Actively Recruiting
GUARDIAN-101: A Phase 1 Dose Escalation and Expansion Study of CLSP-1025 in Adults With Solid Tumors Harboring the p53 R175H Mutation
Led by Clasp Therapeutics, Inc. · Updated on 2026-02-13
90
Participants Needed
21
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating CLSP-1025, a first-in-class T cell engager targeting the p53 R175H mutation, in adults with advanced solid tumors that have this specific mutation and who are HLA-A*02:01 positive. This Phase 1, open-label, multicenter study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and early clinical effects of CLSP-1025 in these patients. The study has two parts: Part A focuses on dose escalation to find the recommended dose(s) for further study, while Part B expands the patient group to further evaluate the treatment's preliminary anti-tumor activity and safety at the selected dose(s). CLSP-1025 is given by intravenous infusion to adult patients with advanced solid tumors that have progressed after standard treatments or have no standard treatment options. Participants will undergo evaluations including safety monitoring, blood sampling for drug levels and immune response, and tumor response assessments for up to 24 months after infusion. The primary outcomes include determining the maximum tolerated dose and objective response rate. Secondary outcomes include treatment-related side effects, pharmacokinetic measures, duration of response, progression-free survival, and overall survival, with ongoing safety and activity monitoring throughout the study.
CONDITIONS
Brief 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 old at the time of signing 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 care or have no standard therapy options
- Tumors must have the TP53 R175H mutation confirmed by an accredited test
- Patients must be HLA-A*02:01 positive by central testing
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Adequate blood, kidney, and liver function
- Patient is willing and able to complete study visits and follow protocol requirements
You will not qualify if you...
- Patients with Li-Fraumeni syndrome or other known inherited p53 R175H mutations
- Patients who have received other p53 R175H-targeted therapies
- Patients not fully recovered from side effects of previous cancer treatments
- Patients with active infections requiring systemic antibiotics
- Any other primary cancer within 2 years before enrollment except certain skin, cervical, bladder, breast, or prostate cancers in remission
- Known active brain metastases or carcinomatous meningitis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months after infusion
Participants receive CLSP-1025 by IV infusion to evaluate its safety, tolerability, and preliminary clinical activity.
Repeated visits for dosing and assessments, timing depends on treatment schedule
Duration - Up to 24 months after infusion
Participants are monitored for safety, treatment response, and survival after completing treatment with CLSP-1025.
Visits for safety and efficacy assessments as scheduled by the study
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
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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