A Study of AK112 in Combination With VG2025 in Colorectal Cancer With Liver Metastases

This open-label, multicenter, phase Ib/II clinical study aims to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of AK112 in combination with VG2025, in the treatment of advanced colorectal cancer with liver metastases.

Inclusion criteria

• Signed informed consent
• Age≥18 years and ≤ 75 years
• Histologically or cytologically confirmed unresectable colorectal cancer with liver metastases; adenocarcinoma type
• Disease progression after first- or second-line standard therapy
• At least one measurable disease based on RECIST v1.1
• ECOG status of 0 or 1
• Estimated life expectancy≥3 months
• Adequate organ function
• Patients with fertility are willing to use an adequate method of contraception

Exclusion criteria

• Histologically or cytologically confirmed non-adenocarcinoma or mixed-type tumors with adenocarcinoma component ≤70%
• Known dMMR or MSI-H
• Known RAS or BRAF mutations
• Participation in another clinical trial
• Systemic anticancer therapy within 4 weeks, small molecule therapy within 2 weeks, antitumor traditional Chinese medicine within 2 weeks before first dose
• Prior immunotherapy other than anti-PD-(L)1 agents
• Live attenuated vaccine within 28 days before or during study treatment and 90 days after last dose
• Active malignancy within the past 3 years
• Known spinal cord compression, active brain or leptomeningeal metastases.
• Significant bleeding events requiring transfusion, invasive intervention, or hospitalization within 3 months before first dose
• Serious infection within 28 days, or systemic anti-infective therapy within 14 days before first dose (except antiviral therapy for hepatitis B/C)
• Active herpesvirus infection with clinical manifestations
• Active autoimmune disease
• Known immunodeficiency
• Known allergy to study drug or excipients, or history of severe allergic reactions to other vaccines
• History of allogeneic organ or hematopoietic stem cell transplantation.
• Clinically significant liver disease
• Any other situations that are not suitable for inclusion in this study judged by investigator