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

Last updated: February 12, 2026
Sponsor: Clasp Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Prostate Cancer

Prostate Cancer, Early, Recurrent

Prostate Disorders

Treatment

CLSP-1025

Clinical Study ID

NCT06778863
CLSP-1025-101
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Patients must be at least 18 years of age at the time of signing the informedconsent.

  • Patients must be willing and able to provide written informed consent

  • Patients must have locally advanced or metastatic solid tumors that have progressedafter standard of care therapy or for which no standard therapy exists

  • Tumors must harbor a TP53 R175H variant mutation confirmed by an accreditedlaboratory-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 timeof enrollment

  • Adequate hematological, renal and hepatic function

  • Per Investigator judgement, patient is willing and able to complete study visitsand/or procedures per the protocol and comply with study requirements for studyparticipation

Exclusion

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 anticancertherapies

  • 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 prostatecancer in remission.

  • Known active central nervous system metastases and/or carcinomatous meningitis

Study Design

Total Participants: 90
Treatment Group(s): 1
Primary Treatment: CLSP-1025
Phase: 1
Study Start date:
February 28, 2025
Estimated Completion Date:
June 30, 2028

Study 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).

Connect with a study center

  • HonorHealth Research Institute

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • HonorHealth Research Institute

    Scottsdale 5313457, Arizona 5551752 85258
    United States

    Active - Recruiting

  • The University of Arizona Cancer Center

    Tucson 5318313, Arizona 5551752 85719
    United States

    Active - Recruiting

  • USC - Norris Comprehensive Cancer Center

    Los Angeles, California 90033
    United States

    Site Not Available

  • University of California San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

  • USC - Norris Comprehensive Cancer Center

    Los Angeles 5368361, California 5332921 90033
    United States

    Active - Recruiting

  • University of California Davis Comprehensive Cancer Center

    Sacramento 5389489, California 5332921 95817
    United States

    Active - Recruiting

  • University of California San Francisco

    San Francisco 5391959, California 5332921 94143
    United States

    Active - Recruiting

  • University of Miami - Sylvester Comprehensive Cancer Center

    Miami, Florida 33136
    United States

    Site Not Available

  • University of Miami - Sylvester Comprehensive Cancer Center

    Miami 4164138, Florida 4155751 33136
    United States

    Active - Recruiting

  • The University of Chicago Comprehensive Cancer Center

    Chicago 4887398, Illinois 4896861 60637
    United States

    Active - Recruiting

  • University of Kentucky Markey Cancer Center

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • University of Kentucky Markey Cancer Center

    Lexington 4297983, Kentucky 6254925 40536
    United States

    Active - Recruiting

  • Johns Hopkins - Sidney Kimmel Comprehensive Cancer Center

    Baltimore 4347778, Maryland 4361885 21287
    United States

    Active - Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Hackensack University Medical Center

    Hackensack 5098706, New Jersey 5101760 07601
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • NYU Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York 5128581, New York 5128638 10065
    United States

    Active - Recruiting

  • NYU Langone Health

    New York 5128581, New York 5128638 10016
    United States

    Active - Recruiting

  • Duke Cancer Institute

    Durham 4464368, North Carolina 4482348 27701
    United States

    Active - Recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania 19111
    United States

    Site Not Available

  • Thomas Jefferson University, Sidney Kimmel Cancer Center

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Fox Chase Cancer Center

    Philadelphia 4560349, Pennsylvania 6254927 19111
    United States

    Active - Recruiting

  • Thomas Jefferson University, Sidney Kimmel Cancer Center

    Philadelphia 4560349, Pennsylvania 6254927 19107
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute (SCRI) Oncology Partners

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Sarah Cannon Research Institute (SCRI) Oncology Partners

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville 4644585, Tennessee 4662168 37232
    United States

    Active - Recruiting

  • Baylor University Medical Center

    Dallas, Texas 75246
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Baylor University Medical Center

    Dallas 4684888, Texas 4736286 75246
    United States

    Active - Recruiting

  • Mary Crowley Cancer Research

    Dallas 4684888, Texas 4736286 75230
    United States

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • Fred Hutchinson Cancer Center

    Seattle 5809844, Washington 5815135 98109
    United States

    Active - Recruiting

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