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NCT04455620 · ClinicalTrials.gov registry record · Phase 1
BNT151 as a Monotherapy and in Combination With Other Anti-cancer Agents in Patients With Solid Tumors
A Phase 1 study, sponsored by BioNTech SE.
- Terminated
- Registry status
- Phase 1
- Development phase
- 49
- Enrollment target
NCT04455620 is a Phase 1 study that was terminated before completion, run by BioNTech SE. The registered enrollment target is 49 participants.
The verdict
NCT04455620, a Phase 1 study, was terminated before completion, sponsored by BioNTech SE.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 49 participants
- Enrollment target
Study Summary
This was an open-label, multicenter Phase I/IIa dose escalation, safety, pharmacokinetic and pharmacodynamic (PD) study of BNT151 with expansion cohorts in various solid tumor indications. The study was planned to be performed in Part 1, Part 2A, and Part 2B with adaptive design elements. Part 2 was not conducted because of the clinical study being terminated early. The monotherapy dose escalation, (Part 1) of this clinical study enrolled participants with various solid tumors that are metastatic or of advanced unresectable stage for whom there was no available standard therapy likely to confer clinical benefit, or participants who are not candidates for such available therapy. Dose escalation followed an accelerated titration design, i.e., started with single participant cohorts followed by larger participant cohorts informed by the 3+3 design. Part 1 of the study also planed to implement a dedicated biomarker cohort in BNT151 monotherapy. The biomarker cohort was planned to recruit participants at selected sites in the United States (US) only. The objective of the cohort was to observe PD activity and drug-induced changes in the blood and tumor and only to generate data for exploratory endpoints or additional research. However, the biomarker cohort was not opened, and therefore no data were generated. During combination dose escalation (Part 2A), participants with squamous cell carcinoma of head and neck, and hepatocellular carcinoma were planned to be enrolled and treated with a combination of BNT151 and pembrolizumab. Once Part 2A was completed, participants with renal cell carcinoma, non-small cell lung cancer, and triple negative breast cancer were planned to be enrolled (Part 2B) and treated with a combination of BNT151 with the respective standard of care (SoC).
Interventions
- BIOLOGICAL BNT151
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2021-01-26 |
| Est. Completion | 2024-05-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04455620
The ClinicalTrials.gov registry entry for NCT04455620 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 49 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 1 intervention - of which BNT151 is the first listed.
NCT04455620 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04455620 about?
NCT04455620 is a clinical study titled "BNT151 as a Monotherapy and in Combination With Other Anti-cancer Agents in Patients With Solid Tumors". This was an open-label, multicenter Phase I/IIa dose escalation, safety, pharmacokinetic and pharmacodynamic (PD) study of BNT151 with expansion cohorts in various solid tumor indications. The study was planned to be performed in Part 1, Part 2A, and Part 2B with adaptive design elements. Part 2 wa...
What is the current status of trial NCT04455620?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2021-01-26. Estimated completion is 2024-05-28.
What interventions are being tested in trial NCT04455620?
The interventions under investigation include: BNT151 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04455620?
This trial is sponsored by BioNTech SE, which has 53 total clinical trials registered on ClinicalTrials.gov.
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