A Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors.
A Phase 1 First-in-Human Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors.
Whitehawk Therapeutics, Inc.
265 participants
Mar 15, 2026
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria5
- Have one of the following solid tumor cancers:
- Monotherapy escalation, backfill and expansion cohorts:
- Endometrial Carcinoma
- Ovarian Cancer
- Combination Escalation, Backfill and Expansion Cohorts a. Ovarian Cancer
Exclusion Criteria9
- Individual with known or suspected uncontrolled central nervous system (CNS) metastases
- Individual with history of carcinomatous meningitis
- Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
- Individual with evidence of corneal keratopathy or history of cornea transplant
- Any serious unresolved toxicities from prior therapy
- Significant cardiovascular disease
- Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 milliseconds (ms)
- History of pneumonitis/interstitial lung disease
- Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention
Interventions
HWK-016 is a MUCIN-16-targeted Antibody-Drug-Conjugate (ADC) being developed for the treatment of solid tumors.
Bevacizumab administered according to the USPI in 21-day cycles
Locations(12)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07470853