A Phase Two Study Evaluating Two Doses of Leronlimab (Pro 140) In Combination With Trifluridine + Tipiracil (TAS-102) + Bevacizumab in Participants With CCR5+, Microsatellite Stable (MSS), Relapsed Refractory Metastatic Colorectal Cancer (mCRC)

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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 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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• If HIV-1 positive, viral load must be \< 50 copies/ml and participant must be on stable ART for at least 3 months.

• Demonstrate positive tumor expression of CCR5 by IHC.

• 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.

• Histologically confirmed for microsatellite stable MSS colorectal cancer by PCR, Immunohistochemistry (IHC) or Next-generation sequencing (NGS).

• Have measurable disease per RECIST 1.1

• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Expected survival of at least three months

• 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).

⁃ Patients must have adequate organ and bone marrow function within 28 days prior to registration, defined as:

⁃ i. Acceptable liver function:

‣ Total bilirubin ≤ 1.5 × upper limit of normal (ULN) OR direct bilirubin ≤ ULN for participants with total bilirubin levels \> 1.5 × ULN

‣ 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:

‣ 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).

‣ White blood cells \> 2500/µL

‣ Absolute neutrophil count \> 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.

⁃ a) No QTC interval exceeding 460 milliseconds (ms) for females, no QTC interval exceeding 450 ms for males.

⁃ 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).

⁃ 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.

⁃ Male participants must agree to use contraception and refrain from donating sperm for at least 120 days after the last dose of study intervention.

⁃ Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study.

Locations
United States
California
City of Hope Orange County Lennar Foundation Cancer Center
RECRUITING
Irvine
Pacific Hematology Oncology Associates
ACTIVE_NOT_RECRUITING
San Francisco
Kentucky
Norton Cancer Institute, Brownsboro Hospital Campus
RECRUITING
Louisville
Nebraska
University of Nebraska Medical Center
RECRUITING
Omaha
Pennsylvania
Fox Chase Cancer Center
RECRUITING
Philadelphia
Washington
Summit Cancer Center
RECRUITING
Spokane
Contact Information
Primary
Joseph Meidling
jmeidling@cytodyn.com
3609808524
Backup
Patrick Vittner
pvittner@cytodyn.com
3609808524
Time Frame
Start Date: 2025-06-16
Estimated Completion Date: 2028-03
Participants
Target number of participants: 60
Treatments
Experimental: 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
Experimental: 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
Related Therapeutic Areas
Sponsors
Leads: CytoDyn, Inc.
Collaborators: Syneos Health

This content was sourced from clinicaltrials.gov