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.
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 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
Sequential
CLSP-1025
DrugCLSP-1025 will be administered by IV infusion
Part A: Determine the maximum tolerated dose (MTD) and/or the recommended dose(s) for expansion (RDE[s])
Rate of dose-limiting toxicities (DLTs) after infusion of CLSP-1025
Part B: Evaluate the Objective response rate (ORR) of CLSP-1025 as a monotherapy in HLA-selected patients with advanced solid tumors that express the p53 R175H mutation
Objective response rate (ORR) per RECIST V1.1 determined by Investigator assessment
Number of patients with treatment-emergent adverse events, as assessed by CTCAE, v5.0
Incidence and severity of treatment-emergent adverse events (TEAEs)
Number of patients with treatment-related adverse events, as assessed by CTCAE, v5.0
Incidence and severity of treatment-related adverse events (TRAEs)
Number of patients with clinically significant changes in QTcF Interval
Incidence of clinically significant changes in QTcF Interval
Maximum plasma concentration (Cmax) of CLSP-1025
To determine the maximum plasma concentration (Cmax) of CLSP-1025
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