Recruiting
Phase 1

HWK-016

Sponsor:

Whitehawk Therapeutics, Inc.

Code:

NCT07470853

Conditions

PROC

Platinum Resistant Ovarian Cancer

Endometrial Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

HWK-016, MUCIN-16-targeted ADC

Bevacizumab

Study Details

Brief 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.

Conditions

PROC

Platinum Resistant Ovarian Cancer

Endometrial Cancer

Study ID

NCT07470853

Start date

Mar 15, 2026

Status verified date

Aug, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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:

1. 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

Enrollment

265 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

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.

Bevacizumab

Bevacizumab administered according to the USPI in 21-day cycles

Primary outcome measure

  • Determine Maximum Tolerated Dose (MTD) [ Time Frame: From Cycle 1, Day 1 Until Cycle 1, Day 21 (21-day cycles) ]
  • Determine Maximum Administered Dose (MAD) [ Time Frame: From Cycle 1, Day 1 to Cycle 1, Day 21 (21-day cycles) until the MTD is reached. ]
  • Determine Recommended Dose For Expansion (RDE) [ Time Frame: From Cycle 1, Day 1 to Cycle 1, Day 21 (21-day cycle) until MTD is identified. ]

Central Contacts and Locations

Central contacts

Clinical Trial Manager Lead

866-742-9495WHWK-Clinical-Trials@whitehawktx.com

Central email mailbox - Whitehawk Therapeutics

WHWK-Clinical-Trials@whitehawktx.com

Locations

University of Arkansas - Winthrop P. Rockefeller Cancer Institute

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Matthew Kovak

501-296-1200MRKovak@uams.edu

START - Los Angeles

Recruiting

Los Angeles, California, United States, 90025

Contacts

Linda Rodriguez

210-593-5250linda.rodriguez@startresearch.com

SCRI - Florida Cancer Specialists

Recruiting

Sarasota, Florida, United States, 34232

Contacts

Bianca Reyes

720-254-2610bianca.reyes@mckesson.com

St. Francis Medical Center (OSF Healthcare)

Recruiting

Peoria, Illinois, United States, 61637

Contacts

Lisa Gale, CRC RN

309-655-3743lisa.m.gale@osfhealthcare.org

Principal Investigator:

Michelle Rowland, MD

Start - Ny

Recruiting

Long Island City, New York, United States, 11042

Contacts

Sadia Morium, Study Coordinator

363-207-5160sadia.morium@startresearch.com

Principal Investigator:

Geraldine O'Sullivan-Coyne, MD

Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Anna Brantley, Sr. Clinical Research Nurse

800-293-5066anna.brantley@osumc.edu

Principal Investigator:

David O'Malley, MD

SCRI - Sydney Kimmel Cancer Center - Jefferson Health

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Ida Micaily

215-955-1800ida.micaily@jefferson.edu

SCRI - Mary Crowley Cancer Research

Recruiting

Dallas, Texas, United States, 75230

Contacts

Reva Schneider

972-566-3000reva.schneider@scri.com

START Mountain

Recruiting

Salt Lake City, Utah, United States, 84119

Contacts

William McKean, MD

801-907-4750

More Information

Sponsor

Whitehawk Therapeutics, Inc.

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Keywords

  • Ovarian Cancer
  • Endometrial Cancer
  • PROC
  • Ovarian
  • Endometrial
  • ADC
  • Phase 1
  • Solid tumor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Whitehawk Therapeutics, Inc. on 2026-08-18.