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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 is a Phase 1 study that was terminated before completion, run by BioNTech SE. The registered enrollment target is 13 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04683939
The ClinicalTrials.gov registry entry for NCT04683939 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 13 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 3 interventions - of which Gemcitabine is the first listed.
NCT04683939 reports 0 study locations.
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.
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