Phase 2 Study of Leronlimab with TAS-102 and Bevacizumab for Previously Treated Metastatic Colorectal Cancer
Sponsor: CytoDyn, Inc.
ClinicalTrials ID:NCT06699836
This study is testing if adding leronlimab to standard treatments TAS-102 and bevacizumab can improve outcomes for patients with metastatic colorectal cancer that has not responded to previous treatments. The study also aims to determine if this combination is safe and well-tolerated.
Patient Parameters
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Program Overview
This clinical trial is exploring whether the drug leronlimab, when combined with standard treatments trifluridine and tipiracil (TAS-102) and bevacizumab, can improve the response rate and survival in patients with metastatic colorectal cancer (mCRC) that has not responded to previous treatments. The study will also assess the safety and tolerability of this combination. Participants will be randomly assigned to receive either 350 mg or 700 mg of leronlimab along with the standard treatments.
Description
This study involves two groups of participants, each receiving a different dose of leronlimab (either 350 mg or 700 mg) in combination with the standard treatments TAS-102 and bevacizumab. The goal is to see if this combination can improve the response rate and survival in patients with metastatic colorectal cancer that has not responded to previous treatments. The study will enroll about 60 participants, with 30 in each group. Participants must be 18 years or older and have confirmed metastatic colorectal cancer that is microsatellite stable (MSS) and CCR5 positive. The study will monitor the safety and effectiveness of the treatment, and participants will be required to undergo various tests and assessments throughout the study period.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 or older with metastatic colorectal cancer that cannot be surgically removed and has spread to other organs.
- If HIV positive, must have a stable viral load under 50 copies/ml and be on stable antiretroviral therapy for at least 3 months.
- Cancer must show positive CCR5 expression.
- Must have been previously treated with specific chemotherapy and targeted therapies.
- Cancer must be microsatellite stable (MSS) as confirmed by specific tests.
- Must have measurable disease according to standard criteria.
- Must have a performance status indicating they are fully active or have some restrictions but can carry out light work.
- Expected to live at least three more months.
- No cancer treatment within the last four weeks, except for certain types of radiation therapy.
- Must have adequate organ and bone marrow function as shown by specific blood tests.
- Must have a normal or non-significant ECG.
- Must agree to use effective contraception during the study and for a period after the last treatment dose.
- Women must have a negative pregnancy test before starting treatment.
- Men must agree to use contraception and not donate sperm for a specified period after treatment.
- Must understand and agree to sign informed consent.
Exclusion Criteria
- Severe allergy to monoclonal antibodies.
- Significant heart disease or low blood pressure.
- History of other cancers, except for certain early-stage cancers that have been treated.
- Active hepatitis B or C or other viral infections.
- Pregnant or breastfeeding, or planning to conceive during the study period.
- Psychiatric or substance abuse issues that could interfere with the study.
- Recent stroke or heart procedures.
- Tumor invading major blood vessels.
- Participation in another clinical trial within the last four weeks.
- Active infections requiring treatment.
- Recent use of anabolic steroids.
- Unable to follow the study protocol.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Quest Clinical Research | 94115 | San Francisco | California |
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