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NCT04710043 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation Trial of BNT152+153 in Patients With Cancer
A Phase 1 study, sponsored by BioNTech SE.
- Completed
- Registry status
- Phase 1
- Development phase
- 86
- Enrollment target
NCT04710043: Completed Phase 1 study, sponsored by BioNTech SE.
NCT04710043 is a Phase 1 study that has completed, run by BioNTech SE. The registered enrollment target is 86 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04710043, a Phase 1 study, has completed, sponsored by BioNTech SE.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 86 participants
- Enrollment target
Study Summary
This is an open-label, multisite Phase I dose escalation, safety, pharmacokinetics (PK) and pharmacodynamics (PD) trial of BNT152+153 in various solid tumor indications. The clinical trial will enroll patients with various solid tumors that are metastatic or unresectable for whom there is no available standard therapy likely to confer clinical benefit, or patients who are not candidates for such available therapy. The trial consists of Part 1 and Part 2 with adaptive design elements: * Part 1 consists of Groups A and B. * Group A is a BNT153 monotherapy dose escalation in patients with advanced solid malignancies until the maximal tolerated dose (MTD) is defined. If MTD is not reached, maximum administered dose (MAD) may be used for further development (or another dose as determined by the safety review committee \[SRC\]). * Group B is a BNT152 monotherapy dose escalation in patients with advanced solid malignancies until the MTD or optimal biological dose (OBD; the lowest safe dose associated with optimal biological activity) is defined, whichever occurs earlier. * Group A will be activated first while the time point for Group B activation is at sponsor's decision. * Part 2 will start after the MTD or MAD or another dose as determined by the SRC have been established for BNT153 and MTD or OBD for BNT152 in Part 1. Part 2 (Part 2A, 2B and 2C) is a dose escalation of BNT152+153 in patients with advanced solid malignancies until the recommended Phase II dose (RP2D) is defined. * Part 2 may implement a biomarker cohort if a clinical benefit is observed at one or more doses of BNT152+153 that show a clear PD effect in the peripheral blood. The Biomarker Cohort will recruit patients at selected sites.
Primary Outcome
TEAEs will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v.5.0.
Interventions
- DRUG BNT152
- DRUG BNT153
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2021-06-08 |
| Est. Completion | 2025-09-10 |
| Phase | Phase 1 |
What the finished NCT04710043 record still lists
NCT04710043 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% higher).
The record links to 0 conditions, and to 2 interventions - of which BNT152 is the first listed.
NCT04710043 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04710043 about?
NCT04710043 is a clinical study titled "Dose Escalation Trial of BNT152+153 in Patients With Cancer". This is an open-label, multisite Phase I dose escalation, safety, pharmacokinetics (PK) and pharmacodynamics (PD) trial of BNT152+153 in various solid tumor indications. The clinical trial will enroll patients with various solid tumors that are metastatic or unresectable for whom there is no availa...
What is the current status of trial NCT04710043?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 86 participants. The study started on 2021-06-08. Estimated completion is 2025-09-10.
What interventions are being tested in trial NCT04710043?
The interventions under investigation include: BNT152 (DRUG), BNT153 (DRUG).
Who is sponsoring clinical trial NCT04710043?
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 NCT04710043's enrollment target sits among peer trials
86 652nd of 2000 higher than 1,345 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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