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

Part of paid clinical trials in Irvine, California.

Sponsor
CytoDyn, Inc.
Study ID
NCT06699836
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Metastatic Colorectal Cancer (mCRC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 350 mg leronlimab — DRUG
    Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
  • 700 mg leronlimab — DRUG
    Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)

Study Details

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.

Key Dates

Start date
Jun 16, 2025
Status verified
Sep 2025
Primary completion
Jan 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
66 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 350 mg dose of leronlimab in combination with Trifluridine + Tipiracil (TAS-102) + Bevacizumab
    350 mg dose of leronlimab in combination with Trifluridine + Tipiracil (TAS-102) + Bevacizumab
  • Experimental: 700 mg dose of leronlimab in combination with Trifluridine + Tipiracil (TAS-102) + Bevacizumab
    700 mg dose of leronlimab in combination with Trifluridine + Tipiracil (TAS-102) + Bevacizumab

Primary Outcome Measure

The efficacy of leronlimab in combination with trifluridine and tipiracil + bevacizumab in participants with relapsed, refractory, MSS, mCRC. [ Time Frame: From enrolment through end of treatment at 12 months ]

Locations (7)

FacilityCityStateZIPSite coordinators
City of Hope Orange County Lennar Foundation Cancer CenterIrvineCalifornia92618-
Pacific Hematology Oncology AssociatesSan FranciscoCalifornia94115-
Georgetown University Medical CenterWashington D.C.District of Columbia20007-
Norton Cancer Institute, Brownsboro Hospital CampusLouisvilleKentucky40241-
University of Nebraska Medical CenterOmahaNebraska68198-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Summit Cancer CenterSpokaneWashington99208-

Find similar trials in Irvine, CA

By research site
City of Hope Orange County Lennar Foundation Cancer Center· Irvine, CAPacific Hematology Oncology Associates· San Francisco, CAGeorgetown University Medical Center· Washington D.C., DCNorton Cancer Institute, Brownsboro Hospital Campus· Louisville, KYUniversity of Nebraska Medical Center· Omaha, NEFox Chase Cancer Center· Philadelphia, PA

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