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Recruiting Phase 1

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

NCT06778863 · tracked via the Priya Life Science USA tracker
Sponsor
Clasp Therapeutics, Inc
Phase
Phase 1
Started
2025-02-28
Last updated
2026-02-13

Condition(s) studied

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

Investigational drug(s) / intervention(s)

CLSP-1025

CLSP-1025: CLSP-1025 will be administered by IV infusion

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Part A: Determine the maximum tolerated dose (MTD) and/or the recommended dose(s) for expansion (RDE[s]) — 28 days after infusion
    Rate of dose-limiting toxicities (DLTs) after infusion of CLSP-1025
  • 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
    Objective response rate (ORR) per RECIST V1.1 determined by Investigator assessment

Trial sites (21)

FacilityCityRegionStatus
HonorHealth Research Institute Scottsdale Arizona Recruiting
The University of Arizona Cancer Center Tucson Arizona Recruiting
USC - Norris Comprehensive Cancer Center Los Angeles California Recruiting
University of California Davis Comprehensive Cancer Center Sacramento California Recruiting
University of California San Francisco San Francisco California Recruiting
University of Miami - Sylvester Comprehensive Cancer Center Miami Florida Recruiting
The University of Chicago Comprehensive Cancer Center Chicago Illinois Recruiting
University of Kentucky Markey Cancer Center Lexington Kentucky Recruiting
Johns Hopkins - Sidney Kimmel Comprehensive Cancer Center Baltimore Maryland Recruiting
Hackensack University Medical Center Hackensack New Jersey Recruiting
NYU Langone Health New York New York Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
Duke Cancer Institute Durham North Carolina Recruiting
Thomas Jefferson University, Sidney Kimmel Cancer Center Philadelphia Pennsylvania Recruiting
Fox Chase Cancer Center Philadelphia Pennsylvania Recruiting
Sarah Cannon Research Institute (SCRI) Oncology Partners Nashville Tennessee Recruiting
Vanderbilt University Medical Center Nashville Tennessee Recruiting
Mary Crowley Cancer Research Dallas Texas Recruiting
Baylor University Medical Center Dallas Texas Recruiting
MD Anderson Cancer Center Houston Texas Recruiting
Fred Hutchinson Cancer Center Seattle Washington Recruiting

More Clasp Therapeutics, Inc. trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06778863 on ClinicalTrials.gov ↗ ← All trials in the USA