Colorectal Cancer With Hepatic MetastasesPhase 1/2NCT07357220
A Study of AK112 in Combination With VG2025 in Colorectal Cancer With Liver Metastases
A Phase 1/2 study testing VG2025 and AK112 in people with Colorectal Cancer With Hepatic Metastases, run by Akeso at 1 site in China.
Trial summary
An open-label, multicenter, phase Ib/II study of AK112 in combination with VG2025 for advanced colorectal cancer with liver metastases. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer With Hepatic Metastases
- What is being tested?
- VG2025 and AK112
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2026to 28 Feb 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Estimated life expectancy≥3 months
- Adequate organ function
- Patients with fertility are willing to use an adequate method of contraception
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital, Zhejiang University School of Medicine，No. 79, Qingchun Road, Shangcheng District, Hangzhou City, Zhejiang Province
Hangzhou, Zhejiang
Liang Tingbo, MD, +86-13486180288, liangtingbo@zju.edu.cn
About this study
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
An open-label, multicenter, phase Ib/II study of AK112 in combination with VG2025 for advanced colorectal cancer with liver metastases.
Read the 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.
- Being tested
- VG2025, AK112
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VG2025Biological
Recommended Phase II Dose, Intratumoral Injection, Q4W
AK112Drug
20mg/kg, ivgtt, Q2W
| Study group | Role | What they receive |
|---|---|---|
| Cohort A (VG2025+AK112) | Experimental | VG2025 (Recommended Phase II Dose), Intratumoral Injection, Q4W + AK112 (20mg/kg), ivgtt, Q2W. Receives: Biological: VG2025; Drug: AK112 |
| Cohort B (AK112) | Experimental | AK112 (20mg/kg), ivgtt, Q2W Receives: Drug: AK112 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants experiencing dose-limiting toxicities (DLTs)
Number of participants who meet the criteria of dose-limiting toxicities (DLTs) in DLT observation period
Measured: 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
Measured: 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
Measured: Time Frame: Up to 2 years
Secondary outcomes (7)
Progression free survival (PFS)
Time from the date of enrollment until the first documentation of disease progression or death due to any cause, whichever occurs first, as assessed by RECIST version 1.1
Measured: Up to 2 years
Disease control rate (DCR)
Proportion of participants with complete response (CR), partial response (PR), or stable disease (SD), as assessed by RECIST version 1.1
Measured: Up to 2 years
Duration of response (DoR)
Time from the first documentation of objective response to the first documented disease progression as assessed by RECIST version 1.1 or death due to any cause, whichever occurs first
Measured: Up to 2 years
Time to response (TTR)
Time from the start of the treatment to the first objective tumor response observed for patients who achieved complete response (CR) or partial response (PR), as assessed by RECIST version 1.1
Measured: Up to 2 years
Overall survival (OS)
Time from the date of enrollment to death from any cause
Measured: Up to 2 years
Observed concentrations of AK112
Observed serum concentrations of AK112 at different time points after AK112 administration
Measured: Up to 2 years
Number of participants with detectable anti-drug antibodies (ADAs) to AK112
Number of participants who develop detectable anti-drug antibodies (ADAs) to AK112
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start2 Mar 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer With Hepatic MetastasesStudies of the same condition, open and under way.
- More trials run by AkesoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Virogin Biotech Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07357220
- Sponsor's protocol ID
- AK112-212
- Status last verified
- Jan 2026
- First submitted
- 24 Dec 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07357220
- Acronym / sponsor ID
- AK112-212
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Virogin Biotech Co., Ltd.
- Study start
- 2 Mar 2026 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A (VG2025+AK112) | Experimental | Biological: VG2025, Drug: AK112VG2025 (Recommended Phase II Dose), Intratumoral Injection, Q4W + AK112 (20mg/kg), ivgtt, Q2W. |
| Cohort B (AK112) | Experimental | Drug: AK112AK112 (20mg/kg), ivgtt, Q2W |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VG2025Recommended Phase II Dose, Intratumoral Injection, Q4W | Biological | Cohort A (VG2025+AK112) |
| AK11220mg/kg, ivgtt, Q2W | Drug | Cohort A (VG2025+AK112), Cohort B (AK112) |
Primary outcome
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 who meet the criteria of dose-limiting toxicities (DLTs) in DLT observation period
Number of participants with adverse events (AEs) and severity
Time frame: 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: Time Frame: Up to 2 years
Proportion of participants with complete response (CR) or partial response (PR), as assessed by RECIST version 1.1
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing VG2025 and AK112 in people with Colorectal Cancer With Hepatic Metastases, run by Akeso at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ting Liu (+86 (0760) 8987 3999, clinicaltrials@akesobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.