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