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A Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation
Sponsor: Clasp Therapeutics, Inc.
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.
Official title: GUARDIAN-101: A Phase 1 Dose Escalation and Expansion Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2025-02-28
Completion Date
2028-06
Last Updated
2026-02-13
Healthy Volunteers
No
Conditions
Interventions
CLSP-1025
CLSP-1025 will be administered by IV infusion
Locations (21)
HonorHealth Research Institute
Scottsdale, Arizona, United States
The University of Arizona Cancer Center
Tucson, Arizona, United States
USC - Norris Comprehensive Cancer Center
Los Angeles, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
University of California San Francisco
San Francisco, California, United States
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, United States
The University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
University of Kentucky Markey Cancer Center
Lexington, Kentucky, United States
Johns Hopkins - Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
NYU Langone Health
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Duke Cancer Institute
Durham, North Carolina, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute (SCRI) Oncology Partners
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Mary Crowley Cancer Research
Dallas, Texas, United States
Baylor University Medical Center
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States