Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as anti-B7-H3 antibody conjugated to topoisomerase I inhibitor, DB-1311
BNT324 · 4 trials · 4 indications
By arm. rPFS is defined as time from randomization to radiographic disease progression per Prostate Cancer Working Group 3 (PCWG3)-modified Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria, or death from any cause, whichever occurs first.
By arm. OS is defined as time from randomization to death from any cause.
ORR defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) is observed as best overall response (per response evaluation criteria in solid tumors \[RECIST\] version 1.1 based on the investigator's assessment).
ORR, defined as the proportion of participants in whom a confirmed CR or PR is observed as best overall response (per RECIST version 1.1 based on the investigator's assessment).
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 |
|---|---|---|
| BNT324 | EXPERIMENTAL | - |
| Docetaxel plus prednisone/ prednisolone | ACTIVE_COMPARATOR | - |
| 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 |
| Part 1 - BNT324 + BNT327 combination therapy | EXPERIMENTAL | Escalating combination dose levels of BNT324 and BNT327 to define RP2D and RP2D-1 for NSCLC and SCLC. |
| Part 2 - Cohort 1: RP2D of BNT324 + BNT327 and RP2D-1 of BNT324 + BNT327 | EXPERIMENTAL | In subpopulation 1 of NSCLC actionable oncogenic alteration (AGA) negative, first-line (1L) |
| Part 2 - Cohort 2: RP2D of BNT324 + BNT327 and RP2D-1 of BNT324 + BNT327 | EXPERIMENTAL | In SCLC, second-line plus (2L+) |
| Part 2 - Cohort 3: RP2D of BNT324 + BNT327 | EXPERIMENTAL | In subpopulation 1 of NSCLC AGA negative, 2L+ |
| Part 2 - Cohort 4: RP2D of BNT324 + BNT327 | EXPERIMENTAL | In subpopulation 2 of NSCLC AGA negative, 1L |
| Part 2 - Cohort 5: RP2D of BNT324 + BNT327 | EXPERIMENTAL | In subpopulation 2 of NSCLC AGA negative, 2L+ |
| Part 2 - Cohort 6: RP2D of BNT324 + BNT327 | EXPERIMENTAL | In NSCLC AGA positive |
| Part 2 - Cohort 7: RP2D of BNT324 + BNT327 | EXPERIMENTAL | In SCLC, 1L |
| 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 |
|---|---|---|
| BNT324 | DRUG | Intravenous infusion |
| Docetaxel | DRUG | Intravenous infusion |
| Prednisone/prednisolone | DRUG | Oral |
| DB-1311/BNT324 | DRUG | Administered I.V. |
| BNT327 | DRUG | Administered I.V. |
| DB-1305/BNT325 | DRUG | Administered I.V. |
| 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 |
Key Inclusion Criteria: * Are male adults (defined as ≥18 years of age or of an acceptable age according to local regulations at the time of giving informed consent). * Must have documented progressive prostate cancer based on at least one of the following criteria: * Serum/plasma PSA progressio...
BNT324 is an investigational oncology therapy being developed by BioNTech SE for advanced solid tumors, including advanced lung cancer and metastatic castration-resistant prostate cancer. It is an antibody-drug conjugate, specifically an anti-B7-H3 antibody conjugated to a topoisomerase I inhibitor. It is in clinical development and has not been approved.
BNT324 targets B7-H3. It is an antibody-drug conjugate in which an anti-B7-H3 antibody is conjugated to a topoisomerase I inhibitor, so the antibody directs the payload toward B7-H3-expressing cells. B7-H3 is the molecular target of the antibody component.
BNT324 is developed by BioNTech SE, which trades under the ticker BNTX. The asset is also known as DB-1311, and the combined designation DB-1311/BNT324 appears in study titles, reflecting the anti-B7-H3 antibody conjugated to a topoisomerase I inhibitor.
BNT324 is in Phase 1 development overall, with a Phase 3 trial also recruiting. The Phase 3 study, NCT07365995, compares BNT324 with docetaxel in metastatic castration-resistant prostate cancer. BNT324 is investigational and is not approved; it remains in clinical development across its programs.
BNT324 is being studied in four recruiting trials: NCT07365995, a Phase 3 trial versus docetaxel in metastatic castration-resistant prostate cancer; NCT06953089, a Phase 2 combination study in advanced solid tumors; NCT06892548, a Phase 1 combination with BNT327 in advanced lung cancer; and NCT05914116, a Phase 1/2a study in advanced solid tumors.
Yes. BNT324 is also known as DB-1311, and the two names are combined as DB-1311/BNT324 in some study titles. It is described as an anti-B7-H3 antibody conjugated to a topoisomerase I inhibitor. Searches for DB-1311 refer to the same investigational asset developed by BioNTech SE.