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NCT06778863 | RECRUITING | Advanced Solid Tumor

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

Clasp Therapeutics, Inc.

Brief 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.

Condition or disease

Advanced Solid Tumor

Unresectable Solid Tumor

Metastatic Solid Tumor

Colorectal Adenocarcinoma

Pancreatic Adenocarcinoma

Lung Cancer

Ovarian Cancer

Breast Cancer

Head and Neck Squamous Cell Carcinoma

Prostate Cancer

Bladder Cancer

Intervention/treatment

CLSP-1025

Phase

PHASE1

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).

Study Type : INTERVENTIONAL
Estimated Enrollment : 90 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2025-02-28
Estimated Primary Completion Date : 2027-12
Estimated Study Completion Date : 2028-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
A Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation

Location Details

NCT06778863

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

HonorHealth Research Institute

Scottsdale, Arizona, United States, 85258

RECRUITING

United States, California

USC - Norris Comprehensive Cancer Center

Los Angeles, California, United States, 90033

RECRUITING

United States, California

University of California San Francisco

San Francisco, California, United States, 94143

RECRUITING

United States, Florida

University of Miami - Sylvester Comprehensive Cancer Center

Miami, Florida, United States, 33136

RECRUITING

United States, Kentucky

University of Kentucky Markey Cancer Center

Lexington, Kentucky, United States, 40536

RECRUITING

United States, New Jersey

Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601

RECRUITING

United States, New York

NYU Langone Health

New York, New York, United States, 10016

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

RECRUITING

United States, Pennsylvania

Thomas Jefferson University, Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, United States, 19107

RECRUITING

United States, Pennsylvania

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States, 19111

RECRUITING

United States, Tennessee

Sarah Cannon Research Institute (SCRI) Oncology Partners

Nashville, Tennessee, United States, 37203

RECRUITING

United States, Texas

Baylor University Medical Center

Dallas, Texas, United States, 75246

RECRUITING

United States, Texas

MD Anderson Cancer Center

Houston, Texas, United States, 77030