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NCT07444814 · ClinicalTrials.gov registry record · Phase 1
Study Evaluating the Safety and Efficacy of HWK-007, a PTK7-directed Antibody Drug Conjugate in Participants With Advanced Solid Tumors
A Phase 1 study of Ovarian Cancer and Endometrial Cancer, sponsored by Whitehawk Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 226
- Enrollment target
- 12
- Study locations
NCT07444814: Recruiting Phase 1 study of Ovarian Cancer and Endometrial Cancer, sponsored by Whitehawk Therapeutics.
NCT07444814 is a Phase 1 study of Ovarian Cancer and Endometrial Cancer that is actively recruiting participants, run by Whitehawk Therapeutics. The registered enrollment target is 226 participants, below the 728-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (69% lower). The trial reports 12 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07444814, a Phase 1 study of Ovarian Cancer and Endometrial Cancer, is actively recruiting participants, sponsored by Whitehawk Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 226 participants
- Enrollment target
- 12
- Study locations
Study 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.
Primary Outcome
Determine the highest dose of HWK-007 that can be administered without signs of toxicity measured at the end of Cycle 1 (21 day cycle) by: Incidence and severity of Adverse Events (AE). Incidence of Dose-Limiting Toxicities (DLT). Incidence of Serious Adverse Events (SAE).
Conditions Studied
Interventions
- DRUG HWK-007
Study Locations (12)
Texas
- NEXT Oncology - Austin - Austin
- NEXT - Oncology - Houston - Houston
- START - San Antonio - San Antonio
Arkansas
- University of Arkansas - Little Rock
California
- UCLA - Hematology/Oncology Clinical Research Unit - Los Angeles
Illinois
- St. Francis Medical Center (OSF Healthcare) - Peoria
Michigan
- START - Midwest - Grand Rapids
New Jersey
- Hackensack University Medical Center - John Theurer Cancer Center - Hackensack
New York
- Roswell Park Comprehensive Care Center - Buffalo
Ohio
- University Hospital - Cleveland Medical Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 226 participants |
| Start Date | 2025-12-19 |
| Est. Completion | 2028-12 |
| Phase | Phase 1 |
What NCT07444814 shows while recruiting
NCT07444814 is an interventional study that assigns participants to a tested intervention. The registered 226 participants enrollment target is mid-sized for trials with a published cap, below the 728-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (69% lower).
The record links to 7 conditions, with Ovarian Cancer appearing as the primary indexed condition, and to 1 intervention - of which HWK-007 is the first listed.
NCT07444814 lists 12 locations in 10 states (Texas, Arkansas, California).
Frequently Asked Questions
What is clinical trial NCT07444814 about?
NCT07444814 is a clinical study titled "Study Evaluating the Safety and Efficacy of HWK-007, a PTK7-directed Antibody Drug Conjugate in Participants With Advanced Solid Tumors". 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 ...
What is the current status of trial NCT07444814?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 226 participants. The study started on 2025-12-19. Estimated completion is 2028-12.
What conditions does trial NCT07444814 study?
This clinical trial studies the following conditions: Ovarian Cancer, Endometrial Cancer, Platinum-resistant Ovarian Cancer, PROC, Ovarian Cancer Metastatic.
What interventions are being tested in trial NCT07444814?
The interventions under investigation include: HWK-007 (DRUG).
Who is sponsoring clinical trial NCT07444814?
This trial is sponsored by Whitehawk Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07444814 being conducted?
This trial has 12 study locations across Arkansas, California, Illinois, Michigan, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07444814's enrollment target sits among peer trials
226 86th of 322 higher than 237 of 322 other Ovarian Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ovarian Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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