RecruitingPhase 1NCT07444814

Study Evaluating the Safety and Efficacy of HWK-007, a PTK7-directed Antibody Drug Conjugate in Participants With Advanced Solid Tumors

A Phase 1 First-in-Human Study of PTK7-Directed Antibody Drug Conjugate HWK-007 in Participants With Advanced Solid Tumors


Sponsor

Whitehawk Therapeutics, Inc.

Enrollment

226 participants

Start Date

Dec 19, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

HWK-007-101 is a multicenter, open-label, first-in-human (FIH) Phase 1 study evaluating HWK-007, a protein tyrosine kinase 7 (PTK7)-targeted antibody drug conjugate (ADC), in adult participants with advanced or metastatic solid tumors known to be expressing PTK7. The study employs a sequential dose escalation and dose expansion design without a control group.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing a new cancer drug called HWK-007, which is an antibody-drug conjugate — a targeted therapy that delivers chemotherapy directly to cancer cells using a guided protein. The trial is testing it in people with certain advanced solid tumors that have not responded to standard treatment. **You may be eligible if:** - You have been diagnosed with one of the following advanced cancers: non-squamous non-small cell lung cancer (without EGFR mutation), endometrial cancer, or platinum-resistant ovarian cancer - Your cancer has not responded to prior treatments - You are in generally good health and able to tolerate the study treatment **You may NOT be eligible if:** - You have uncontrolled brain metastases (cancer that has spread to the brain) - You have an active, uncontrolled infection - You have a history of severe corneal eye disease or have had a cornea transplant - You have a history of lung inflammation (pneumonitis or interstitial lung disease) - You have significant heart problems or a prolonged QT interval on your ECG - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHWK-007

HWK-007 is a PTK7- targeted ADC being developed for the treatment of solid tumors.


Locations(12)

University of Arkansas

Little Rock, Arkansas, United States

UCLA - Hematology/Oncology Clinical Research Unit

Los Angeles, California, United States

St. Francis Medical Center (OSF Healthcare)

Peoria, Illinois, United States

START - Midwest

Grand Rapids, Michigan, United States

Hackensack University Medical Center - John Theurer Cancer Center

Hackensack, New Jersey, United States

Roswell Park Comprehensive Care Center

Buffalo, New York, United States

University Hospital - Cleveland Medical Center

Cleveland, Ohio, United States

NEXT Oncology - Austin

Austin, Texas, United States

NEXT - Oncology - Houston

Houston, Texas, United States

START - San Antonio

San Antonio, Texas, United States

NEXT Oncology - Virginia Cancer Specialists

Fairfax, Virginia, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07444814


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