Actively Recruiting
The Phase-2 CCR5-targeting Leronlimab With Oral Chemotherapy and VEGF-inhibitor Enriched Regimen Trial (CLOVER)
Led by CytoDyn, Inc. · Updated on 2026-04-03
60
Participants Needed
7
Research Sites
141 weeks
Total Duration
On this page
Sponsors
C
CytoDyn, Inc.
Lead Sponsor
S
Syneos Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Phase-2 CCR5-targeting Leronlimab With Oral Chemotherapy and VEGF-inhibitor Enriched Regimen Trial (CLOVER)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects age 63 18 years with treated colorectal cancer and unresectable metastases
- If HIV-1 positive, viral load must be < 50 copies/ml and on stable ART for at least 3 months
- Adult patients with metastatic colorectal cancer who have received and progressed on or are intolerant to at least two prior standard treatments including chemotherapy and targeted therapies
- Histologically confirmed microsatellite stable (MSS) colorectal cancer
- Measurable disease according to RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival of at least three months
- No anti-cancer treatment within the last two weeks or at least 5 half-lives before treatment, except recovered from palliative radiation
- Adequate organ and bone marrow function within 28 days prior to first dosing
- Normal or clinically non-significant ECG with no prolonged QTc
- Agreement to use two medically accepted contraception methods or abstinence from study entry to 6 months after last treatment
- Negative pregnancy tests for females of childbearing potential before treatment
- Male participants agree to use contraception and avoid sperm donation for 6 months after last dose
- Ability to understand and sign informed consent
You will not qualify if you...
- Known severe hypersensitivity to monoclonal antibodies
- Clinically significant active coronary heart disease or cardiovascular insufficiency
- Active or progressing malignancy requiring treatment within past 2 years, except certain skin and in situ cancers
- Active hepatitis B or C infection or other known viral infections
- Pregnant, breastfeeding, or planning conception during study and 120 days after last dose
- Psychiatric or substance abuse disorders interfering with study cooperation
- Stroke or transient ischemic attack within 6 months prior to screening
- Cardiac stent or bypass surgery within 6 months prior to screening
- Tumor invasion of major vascular structures
- Participation in investigational study or device use within 4 weeks prior to first dose
- Active, uncontrolled infections requiring systemic therapy
- Inability to follow study protocol
- Prior treatment with Trifluridine + Tipiracil before first study dose
- Serious non-malignant or malignant diseases compromising study objectives including recurrent ascites or pleural effusion requiring frequent drainage
AI-Screening
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Trial Site Locations
Total: 7 locations
1
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, United States, 92618
Actively Recruiting
2
Pacific Hematology Oncology Associates
San Francisco, California, United States, 94115
Completed
3
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
4
Norton Cancer Institute, Brownsboro Hospital Campus
Louisville, Kentucky, United States, 40241
Actively Recruiting
5
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
6
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
7
Summit Cancer Center
Spokane, Washington, United States, 99208
Actively Recruiting
Research Team
J
Joseph Meidling
CONTACT
P
Patrick Vittner
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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