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

Akeso

Status and phase: Begins enrollment this month; Phase 2; Phase 1

Conditions: Colorectal Cancer With Hepatic Metastases

Treatments: Biological: VG2025; Drug: AK112

Study type: Interventional

Funder types: Industry

Identifiers

NCT07357220

AK112-212

Details and patient eligibility

About

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

Full description

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Cohort A (VG2025+AK112)

Experimental group

Description:

VG2025 (Recommended Phase II Dose), Intratumoral Injection, Q4W + AK112 (20mg/kg), ivgtt, Q2W.

Treatment:

Drug: AK112

Biological: VG2025

Cohort B (AK112)

Experimental group

Description:

AK112 (20mg/kg), ivgtt, Q2W

Treatment:

Drug: AK112