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)
CytoDyn, Inc.
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.
Description
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 the safety and tolerability when used in combination with trifluridine and tipiracil + bevacizumab in patients with MSS, relapsed refractory, mCRC who have received and progressed, or are intolerant, of at least two prior standard of care treatment regimes, which may have included fluoropyrimidine, oxaliplatin, or irinotecan chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy. This study will…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or female subjects age ≥ 18 years with a history of treated colorectal cancer with unresectable metastases of the primary colorectal cancer to other organs. 2. If HIV-1 positive, viral load must be \< 50 copies/ml and participant must be on stable ART for at least 3 months. 3. Adult patients with metastatic colorectal cancer (mCRC) received and progressed, or are intolerant, of at least two prior standard of care treatment regimes, which may have included fluoropyrimidine-, oxaliplatin-, or irinotecan chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and me…
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 CenterIrvine, California
- Pacific Hematology Oncology AssociatesSan Francisco, California
- Georgetown University Medical CenterWashington D.C., District of Columbia
- Norton Cancer Institute, Brownsboro Hospital CampusLouisville, Kentucky
- University of Nebraska Medical CenterOmaha, Nebraska
- Fox Chase Cancer CenterPhiladelphia, Pennsylvania