NCT07444814RecruitingPhase 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 First-in-Human Study of PTK7-Directed Antibody Drug Conjugate HWK-007 in Participants With Advanced Solid Tumors
Source: ClinicalTrials.gov · Last updated 5 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 226 (estimated)
- First submitted
- 11 Feb 2026
- Start date
- 19 Dec 2025
- Primary completion date
- 31 Oct 2028
- Lead sponsor
- Whitehawk Therapeutics, Inc.
- Diseases
- Endometrial cancer, Lung cancer, Ovarian cancer
- NCT number
- NCT07444814
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 226
- From 19 Dec 2025 to the primary completion date, 31 Oct 2028
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any serious unresolved toxicities from prior therapy
Other illness
- 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
- Significant cardiovascular disease
- History of pneumonitis/interstitial lung disease
Lab values
- Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 milliseconds (ms)
Other
- Individual with known or suspected uncontrolled central nervous system (CNS) metastases
- Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NEXT Oncology - Austin Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| Roswell Park Comprehensive Care Center Coordinator of this site? Confirm its status | Buffalo | United States | Recruiting |
| University Hospital Cleveland Medical Center Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| NEXT Oncology - Virginia Cancer Specialists Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| START | Midwest Coordinator of this site? Confirm its status | Grand Rapids | United States | Recruiting |
| Hackensack University Medical Center - John Theurer Cancer Center Coordinator of this site? Confirm its status | Hackensack | United States | Recruiting |
| Next Oncology - Houston Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| University of Arkansas Coordinator of this site? Confirm its status | Little Rock | United States | Recruiting |
| UCLA - Hematology/Oncology Clinical Research Unit Coordinator of this site? Confirm its status | Los Angeles | United States | Not yet recruiting |
| St. Francis Medical Center, OSF Healthcare Coordinator of this site? Confirm its status | Peoria | United States | Recruiting |
| START | San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Fred Hutchinson Cancer Center Coordinator of this site? Confirm its status | Seattle | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.