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NCT07470853 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Endometrial Cancer and Platinum-resistant Ovarian Cancer, sponsored by Whitehawk Therapeutics.

Recruiting
Registry status
Phase 1
Development phase
265
Enrollment target
12
Study locations

NCT07470853: Recruiting Phase 1 study of Endometrial Cancer and Platinum-resistant Ovarian Cancer, sponsored by Whitehawk Therapeutics.

NCT07470853 is a Phase 1 study of Endometrial Cancer and Platinum-resistant Ovarian Cancer that is actively recruiting participants, run by Whitehawk Therapeutics. The registered enrollment target is 265 participants, below the 523-participant average among 181 other Endometrial Cancer trials with a reported enrollment target (49% lower). The trial reports 12 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07470853, a Phase 1 study of Endometrial Cancer and Platinum-resistant Ovarian Cancer, is actively recruiting participants, sponsored by Whitehawk Therapeutics.

RECRUITING
Registry status
Phase 1
Development phase
265 participants
Enrollment target
12
Study locations

Study 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.

Primary Outcome

Determine the highest dose of HWK-016 that can be administered without signs of toxicity, measured at the end of Cycle 1(21-day cycle) by: Incidence and severity of Adverse Events (AE). Incidence of Dose-Limiting Toxicities (DLT). Incidence of Serious Adverse Events (SAE). Evaluate the safety and tolerability of HWK-016 at the selected RDE(s) determined from Phase 1a, as monotherapy (Part A) in participants with ovarian and endometrial cancers and in combination therapy with bevacizumab (Part B)

Conditions Studied

Endometrial Cancer Platinum-resistant Ovarian Cancer PROC

Interventions

  • DRUG Bevacizumab
  • DRUG HWK-016, MUCIN-16-targeted ADC

Study Locations (12)

New York

  • Start - Ny - Lake Success
  • Memorial Sloan Kettering Cancer Center - New York

Arkansas

  • University of Arkansas - Winthrop P. Rockefeller Cancer Institute - Little Rock

California

  • START - Los Angeles - Los Angeles

Florida

  • SCRI - Florida Cancer Specialists - Sarasota

Illinois

  • St. Francis Medical Center (OSF Healthcare) - Peoria

Michigan

  • Karmanos Cancer Center - Detroit

North Carolina

  • Atrium Health - Wake Forest - Charlotte

Ohio

  • Ohio State University Wexner Medical Center - Columbus

Trial Details

FieldValue
Enrollment Target 265 participants
Start Date 2026-03-15
Est. Completion 2028-02
Phase Phase 1
Whitehawk Therapeutics

2 total trials

What NCT07470853 shows while recruiting

NCT07470853 is an interventional study that assigns participants to a tested intervention. The registered 265 participants enrollment target is mid-sized for trials with a published cap, below the 523-participant average among 181 other Endometrial Cancer trials with a reported enrollment target (49% lower).

The record links to 3 conditions, with Endometrial Cancer appearing as the primary indexed condition, and to 2 interventions - of which Bevacizumab is the first listed.

NCT07470853 lists 12 locations in 11 states (New York, Arkansas, California).

Frequently Asked Questions

What is clinical trial NCT07470853 about?

NCT07470853 is a clinical study titled "A Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors.". 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 ...

What is the current status of trial NCT07470853?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 265 participants. The study started on 2026-03-15. Estimated completion is 2028-02.

What conditions does trial NCT07470853 study?

This clinical trial studies the following conditions: Endometrial Cancer, Platinum-resistant Ovarian Cancer, PROC.

What interventions are being tested in trial NCT07470853?

The interventions under investigation include: Bevacizumab (DRUG), HWK-016, MUCIN-16-targeted ADC (DRUG).

Who is sponsoring clinical trial NCT07470853?

This trial is sponsored by Whitehawk Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07470853 being conducted?

This trial has 12 study locations across Arkansas, California, Florida, Illinois, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Endometrial Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07470853's enrollment target sits among peer trials

265 54th of 181 higher than 128 of 181 other Endometrial Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Endometrial Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT07470853

Source: ClinicalTrials.gov NCT07470853, the US trial registry maintained by the National Library of Medicine. NCT07470853 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.