A Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation
A Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation
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.
Miscellaneous
Phase I
Adults
Mol. targeted/Immunotherapy/Biologics
CLSP-1025
Berlin, Jordan
National
Vanderbilt University
02-15-2026
Eligibility
18 Years and older
ALL
false
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
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
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
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
