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NCT06069778 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, and Efficacy of mFOLFIRINOX ± BNT321 as Adjuvant Therapy Following Curative Resection in Patients With Pancreatic Adenocarcinoma
A Phase 1 study, sponsored by BioNTech SE.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT06069778 is a Phase 1 study that was terminated before completion, run by BioNTech SE. The registered enrollment target is 1 participants.
The verdict
NCT06069778, a Phase 1 study, was terminated before completion, sponsored by BioNTech SE.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
This study was designed as a Phase 1/randomized Phase 2 open-label study of modified(m) FOLFIRINOX ± BNT321 for adjuvant therapy in pancreatic ductal adenocarcinoma (PDAC) patients post R0 or R1 resection. The Phase 1, dose escalation part of this study was planned to be a limited evaluation of two planned BNT321 dose levels (DLs) in combination with mFOLFIRINOX chemotherapy (24 weeks) followed by BNT321 monotherapy (24 weeks). Following completion of the dose escalation Phase 1 and identification of the recommended Phase 2 dose (RP2D), the study was designed as a 2-arm, randomized Phase 2 of mFOLFIRINOX ± BNT321 to evaluate the efficacy of mFOLFIRINOX + BNT321 versus mFOLFIRINOX alone as adjuvant therapy in PDAC patients post R0 or R1 resection. Treatment cycles were every 2 weeks (14 days).
Interventions
- DRUG mFOLFIRINOX
- DRUG BNT321 0.5 mg/kg
- DRUG BNT321 DL 2
- DRUG BNT321 RP2D
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2024-03-27 |
| Est. Completion | 2024-09-18 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06069778
The ClinicalTrials.gov registry entry for NCT06069778 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 1 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 mFOLFIRINOX is the first listed.
NCT06069778 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06069778 about?
NCT06069778 is a clinical study titled "Safety, Tolerability, and Efficacy of mFOLFIRINOX ± BNT321 as Adjuvant Therapy Following Curative Resection in Patients With Pancreatic Adenocarcinoma". This study was designed as a Phase 1/randomized Phase 2 open-label study of modified(m) FOLFIRINOX ± BNT321 for adjuvant therapy in pancreatic ductal adenocarcinoma (PDAC) patients post R0 or R1 resection. The Phase 1, dose escalation part of this study was planned to be a limited evaluation of two...
What is the current status of trial NCT06069778?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2024-03-27. Estimated completion is 2024-09-18.
What interventions are being tested in trial NCT06069778?
The interventions under investigation include: mFOLFIRINOX (DRUG), BNT321 0.5 mg/kg (DRUG), BNT321 DL 2 (DRUG), BNT321 RP2D (DRUG).
Who is sponsoring clinical trial NCT06069778?
This trial is sponsored by BioNTech SE, which has 53 total clinical trials registered on ClinicalTrials.gov.
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