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A Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation

NCT06778863 · Clasp Therapeutics, Inc.
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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
About this study
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
Key Inclusion Criteria: * 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 * Per Investigator judgement, patient is willing and able to complete study visits and/or procedures per the protocol and comply with study requirements for study participation Key Exclusion Criteria: * 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 (eg, cervix, bladder, breast) or prostate cancer in remission. * Known active central nervous system metastases and/or carcinomatous meningitis
Study design
Enrollment target: 90 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-02-28
Estimated completion: 2028-06
Last updated: 2026-02-13
Interventions
Drug: CLSP-1025
Primary outcomes
  • Part A: Determine the maximum tolerated dose (MTD) and/or the recommended dose(s) for expansion (RDE[s]) (28 days after infusion)
  • Part B: Evaluate the Objective response rate (ORR) of CLSP-1025 as a monotherapy in HLA-selected patients with advanced solid tumors that express the p53 R175H mutation (Up to 24 months after infusion)
Sponsor
Clasp Therapeutics, Inc. · industry
Contacts & investigators
ContactLauren Harshman, MD · contact · LHarshman@clasptx.com · +1-617-812-1431
All locations (21)
HonorHealth Research InstituteRecruiting
Scottsdale, Arizona, United States
The University of Arizona Cancer CenterRecruiting
Tucson, Arizona, United States
USC - Norris Comprehensive Cancer CenterRecruiting
Los Angeles, California, United States
University of California Davis Comprehensive Cancer CenterRecruiting
Sacramento, California, United States
University of California San FranciscoRecruiting
San Francisco, California, United States
University of Miami - Sylvester Comprehensive Cancer CenterRecruiting
Miami, Florida, United States
The University of Chicago Comprehensive Cancer CenterRecruiting
Chicago, Illinois, United States
University of Kentucky Markey Cancer CenterRecruiting
Lexington, Kentucky, United States
Johns Hopkins - Sidney Kimmel Comprehensive Cancer CenterRecruiting
Baltimore, Maryland, United States
Hackensack University Medical CenterRecruiting
Hackensack, New Jersey, United States
NYU Langone HealthRecruiting
New York, New York, United States
Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
Duke Cancer InstituteRecruiting
Durham, North Carolina, United States
Thomas Jefferson University, Sidney Kimmel Cancer CenterRecruiting
Philadelphia, Pennsylvania, United States
Fox Chase Cancer CenterRecruiting
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute (SCRI) Oncology PartnersRecruiting
Nashville, Tennessee, United States
Vanderbilt University Medical CenterRecruiting
Nashville, Tennessee, United States
Mary Crowley Cancer ResearchRecruiting
Dallas, Texas, United States
Baylor University Medical CenterRecruiting
Dallas, Texas, United States
MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Fred Hutchinson Cancer CenterRecruiting
Seattle, Washington, United States
A Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation · TrialPath