Spots Global Cancer Trial Database for A First-in-human Study of PRTH-101 Monotherapy +/- Pembrolizumab in Subjects With Advanced Malignancies
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Trial Identification
Brief Title: A First-in-human Study of PRTH-101 Monotherapy +/- Pembrolizumab in Subjects With Advanced Malignancies
Official Title: 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
Study ID: NCT05753722
Conditions
Study Description
Brief 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.
Detailed 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 fibers lose alignment and loosen, creating gaps in the tumor barrier, thus allowing T-cells to enter and naturally attack the tumor. The main question\[s\] it aims to answer are: * to evaluate the safety and tolerability of PRTH-101 as mono therapy and in combination with pembrolizumab, * to determine the recommended Phase 2 dose as mono therapy and in combination with pembrolizumab, * to evaluate anti-tumor activity of PRTH-101 as mono therapy and in combination with pembrolizumab in selected indications
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Yale Cancer Center, New Haven, Connecticut, United States
Mass General Cancer Center, Boston, Massachusetts, United States
Providence Cancer Institute Franz Clinic, Portland, Oregon, United States
University of Pittsburgh Medical Center Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Next Oncology, Irving, Texas, United States
NEXT Oncology, San Antonio, Texas, United States
Next Oncology, Fairfax, Virginia, United States
Contact Details
Name: Joseph Paul Eder, MD
Affiliation: Incendia Therapeutics
Role: STUDY_CHAIR
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