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

ConditionsEndometrial Cancer Ovarian Cancer Ovarian Cancer Metastatic Ovarian Cancer Metastatic Recurrent Non-squamous EGFR Wt NSCLC Platinum Resistant Ovarian Cancer PROC

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorWhitehawk Therapeutics, Inc.

About this trial

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 criteria

Qualifiers

non-squamous EGFR-Wt NSCLC

Endometrial carcinoma

Platinum Resistant Ovarian Cancer

Non-squamous EGFR-Wt NSCLC

Disqualifiers

Individual with known or suspected uncontrolled central nervous system (CNS) metastases

Individual with history of carcinomatous meningitis

Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection

Individual with evidence of corneal keratopathy or history of cornea transplant

Trial design

Treatments tested in this trial

HWK-007

Treatment groups

226 Participants

are divided into 5 treatment groups

Locations

Arkansas

University of Arkansas72205-7199, Little Rock United States

California

UCLA - Hematology/Oncology Clinical Research Unit90095, Los Angeles United States

Illinois

St. Francis Medical Center (OSF Healthcare)61637, Peoria United States

Michigan

START - Midwest49546, Grand Rapids United States

Sponsors and collaborators

Whitehawk Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov