Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05914116 | A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors | PHASE1 | RECRUITING | 862 | — | — | Aug 17, 2023 | May 1, 2028 | Nov 21, 2025 | 107 | United States, Australia +2 |
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, V503, GARDASIL |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| AstraZeneca PLC | AZN | 1 | — | Trastuzumab deruxtecan |