NCT06699836

Brief 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. 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. 2.Is leronlimab safe and well tolerated in these subjects when used in combination with standard of care therapies trifluridine and tipiracil+ bevacizumab.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
22mo left

Started Jun 2025

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Jun 2025Mar 2028

First Submitted

Initial submission to the registry

November 19, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

June 16, 2025

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

2.5 years

First QC Date

November 19, 2024

Last Update Submit

September 30, 2025

Conditions

Metastatic Colorectal Cancer (mCRC)

Keywords

Microsatellite StableMetastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • To evaluate the efficacy of leronlimab in combination with trifluridine and tipiracil + bevacizumab in participants with CCR5+, refractory, MSS, mCRC.

    Efficacy will be measured as the effect on objective response rate (ORR) of leronlimab when used in combination with trifluridine and tipiracil + bevacizumab in patients with CCR5+, refractory, MSS, mCRC. ORR is defined as the proportion of subjects with the best overall response (BOR) or confirmed CR or confirmed PR according to RECIST version 1.1.

    From enrolment through end of treatment at 12 months

Secondary Outcomes (2)

  • To assess the safety and tolerability of leronlimab when used in combination with trifluridine and tipiracil + bevacizumab in patients with CCR5+, refractory, MSS, mCRC.

    From enrolment through end of treatment at 12 months.

  • To assess the duration of response of leronlimab in combination with trifluridine and tipiracil + bevacizumab in participants with CCR5+, MSS, mCRC

    From enrolment through end of treatment at 12 months.

Study Arms (2)

350 mg dose of leronlimab in combination with Trifluridine + Tipiracil (TAS-102) + Bevacizumab

EXPERIMENTAL

350 mg dose of leronlimab in combination with Trifluridine + Tipiracil (TAS-102) + Bevacizumab

Drug: 350 mg leronlimab

700 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

Drug: 700 mg leronlimab

Interventions

350 mg leronlimabDRUG

Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)

Also known as: PRO 140
350 mg dose of leronlimab in combination with Trifluridine + Tipiracil (TAS-102) + Bevacizumab
700 mg leronlimabDRUG

Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)

Also known as: PRO 140
700 mg dose of leronlimab in combination with Trifluridine + Tipiracil (TAS-102) + Bevacizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • +10 more criteria

You may not qualify if:

  • Known severe hypersensitivity towards monoclonal antibodies.
  • Clinically significant active coronary heart disease and cardiovascular insufficiency with hypotension (systolic blood pressure \<100 mmHg) per PI discretion
  • Prior history of other malignancies, except early-stage prostate cancer or basal cell carcinoma that has been surgically resected.
  • Active hepatitis B (defined as having a positive hepatitis B surface antigen \[HBsAg\] test) or hepatitis C or known viral infections.
  • 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.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Stroke and/or transient ischemic attack within 6 months prior to screening.
  • Placement of a cardiac stent or bypass surgery within 6 months of screening
  • Tumor invasion of a large vascular structure (e.g., pulmonary artery, superior or inferior vena cava).
  • 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.
  • Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
  • Inability to follow protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California, 92618, United States

RECRUITING

Pacific Hematology Oncology Associates

San Francisco, California, 94115, United States

ACTIVE NOT RECRUITING

Norton Cancer Institute, Brownsboro Hospital Campus

Louisville, Kentucky, 40241, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

RECRUITING

Summit Cancer Center

Spokane, Washington, 99208, United States

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

leronlimab

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Joseph Meidling

CONTACT

3609808524jmeidling@cytodyn.com

Patrick Vittner

CONTACT

3609808524pvittner@cytodyn.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2024

First Posted

November 21, 2024

Study Start

June 16, 2025

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

October 2, 2025

Record last verified: 2025-09

Locations

US(6)