Experimental combo targets Hard-to-Treat colorectal liver metastases
NCT ID NCT07357220
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 72 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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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Genom att skicka in godkänner du våra Användarvillkor
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.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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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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