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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07147348 | A First-in-human, Dose Escalation and Indication Expansion Study of BNT3212 as Monotherapy or in Combination With BNT327 in Adults With Advanced Solid Tumors | PHASE1 | RECRUITING | 375 | — | — | Aug 27, 2025 | Aug 1, 2028 | Apr 6, 2026 | 16 | Australia, China |
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, V503, GARDASIL |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| AstraZeneca PLC | AZN | 1 | — | Trastuzumab deruxtecan |