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

RecruitingPhase 1Ages 18 Years - anyAllClasp Therapeutics, Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • CLSP-1025
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Where

21 sites
HonorHealth Research Institute
Scottsdale, United States
The University of Arizona Cancer Center
Tucson, United States
USC - Norris Comprehensive Cancer Center
Los Angeles, United States
University of California Davis Comprehensive Cancer Center
Sacramento, United States
University of California San Francisco
San Francisco, United States
University of Miami - Sylvester Comprehensive Cancer Center
Miami, United States
The University of Chicago Comprehensive Cancer Center
Chicago, United States
University of Kentucky Markey Cancer Center
Lexington, United States

โ€ฆand 13 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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