Study Evaluating the Safety and Efficacy of HWK-007, a PTK7-directed Antibody Drug Conjugate in Participants With Advanced Solid Tumors
Recruiting · NCT07444814 · Interventional (participants receive a specific treatment) · Lead sponsor: Whitehawk Therapeutics, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
HWK-007
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
12 locations listed across 10 US states.
- University of Arkansas - Little Rock, Arkansas, United States
- UCLA - Hematology/Oncology Clinical Research Unit - Los Angeles, California, United States
- St. Francis Medical Center (OSF Healthcare) - Peoria, Illinois, United States
- START - Midwest - Grand Rapids, Michigan, United States
- Hackensack University Medical Center - John Theurer Cancer Center - Hackensack, New Jersey, United States
- Roswell Park Comprehensive Care Center - Buffalo, New York, United States
- University Hospital - Cleveland Medical Center - Cleveland, Ohio, United States
- NEXT Oncology - Austin - Austin, Texas, United States
- NEXT - Oncology - Houston - Houston, Texas, United States
- START - San Antonio - San Antonio, Texas, United States
- NEXT Oncology - Virginia Cancer Specialists - Fairfax, Virginia, United States
- Fred Hutchinson Cancer Center - Seattle, Washington, United States