Phase II Study of Anti-PD-1/VEGF Bispecific Antibody Ivonescimab in Patients With Previously Treated Metastatic Colorectal Cancer
M.D. Anderson Cancer Center
Summary
The goal of this clinical research study is to learn if ivonescimab can help to control previously treated, metastatic colorectal cancer.
Description
Primary Objective: • To evaluate the efficacy of ivonescimab, as determined by the objective response rate per iRECIST, in three distinct cohorts of patients with treatment-refractory metastatic colorectal cancer: 1) dMMR/MSI-H refractory to anti-PD-1 therapy, 2) pMMR/MSS without liver metastases, and 3) pMMR/MSS with liver metastases. Secondary Objective: * To evaluate the safety of ivonescimab in patients with metastatic colorectal cancer. * To evaluate the efficacy of ivonescimab, as determined by the objective response rate per RECIST 1.1, in three distinct cohorts of patients with trea…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugIvonescimab
Given by IV
Location
- The University of Texas M. D. Anderson Cancer CenterHouston, Texas