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Monoclonal Antibodies

Leronlimab 525mg for Solid Tumors

Phase 2
Waitlist Available
Research Sponsored by CytoDyn, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
who have disease progression on standard therapy
who are receiving a standard anticancer treatment but no subsequent approved treatment would be available upon progression
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the time of first treatment until 12 weeks after study treatment completion
Awards & highlights

Study Summary

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

Eligible Conditions
  • Solid Tumors

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in Eastern Cooperative Oncology Group (ECOG) performance status from baseline to subsequent scheduled visits
Incidence of abnormal laboratory tests results
Number, frequency, and severity of adverse events (AEs)
Secondary outcome measures
Neoplasm Metastasis
Overall response rate (ORR, defined as CR + PR) in subjects with CCR5+ locally advanced or metastatic solid tumors treated with leronlimab
Overall survival defined as time in months from the date of first study treatment to the date of death
+3 more

Side effects data

From 2018 Phase 2 & 3 trial • 52 Patients • NCT02483078
4%
Nausea
4%
Fatigue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pro 140 Weekly for 1 Week
Part 2 PRO 140 Open Label for 24 Weeks
Placebo Weekly for 1 Week

Trial Design

1Treatment groups
Experimental Treatment
Group I: Leronlimab 525mgExperimental Treatment1 Intervention
Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)

Find a Location

Who is running the clinical trial?

Amarex Clinical ResearchOTHER
26 Previous Clinical Trials
1,652 Total Patients Enrolled
CytoDyn, Inc.Lead Sponsor
23 Previous Clinical Trials
2,528 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Basket Study of Leronlimab (PRO 140) in Patients With CCR5+ Locally Advanced or Metastatic Solid Tumors
2020. "Basket Study of Leronlimab (PRO 140) in Patients With CCR5+ Locally Advanced or Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04504942.
~6 spots leftby Apr 2025
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