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Also known as DB-1311
DB-1311/BNT324 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part 1 Cohort 1A, DB-1311/BNT324+ BNT327 combination therapy | EXPERIMENTAL | Escalating combination dose levels of DB-1311/BNT324 and BNT327 to define RP2D (Recommended Phase 2 Dose) and RP2D-1 in target population. |
| Part 1 Cohort 2, DB-1311/BNT324+ DB-1305 /BNT325 combination therapy | EXPERIMENTAL | Escalating combination dose levels of DB-1311/BNT324 and DB-1305/BNT325 to define RP2D and RP2D-1 in target population. |
| Part 2 Arm 1: RP2D of DB-1311/BNT324 + BNT327 | EXPERIMENTAL | In participants with unresectable advanced/metastatic HCC |
| Part 2 Arm 2: RP2D of DB-1311/BNT324 + BNT327 | EXPERIMENTAL | In participants with unresectable advanced/ metastatic CC |
| Part2 Arm 3:RP2D of DB-1311/BNT324 + BNT327 | EXPERIMENTAL | In participants with unresectable advanced/metastatic melanoma |
| Part 2 Arm 4: RP2D of DB-1311/BNT324 + BNT327 | EXPERIMENTAL | In participants with recurrent/metastatic HNSCC |
| Part 2 Arm 5: RP2D of DB-1311/BNT324 +DB-1305/BNT325 and RP2D-1 of DB-1311/BNT324 +DB-1305/BNT325 | EXPERIMENTAL | In participants with advanced/unresectable metastatic NSCLC |
| Part 1 Cohort 1B, DB-1311/BNT324+ BNT327 combination therapy | EXPERIMENTAL | Escalating combination dose levels of DB-1311/BNT324 and BNT327 to define RP2D and RP2D-1 in target population. |
| Part 2 Arm 6: RP2D of DB-1311/BNT324 + BNT327 | EXPERIMENTAL | In participants with unresectable advanced/metastatic PSOC |
| Part 2 Arm 7: RP2D of DB-1311/BNT324 + BNT327 | EXPERIMENTAL | In participants with unresectable advanced/metastatic PDAC |
| Part 2 Arm 8: RP2D of DB-1311/BNT324 + BNT327 | EXPERIMENTAL | In participants with unresectable advanced/metastatic breast cancer |
| Part 2 Arm 9: RP2D of DB-1311/BNT324 + BNT327 | EXPERIMENTAL | In participants with unresectable advanced/metastatic CRC |
| Part 2 Arm 10: RP2D of DB-1311/BNT324 + BNT327 | EXPERIMENTAL | In participants with unresectable advanced/metastatic mCRPC |
| Name | Type | Description |
|---|---|---|
| DB-1311/BNT324 | DRUG | Administered I.V. |
| BNT327 | DRUG | Administered I.V. |
| DB-1305/BNT325 | DRUG | Administered I.V. |
Inclusion Criteria: * Adults aged ≥ 18 years or acceptable age according to local regulations at the time of voluntarily signing informed consent. * At least one measurable lesion as assessed by the Investigator according to RECIST v1.1 criteria. * Has a life expectancy of ≥ 3 months. * Has an East...
| 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 |
DB-1311 is an investigational small molecule being developed for the treatment of advanced solid tumors and solid tumors. It is currently being studied in clinical trials for patients with advanced or metastatic solid tumors, including a Phase 1/2a study and a Phase 2 combination study.
DB-1311 is being developed by BioNTech SE, a biotechnology company traded on the NASDAQ under the ticker BNTX. The company is conducting clinical trials for this investigational oncology drug in multiple countries, including the United States, Australia, China, and Taiwan.
DB-1311 is in Phase 1 clinical development as an investigational drug. It has not been approved by regulatory authorities and is still being evaluated in clinical trials. The drug has received Fast Track designation from the FDA, which is intended to expedite its development and review.
DB-1311 is being studied in two recruiting clinical trials. NCT05914116 is a Phase 1/2a study of DB-1311/BNT324 in advanced or metastatic solid tumors with an enrollment of 862. NCT06953089 is a Phase 2 study of DB-1311 in combination with BNT327 or DB-1305 in advanced or metastatic solid tumors with an enrollment of 450.
Yes, DB-1311 is also known as DB-1311/BNT324. The drug is referred to by this combined name in clinical trial records, such as in the Phase 1/2a study NCT05914116, which is titled 'A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors'.