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NCT04101357 · ClinicalTrials.gov registry record · Phase 1
Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT411
A Phase 1 study, sponsored by BioNTech SE.
- Terminated
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
NCT04101357 is a Phase 1 study that was terminated before completion, run by BioNTech SE. The registered enrollment target is 54 participants.
The verdict
NCT04101357, a Phase 1 study, was terminated before completion, sponsored by BioNTech SE.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
Study Summary
This first-in-human (FIH) trial aimed to establish a safe dose of BNT411 as a monotherapy and in combination with atezolizumab, carboplatin and etoposide. BNT411 is a toll-like receptor 7 (TLR7) agonist which is expected to mount broad innate and adaptive immune reactions, especially in combination with cytotoxic therapies and immune checkpoint inhibitors.
Interventions
- DRUG Carboplatin
- DRUG Atezolizumab
- DRUG Etoposide
- DRUG BNT411
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2020-06-19 |
| Est. Completion | 2024-05-23 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04101357
The ClinicalTrials.gov registry entry for NCT04101357 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioNTech SE, which has 53 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Carboplatin is the first listed.
NCT04101357 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04101357 about?
NCT04101357 is a clinical study titled "Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT411". This first-in-human (FIH) trial aimed to establish a safe dose of BNT411 as a monotherapy and in combination with atezolizumab, carboplatin and etoposide. BNT411 is a toll-like receptor 7 (TLR7) agonist which is expected to mount broad innate and adaptive immune reactions, especially in combination ...
What is the current status of trial NCT04101357?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2020-06-19. Estimated completion is 2024-05-23.
What interventions are being tested in trial NCT04101357?
The interventions under investigation include: Carboplatin (DRUG), Atezolizumab (DRUG), Etoposide (DRUG), BNT411 (DRUG).
Who is sponsoring clinical trial NCT04101357?
This trial is sponsored by BioNTech SE, which has 53 total clinical trials registered on ClinicalTrials.gov.
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