Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DB-1303/BNT323 · 3 trials · 3 indications
Defined as the time from randomization to the first documented disease progression per RECIST 1.1 as assessed by BICR or death due to any cause, whichever occurs first
PFS by BICR according to RECIST 1.1 in the HR+, HER2-low population
Percentage of participants in Part 1 with DLTs
Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) or Treatment Emergent Adverse Event of Special Interest include those \>/= G3 leading to dose reduction, interruption or discontinuation as assessed by CTCAE v5.0, abnormal vital signs, abnormal 12-lead ECGs, abnormal safety laboratory tests, abnormal ECOG PS, abnormal ECHO/MUGA (LVEF).
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-1303 based on the data collected during Part 1
Phase 2: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) or Treatment Emergent Adverse Event of Special Interest include those \>/= G3 leading to dose reduction, interruption or discontinuation as assessed by CTCAE v5.0, abnormal vital signs, abnormal 12-lead ECGs, abnormal safety laboratory tests, abnormal ECOG PS, abnormal ECHO/MUGA (LVEF).
Percentage of participants with SAEs in Part 2 graded according to NCI CTCAE v5.0
The percentage of subjects who had a best response of CR or PR, for Part 2 only which was maintained ≥4 weeks.
Maximum observed plasms concentration (Cmax) and Area under the concentration-time curve from 0 to infinity of DB-1303 and P1003 (+/- Ritonavir)
Maximum observed plasms concentration (Cmax) and Area under the concentration-time curve from 0 to infinity of DB-1303 and P1003 (+/- Itraconazole)
| Arm | Type | Description |
|---|---|---|
| DB-1303/BNT323 | EXPERIMENTAL | Enrolled patients will receive DB-1303/BNT323 by intravenous (I.V.) infusion |
| T-DM1 | EXPERIMENTAL | Enrolled patients will receive T-DM1 by I.V. infusion |
| investigator's choice single agent chemotherapy | ACTIVE_COMPARATOR | Enrolled Subjects will be randomized to receive investigator's choice single agent chemotherapy (capecitabine:1000 or 1250 mg/m2, Oral, Twice daily orally for 2 weeks followed by a 1-week rest period in 3-week cycles; paclitaxel：80 mg/m2， IV, Every week (QW) in 3-week cycles; or nab-paclitaxel: 100 mg/m2, IV, Every week (QW) for 3 weeks followed by a one-week rest period in 4-week cycles) until RECIST 1.1 defined disease progression (PD), unless there is unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation is met. |
| DB-1303/BNT323 Dose Level 1 | EXPERIMENTAL | Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 1 on Day 1 of each cycle Q3W |
| DB-1303/BNT323 Dose Level 2 | EXPERIMENTAL | Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 2 on Day 1 of each cycle Q3W |
| DB-1303/BNT323 Dose Level 3 | EXPERIMENTAL | Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 3 on Day 1 of each cycle Q3W |
| DB-1303/BNT323 Dose Level 4 | EXPERIMENTAL | Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 4 on Day 1 of each cycle Q3W |
| DB-1303/BNT323 Dose Level 5 | EXPERIMENTAL | Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 5 on Day 1 of each cycle Q3W |
| DB-1303/BNT323 Dose Expansion 1 | EXPERIMENTAL | Enrolled Subjects will be randomized to receive a single-dose of DB-1303/BNT323 on a selected dose level 1 or dose level 2 Day 1 of each cycle Q3W |
| DB-1303/BNT323 Dose Expansion 2 | EXPERIMENTAL | Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W |
| DB-1303/BNT323 Dose Expansion 3 | EXPERIMENTAL | Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W |
| DB-1303/BNT323 Dose Expansion 4 | EXPERIMENTAL | Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W |
| DB-1303/BNT323 Dose Expansion 5 | EXPERIMENTAL | Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W |
| DB-1303/BNT323 Dose Level 6 | EXPERIMENTAL | Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 6 on Day 1 of each cycle Q3W |
| DB-1303/BNT323 Dose Level 7 | EXPERIMENTAL | Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 7 on Day 1 of each cycle Q3W |
| DB-1303/BNT323 Dose Expansion 6 | EXPERIMENTAL | Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W |
| DB-1303/BNT323 Dose Expansion 7 | EXPERIMENTAL | Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W |
| DB-1303/BNT323 Dose Expansion 8 | EXPERIMENTAL | Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W |
| DB-1303/BNT323 Dose Expansion 9 | EXPERIMENTAL | Enrolled Subjects will be randomized to receive a single-dose of DB-1303/BNT323 on a selected dose level 1 or dose level 2 on Day 1 of each cycle Q3W |
| DB-1303/BNT323 Dose Expansion 10 | EXPERIMENTAL | Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W along with ritonavir or itraconazole to assess the DDI potential |
| DB-1303/BNT323 Dose Expansion 11 | EXPERIMENTAL | Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W |
| DB-1303/BNT323 Dose Expansion 12 | EXPERIMENTAL | Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level 1 or dose level 2 in combination with Pertuzumab on Day 1 of each cycle Q3W |
| DB-1303/BNT323 Dose Expansion 13 | EXPERIMENTAL | Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W |
| DB-1303/BNT323 Dose Expansion 14 | EXPERIMENTAL | China Only:Subjects who were previously treated with trastuzumab and taxane will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W |
| DB-1303/BNT323 Dose Expansion 15 | EXPERIMENTAL | China Only: Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W |
| DB-1303/BNT323 Dose Expansion 16 | EXPERIMENTAL | Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W |
| DB-1303/BNT323 Dose Expansion 17 | EXPERIMENTAL | Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W |
| Name | Type | Description |
|---|---|---|
| DB-1303/BNT323 | DRUG | Administered I.V. |
| T-DM1 | DRUG | Administered I.V. |
| Capecitabine | DRUG | Oral |
| Paclitaxel | DRUG | IV |
| Nab-paclitaxel | DRUG | IV |
| Pertuzumab Injection | DRUG | Administered IV |
| Ritonavir | DRUG | Administered oral |
| Itraconazole | DRUG | Administered oral |
Inclusion Criteria: * Male or female adults ≥ 18 years at the time of voluntary signing of informed consent. * Pathologically confirmed unresectable or metastatic HER2 positive breast cancer previously treated with trastuzumab and taxane * Eastern Cooperative Oncology Group (ECOG) performance statu...
DB-1303/BNT323 is an investigational monoclonal antibody being developed for HER2-positive advanced solid tumors, HER2-positive breast cancer, and HER2-low, hormone receptor positive metastatic breast cancer. It is currently in clinical trials for these oncology indications.
DB-1303/BNT323 targets HER2, a protein found on the surface of certain cancer cells. By binding to HER2, it is designed to deliver treatment directly to HER2-expressing tumors, which is relevant in HER2-positive and HER2-low cancers.
DB-1303/BNT323 is being developed by BioNTech SE, a biotechnology company traded on the NASDAQ under the ticker BNTX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various cancer indications.
DB-1303/BNT323 is in Phase 1 clinical development, with an ongoing Phase 1/2a study. It has also received Breakthrough Therapy and Fast Track designations from the FDA, indicating its potential to address serious conditions.
DB-1303/BNT323 is being studied in three clinical trials: NCT05150691, a Phase 1/2a study in advanced solid tumors; NCT06018337, a Phase 3 study in metastatic breast cancer; and NCT06265428, a Phase 3 study in HER2-positive breast cancer.
Yes, DB-1303/BNT323 is also known as BNT323. The drug is referred to by both names in clinical trial registrations and scientific literature, and they refer to the same investigational therapy.