A Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation
Start Date
2/28/2025
Completion Date
6/1/2028
Summary
Phase 1 dose escalation and expansion study of CLSP-1025, a first-in-class HLA-A\*02:01 specific T cell engager (TCE) targeting solid tumors that harbor the p53 R175H mutation.
Detailed Description
This Phase 1, open-label, multicenter study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of CLSP-1025 when administered to HLA-A\*02:01-positive adult patients with advanced solid tumors that harbor the p53 R175H mutation. The study will be conducted in 2 parts: Part A Monotherapy Dose Escalation to determine the recommended dose(s) for expansion (RDE\[s\]) and Part B Monotherapy Expansion to explore the preliminary antitumor activity as well as further characterize the safety, tolerability, PK, and PD of CLSP-1025 at the RDE(s).
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
CLSP-1025
Conditions
Locations
HonorHealth Research Institute
Scottsdale, Arizona 85258
United States
The University of Arizona Cancer Center
Tucson, Arizona 85719
United States
USC - Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
United States
University of California San Francisco
San Francisco, California 94143
United States
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida 33136
United States
The University of Chicago Comprehensive Cancer Center
Chicago, Illinois 60637
United States
University of Kentucky Markey Cancer Center
Lexington, Kentucky 40536
United States
Johns Hopkins - Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland 21287
United States
Hackensack University Medical Center
Hackensack, New Jersey 07601
United States
NYU Langone Health
New York, New York 10016
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Duke Cancer Institute
Durham, North Carolina 27701
United States
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania 19107
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United States
Sarah Cannon Research Institute (SCRI) Oncology Partners
Nashville, Tennessee 37203
United States
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
Mary Crowley Cancer Research
Dallas, Texas 75230
United States
Baylor University Medical Center
Dallas, Texas 75246
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
Fred Hutchinson Cancer Center
Seattle, Washington 98109
United States