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

RecruitingPhase 1

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

Who can join

Ages 18 and older · All sexes

Full eligibility 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

About the study

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.

What is being tested

Sponsor: Clasp Therapeutics, Inc. · Participants: 90 · Started: Feb 28, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06778863

Locations in the U.S.

ArizonaHonorHealth Research Institute, Scottsdale
The University of Arizona Cancer Center, Tucson
CaliforniaUSC - Norris Comprehensive Cancer Center, Los Angeles
University of California Davis Comprehensive Cancer Center, Sacramento
University of California San Francisco, San Francisco
FloridaUniversity of Miami - Sylvester Comprehensive Cancer Center, Miami
IllinoisThe University of Chicago Comprehensive Cancer Center, Chicago
KentuckyUniversity of Kentucky Markey Cancer Center, Lexington
MarylandJohns Hopkins - Sidney Kimmel Comprehensive Cancer Center, Baltimore
New JerseyHackensack University Medical Center, Hackensack
New YorkMemorial Sloan Kettering Cancer Center, New York
NYU Langone Health, New York
North CarolinaDuke Cancer Institute, Durham
PennsylvaniaFox Chase Cancer Center, Philadelphia
Thomas Jefferson University, Sidney Kimmel Cancer Center, Philadelphia
TennesseeSarah Cannon Research Institute (SCRI) Oncology Partners, Nashville
Vanderbilt University Medical Center, Nashville
TexasBaylor University Medical Center, Dallas
Mary Crowley Cancer Research, Dallas
MD Anderson Cancer Center, Houston
WashingtonFred Hutchinson Cancer Center, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.