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Experimental combo targets Hard-to-Treat colorectal liver metastases

NCT ID NCT07357220

Disease control Sponsor: Akeso Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a combination of two experimental treatments—AK112 (given through a vein) and VG2025 (injected directly into liver tumors)—in 72 adults with advanced colorectal cancer that has spread to the liver and hasn't responded to prior therapy. The goal is to see if the combo is safe and can shrink tumors. It's an early-phase trial, so the main focus is on safety and finding the right dose.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AK112 (a drug) and VG2025 (a biologic injected into the tumor)
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced colorectal cancer that has spread to the liver and hasn't responded to standard therapy.
What could go wrong
This is an early-phase trial with only 72 participants, so results may not apply to everyone. The combination could cause side effects or fail to shrink tumors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 72 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

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

    Hangzhou, Zhejiang, China

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