Leronlimab + Standard Treatment for Colorectal Cancer

Overseen By Patrick Vittner

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: CytoDyn, Inc.

Must not be taking: Anabolic steroids

Disqualifiers: Coronary heart disease, Hepatitis B, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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 CCR5+, 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 CCR5+, 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 Criteria

This trial is for adults over 18 with colorectal cancer that has spread and can't be removed by surgery. They must have tried other treatments, including chemotherapy and anti-VEGF or anti-EGFR therapy if suitable. Participants need to show CCR5+ in their tumors, have stable health (ECOG 0 or 1), measurable disease per RECIST 1.1, no recent cancer treatment except palliative radiation, and an expected survival of at least three months.

Inclusion Criteria

I am HIV positive with a viral load under 50 copies/ml and have been on stable ART for 3+ months.

Demonstrate positive tumor expression of CCR5 by IHC

Have measurable disease per RECIST 1.1

Exclusion Criteria

Known severe hypersensitivity towards monoclonal antibodies

I do not have serious heart disease or very low blood pressure.

Are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the Screening Visit through 120 days after the last dose of study intervention

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive leronlimab in combination with trifluridine and tipiracil + bevacizumab

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Leronlimab

Trial Overview The study tests two doses of leronlimab (700 mg and 350 mg) combined with trifluridine/tipiracil + bevacizumab in patients with metastatic colorectal cancer who've progressed after prior treatments. It's designed to see if this combination improves response rates/survival times compared to standard care alone and assess its safety.

Participant Groups

Group I: 700 mg dose of leronlimab in combination with Trifluridine + Tipiracil (TAS-102) + Bevacizumab Experimental Treatment 1 Intervention

Group II: 350 mg dose of leronlimab in combination with Trifluridine + Tipiracil (TAS-102) + Bevacizumab Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

CytoDyn, Inc.

Lead Sponsor

Trials

25

Recruited

2,600+

Syneos Health

Collaborator

Trials

181

Recruited

69,600+