A Study of RGX-202-01 (Ompenaclid) as Combination Therapy in RAS Mutant Advanced Colorectal Cancer

Exclusion criteria

• . The patient has signed informed consent prior to initiation of any study-specific procedures or treatment.
• . The patient must have previously untreated metastatic colorectal adenocarcinoma, defined as cancer that is metastatic and for which additional radiation therapy or other locoregional therapies in curative intent are not considered feasible or beneficial. Note that patients who have had previous systemic anticancer therapy as neoadjuvant or adjuvant therapy and had a metastatic recurrence at least 12 months after the last dose of adjuvant oxaliplatin will also be eligible.
• . The patient must have a tumor that is laboratory-confirmed to be RAS-mutant based on the tumor tissue analysis. RAS-mutant status confirmation by liquid biopsy is acceptable only if the tumor sample is not available. For patients with newly diagnosed disease, RAS-mutant status must be obtained before initiation of therapy.
• . The patient must have disease that is measurable by standard imaging techniques by RECIST version 1.1 or by physical examination methods (ruler or calipers). For patients with prior radiation therapy, measurable lesions must be outside of any prior radiation field(s), unless disease progression has been documented at that disease site subsequent to radiation.