Actively Recruiting
A Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation
Led by Clasp Therapeutics, Inc. · Updated on 2026-02-13
90
Participants Needed
21
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be at least 18 years of age at the time of signing the informed consent.
- Patients must be willing and able to provide written informed consent.
- Patients must have locally advanced or metastatic solid tumors that have progressed after standard of care therapy or for which no standard therapy exists.
- Tumors must harbor a TP53 R175H variant mutation confirmed by an accredited laboratory-based test.
- Patients must be HLA-A*02:01 positive by central assay.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at the time of enrollment.
- Adequate hematological, renal and hepatic function.
- Patient is willing and able to complete study visits and procedures per the protocol and comply with study requirements.
You will not qualify if you...
- Patients with Li-Fraumeni syndrome or other known germline p53 R175H mutation.
- Patients who have received other p53 R175H-directed therapies.
- Patients who have not fully recovered from adverse events due to previous anticancer therapies.
- Patients with active infection requiring systemic antimicrobial therapy.
- Any other primary malignancy within the 2 years prior to enrollment (except for non-melanoma skin cancer, carcinoma in situ such as cervix, bladder, breast, or prostate cancer in remission).
- Known active central nervous system metastases and/or carcinomatous meningitis.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 21 locations
1
HonorHealth Research Institute
Scottsdale, Arizona, United States, 85258
Actively Recruiting
2
The University of Arizona Cancer Center
Tucson, Arizona, United States, 85719
Actively Recruiting
3
USC - Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
4
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
5
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
6
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
7
The University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
8
University of Kentucky Markey Cancer Center
Lexington, Kentucky, United States, 40536
Actively Recruiting
9
Johns Hopkins - Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
10
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
11
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
12
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
13
Duke Cancer Institute
Durham, North Carolina, United States, 27701
Actively Recruiting
14
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
15
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
16
Sarah Cannon Research Institute (SCRI) Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
17
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
18
Mary Crowley Cancer Research
Dallas, Texas, United States, 75230
Actively Recruiting
19
Baylor University Medical Center
Dallas, Texas, United States, 75246
Actively Recruiting
20
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
21
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
L
Lauren Harshman, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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