OncoMatch/Clinical Trials/NCT06699836
A Phase 2 Study of Leronlimab in Combination With TAS-102 + Bevacizumab in Previously Treated Participants With mCRC
Is NCT06699836 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including 350 mg leronlimab and 700 mg leronlimab for metastatic colorectal cancer (mcrc).
Treatment: 350 mg leronlimab · 700 mg leronlimab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: CCR5 overexpression (positive tumor expression by IHC)
Demonstrate positive tumor expression of CCR5 by IHC
Required: MMR microsatellite stable
Histologically confirmed for microsatellite stable MSS colorectal cancer by PCR, Immunohistochemistry (IHC) or Next-generation sequencing (NGS)
Allowed: RAS wild-type
if RAS wild-type and medically appropriate, an anti-EGFR therapy
Disease stage
Metastatic disease required
unresectable metastases of the primary colorectal cancer to other organs; measurable disease per RECIST 1.1
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: fluoropyrimidine-based chemotherapy
previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy
Must have received: oxaliplatin-based chemotherapy
previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy
Must have received: irinotecan-based chemotherapy
previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy
Must have received: anti-VEGF therapy
previously treated with ... an anti-VEGF therapy
Must have received: anti-EGFR therapy
if RAS wild-type and medically appropriate, an anti-EGFR therapy
Lab requirements
Blood counts
Hemoglobin ≥ 9 g/dL (without pRBC transfusion within prior 2 weeks; stable erythropoietin ≥ ~3 months); WBC > 2500/µL; ANC > 1500/µL; Platelet count > 100,000/µL
Kidney function
GFR ≥ 30 mL/min
Liver function
Total bilirubin ≤ 1.5 × ULN OR direct bilirubin ≤ ULN for participants with total bilirubin levels > 1.5 × ULN; AST and ALT ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases)
Cardiac function
Clinically normal resting 12-lead ECG or, if abnormal, considered not clinically significant by PI; No QTC interval exceeding 460 ms for females, 450 ms for males
Patients must have adequate organ and bone marrow function within 28 days prior to registration, defined as: Acceptable liver function: Total bilirubin ≤ 1.5 × ULN OR direct bilirubin ≤ ULN for participants with total bilirubin levels > 1.5 × ULN; AST and ALT ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases). Acceptable renal function: GFR ≥ 30 mL/min. Acceptable hematologic status: Hemoglobin ≥ 9 g/dL (without pRBC transfusion within prior 2 weeks; stable erythropoietin ≥ ~3 months); WBC > 2500/µL; ANC > 1500/µL; Platelet count > 100,000/µL. Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator. No QTC interval exceeding 460 ms for females, no QTC interval exceeding 450 ms for males.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Orange County Lennar Foundation Cancer Center · Irvine, California
- Pacific Hematology Oncology Associates · San Francisco, California
- Norton Cancer Institute, Brownsboro Hospital Campus · Louisville, Kentucky
- University of Nebraska Medical Center · Omaha, Nebraska
- Fox Chase Cancer Center · Philadelphia, Pennsylvania
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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