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Not yet recruiting NCT07357220

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

Phase I / Phase II Interventional Colorectal Cancer With Hepatic Metastases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VG2025, AK112.
Who it may be relevant to
Registry conditions: Colorectal Cancer With Hepatic Metastases. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Detailed 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.

Interventions

  • Biological VG2025
    Recommended Phase II Dose, Intratumoral Injection, Q4W
  • Drug AK112
    20mg/kg, ivgtt, Q2W

Primary outcome measures

  • Number of participants experiencing dose-limiting toxicities (DLTs) [Time frame: From Day 1 to Day 28 after the first tumour vaccine was administrated in safety run-in cohorts]
  • Number of participants with adverse events (AEs) and severity [Time frame: From ICF up to 30 days after last study treatment]
  • Objective Response Rate (ORR) [Time frame: Time Frame: Up to 2 years]
Secondary outcome measures (7)
  • Progression free survival (PFS) [Time frame: Up to 2 years]
  • Disease control rate (DCR) [Time frame: Up to 2 years]
  • Duration of response (DoR) [Time frame: Up to 2 years]
  • Time to response (TTR) [Time frame: Up to 2 years]
  • Overall survival (OS) [Time frame: Up to 2 years]
  • Observed concentrations of AK112 [Time frame: Up to 2 years]
  • Number of participants with detectable anti-drug antibodies (ADAs) to AK112 [Time frame: Up to 2 years]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital, Zhejiang University School of Medicine，No. 79, Qingchun Roa — Hangzhou

Identifiers

NCT: NCT07357220 · AK112-212

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