NCT06959550

Phase II Study of Anti-PD-1/VEGF Bispecific Antibody Ivonescimab in Patients With Previously Treated Metastatic Colorectal Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical research study is to learn if ivonescimab can help to control previously treated, metastatic colorectal cancer.

Detailed 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 treatment-refractory metastatic colorectal cancer: 1) dMMR/MSI-H refractory to anti-PD-1 therapy, 2) pMMR/non-MSI-H without liver metastases, and 3) pMMR/non-MSI-H with liver metastases. * To evaluate changes in intratumoral CD8+ T cell density following ivonescimab therapy. Exploratory Objectives: * To assess the time to response following treatment with ivonescimab in patients with metastatic colorectal cancer. * To assess the durability of response following treatment with ivonescimab in patients with metastatic colorectal cancer. * To evaluate progression-free survival following treatment with ivonescimab in patients with metastatic colorectal cancer. * To evaluate overall survival following treatment with ivonescimab in patients with metastatic colorectal cancer. * To investigate clinical, pathologic, and molecular features associated with therapeutic response to ivonescimab in patients with metastatic colorectal cancer. * To investigate changes in immune cell composition and distance relationships within the metastatic CRC tumor microenvironment following ivonescimab therapy. * To evaluate changes in peripheral immune cell populations in metastatic CRC patients following ivonescimab therapy.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Ivonescimab	Given by IV

Timeline

• Start date: 2025-07-28
• Primary completion: 2028-07-01
• Completion: 2030-07-01
• First posted: 2025-05-06
• Last updated: 2025-11-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study