An Open-Label Phase 1 Dose-Escalation and Expansion Study Investigating the Safety, Pharmacokinetics, Pharmacodynamics, and Activity of PRTH-101 Alone or in Combination With Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors
Incendia Therapeutics
Summary
The goal of this Open-Label Study is to evaluate the safety and tolerability of PRTH-101 alone or in combination with pembrolizumab in adults with advance or metastatic solid tumors.
Description
The goal of this Open-Label Study is to evaluate the safety and tolerability of PRTH-101 alone or in combination with pembrolizumab in adults with advance or metastatic solid tumors. PRTH-101 is a therapeutic antibody that specifically binds to and blocks DDR1, a protein expressed on tumor cells that binds collagen to make a minimally permeable physical barrier that blocks immune cells from interacting with and attacking tumor cells. These "immune cell-excluded" solid tumors are resistant to attack by the immune system (as well as other existing therapies). By disabling DDR1, the collagen fib…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Subject must be willing and able to read, understand, and sign an Informed Consent Form. 2. Subject must be age ≥18 years. 3. Subject has metastatic or advanced, unresectable malignancy and measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed at Screening, excluding hepatocellular carcinoma, sarcomas, and gliomas. 4. Subject has a pathologically documented advanced/unresectable or metastatic cancer that is refractory to or intolerable to or the subject is unwilling or ineligible to receive standard treatment known to confer benef…
Interventions
- BiologicalPRTH-101
PRTH-101 is a humanized immunoglobulin gamma-1 (IgG1) monoclonal antibody
- BiologicalPembrolizumab
PRTH-101 in combination with Pembrolizumab
Locations (11)
- Honor Health Research InstituteScottsdale, Arizona
- Yale Cancer CenterNew Haven, Connecticut
- Mass General Cancer CenterBoston, Massachusetts
- Providence Cancer Institute Franz ClinicPortland, Oregon
- University of Pittsburgh Medical Center Hillman Cancer CenterPittsburgh, Pennsylvania
- Vanderbilt-Ingram Cancer CenterNashville, Tennessee