RecruitingPhase 2NCT06558773

GSL Synthetase Inhibitor Plus Immune Checkpoint Inhibitor and/or Regorafenib in Previously Treated pMMR/MSS CRC.

GSL Synthetase Inhibitor in Combination With Immune Checkpoint Inhibitor and/or Regorafenib for Patients With Advanced/Metastatic pMMR/MSS Colorectal Cancer:an Open-Label, Randomized,Phase II Study

Sponsor

Chinese PLA General Hospital

Enrollment

120 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

Colorectal, Cancer

Summary

In this single-center,open-label, randomized, phase II study, the efficacy and feasibility of GSL synthetase inhibitor in combination with immune checkpoint inhibitor and/or regorafenib therapeutic regimen will be evaluated in patients with advanced/metastatic proficient mismatch repair/microsatellite stable (pMMR/MSS) colorectal cancer (CRC).In this clinical trial, a total of 120 eligible patients were stratified randomly (with/without liver metastases) assigned to the 3 arms in a 1:1:1 ratio: comparator group-arm A (Regorafenib+Immune checkpoint inhibitor) ,experimental group-arm B (Eliglustat+Immune checkpoint inhibitor) and experimental group-arm C (Eliglustat+Immune checkpoint inhibitor+Regorafenib).It aims to: 1).assess the antitumor effects of GSL synthetase inhibitor in combination with immune checkpoint inhibitor and/or regorafenib;2).evaluate the immunological or clinical predictive biomarkers for efficacy and toxicity; 3).detect the transformation of tumor microenvironment (TME) and dynamic changes of immune cells in peripheral blood after the treatment with GSL synthetase inhibitor in combination with immune checkpoint inhibitor and/or regorafenib.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug that blocks an enzyme called GSL synthetase, used in combination with immunotherapy and/or regorafenib, for people with metastatic colorectal cancer that has already been treated with at least two other regimens and has a specific tumor profile (called pMMR/MSS) that usually does not respond well to immunotherapy. **You may be eligible if...** - You are aged 18–75 with confirmed metastatic or locally advanced colorectal cancer - Your tumor has the pMMR/MSS profile - You have already tried at least two prior treatment regimens without success - You have at least one measurable tumor and good organ function **You may NOT be eligible if...** - You have had more than the allowed previous treatments without recovery - You have severe organ dysfunction or very poor performance status - You are pregnant or unable to use effective contraception - Your previous treatment ended less than 4 weeks ago without recovery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGRegorafenib+Immune checkpoint inhibitor

Regorafenib orally 80mg daily .Dose escalation to120mg daily was allowed if well tolerated. Immune checkpoint inhibitor (physician decided) .

DRUGEliglustat+Immune checkpoint inhibitor

Eliglustat 84mg will be administered twice daily in the first 14 days and the following every other week. Immune checkpoint inhibitor (physician decided) .

DRUGEliglustat+Immune checkpoint inhibitor +Regorafenib

Eliglustat 84mg will be administered twice daily in the first 14 days and the following every other week. Immune checkpoint inhibitor (physician decided) . Regorafenib orally 80mg daily .Dose escalation to 120mg daily was allowed if well tolerated.

Locations(1)

China

Beijing, Biotherapeutic Department of Chinsese PLA Gereral Hospital, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06558773

Related Trials

A Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of VVD-133214 as Monotherapy and in Combination in Participants With Advanced Solid Tumors

NCT0600424529 locations

Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer

NCT062058361 location

A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors

NCT073188059 locations

A Study of PT0511 in Participants With KRAS Mutated or Amplified Advanced Solid Tumors

NCT073001505 locations

Addition of Antibiotics to Upfront Treatment Regimen for Colorectal Cancer

NCT067280722 locations