NCT07357220Not yet recruitingPhase 1/2
A Study of AK112 in Combination With VG2025 in Colorectal Cancer With Liver Metastases
A Phase Ib/II Clinical Study Evaluating the Safety and Efficacy of AK112 in Combination With VG2025 in Patients With Advanced Colorectal Cancer With Liver Metastases
Source: ClinicalTrials.gov · Last updated 21 Jan 2026
Brief summary (registry, in English)
An open-label, multicenter, phase Ib/II study of AK112 in combination with VG2025 for advanced colorectal cancer with liver metastases.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 72 (estimated)
- First submitted
- 24 Dec 2025
- Start date
- Mar 2026
- Primary completion date
- Feb 2027
- Lead sponsor
- Akeso
- Diseases
- Colorectal cancer
- NCT number
- NCT07357220
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 72
- From Mar 2026 to the primary completion date, Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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)
Other illness
- Active malignancy within the past 3 years
- Active herpesvirus infection with clinical manifestations
- Active autoimmune disease
- 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
Other
- 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
- Known spinal cord compression, active brain or leptomeningeal metastases.
- Known immunodeficiency
- Any other situations that are not suitable for inclusion in this study judged by investigator
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital, Zhejiang University School of Medicine，No. 79, Qingchun Road, Shangcheng District, Hangzhou City, Zhejiang Province Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.