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 | 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-1305/BNT325 is an investigational small molecule being developed for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development, and the ongoing first-in-human study is evaluating its safety and efficacy in patients with advanced or metastatic solid tumors.
DB-1305/BNT325 is being developed by BioNTech SE, a biotechnology company traded on the NASDAQ under the ticker symbol BNTX. The company is conducting a Phase 1 clinical trial to evaluate this investigational therapy in patients with advanced solid tumors.
DB-1305/BNT325 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The drug has received Fast Track designation from the FDA, which is intended to expedite the development and review of therapies for serious conditions.
DB-1305/BNT325 is being studied in a Phase 1 first-in-human trial with the identifier NCT05438329. This trial is active but not recruiting, with an estimated enrollment of 1123 participants. The study is being conducted in the United States, China, and Puerto Rico for patients aged 18 years and older with advanced solid tumors.
Yes, DB-1305/BNT325 is also known as BNT325. The drug is being developed by BioNTech SE and is currently in Phase 1 clinical trials for advanced solid tumors. The ongoing study, NCT05438329, is a first-in-human trial evaluating this investigational therapy.