A Phase 1 First-in-Human Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors.
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Arkansas
University of Arkansas - Winthrop P. Rockefeller Cancer Institute
NOT_YET_RECRUITING
Little Rock
California
START - Los Angeles
RECRUITING
Los Angeles
Florida
SCRI - Florida Cancer Specialists
NOT_YET_RECRUITING
Sarasota
Illinois
St. Francis Medical Center (OSF Healthcare)
NOT_YET_RECRUITING
Peoria
Michigan
Karmanos Cancer Center
NOT_YET_RECRUITING
Detroit
North Carolina
Atrium Health - Wake Forest
NOT_YET_RECRUITING
Charlotte
New York
Start - Ny
RECRUITING
Lake Success
Memorial Sloan Kettering Cancer Center
NOT_YET_RECRUITING
New York
Ohio
Ohio State University Wexner Medical Center
NOT_YET_RECRUITING
Columbus
Pennsylvania
SCRI - Sydney Kimmel Cancer Center - Jefferson Health
NOT_YET_RECRUITING
Philadelphia
Texas
SCRI - Mary Crowley Cancer Research
NOT_YET_RECRUITING
Dallas
Utah
START Mountain
RECRUITING
Salt Lake City
Contact Information
Primary
Clinical Trial Manager Lead
WHWK-Clinical-Trials@whitehawktx.com
888-392-9025
Backup
Central email mailbox - Whitehawk Therapeutics
WHWK-Clinical-Trials@whitehawktx.com
Time Frame
Start Date:2026-03-15
Estimated Completion Date:2028-02
Participants
Target number of participants:265
Treatments
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