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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 is a Phase 1 study that has completed, run by BioNTech SE. The registered enrollment target is 86 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04710043
The ClinicalTrials.gov registry entry for NCT04710043 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 86 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 2 interventions - of which BNT152 is the first listed.
NCT04710043 reports 0 study locations.
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.
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