NCT07357220

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1

Timeline
22mo left

Started Mar 2026

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Mar 2026Feb 2028

First Submitted

Initial submission to the registry

December 24, 2025

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 2, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2028

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

12 months

First QC Date

December 24, 2025

Last Update Submit

January 12, 2026

Conditions

Colorectal Cancer With Hepatic Metastases

Outcome Measures

Primary Outcomes (3)

  • Number of participants experiencing dose-limiting toxicities (DLTs)

    Number of participants who meet the criteria of dose-limiting toxicities (DLTs) in DLT observation period

    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

    Number of participants experiencing adverse events (AEs) and severity, graded according to CTCAE v5.0

    From ICF up to 30 days after last study treatment

  • Objective Response Rate (ORR)

    Proportion of participants with complete response (CR) or partial response (PR), as assessed by RECIST version 1.1

    Time Frame: Up to 2 years

Secondary Outcomes (7)

  • Progression free survival (PFS)

    Up to 2 years

  • Disease control rate (DCR)

    Up to 2 years

  • Duration of response (DoR)

    Up to 2 years

  • Time to response (TTR)

    Up to 2 years

  • Overall survival (OS)

    Up to 2 years

  • +2 more secondary outcomes

Study Arms (2)

Cohort A (VG2025+AK112)

EXPERIMENTAL

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

Biological: VG2025Drug: AK112

Cohort B (AK112)

EXPERIMENTAL

AK112 (20mg/kg), ivgtt, Q2W

Drug: AK112

Interventions

VG2025BIOLOGICAL

Recommended Phase II Dose, Intratumoral Injection, Q4W

Cohort A (VG2025+AK112)
AK112DRUG

20mg/kg, ivgtt, Q2W

Cohort A (VG2025+AK112)Cohort B (AK112)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hangzhou, Zhejiang, China

Location

Central Study Contacts

Ting Liu

CONTACT

+86 (0760) 8987 3999clinicaltrials@akesobio.com

Tingbo Liang, MD

CONTACT

+86-13486180288liangtingbo@zju.edu.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 24, 2025

First Posted

January 21, 2026

Study Start

March 2, 2026

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

February 28, 2028

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)