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

Overview

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.

Detailed Description

This Phase 1, open-label, multicenter study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of CLSP-1025 when administered to HLA-A*02:01-positive adult patients with advanced solid tumors that harbor the p53 R175H mutation. The study will be conducted in 2 parts: Part A Monotherapy Dose Escalation to determine the recommended dose(s) for expansion (RDE[s]) and Part B Monotherapy Expansion to explore the preliminary antitumor activity as well as further characterize the safety, tolerability, PK, and PD of CLSP-1025 at the RDE(s).

Who Can Participate

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

Disclaimer

This summary is based on publicly available information from clinicaltrials.gov and is intended to help patients discuss possible trial options with their oncology care team. ClinicalTrials.gov and related public listings do not independently review or approve the safety and scientific merit of every study.

Participation decisions can be made only after review by the study team and your treating clinician.