A Study of AK112 in Combination With VG2025 in Colorectal Cancer With Liver Metastases
Starting soon · Phase 1/Phase 2
Conditions studied: Colorectal Cancer With Hepatic Metastases
In brief
An open-label, multicenter, phase Ib/II study of AK112 in combination with VG2025 for advanced colorectal cancer with liver metastases.
Key facts
- Study ID
- NCT07357220
- Run by
- Akeso
- People needed
- 72
- Starts
- 2026-03-02
- Expected to finish
- 2028-02-28
- Last updated by the study team
- 2026-01-21
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- The First Affiliated Hospital, Zhejiang University School of Medicine，No. 79, Qingchun Road, Shangcheng District, Hangzhou City, Zhejiang Province — Hangzhou, Zhejiang, China
Full record on ClinicalTrials.gov
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