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New drug HWK-016 takes aim at Hard-to-Treat cancers

NCT ID NCT07470853

Disease control Sponsor: Whitehawk Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 19, 2026 · Updated 4 times

Summary

This early-phase study tests a new drug called HWK-016 in people with advanced ovarian or endometrial cancers that have not responded to other treatments. The drug is designed to deliver a toxic payload directly to cancer cells that carry a specific marker (MUC16). The main goals are to find the safest dose and to understand side effects. About 265 adults will take part, and some will also receive a second drug called bevacizumab.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 265 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

endometrial cancer endometrial carcinoma endometrium neoplasm ovarian cancer ovarian carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Endometrial cancer Platinum-resistant ovarian cancer PROC

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Atrium Health - Wake Forest

    NOT_YET_RECRUITING

    Charlotte, North Carolina, 282204, United States

  • Karmanos Cancer Center

    NOT_YET_RECRUITING

    Detroit, Michigan, 48201, United States

  • Memorial Sloan Kettering Cancer Center

    NOT_YET_RECRUITING

    New York, New York, 07920, United States

  • Ohio State University Wexner Medical Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • SCRI - Florida Cancer Specialists

    RECRUITING

    Sarasota, Florida, 34232, United States

  • SCRI - Mary Crowley Cancer Research

    RECRUITING

    Dallas, Texas, 75230, United States

  • SCRI - Sydney Kimmel Cancer Center - Jefferson Health

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • START - Los Angeles

    RECRUITING

    Los Angeles, California, 90025, United States

  • START Mountain

    RECRUITING

    Salt Lake City, Utah, 84119, United States

  • St. Francis Medical Center (OSF Healthcare)

    RECRUITING

    Peoria, Illinois, 61637, United States

  • Start - Ny

    RECRUITING

    Long Island City, New York, 11042, United States

  • University of Arkansas - Winthrop P. Rockefeller Cancer Institute

    RECRUITING

    Little Rock, Arkansas, 72205, United States

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Other studies related to the condition(s) this trial covers.