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NCT03838367 · ClinicalTrials.gov registry record · Phase 1
Leronlimab (PRO 140) Combined With Carboplatin in Patients With Cytokine Chemokine Receptor 5 Positive (CCR5+) mTNBC
A Phase 1 study, sponsored by CytoDyn.
- Terminated
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT03838367: Clinical Trial Phase 1 study, sponsored by CytoDyn.
NCT03838367 is a Phase 1 study that was terminated before completion, run by CytoDyn. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03838367, a Phase 1 study, was terminated before completion, sponsored by CytoDyn.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
This is a phase Ib/II Study of Leronlimab (PRO 140) combined with Carboplatin in Patients with CCR5+ Metastatic Triple Negative Breast Cancer (mTNBC). Study population will consist of patients with CCR5-positive, locally advanced or metastatic triple-negative breast cancer (mTNBC) who are naïve to chemotherapy in metastatic setting but have been exposed to anthracyclines and taxane in neoadjuvant and adjuvant settings (first-line).
Primary Outcome
The MTD is defined as 1 dose level (cohort) below the dose in which dose limiting toxicities (DLTs) were observed in \>= 33% of the participants.
Interventions
- DRUG 350 mg leronlimab
- DRUG 700 mg leronlimab
- DRUG 525 mg leronlimab
- DRUG AUC 5 Carboplatin
- DRUG Maximum Tolerated Dose (MTD) of leronlimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2019-04-22 |
| Est. Completion | 2022-09-16 |
| Phase | Phase 1 |
Why NCT03838367 stopped before completion
NCT03838367 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 5 interventions - of which 350 mg leronlimab is the first listed.
NCT03838367 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03838367 about?
NCT03838367 is a clinical study titled "Leronlimab (PRO 140) Combined With Carboplatin in Patients With Cytokine Chemokine Receptor 5 Positive (CCR5+) mTNBC". This is a phase Ib/II Study of Leronlimab (PRO 140) combined with Carboplatin in Patients with CCR5+ Metastatic Triple Negative Breast Cancer (mTNBC). Study population will consist of patients with CCR5-positive, locally advanced or metastatic triple-negative breast cancer (mTNBC) who are naïve to ...
What is the current status of trial NCT03838367?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2019-04-22. Estimated completion is 2022-09-16.
What interventions are being tested in trial NCT03838367?
The interventions under investigation include: 350 mg leronlimab (DRUG), 700 mg leronlimab (DRUG), 525 mg leronlimab (DRUG), AUC 5 Carboplatin (DRUG), Maximum Tolerated Dose (MTD) of leronlimab (DRUG).
Who is sponsoring clinical trial NCT03838367?
This trial is sponsored by CytoDyn, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03838367's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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