Metastatic Colorectal Cancer Clinical Trial
Official title:
Phase Ib Study With the Combination of LB-100 (PP2A Inhibitor) and Azenosertib (WEE1 Inhibitor) in Metastatic Colorectal Cancer Patients
This Phase Ib trial studies the side effects and best dose of LB-100 and azenosertib for the treatment of patients with metastatic colorectal cancer. Azenosertib blocks a protein that is involved in the repair of damaged DNA, this protein is called WEE1. Inhibiting WEE1 drives cancer cells into a state of cell division without repair of the damaged DNA, resulting in cell death. LB-100 has been shown to make anticancer drugs work better at killing cancer. LB-100 blocks a protein called PP2A. Blocking this protein increases the stress signals for the tumor cells that express PP2A. Research has shown that azenosertib and LB-100 may enhance each others effect when treating metastatic colorectal cancer.
The goal of this Phase Ib monocenter, open-label, non-randomized clinical trial is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of the combination of LB-100 and azenosertib in patients with metastatic colorectal cancer. This study will consist of a dose escalation phase and a dose expansion phase. The dose escalation phase is designed to find the recommended phase II dose of LB-100 and azenosertib when given together. The dose expansion phase further explores the clinical activity, safety, tolerability and pharmacokinetics/dynamics of LB-100 and azenosertib. Clinical assessments will be performed routinely to monitor safety. Anti-tumor activity will be measured by CT scan according to RECIST version 1.1 criteria. Tumor biopsies will be obtained for exploratory objectives. ;
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