RecruitingPhase 2NCT06699836

The Phase-2 CCR5-targeting Leronlimab With Oral Chemotherapy and VEGF-inhibitor Enriched Regimen Trial (CLOVER)

A Phase Two Study Evaluating Two Doses of Leronlimab (PRO 140) In Combination With Trifluridine + Tipiracil (TAS-102) + Bevacizumab in Participants With Microsatellite Stable (MSS), Relapsed Refractory Metastatic Colorectal Cancer (mCRC)


Sponsor

CytoDyn, Inc.

Enrollment

60 participants

Start Date

Jun 16, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open label, randomized, two arm, multi-center study to explore the effect of leronlimab on the overall response rate/ overall survival and safety and tolerability when used in combination with trifluridine and tipiracil + bevacizumab in patients with MSS, mCRC who have progressed on prior treatment before participating in the study. The main questions this study aims to answer are: 1. Can leronlimab, in combination with standard of care therapies trifluridine and tipiracil+ bevacizumab, increase the objective response rate in persons with MSS, mCRC who have progressed on prior treatment before participating in the study. 2. Is leronlimab safe and well tolerated in these subjects when used in combination with standard of care therapies trifluridine and tipiracil+ bevacizumab.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding leronlimab — a drug that blocks a protein called CCR5 on cancer cells — to a standard chemotherapy combination (TAS-102 plus bevacizumab) improves outcomes for people with metastatic colorectal cancer that has already been treated with multiple prior therapies. **You may be eligible if...** - You are 18 years or older with metastatic colorectal cancer (cancer that has spread to other organs) - Your tumor has tested positive for the CCR5 protein - You have already received standard chemotherapy treatments including fluoropyrimidine, oxaliplatin, irinotecan, and anti-VEGF therapy - Your cancer is microsatellite stable (MSS) - If HIV-positive, your viral load is undetectable and you are on stable HIV treatment **You may NOT be eligible if...** - Your tumor does not express CCR5 - You have not yet received the required prior treatments - You have significant organ dysfunction - Your cancer is MSI-H (a type that responds to immunotherapy) 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

DRUG350 mg leronlimab

Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)

DRUG700 mg leronlimab

Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)


Locations(7)

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California, United States

Pacific Hematology Oncology Associates

San Francisco, California, United States

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Norton Cancer Institute, Brownsboro Hospital Campus

Louisville, Kentucky, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Summit Cancer Center

Spokane, Washington, United States

View Full Details on ClinicalTrials.gov

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

Visit

NCT06699836


Related Trials