Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DB-1305/BNT325 · 1 trial · 1 indication
Percentage of participants in Part 1 with DLTs
Percentage of participants with TEAEs in Part 1 graded according to NCI CTCAE v5.0
Percentage of Participants with SAEs in Part 1 graded according to NCI CTCAE v5.0
MTD on the data collected during Part 1
RP2D of DB-1305/BNT325 based on the data collected during Part 1
Percentage of participants with TEAEs in Part 2 graded according to NCI CTCAE v5.0 (secondary outcome measure in cohort 3)
Percentage of participants with SAEs in Part 2 graded according to NCI CTCAE v5.0 (secondary outcome measure in cohort 3)
The percentage of subjects who had a best response rating of CR and PR
| Arm | Type | Description |
|---|---|---|
| DB-1305/BNT325 Dose Level 1 | EXPERIMENTAL | Enrolled subjects will receive DB-1305/BNT325 at Dose Level 1 |
| DB-1305/BNT325 Dose Level 2 | EXPERIMENTAL | Enrolled subjects will receive DB-1305/BNT325 at Dose Level 2 |
| DB-1305/BNT325 Dose Level 3 | EXPERIMENTAL | Enrolled subjects will receive DB-1305/BNT325 at Dose Level 3 |
| DB-1305/BNT325 Dose Level 4 | EXPERIMENTAL | Enrolled subjects will receive DB-1305/BNT325 at Dose Level 4 |
| DB-1305/BNT325 Dose Level 5 | EXPERIMENTAL | Enrolled subjects will receive DB-1305/BNT325 at Dose Level 5 |
| DB-1305/BNT325 Dose Level 6 | EXPERIMENTAL | Enrolled subjects will receive DB-1305/BNT325 at Dose Level 6 |
| DB-1305/BNT325 Dose Level 7 | EXPERIMENTAL | Enrolled subjects will receive DB-1305/BNT325 at Dose Level 7 |
| DB-1305/BNT325 in combination with pembrolizumab | EXPERIMENTAL | Enrolled subjects will receive DB-1305/BNT325 in combination with pembrolizumab |
| DB-1305/BNT325 Dose Expansion 1 | EXPERIMENTAL | subjects with Non-Small Cell Lung Cancer (NSCLC) with actionable genetic alterations (AGAs) who will receive DB-1305/BNT325 on either dose level 1 or dose level 2 |
| DB-1305/BNT325 Dose Expansion 2 | EXPERIMENTAL | Enrolled subjects with NSCLC without AGAs who will receive DB-1305/BNT325 on either dose level 1 or dose level 2 |
| DB-1305/BNT325 Dose Expansion 3 | EXPERIMENTAL | Enrolled subjects with OC who will receive DB-1305/BNT325 on either dose level 1 or dose level 2 |
| DB-1305/BNT325 Dose Expansion 4 | EXPERIMENTAL | Enrolled subjects with BC who will receive DB-1305/BNT325 on a selected dose level (RP2D) |
| DB-1305/BNT325 Dose Expansion 5 | EXPERIMENTAL | Enrolled subjects with Triple-Negative Breast Cancer (TNBC) who have progressed on or after standard systemic treatments and without prior treatment of sacituzumab govitecan who will receive DB-1305/BNT325 on a selected dose level (RP2D) |
| DB-1305/BNT325 Dose Expansion 6 | EXPERIMENTAL | Enrolled subjects with TNBC with treatment failure on sacituzumab govitecan who will receive DB-1305/BNT325 on a selected dose level (RP2D) |
| DB-1305/BNT325 Dose Expansion 7 | EXPERIMENTAL | Enrolled subjects with EC who will receive DB-1305/BNT325 on a selected dose level (RP2D) |
| DB-1305/BNT325 Dose Expansion 8 | EXPERIMENTAL | Enrolled subjects with malignant mesothelioma will receive DB-1305/BNT325 on a selected dose level (RP2D) |
| DB-1305/BNT325 Dose Expansion 9 | EXPERIMENTAL | Enrolled subjects with Cervical Cancer (CC) who will receive DB-1305/BNT325 on a selected dose level (RP2D) |
| Experimental: DB-1305/BNT325 Dose Expansion 10 | EXPERIMENTAL | Enrolled subjects with pancreatic cancer who will receive DB-1305/BNT325 on a selected dose level (RP2D) |
| DB-1305/BNT325 Dose Expansion 11 | EXPERIMENTAL | Enrolled subjects with Castration-Resistant Prostate Cancer (CRPC) who will receive DB-1305/BNT325 on a selected dose level (RP2D) |
