RECRUITING

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

Conditions

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 CLSP-1025 T Cell Engager TCE TP53

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-02-28

Study Completion:2028-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06778863

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Lauren Harshman, MD

CONTACT

+1-617-812-1431

LHarshman@clasptx.com

Study Locations (Sites)

Sarah Cannon Research Institute

Nashville, Tennessee, 37203

United States

Collaborators and Investigators

Sponsor: Clasp Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-28

Study Completion Date2028-06

Study Record Updates

Study Start Date2025-02-28

Study Completion Date2028-06

Terms related to this study

Keywords Provided by Researchers

CLSP-1025
T Cell Engager
TCE
TP53

Additional Relevant MeSH Terms

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