Basket Study of Leronlimab (PRO 140) in Patients With CCR5+ Locally Advanced or Metastatic Solid Tumors

NCT04504942 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CD09_Basket
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

A single arm phase II study with 30 patients of leronlimab (PRO 140) in patients with CCR5+ locally advanced or metastatic solid tumors.

Conditions

Solid Tumor, Adult

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Adverse Events (AEs), and Serious Adverse Events (SAEs).

  Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the investigator believed were clinically significant to the research subject were reported as adverse events.

  From the time of first treatment (T1) until the last study visits completion (up to approximately 16 months)

• Changes in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to Subsequent Scheduled Visits

  The ECOG was utilized to assess the ability of patients to tolerate treatment. The ECOG is a 5-point scale, where a higher score indicates a greater lack of tolerance of the treatment. Response choices included: 0 = Asymptomatic; Fully active, able to carry on all pre-disease performance without restriction, 1 = Symptomatic but completely ambulatory; Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work, 2 = Symptomatic, \<50% in bed during the day; Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours, 3 = Symptomatic, \>50% in bed during the day; Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours, 4 = Bedbound; Completely disabled; cannot carry on any selfcare; totally confined to bed or chair, 5 = Dead.

  From the time of first treatment (T1) until the last study visits completion (up to approximately 16 months)

Secondary Outcomes (5)

• Progression Free Survival (PFS) Defined as Time in Months From the Date of First Study Treatment to the Date of Disease Progression or Death From Any Cause, Whichever Comes First.

  The time in months from start of treatment to progression or death will be measured for all patients who receive at least one dose of study drug. Participants were followed on study until last study visit completion up to approximately 16 months.

• Overall Response Rate (ORR, Defined as CR (Complete Response) + PR (Partial Response)) in Subjects With CCR5+ Locally Advanced or Metastatic Solid Tumors Treated With Leronlimab.

  The time in months from start of treatment to progression or death will be measured for all patients who receive at least one dose of study drug. Participants were followed on study until last study visit completion up to approximately 16 months.

• Mean Time to New Metastases (TTNM)

  From the time of first treatment (T1) until the last study visits completion (up to approximately 16 months).

• The Change From Baseline in Circulating Tumor Cells (CTC) Level in the Peripheral Blood.

  From date of first treatment until the date of first documented progression or date of death from any cause, whichever came first. From the time of first treatment (T1) until the last study visits completion (up to approximately 16 months).

• Overall Survival Defined as Time in Months From the Date of First Study Treatment to the Date of Death

  Overall survival is calculated by long-term follow-up date - PRO 140 (leronlimab) start date, up to approximately 57 months.

Study Arms (1)

Leronlimab 525mg

EXPERIMENTAL

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

Drug: Leronlimab

Interventions

Leronlimab DRUG

Drug: Leronlimab 525mg

Also known as: Standard-of-care chemotherapy or radiotherapy

Leronlimab 525mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have a histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumors:
• who have disease progression on standard therapy,
• who are receiving a standard anticancer treatment but no subsequent approved treatment would be available upon progression,
• who are unable to receive standard therapy, or
• for whom standard therapy does not exist.
• Demonstrate CCR5 + by IHC (\>10% of primary or metastatic tumor cells shows membranous staining and/or high predominance of CCR5+ tumor-infiltrating leukocytes completed at the reference laboratory of Dr. Hallgeir Rui at Medical College of Wisconsin).
• Note: This test will be done as part of the pre-screening period. It will be performed in archival metastatic tissue. If archival tissue is not available then, fresh biopsy will be done;
• Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion (in case archival tissue is not available);
• Patients must have measurable disease based on RECIST v1.1;
• ≥ 18 years of age;
• Patients must exhibit a/an ECOG performance status of 0-1;
• Life expectancy of at least 6 months;
• Patients must have adequate organ and bone marrow function within 28 days prior to registration, as defined below:
• leukocytes ≥ 3,000/mcL;
• absolute neutrophil count ≥ 1,500/mcL;

You may not qualify if:

• Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 28 days prior to enrollment;
• Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to leronlimab (PRO 140) are not eligible;
• Patients who have had prior exposure to CCR5 antagonists are not eligible;
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Note: Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability;
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator;
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial; and
• Is pregnant or breastfeeding, or expecting to conceive or have children within the projected duration of the trial, starting with the pre-screening or screening visit through the duration of study participation.

Sponsors & Collaborators

• CytoDyn, Inc.: lead
• Amarex Clinical Research: collaborator

Study Sites (1)

Quest Clinical Research

San Francisco, California, 94115, United States

Location

MeSH Terms

Interventions

leronlimab; Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Vice President, Clinical Operations
• Organization: CytoDyn

jmeidling@cytodyn.com

3609808524

Study Officials

• Jacob Lalezari, MD

  CytoDyn, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: August 7, 2020
• Study Start: May 1, 2020
• Primary Completion: November 7, 2021
• Study Completion: January 27, 2025
• Last Updated: January 23, 2026
• Results First Posted: January 23, 2026

Record last verified: 2021-09

Locations

US (1)