| DB-1305/BNT325 Dose Expansion PB1 | EXPERIMENTAL | Enrolled subjects with NSCLC without AGAs who will receive DB-1305/BNT325 on a selected dose level in combination with pembrolizumab |
| Experimental: DB-1305/BNT325 Dose Level 8 | EXPERIMENTAL | Enrolled subjects will receive DB-1305/BNT325 at Dose Level 8 |
| Experimental: DB-1305/BNT325 in combination with BNT327 | EXPERIMENTAL | Enrolled subjects will receive DB-1305/BNT325 in combination with BNT327 |
| Experimental: DB-1305/BNT325 Dose Expansion PM1 | EXPERIMENTAL | Enrolled subjects with NSCLC without AGAs who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327 |
| Experimental: DB-1305/BNT325 Dose Expansion PM2 | EXPERIMENTAL | Enrolled subjects with NSCLC with AGAs who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327 |
| Experimental: DB-1305/BNT325 Dose Expansion PM3 | EXPERIMENTAL | Enrolled subjects with CC who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327 |
| Experimental: DB-1305/BNT325 Dose Expansion PM4 | EXPERIMENTAL | Enrolled subjects with OC who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327 |
| Experimental: DB-1305/BNT325 Dose Expansion PM5 | EXPERIMENTAL | Enrolled subjects with TNBC who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327 |
| DB-1305/BNT325 Dose Expansion 12 | EXPERIMENTAL | Enrolled subjects with head and neck cancer who will receive DB-1305/BNT325 on a selected dose level (RP2D) |
| DB-1305/BNT325 Dose Level 9 | EXPERIMENTAL | Enrolled subjects will receive DB-1305/BNT325 at Dose Level 9 |
| DB-1305/BNT325 Dose Expansion PM6 | EXPERIMENTAL | Enrolled subjects with NSCLC without AGA who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327 |
| Name | Type | Description |
|---|---|---|
| DB-1305/BNT325 | DRUG | Administered Injection of Vein (I.V.) |
| Pembrolizumab | COMBINATION_PRODUCT | Administered I.V. |
| BNT327 | DRUG | Administered I.V. |
Inclusion Criteria: * Male or female adults (defined as ≥ 18 years of age or acceptable age according to local regulations at the time of voluntarily signing of informed consent). * Histologically or cytologically confirmed unresectable advanced/ metastatic solid tumors who have relapsed or progres...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
DB-1305/BNT325 is being studied for the treatment of advanced solid tumors. It is an investigational therapy in Phase 1 clinical development and has not been approved for any indication. The research focuses on patients with advanced or metastatic solid tumors who are 18 years or older.
DB-1305/BNT325 is being developed by BioNTech SE, a biotechnology company traded on the Nasdaq under the ticker symbol BNTX. BioNTech is the sponsor of the clinical program evaluating this agent in advanced solid tumors.
DB-1305/BNT325 is in Phase 1 clinical development. The ongoing first-in-human study is designed to evaluate the therapy in patients with advanced or metastatic solid tumors. As an investigational agent, it has not received regulatory approval for any indication.
DB-1305/BNT325 is being evaluated in a single active clinical trial, NCT05438329, titled First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors. The trial is currently active but not recruiting, with an enrollment of 1,123 participants across the United States, China, and Puerto Rico.
Yes, DB-1305/BNT325 is also known as BNT325. The dual name reflects the collaboration between the developers, and both names refer to the same investigational compound being studied in advanced solid tumors.