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

Conditions

• Endometrial Cancer
• PROC
• Platinum Resistant Ovarian Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• HWK-016, MUCIN-16-targeted ADC — DRUG
  HWK-016 is a MUCIN-16-targeted Antibody-Drug-Conjugate (ADC) being developed for the treatment of solid tumors.
• Bevacizumab — DRUG
  Bevacizumab administered according to the USPI in 21-day cycles

Study Details

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.

Key Dates

Start date

Mar 15, 2026

Status verified

Mar 2026

Primary completion

Feb 29, 2028

Completion

Feb 29, 2028

Study Design

Enrollment

265 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part A - Dose Escalation - 21 Day treatment cycles
  Escalating doses of HWK-016, a MUCIN-16-targeted ADC administered intravenously (IV)
• Experimental: Part A - Dose Expansion Group 1 - 21-day treatment cycle - Tumor TBD
  Dose Optimization of Recommended dose for expansion 1
• Experimental: Part A - Dose Expansion Group 2 - 21-day treatment cycle - Tumor TBD
  Expanded enrolment at Recommended Dose for Expansion 2 in Ovarian Cancer
• Experimental: Part A - Dose Expansion Group 3 - 21-day treatment cycle - Tumor TBD
  Expansion of enrolment at RDE 1 or 2 in Tumor TBD
• Experimental: Part B - Dose Escalation - 21 Day treatment cycles of HWK-016 in combination with Bevacizumab
  Escalating doses of HWK-016, a MUCIN-16-targeted ADC administered intravenously (IV) combined with Bevacizumab (IV) in Ovarian cancer
• Experimental: Part A - Dose Expansion Group 4 - 21-day treatment cycle - Tumor TBD
  Expansion of enrolment at RDE 1 or 2 in Tumor TBD
• Experimental: Part B - Dose Expansion Cohort 1- 21 Day cycles of HWK-016 in combination with Bevacizumab
  Expanded enrolment at RDE of HWK-016, a MUCIN-16-targeted ADC administered intravenously (IV) combined with Bevacizumab (IV) in Ovarian cancer
• Experimental: Part B - Dose Expansion Cohort 2 - 21 Day cycles of HWK-016 in combination with Bevacizumab
  Expanded enrolment at RDE of HWK-016, a MUCIN-16-targeted ADC administered intravenously (IV) combined with Bevacizumab (IV) in Tumor TBD

Primary Outcome Measure

Determine Maximum Tolerated Dose (MTD) [ Time Frame: From Cycle 1, Day 1 Until Cycle 1, Day 21 (21-day cycles) ]

Central Contacts

• Clinical Trial Manager Lead
  888-392-9025
  [email protected]
• Central email mailbox - Whitehawk Therapeutics
  [email protected]

Locations (12)

Find similar trials in Little Rock, AR

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