NCT04504942

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: CytoDyn, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Leronlimab (PRO 140) will be administered subcutaneously as weekly dose of 525 mg until disease progression or intolerable toxicity. Subjects participating in this study will be allowed to receive/continue standard-of-care chemotherapy or radiotherapy as per the dosing schedule included on the package insert. In this study, patients will be evaluated for tumor response approximately every 3 months or according to institution's standard practice by CT, PET/CT or MRI with contrast (per treating investigator's discretion) using the same method as at baseline.

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
DRUG	Leronlimab	Drug: Leronlimab 525mg

Timeline

• Start date: 2020-05-01
• Primary completion: 2021-11-07
• Completion: 2025-01-27
• First posted: 2020-08-07
• Last updated: 2026-01-23
• Results posted: 2026-01-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study