Phase II Study of Anti-PD-1/VEGF Bispecific Antibody Ivonescimab in Patients With Previously Treated Metastatic Colorectal Cancer
Trial Parameters
Brief Summary
The goal of this clinical research study is to learn if ivonescimab can help to control previously treated, metastatic colorectal cancer.
Eligibility Criteria
Inclusion Criteria: 1. Capable of giving signed informed consent 2. Male and female adult participants 18 years of age or older on day of signing informed consent. 3. Histological or cytological confirmed advanced, metastatic adenocarcinoma of colon or rectum. 4. Known MMR or MSI status performed by local standard of practice. (e.g., IHC and/or PCR, next-generation sequencing) 5. Cohort-specific criteria * Cohort 1: MSI-H/dMMR: ICI-refractory * dMMR or MSI-H per local testing * Demonstrated radiographic or clinical disease progression following treatment with immune checkpoint inhibitors including anti-PD-1 +/- anti-CTLA-4 therapy. If progression occurred after first imaging assessment, then pseudo-progression should be excluded by concurrent carcinoembryonic antigen (CEA) or other tumor marker or ctDNA elevation, or clinical symptom progression, or short-interval repeat imaging confirming progression. * Must have received at least 2 doses of a PD1/PD-L1 inhibitor. * Progressive diseas