Study Evaluating the Safety and Efficacy of HWK-007, a PTK7-directed Antibody Drug Conjugate in Participants With Advanced Solid Tumors
Recruiting now · Phase 1
Conditions studied: Endometrial Cancer, Ovarian Cancer, Ovarian Cancer Metastatic, Ovarian Cancer Metastatic Recurrent, Non-squamous EGFR Wt NSCLC, Platinum Resistant Ovarian Cancer, PROC
In brief
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.
Key facts
- Study ID
- NCT07444814
- Run by
- Whitehawk Therapeutics, Inc.
- People needed
- 226
- Starts
- 2025-12-19
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2026-08-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Have one of the following solid tumor cancers:
- Monotherapy escalation and backfill cohorts:
- non-squamous EGFR-Wt NSCLC
- Endometrial carcinoma
- Platinum Resistant Ovarian Cancer
- Monotherapy expansion cohorts:
- Non-squamous EGFR-Wt NSCLC
- Additional tumor indications to be defined in a future amendment
You may not qualify if…
- 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
- Any serious unresolved toxicities from prior therapy
- Significant cardiovascular disease
- Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 milliseconds (ms)
- History of pneumonitis/interstitial lung disease
- Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention
Where it is running
- University of Arkansas — Little Rock, Arkansas, United States (enrolling)
- START - San Antonio — San Antonio, Texas, United States (enrolling)
- NEXT Oncology - Virginia Cancer Specialists — Fairfax, Virginia, United States (enrolling)
- St. Francis Medical Center (OSF Healthcare) — Peoria, Illinois, United States (enrolling)
- START - Midwest — Grand Rapids, Michigan, United States (enrolling)
- Hackensack University Medical Center - John Theurer Cancer Center — Hackensack, New Jersey, United States (enrolling)
- Roswell Park Comprehensive Care Center — Buffalo, New York, United States (enrolling)
- University Hospital - Cleveland Medical Center — Cleveland, Ohio, United States (enrolling)
- NEXT Oncology - Austin — Austin, Texas, United States (enrolling)
- NEXT - Oncology - Houston — Houston, Texas, United States (enrolling)
- UCLA - Hematology/Oncology Clinical Research Unit — Los Angeles, California, United States
- Fred Hutchinson Cancer Center — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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