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Phase 1Recruiting

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

Sponsored by Clasp Therapeutics, Inc.

About this study

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.

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).

Where this study is enrolling (21)

  • HonorHealth Research Institute

    Scottsdale, Arizona

    I'm interested

  • The University of Arizona Cancer Center

    Tucson, Arizona

    I'm interested

  • University of California San Francisco

    San Francisco, California

    I'm interested

  • USC - Norris Comprehensive Cancer Center

    Los Angeles, California

    I'm interested

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California

    Call 916-703-5558

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Show all 21 locations

  • University of Miami - Sylvester Comprehensive Cancer Center

    Miami, Florida

    Call 407-765-9589

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  • The University of Chicago Comprehensive Cancer Center

    Chicago, Illinois

    I'm interested

  • University of Kentucky Markey Cancer Center

    Lexington, Kentucky

    Call 859-257-4488

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  • Johns Hopkins - Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland

    Call 410-955-8964

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  • Hackensack University Medical Center

    Hackensack, New Jersey

    I'm interested

  • NYU Langone Health

    New York, New York

    Call 212-263-4432

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  • Memorial Sloan Kettering Cancer Center

    New York, New York

    Call 646-608-4042

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  • Duke Cancer Institute

    Durham, North Carolina

    Call 866-385-3123

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  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania

    I'm interested

  • Thomas Jefferson University, Sidney Kimmel Cancer Center

    Philadelphia, Pennsylvania

    I'm interested

  • Vanderbilt University Medical Center

    Nashville, Tennessee

    Call 615-936-8422

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  • Sarah Cannon Research Institute (SCRI) Oncology Partners

    Nashville, Tennessee

    Call 615-329-7640

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  • MD Anderson Cancer Center

    Houston, Texas

    Call 877-632-6789

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  • Mary Crowley Cancer Research

    Dallas, Texas

    Call 972-566-3000

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  • Baylor University Medical Center

    Dallas, Texas

    Call 888-507-3732

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  • Fred Hutchinson Cancer Center

    Seattle, Washington

    Call 855-557-0555

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Who can participate

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

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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.