Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DB-1311 · 1 trial · 1 indication
Percentage of participants in Part 1 with DLTs
Percentage of participants with TEAEs graded according to National Cancer Institute (NCI) CTCAE v5.0
Percentage of Participants with SAEs graded according to NCI CTCAE v5.0
MTD on the data collected during Part 1
RP2D of DB-1311/BNT324 based on the data collected during Part 1
Objective Response Rate (ORR) as determined by investigator per RECIST 1.1 in non-PC/non-GBM participants per RECIST v1.1 for soft tissue and Prostate Cancer Working Group 3 (PCWG3) criteria for bone metastases in PC participants, and ORR per neuro-oncology 2.0 (RANO 2.0) criteria in GBM participants.
| Arm | Type | Description |
|---|---|---|
| DB-1311/BNT324 Dose Level 1 | EXPERIMENTAL | Enrolled Subjects will receive a single-dose of DB-1311/BNT324 at Dose Level 1 on Day 1 of each cycle Q3W (every 3 weeks) |
| DB-1311/BNT324 Dose Level 2 | EXPERIMENTAL | Enrolled Subjects will receive a single-dose of DB-1311/BNT324 at Dose Level 2 on Day 1 of each cycle Q3W |
| DB-1311/BNT324 Dose Level 3 | EXPERIMENTAL | Enrolled Subjects will receive a single-dose of DB-1311/BNT324 at Dose Level 3 on Day 1 of each cycle Q3W |
| DB-1311/BNT324 Dose Level 4 | EXPERIMENTAL | Enrolled Subjects will receive a single-dose of DB-1311/BNT324 at Dose Level 4 on Day 1 of each cycle Q3W |
| DB-1311/BNT324 Dose Level 5 | EXPERIMENTAL | Enrolled Subjects will receive a single-dose of DB-1311/BNT324 at Dose Level 5 on Day 1 of each cycle Q3W |
| DB-1311/BNT324 Dose Expansion 1 | EXPERIMENTAL | Subjects with advanced/unresectable, or metastatic SCLC who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324 randomized at dose level 1 or 2. |
| DB-1311/BNT324 Dose Expansion 2 | EXPERIMENTAL | Subjects with advanced/unresectable, or metastatic NSCLC who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324 randomized at dose level 1 or 2. |
| DB-1311/BNT324 Dose Expansion 3 | EXPERIMENTAL | Subjects with advanced/unresectable, or metastatic ESCC who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324. |
| DB-1311/BNT324 Dose Expansion 4 | EXPERIMENTAL | Subjects with advanced/unresectable, or metastatic CRPC who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324 randomized at dose level 1 or 2. |
| DB-1311/BNT324 Dose Expansion 5 | EXPERIMENTAL | Subjects with advanced/unresectable, or metastatic melanoma who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324. |
| DB-1311/BNT324 Dose Expansion 6 | EXPERIMENTAL | Subjects with advanced/unresectable, or metastatic HCC who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324. |
| DB-1311/BNT324 Dose Expansion 7 | EXPERIMENTAL | Subjects with advanced/unresectable, or metastatic cervical cancer who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324. |
| DB-1311/BNT324 Dose Expansion 8 | EXPERIMENTAL | Subjects with other advanced or metastatic solid tumors who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324. |
| DB-1311/BNT324 Dose Expansion 9 | EXPERIMENTAL | Subjects with advanced/unresectable, or metastatic HNSCC (not including nasopharyngeal carcinoma \[NPC\]) who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324. |
| DB-1311/BNT324 Dose Expansion 10 | EXPERIMENTAL | Subjects with advanced or metastatic rare tumor types who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324. |
| DB-1311/BNT324 Dose Expansion 11 | EXPERIMENTAL | Subjects with metastatic CRPC who have progressed on or after standard systemic treatments including no more than 2 lines of systemic chemotherapy, novel hormone therapy and lutetium-177 radioligand therapy, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324. |
| DB-1311/BNT324 Dose Expansion 12 | EXPERIMENTAL | Taxane-naive subjects with metastatic CRPC who have progressed on or after novel hormone therapy, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324. |
| DB-1311/BNT324 Dose Expansion 13 | EXPERIMENTAL | Subjects with advanced/unresectable, or metastatic HNSCC (not including NPC) who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324. |
| DB-1311/BNT324 Dose Expansion 14 | EXPERIMENTAL | Subjects with epithelial OC who have had 1-3 prior lines of systemic treatment and are platinum-resistant, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324 randomized at dose level 1 or 2. |
| DB-1311/BNT324 Dose Expansion 15 | EXPERIMENTAL | Subjects with Subjects with advanced/unresectable, or metastatic melanoma, ESCC, PROC and CC who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via IV will be used for DB-1311/BNT324. Lopinavir and ritonavir/ Itraconazole will be administered orally twice a day/ once a day. |
| DB-1311/BNT324 Dose Expansion 16 | EXPERIMENTAL | Taxane-naive subjects with metastatic CRPC who have progressed on or after NHT, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324, combined with enzalutamide 160mg QD orally. |
| DB-1311/BNT324 Dose Expansion 17 | EXPERIMENTAL | Taxane-naive subjects with metastatic CRPC who have progressed on or after NHT, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324, combined with abiraterone 1000mg QD orally. |
| DB-1311/BNT324 Dose Expansion 18 | EXPERIMENTAL | CSPC subjects with suboptimal PSA response to ADT/NHT, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324, combined with enzalutamide 160mg or abiraterone 1000mg QD orally. |
| Name | Type | Description |
|---|---|---|
| DB-1311 | DRUG | Administered I.V.(intravenous infusion) |
| Lopinavir and Ritonavir Tablets | DRUG | Lopinavir and Ritonavir Tablets |
| itraconazole | DRUG | itraconazole |
| Enzalutamide | DRUG | oral administration |
| Abiraterone | DRUG | oral administration |
Inclusion Criteria: 1. 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). 2. Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor that has 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-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'.