Expanded Access Program for Leronlimab in Metastatic TNBC
Summary
NIH's ClinicalTrials.gov registered an Expanded Access Program for investigational leronlimab (PRO 140) in metastatic triple-negative breast cancer, offering a pathway for patients lacking satisfactory treatment options and unable to enroll in clinical trials. The observational, open-label study documents program eligibility, interventions, and study design. No new compliance obligations are created for sponsors, healthcare providers, or patients.
What changed
The document registers a new Expanded Access Program (EAP) for leronlimab, an investigational CCR5 antagonist, for patients with locally advanced or metastatic triple-negative breast cancer on ClinicalTrials.gov. The study is observational, non-randomized, and open-label, designed to provide compassionate access to patients without satisfactory treatment options and unable to participate in clinical trials.
Sponsors and healthcare institutions offering expanded access should reference this registry for program transparency. Patients and investigators may review eligibility criteria and contact the sponsor regarding potential enrollment. This registry entry is informational and does not impose additional regulatory burdens.
Archived snapshot
Apr 18, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
An Open-Label, Multicenter, Non-Randomized Expanded Access Protocol (EAP) Designed to Provide Leronlimab to Patients With Locally Advanced or Metastatic Triple-Negative Breast Cancer (mTNBC)
Observational NCT07536815 Kind: OBSERVATIONAL Apr 17, 2026
Abstract
This Expanded Access Program provides investigational access to leronlimab (PRO 140) for patients with advanced or metastatic triple-negative breast cancer (TNBC) who lack satisfactory treatment options and are unable to participate in a clinical trial.
Conditions: TNBC, TNBC - Triple-Negative Breast Cancer, TNBC, Triple Negative Breast Cancer
Interventions: leronlimab (PRO 140)
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