🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT07357220
Starting soon Phase 1/2

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

NCT07357220 · tracked via the Priya Life Science China tracker
Sponsor
Akeso
Phase
Phase 1/2
Started
2026-03-02
Last updated
2026-01-21

Condition(s) studied

Colorectal Cancer With Hepatic Metastases

Investigational drug(s) / intervention(s)

VG2025AK112

VG2025: Recommended Phase II Dose, Intratumoral Injection, Q4W

AK112: 20mg/kg, ivgtt, Q2W

Study summary

An open-label, multicenter, phase Ib/II study of AK112 in combination with VG2025 for advanced colorectal cancer with liver metastases.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Signed informed consent 2. Age≥18 years and ≤ 75 years 3. Histologically or cytologically confirmed unresectable colorectal cancer with liver metastases; adenocarcinoma type 4. Disease progression after first- or second-line standard therapy 5. At least one measurable disease based on RECIST v1.1 6. ECOG status of 0 or 1 7. Estimated life expectancy≥3 months 8. Adequate organ function 9. Patients with fertility are willing to use an adequate method of contraception Exclusion Criteria: 1. Histologically or cytologically confirmed non-adenocarcinoma or mixed-type tumors with adenocarcinoma component ≤70% 2. Known dMMR or MSI-H 3. Known RAS or BRAF mutations 4. Participation in another clinical trial 5. Systemic anticancer therapy within 4 weeks, small molecule therapy within 2 weeks, antitumor traditional Chinese medicine within 2 weeks before first dose 6. Prior immunotherapy other than anti-PD-(L)1 agents 7. Live attenuated vaccine within 28 days before or during study treatment and 90 days after last dose 8. Active malignancy within the past 3 years 9. Known spinal cord compression, active brain or leptomeningeal metastases. 10. Significant bleeding events requiring transfusion, invasive intervention, or hospitalization within 3 months before first dose 11. Serious infection within 28 days, or systemic anti-infective therapy within 14 days before first dose (except antiviral therapy for hepatitis B/C) 12. Active herpesvirus infection with clinical manifestations 13. Active autoimmune disease 14. Known immunodeficiency 15. Known allergy to study drug or excipients, or history of severe allergic reactions to other vaccines 16. History of allogeneic organ or hematopoietic stem cell transplantation. 17. Clinically significant liver disease 18. Any other situations that are not suitable for inclusion in this study judged by investigator

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital, Zhejiang University School of Medicine,No. 79, Qingchun Road, Shangcheng District, Hangzhou City, Zhejiang Province Hangzhou Zhejiang

More Akeso trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07357220 on ClinicalTrials.gov ↗ ← All trials in China