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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: Clinical Trial Phase 1 study, sponsored by BioNTech SE.
NCT04101357 is a Phase 1 study that was terminated before completion, run by BioNTech SE. The registered enrollment target is 54 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
DLTs were defined as any non-immune-related adverse events (AEs) or immune-related AEs during the first treatment cycle that was of Grade 3 and that did not resolve to Grade 1 or lower within a week, or that were of Grade 4. AEs were graded for severity using National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v5.0), where Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4 - Life-threatening consequences; and Grade 5: Death related to AE.
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 |
Why NCT04101357 stopped before completion
NCT04101357 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 4 interventions - of which Carboplatin is the first listed.
NCT04101357 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04101357's enrollment target sits among peer trials
54 931st of 2000 higher than 1,053 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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