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NCT04683939 · ClinicalTrials.gov registry record · Phase 1
Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT141 in Patients With Unresectable or Metastatic CLDN18.2-positive Gastric, Pancreatic, Ovarian and Biliary Tract Tumors
A Phase 1 study, sponsored by BioNTech SE.
- Terminated
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT04683939: Clinical Trial Phase 1 study, sponsored by BioNTech SE.
NCT04683939 is a Phase 1 study that was terminated before completion, run by BioNTech SE. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04683939, a Phase 1 study, was terminated before completion, sponsored by BioNTech SE.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
This study was planned as an open-label, multi-site, Phase I/IIa dose escalation, safety, and pharmacokinetic (PK) trial of BNT141 followed by expansion cohorts in patients with Claudin 18.2 (CLDN18.2)-positive tumors. The sponsor decided to stop the development of BNT141 on 24 July 2023 and the study was terminated early.
Primary Outcome
All TEAEs are included, i.e., AEs with an onset date on or after the first dose of BNT141 (if the AE was absent before the first dose) or worsened after the first dose of BNT141 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT141 are included only if assessed as related to BNT141 by the investigator. Intensity of AEs was graded according to the NCI CTCAE v5.0, i.e.,: Grade 1 - Mild, Grade 2 - Moderate, Grade 3 - Severe, Grade 4 - Life-t
Interventions
- DRUG Gemcitabine
- DRUG Nab-paclitaxel
- DRUG BNT141
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2022-01-18 |
| Est. Completion | 2023-07-24 |
| Phase | Phase 1 |
Why NCT04683939 stopped before completion
NCT04683939 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 3 interventions - of which Gemcitabine is the first listed.
NCT04683939 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04683939 about?
NCT04683939 is a clinical study titled "Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT141 in Patients With Unresectable or Metastatic CLDN18.2-positive Gastric, Pancreatic, Ovarian and Biliary Tract Tumors". This study was planned as an open-label, multi-site, Phase I/IIa dose escalation, safety, and pharmacokinetic (PK) trial of BNT141 followed by expansion cohorts in patients with Claudin 18.2 (CLDN18.2)-positive tumors. The sponsor decided to stop the development of BNT141 on 24 July 2023 and the st...
What is the current status of trial NCT04683939?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2022-01-18. Estimated completion is 2023-07-24.
What interventions are being tested in trial NCT04683939?
The interventions under investigation include: Gemcitabine (DRUG), Nab-paclitaxel (DRUG), BNT141 (DRUG).
Who is sponsoring clinical trial NCT04683939?
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 NCT04683939's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 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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