HWK-007, a PTK7-targeted antibody‑drug conjugate for advanced PTK7-positive ovarian, endometrial, and certain non‑squamous lung cancers
A Phase 1 First-in-Human Study of PTK7-Directed Antibody Drug Conjugate HWK-007 in Participants With Advanced Solid Tumors
This study will try HWK-007, a PTK7-targeted antibody‑drug conjugate given every three weeks, to see if it can shrink or control advanced PTK7-positive ovarian, endometrial, or non-squamous EGFR wild-type lung cancers.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 226 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Whitehawk Therapeutics, Inc. Industry-sponsored |
| Locations | 12 sites (Little Rock, Arkansas and 11 other locations) |
| Trial ID | NCT07444814 on ClinicalTrials.gov |
What this trial studies
This first-in-human, open-label Phase 1 study uses sequential dose escalation (Phase 1a) followed by dose expansion (Phase 1b) without a control group to define a safe dose and gather early signs of anti-tumor activity and pharmacokinetics. HWK-007, a PTK7-directed antibody‑drug conjugate, is given by intravenous infusion every three weeks during the dose-escalation phase. Phase 1a enrolls patients with non-squamous EGFR wild-type NSCLC, platinum-resistant ovarian cancer, and endometrial carcinoma, and Phase 1b may open expansion cohorts for non-squamous EGFR WT NSCLC and other indications based on initial safety and activity. The trial is multicenter and will open cohorts at selected U.S. oncology centers.
Who should consider this trial
Good fit: Adults with advanced or metastatic PTK7-expressing non-squamous EGFR wild-type NSCLC, platinum-resistant ovarian cancer, or endometrial carcinoma who meet the study's safety and laboratory criteria and can attend site visits may be eligible.
Not a fit: Patients with uncontrolled CNS metastases, active uncontrolled infections, significant cardiac disease or prolonged QTc, corneal disease, unresolved toxicities from prior therapy, or who are pregnant are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, HWK-007 could become a new targeted treatment option that shrinks tumors or delays progression in patients with PTK7-expressing advanced solid tumors.
How similar studies have performed: Other early-phase antibody‑drug conjugates targeting PTK7 have shown preliminary signals of activity in solid tumors, but clinical benefit for this target class is not yet established.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Little Rock, Arkansas and 11 other locations
- University of Arkansas — Little Rock, Arkansas, United States (Not_yet_recruiting)
- UCLA - Hematology/Oncology Clinical Research Unit — Los Angeles, California, United States (Not_yet_recruiting)
- St. Francis Medical Center (OSF Healthcare) — Peoria, Illinois, United States (Not_yet_recruiting)
- START - Midwest — Grand Rapids, Michigan, United States (Recruiting)
- Hackensack University Medical Center - John Theurer Cancer Center — Hackensack, New Jersey, United States (Not_yet_recruiting)
- Roswell Park Comprehensive Care Center — Buffalo, New York, United States (Not_yet_recruiting)
- University Hospital - Cleveland Medical Center — Cleveland, Ohio, United States (Not_yet_recruiting)
- NEXT Oncology - Austin — Austin, Texas, United States (Recruiting)
- NEXT - Oncology - Houston — Houston, Texas, United States (Recruiting)
- START - San Antonio — San Antonio, Texas, United States (Recruiting)
- NEXT Oncology - Virginia Cancer Specialists — Fairfax, Virginia, United States (Recruiting)
- Fred Hutchinson Cancer Center — Seattle, Washington, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Clinical Trial Manager Lead
- Email: WHWK-Clinical-Trials@whitehawktx.com
- Phone: 888-392-9025
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.