-9495

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.