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New drug HWK-007 targets Hard-to-Treat cancers in early trial

NCT ID NCT07444814

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 06, 2026 · Updated 2 times

Summary

This early-stage study tests a new drug called HWK-007 in people with advanced solid tumors, including certain ovarian, endometrial, and lung cancers. The drug is designed to target a protein (PTK7) found on cancer cells and deliver a chemotherapy-like payload directly to them. The main goals are to find the safest dose and check for side effects. About 226 adults will take part, and the study is currently recruiting.

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 226 people

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

Started

Dec 2025

Expected to finish

Dec 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 and backfill cohorts: 1. non-squamous EGFR-Wt NSCLC 2. Endometrial carcinoma 3. Platinum Resistant Ovarian Cancer 2. Monotherapy expansion cohorts: 1. Non-squamous EGFR-Wt NSCLC 2. Additional tumor indications to be defined in a future amendment 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 lung neoplasm non-small cell lung carcinoma ovarian cancer ovarian carcinoma

As listed by the trial registrant

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

Endometrial cancer Non-squamous EGFR WT NSCLC Ovarian cancer Ovarian cancer metastatic Ovarian cancer metastatic recurrent 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

  • Fred Hutchinson Cancer Center

    NOT_YET_RECRUITING

    Seattle, Washington, 98109, United States

  • Hackensack University Medical Center - John Theurer Cancer Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • NEXT - Oncology - Houston

    RECRUITING

    Houston, Texas, 77054, United States

  • NEXT Oncology - Austin

    RECRUITING

    Austin, Texas, 78758, United States

  • NEXT Oncology - Virginia Cancer Specialists

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Roswell Park Comprehensive Care Center

    RECRUITING

    Buffalo, New York, 14263, United States

  • START - Midwest

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • START - San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • St. Francis Medical Center (OSF Healthcare)

    RECRUITING

    Peoria, Illinois, 61637, United States

  • UCLA - Hematology/Oncology Clinical Research Unit

    NOT_YET_RECRUITING

    Los Angeles, California, 90095, United States

  • University Hospital - Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of Arkansas

    RECRUITING

    Little Rock, Arkansas, 72205-7199, United States

More trials for these conditions

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