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

NCT07444814 · Whitehawk Therapeutics, Inc.
In plain English

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Official title
A Phase 1 First-in-Human Study of PTK7-Directed Antibody Drug Conjugate HWK-007 in Participants With Advanced Solid Tumors
About this study
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
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
Study design
Enrollment target: 226 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-12-19
Estimated completion: 2028-12
Last updated: 2026-03-27
Interventions
Drug: HWK-007
Primary outcomes
  • Determine Maximum Tolerated Dose (MTD) (From Cycle 1, Day 1 until Cycle 1, Day 21 (21-day cycles))
  • Determine Maximum Administered Dose (MAD) (From Cycle 1, Day 1 to Cycle 1, Day 21 (21-day cycles) until the MTD is reached.)
  • Determine the Recommended Dose for Expansion (RDE) (From Cycle 1, Day 1 to Cycle 1, Day 21 (21-day cycles) until MTD is identified.)
Sponsor
Whitehawk Therapeutics, Inc. · industry
Contacts & investigators
ContactClinical Trial Manager Lead · contact · WHWK-Clinical-Trials@whitehawktx.com · 888-392-9025
ContactCentral email mailbox - Whitehawk Therapeutics · contact · WHWK-Clinical-Trials@whitehawktx.com
InvestigatorMargaret C Dugan, MD · study_director, Whitehawk Therapeutics
InvestigatorEdward C Spindler, BS, MBA · study_director, Whitehawk Therapeutics
All locations (12)
University of ArkansasNot Yet Recruiting
Little Rock, Arkansas, United States
UCLA - Hematology/Oncology Clinical Research UnitNot Yet Recruiting
Los Angeles, California, United States
St. Francis Medical Center (OSF Healthcare)Not Yet Recruiting
Peoria, Illinois, United States
START - MidwestRecruiting
Grand Rapids, Michigan, United States
Hackensack University Medical Center - John Theurer Cancer CenterNot Yet Recruiting
Hackensack, New Jersey, United States
Roswell Park Comprehensive Care CenterNot Yet Recruiting
Buffalo, New York, United States
University Hospital - Cleveland Medical CenterNot Yet Recruiting
Cleveland, Ohio, United States
NEXT Oncology - AustinRecruiting
Austin, Texas, United States
NEXT - Oncology - HoustonRecruiting
Houston, Texas, United States
START - San AntonioRecruiting
San Antonio, Texas, United States
NEXT Oncology - Virginia Cancer SpecialistsRecruiting
Fairfax, Virginia, United States
Fred Hutchinson Cancer CenterNot Yet Recruiting
Seattle, Washington, United States
Study Evaluating the Safety and Efficacy of HWK-007, a PTK7-directed Antibody Drug Conjugate in Participants With Advanced Solid Tumors · TrialPath