RECRUITINGPhase 1INTERVENTIONAL
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
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
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
Who Should NOT Join This Trial:
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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
HWK-007
HWK-007 is a PTK7- targeted ADC being developed for the treatment of solid tumors.
Locations (12)
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