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NCT07444814PHASE1Recruiting

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

Whitehawk Therapeutics, Inc.

Start Date

12/19/2025

Completion Date

12/1/2028

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.

Detailed Description

The study consists of 2 phases, Phase 1a (dose escalation) and Phase 1b (dose expansion). In Phase 1a, participants with non-squamous Endothelial Growth Factor Receptor Wild type (EGFR Wt) NSCLC, platinum resistant ovarian cancer (PROC), and endometrial cancer will be enrolled. In Phase 1b, non-squamous EGFR Wt NSCLC expansion cohort(s) will be opened, based on the safety, tolerability, PK, and preliminary antitumor data in Phase 1a. In Phase 1a of the study, HWK-007 will initially be administered as an intravenous (IV) infusion every 3 weeks (Q3W).

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

HWK-007

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Conditions

Endometrial CancerOvarian CancerOvarian Cancer MetastaticOvarian Cancer Metastatic RecurrentNon-squamous EGFR Wt NSCLCPlatinum Resistant Ovarian CancerPROC

Locations

University of Arkansas

Little Rock, Arkansas 72205-7199

United States

UCLA - Hematology/Oncology Clinical Research Unit

Los Angeles, California 90095

United States

St. Francis Medical Center (OSF Healthcare)

Peoria, Illinois 61637

United States

START - Midwest

Grand Rapids, Michigan 49546

United States

Hackensack University Medical Center - John Theurer Cancer Center

Hackensack, New Jersey 07601

United States

Roswell Park Comprehensive Care Center

Buffalo, New York 14263

United States

University Hospital - Cleveland Medical Center

Cleveland, Ohio 44106

United States

NEXT Oncology - Austin

Austin, Texas 78758

United States

NEXT - Oncology - Houston

Houston, Texas 77054

United States

START - San Antonio

San Antonio, Texas 78229

United States

NEXT Oncology - Virginia Cancer Specialists

Fairfax, Virginia 22031

United States

Fred Hutchinson Cancer Center

Seattle, Washington 98109

United States