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A Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

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

NCT06778863•Clasp Therapeutics, Inc.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (21)

HonorHealth Research Institute

Scottsdale, Arizona, United States

The University of Arizona Cancer Center

Tucson, Arizona, United States

USC - Norris Comprehensive Cancer Center

Los Angeles, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

University of California San Francisco

San Francisco, California, United States

University of Miami - Sylvester Comprehensive Cancer Center

Miami, Florida, United States

The University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

University of Kentucky Markey Cancer Center

Lexington, Kentucky, United States

Johns Hopkins - Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Key Dates

Start Date

February 28, 2025

Primary Completion Date

December 1, 2027

Completion Date

June 1, 2028

Last Updated

February 13, 2026

Enrollment

ESTIMATED participants

Conditions

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

Interventions

CLSP-1025

DRUG

Contacts

Lauren Harshman, MD

CONTACT

+1-617-812-1431 LHarshman@clasptx.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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