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RecruitingPhase 1NCT06778863

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

Sponsor

Clasp Therapeutics, Inc.

Enrollment

90 participants

Start Date

Feb 28, 2025

Study Type

INTERVENTIONAL

Conditions

Breast CancerOvarian CancerProstate CancerLung CancerAdvanced Solid TumorMetastatic Solid TumorHead and Neck Squamous Cell CarcinomaPancreatic AdenocarcinomaBladder CancerUnresectable Solid TumorColorectal Adenocarcinoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human clinical trial testing a new cancer immunotherapy drug called CLSP-1025 in patients with advanced solid tumors (cancers that form in organs or tissues) that carry a specific gene mutation called TP53 R175H. This drug works by training the immune system to recognize and kill cancer cells with this mutation. **You may be eligible if...** - You are 18 years of age or older - You have locally advanced or metastatic (spread) solid tumor cancer - Your tumor has the specific TP53 R175H mutation confirmed by a laboratory test - You carry a specific immune marker called HLA-A*02:01 (determined by a central test) - Your cancer has grown after standard treatments, or no standard treatment exists - You have good general functional status (ECOG 0–1) - Your blood, kidney, and liver function are adequate **You may NOT be eligible if...** - Your tumor does not have the TP53 R175H mutation - You are not HLA-A*02:01 positive - You have certain active autoimmune conditions or other serious health issues Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCLSP-1025

CLSP-1025 will be administered by IV infusion

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

NYU Langone Health

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Duke Cancer Institute

Durham, North Carolina, United States

Thomas Jefferson University, Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Sarah Cannon Research Institute (SCRI) Oncology Partners

Nashville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Mary Crowley Cancer Research

Dallas, Texas, United States

Baylor University Medical Center

Dallas, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

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NCT06778863

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