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NCT06778863PHASE1Recruiting

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

Clasp Therapeutics, Inc.

Start Date

2/28/2025

Completion Date

6/1/2028

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.

Detailed 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).

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

CLSP-1025

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Conditions

Advanced Solid TumorUnresectable Solid TumorMetastatic Solid TumorColorectal AdenocarcinomaPancreatic AdenocarcinomaLung CancerOvarian CancerBreast CancerHead and Neck Squamous Cell CarcinomaProstate CancerBladder Cancer

Locations

HonorHealth Research Institute

Scottsdale, Arizona 85258

United States

The University of Arizona Cancer Center

Tucson, Arizona 85719

United States

USC - Norris Comprehensive Cancer Center

Los Angeles, California 90033

United States

University of California Davis Comprehensive Cancer Center

Sacramento, California 95817

United States

University of California San Francisco

San Francisco, California 94143

United States

University of Miami - Sylvester Comprehensive Cancer Center

Miami, Florida 33136

United States

The University of Chicago Comprehensive Cancer Center

Chicago, Illinois 60637

United States

University of Kentucky Markey Cancer Center

Lexington, Kentucky 40536

United States

Johns Hopkins - Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland 21287

United States

Hackensack University Medical Center

Hackensack, New Jersey 07601

United States

NYU Langone Health

New York, New York 10016

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Duke Cancer Institute

Durham, North Carolina 27701

United States

Thomas Jefferson University, Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania 19107

United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania 19111

United States

Sarah Cannon Research Institute (SCRI) Oncology Partners

Nashville, Tennessee 37203

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232

United States

Mary Crowley Cancer Research

Dallas, Texas 75230

United States

Baylor University Medical Center

Dallas, Texas 75246

United States

MD Anderson Cancer Center

Houston, Texas 77030

United States

Fred Hutchinson Cancer Center

Seattle, Washington 98109

United States