Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BNT3214 · 1 trial · 1 indication
Per DL/cohort. By United States National Cancer Institute Common Terminology Criteria for Adverse Events grading, seriousness, and relatedness.
Per DL/cohort.
During the DLT evaluation period
Per DL/cohort. Defined as the percentage of participants in whom a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 (based on the investigator's assessment) is observed as best overall response.
| Arm | Type | Description |
|---|---|---|
| Part A - Escalating DLs of BNT3214 | EXPERIMENTAL | Up to 7 DLs of BNT3214. In Part A, participants will stay on the same DL. In DL1 and DL2, intra-participant dose escalation will be allowed at the discretion of the investigator as specified in the protocol. |
| Part B (optional) - Selected DLs of BNT3214 | EXPERIMENTAL | Up to 4 DLs. The starting dose for Part B will be at least one DL below the DL that has been declared safe for Part A. |
| Part C - Optimized DL of BNT3214 | EXPERIMENTAL | Optimized dose of BNT3214 selected based on totality of data from Parts A and (if conducted) Part B. |
| Part C - Dose expansion of BNT3214 | EXPERIMENTAL | DLs as recommended based on the totality of available data from previous parts. |
| Name | Type | Description |
|---|---|---|
| BNT3214 | DRUG | Intravenous infusion |
Inclusion Criteria: * Participants aged ≥18 years of age inclusive at the time of giving informed consent. * Have at least one measurable tumor lesion based on RECIST v1.1. One lesion with prior local treatment (i.e., radiotherapy) can be considered measurable only if a disease progression from pri...
BNT3214 is an investigational small molecule being developed for the treatment of advanced solid tumor cancer. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and preliminary efficacy in patients.
BNT3214 is being developed by BioNTech SE, a biotechnology company traded on the NASDAQ under the ticker symbol BNTX. The company is conducting a Phase 1 clinical trial to evaluate the drug's safety and preliminary efficacy in adults with advanced solid tumors.
BNT3214 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 1 trial is recruiting participants to assess the safety and preliminary efficacy of BNT3214 in adults with advanced solid tumors.
BNT3214 is being studied in one active Phase 1 clinical trial with the identifier NCT07455734. This early-phase trial is assessing the safety and preliminary efficacy of BNT3214 in adults with advanced solid tumors. The trial is recruiting participants in Australia, China, South Korea, and Taiwan, with a planned enrollment of 533 patients.
Yes, the Phase 1 clinical trial of BNT3214 is randomized and controlled, but it is not double-blinded. The trial, identified as NCT07455734, is designed to compare BNT3214 against a control, and it is actively recruiting patients with advanced solid tumor cancer.