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)
Number of participants experiencing dose-limiting toxicities (DLTs) — From Day 1 to Day 28 after the first tumour vaccine was administrated in safety run-in cohorts Number of participants who meet the criteria of dose-limiting toxicities (DLTs) in DLT observation period
Number of participants with adverse events (AEs) and severity — From ICF up to 30 days after last study treatment Number of participants experiencing adverse events (AEs) and severity, graded according to CTCAE v5.0
Objective Response Rate (ORR) — Time Frame: Up to 2 years Proportion of participants with complete response (CR) or partial response (PR), as assessed by RECIST version 1.1
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital, Zhejiang University School of Medicine,No. 79, Qingchun Road, Shangcheng District, Hangzhou City, Zhejiang Province
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.
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