A Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors.
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorWhitehawk Therapeutics, Inc.
About this trial
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 criteria
Qualifiers
Endometrial Carcinoma
Ovarian Cancer
Combination Escalation, Backfill and Expansion Cohorts a. Ovarian Cancer
Disqualifiers
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
Trial design
Treatments tested in this trial
- HWK-016, MUCIN-16-targeted ADC
- Bevacizumab
Treatment groups
265 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Whitehawk Therapeutics, Inc.
Lead sponsor
Catalyst Pharmaceutical Research
Collaborator
Source ClinicalTrials.gov