A Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tum… (NCT07470853) | Clinical Trial Compass
RecruitingPhase 1
A Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors.
United States265 participantsStarted 2026-03-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Monotherapy escalation, backfill and expansion cohorts:
✓. Endometrial Carcinoma
✓. Ovarian Cancer
✓. Combination Escalation, Backfill and Expansion Cohorts a. Ovarian Cancer
Exclusion criteria
✕. 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
✕
What they're measuring
1
Determine Maximum Tolerated Dose (MTD)
Timeframe: From Cycle 1, Day 1 Until Cycle 1, Day 21 (21-day cycles)
2
Determine Maximum Administered Dose (MAD)
Timeframe: From Cycle 1, Day 1 to Cycle 1, Day 21 (21-day cycles) until the MTD is reached.
3
Determine Recommended Dose For Expansion (RDE)
Timeframe: From Cycle 1, Day 1 to Cycle 1, Day 21 (21-day cycle) until MTD is identified.