Actively Recruiting
Study Evaluating the Safety and Efficacy of HWK-007, a PTK7-directed Antibody Drug Conjugate in Participants With Advanced Solid Tumors
Led by Whitehawk Therapeutics, Inc. · Updated on 2026-03-27
226
Participants Needed
12
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study Evaluating the Safety and Efficacy of HWK-007, a PTK7-directed Antibody Drug Conjugate in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have one of the following solid tumor cancers: non-squamous EGFR-Wt NSCLC, endometrial carcinoma, or platinum resistant ovarian cancer
- For dose expansion: non-squamous EGFR-Wt NSCLC or other tumor types defined later
- Adults aged 18 years or older
You will not qualify if you...
- Known or suspected uncontrolled central nervous system (CNS) metastases
- History of carcinomatous meningitis
- Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
- Evidence of corneal keratopathy or history of cornea transplant
- Any serious unresolved toxicities from prior therapy
- Significant cardiovascular disease
- QTcF interval 470 milliseconds or longer
- History of pneumonitis or interstitial lung disease
- Pregnant, breastfeeding, or planning to breastfeed during study or within 30 days of last dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
University of Arkansas
Little Rock, Arkansas, United States, 72205-7199
Not Yet Recruiting
2
UCLA - Hematology/Oncology Clinical Research Unit
Los Angeles, California, United States, 90095
Not Yet Recruiting
3
St. Francis Medical Center (OSF Healthcare)
Peoria, Illinois, United States, 61637
Not Yet Recruiting
4
START - Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
5
Hackensack University Medical Center - John Theurer Cancer Center
Hackensack, New Jersey, United States, 07601
Not Yet Recruiting
6
Roswell Park Comprehensive Care Center
Buffalo, New York, United States, 14263
Not Yet Recruiting
7
University Hospital - Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Not Yet Recruiting
8
NEXT Oncology - Austin
Austin, Texas, United States, 78758
Actively Recruiting
9
NEXT - Oncology - Houston
Houston, Texas, United States, 77054
Actively Recruiting
10
START - San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
11
NEXT Oncology - Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
12
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Not Yet Recruiting
Research Team
C
Clinical Trial Manager Lead
CONTACT
C
Central email mailbox - Whitehawk Therapeutics
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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