Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BNT3212 · 1 trial · 1 indication
Per cohort.
Per cohort. Adverse events (AEs) graded according to the National Cancer Institute Common Terminology Criteria for AEs version 5.0 (NCI CTCAE v5.0).
Per cohort.
Per cohort.
Per cohort. ORR defined as the percentage of participants in whom a confirmed complete response (CR) or partial response (PR) (per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\] based on the investigator's assessment) is observed as best overall response.
| Arm | Type | Description |
|---|---|---|
| Part A - BNT3212 monotherapy (dose escalation) | EXPERIMENTAL | Escalating dose levels of BNT3212 to define the maximum tolerated dose (MTD) in participants with histologically or cytologically confirmed locally advanced/unresectable, recurrent, or metastatic malignant solid tumors who are refractory to or unable to tolerate standard treatment, or for whom no standard treatment is available. |
| Part B - BNT3212 monotherapy dose level (DL)1 (expansion cohort) | EXPERIMENTAL | Indication-specific cohort populations will be tested. |
| Part B - BNT3212 monotherapy DL2 (expansion cohort) | EXPERIMENTAL | Indication-specific cohort populations will be tested. |
| Part B - BNT3212 monotherapy DL3 (expansion cohort) | EXPERIMENTAL | Indication-specific cohort populations will be tested. |
| Part C - BNT3212 + pumitamig combination therapy (dose escalation) | EXPERIMENTAL | Escalating dose levels of BNT3212 plus a fixed dose of pumitamig to define the MTD in participants with histologically or cytologically confirmed locally advanced/unresectable, recurrent, or metastatic malignant solid tumors who are refractory to or unable to tolerate standard treatment, or for whom no standard treatment is available. |
| Part D - BNT3212 DL1 + pumitamig combination therapy (expansion cohort) | EXPERIMENTAL | Indication-specific cohort populations will be tested. Pumitamig will be administered as fixed dose. |
| Part D - BNT3212 DL2 + pumitamig combination therapy (expansion cohort) | EXPERIMENTAL | Indication-specific cohort populations will be tested. Pumitamig will be administered as fixed dose. |
| Part D - BNT3212 DL3 + pumitamig combination therapy (expansion cohort) | EXPERIMENTAL | Indication-specific cohort populations will be tested. Pumitamig will be administered as fixed dose. |
| Name | Type | Description |
|---|---|---|
| BNT3212 | BIOLOGICAL | Intravenous infusion |
| Pumitamig | BIOLOGICAL | Intravenous infusion |
Key Inclusion Criteria: * Participants with histologically or cytologically confirmed locally advanced, recurrent, or metastatic solid tumors that have received prior adequate therapy in accordance with local practice for their tumor type and stage of disease; or for whom the standard therapy is co...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
BNT3212 is an investigational monoclonal antibody being developed for the treatment of advanced solid tumors. It is currently being studied in a first-in-human clinical trial as a monotherapy or in combination with BNT327 in adults with advanced solid tumors. The drug is in Phase 1 clinical development.
BNT3212 targets the epidermal growth factor receptor (EGFR), a receptor protein involved in cell growth and survival. By binding to EGFR, the monoclonal antibody is designed to interfere with signaling pathways that can drive tumor growth. This mechanism is being evaluated in the context of advanced solid tumors.
BNT3212 is being developed by BioNTech SE, a biotechnology company publicly traded under the ticker symbol BNTX. The company is conducting a Phase 1 clinical trial of BNT3212 in adults with advanced solid tumors, with study sites in Australia and China.
BNT3212 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The ongoing Phase 1 trial is a first-in-human study evaluating the safety and tolerability of BNT3212.
BNT3212 is being studied in a single Phase 1 clinical trial with the identifier NCT07147348. This first-in-human study is a dose escalation and indication expansion trial evaluating BNT3212 as monotherapy or in combination with BNT327 in adults with advanced solid tumors. The trial is currently recruiting participants and has a target enrollment of 375.