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

RecruitingPhase 1

Sponsor: Whitehawk Therapeutics, Inc.

Conditions: PROC, Platinum Resistant Ovarian Cancer, Endometrial Cancer

Interventions: HWK-016, MUCIN-16-targeted ADC, Bevacizumab

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (12)

Little Rock, Arkansas, United States
Los Angeles, California, United States
Sarasota, Florida, United States
Peoria, Illinois, United States
Detroit, Michigan, United States
Long Island City, New York, United States
New York, New York, United States
Charlotte, North Carolina, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Dallas, Texas, United States
Salt Lake City, Utah, United States