A Phase 2 Study of Leronlimab in Combination With TAS-102 + Bevacizumab in Previously Treated Participants With mCRC
NCT ID: NCT06699836
Last Updated: 2025-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2025-06-16
2028-03-31
Brief Summary
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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.
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Detailed Description
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This study will enroll approximately 60 participants, 30 participants in each of two arms evaluating either 350 mg or 700 mg of leronlimab, who are 18 years of age or older, with histologically confirmed metastatic colorectal cancer that is microsatellite stable (MSS) and CCR5+ (confirmed by an immunohistochemistry (IHC) assay). Participants will be randomized 1:1 to each arm, where approximately 30 participants will receive 350 mg of leronlimab + trifluridine and tipiracil + bevacizumab and approximately 30 will receive 700 mg of leronlimab + trifluridine and tipiracil + bevacizumab.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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350 mg dose of leronlimab in combination with Trifluridine + Tipiracil (TAS-102) + Bevacizumab
350 mg dose of leronlimab in combination with Trifluridine + Tipiracil (TAS-102) + Bevacizumab
350 mg leronlimab
Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
700 mg dose of leronlimab in combination with Trifluridine + Tipiracil (TAS-102) + Bevacizumab
700 mg dose of leronlimab in combination with Trifluridine + Tipiracil (TAS-102) + Bevacizumab
700 mg leronlimab
Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
Interventions
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350 mg leronlimab
Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
700 mg leronlimab
Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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. Demonstrate positive tumor expression of CCR5 by IHC.
4. Adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy.
5. Histologically confirmed for microsatellite stable MSS colorectal cancer by PCR, Immunohistochemistry (IHC) or Next-generation sequencing (NGS).
6. Have measurable disease per RECIST 1.1
7. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
8. Expected survival of at least three months
9. No anti-cancer treatment within the last four weeks or at least 5 half-lives prior to treatment (except for palliative radiation therapy from which the patient has recovered from all adverse events).
10. Patients must have adequate organ and bone marrow function within 28 days prior to registration, defined as:
i. Acceptable liver function:
1. Total bilirubin ≤ 1.5 × upper limit of normal (ULN) OR direct bilirubin ≤ ULN for participants with total bilirubin levels \> 1.5 × ULN
2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases).
ii. Acceptable renal function:
a) GFR ≥ 30 mL/min iii. Acceptable hematologic status:
1. Hemoglobin ≥ 9 g/dL Note: Criteria must be met without packed red blood cell (pRBC) transfusion within the prior 2 weeks. Participants can be on stable dose of erythropoietin (≥ approximately 3 months).
2. White blood cells \> 2500/µL
3. Absolute neutrophil count \> 1500/µL
4. Platelet count \> 100 000/µL.
11. Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
a) No QTC interval exceeding 460 milliseconds (ms) for females, no QTC interval exceeding 450 ms for males.
12. Both male and female patients and their partners of childbearing potential must agree to use two medically accepted methods of contraception (e.g., barrier contraceptives \[male condom, female condom, or diaphragm with a spermicidal gel\], hormonal contraceptives \[implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings\], or one of the following methods of birth control (intrauterine devices, tubal sterilization or vasectomy) or must practice complete abstinence from intercourse of reproductive potential from study entry to 6 months after the last day of treatment (excluding women who are not of childbearing potential and men who have been sterilized).
13. Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening Visit and negative urine pregnancy test prior to receiving the first dose of study.
14. Male participants must agree to use contraception and refrain from donating sperm for at least 120 days after the last dose of study intervention.
15. Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study.
Exclusion Criteria
2. Clinically significant active coronary heart disease and cardiovascular insufficiency with hypotension (systolic blood pressure \<100 mmHg) per PI discretion
3. Prior history of other malignancies, except early-stage prostate cancer or basal cell carcinoma that has been surgically resected.
4. Active hepatitis B (defined as having a positive hepatitis B surface antigen \[HBsAg\] test) or hepatitis C or known viral infections.
5. 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.
6. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
7. Stroke and/or transient ischemic attack within 6 months prior to screening.
8. Placement of a cardiac stent or bypass surgery within 6 months of screening
9. Tumor invasion of a large vascular structure (e.g., pulmonary artery, superior or inferior vena cava).
10. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
11. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
12. Inability to follow protocol.
18 Years
ALL
No
Sponsors
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Syneos Health
OTHER
CytoDyn, Inc.
INDUSTRY
Responsible Party
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Locations
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City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, United States
Pacific Hematology Oncology Associates
San Francisco, California, United States
Norton Cancer Institute, Brownsboro Hospital Campus
Louisville, Kentucky, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Summit Cancer Center
Spokane, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CD-O-101
Identifier Type: -
Identifier Source: org_study_id
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