Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07455734 | Early-phase Trial to Assess the Safety and Preliminary Efficacy of BNT3214 in Adults With Advanced Solid Tumors | PHASE1 | RECRUITING | 533 | — | — | Mar 30, 2026 | Oct 1, 2030 | May 14, 2026 | 5 | Australia, China +1 |
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...