UAMS - Translational Research Institute

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

Purpose

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.

Conditions

PROC
Platinum Resistant Ovarian Cancer
Endometrial Cancer

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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

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

Study Design

Phase: Phase 1
Study Type: Interventional
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Dose escalation will use a BOIN design.
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Part A - Dose Escalation - 21 Day treatment cycles	Escalating doses of HWK-016, a MUCIN-16-targeted ADC administered intravenously (IV)	Drug: HWK-016, MUCIN-16-targeted ADC HWK-016 is a MUCIN-16-targeted Antibody-Drug-Conjugate (ADC) being developed for the treatment of solid tumors. Other names: HWK-016
Experimental Part A - Dose Expansion Group 1 - 21-day treatment cycle - Tumor TBD	Dose Optimization of Recommended dose for expansion 1	Drug: HWK-016, MUCIN-16-targeted ADC HWK-016 is a MUCIN-16-targeted Antibody-Drug-Conjugate (ADC) being developed for the treatment of solid tumors. Other names: HWK-016
Experimental Part A - Dose Expansion Group 2 - 21-day treatment cycle - Tumor TBD	Expanded enrolment at Recommended Dose for Expansion 2 in Ovarian Cancer	Drug: HWK-016, MUCIN-16-targeted ADC HWK-016 is a MUCIN-16-targeted Antibody-Drug-Conjugate (ADC) being developed for the treatment of solid tumors. Other names: HWK-016
Experimental Part A - Dose Expansion Group 3 - 21-day treatment cycle - Tumor TBD	Expansion of enrolment at RDE 1 or 2 in Tumor TBD	Drug: HWK-016, MUCIN-16-targeted ADC HWK-016 is a MUCIN-16-targeted Antibody-Drug-Conjugate (ADC) being developed for the treatment of solid tumors. Other names: HWK-016
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	Drug: HWK-016, MUCIN-16-targeted ADC HWK-016 is a MUCIN-16-targeted Antibody-Drug-Conjugate (ADC) being developed for the treatment of solid tumors. Other names: HWK-016 Drug: Bevacizumab Bevacizumab administered according to the USPI in 21-day cycles
Experimental Part A - Dose Expansion Group 4 - 21-day treatment cycle - Tumor TBD	Expansion of enrolment at RDE 1 or 2 in Tumor TBD	Drug: HWK-016, MUCIN-16-targeted ADC HWK-016 is a MUCIN-16-targeted Antibody-Drug-Conjugate (ADC) being developed for the treatment of solid tumors. Other names: HWK-016
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	Drug: HWK-016, MUCIN-16-targeted ADC HWK-016 is a MUCIN-16-targeted Antibody-Drug-Conjugate (ADC) being developed for the treatment of solid tumors. Other names: HWK-016 Drug: Bevacizumab Bevacizumab administered according to the USPI in 21-day cycles
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	Drug: HWK-016, MUCIN-16-targeted ADC HWK-016 is a MUCIN-16-targeted Antibody-Drug-Conjugate (ADC) being developed for the treatment of solid tumors. Other names: HWK-016 Drug: Bevacizumab Bevacizumab administered according to the USPI in 21-day cycles

Recruiting Locations

START - Los Angeles
Los Angeles, California 90025

Contact:
Linda Rodriguez
210-593-5250
linda.rodriguez@startresearch.com

Start - Ny
Lake Success, New York 11042

Contact:
Geraldine O'Sullivan-Coyne, MD
363-207-5160

START Mountain
Salt Lake City, Utah 84119

Contact:
William McKean, MD
801-907-4750

More Details

NCT ID: NCT07470853
Status: Recruiting
Sponsor: Whitehawk Therapeutics, Inc.

Study Contact

Clinical Trial Manager Lead
888-392-9025
WHWK-Clinical-Trials@whitehawktx.com

Detailed Description

HWK-016-101 is a Phase 1 study evaluating HWK-016, a mucin-16 (MUC-16) targeted antibody-drug conjugate (ADC) in adult participants with advanced or metastatic solid tumors.