Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as trastuzumab pamirtecan, DB-1303
BNT323 · 5 trials · 6 indications
By treatment arm. Defined as the time from randomization to the first objective tumor progression (per RECIST v1.1) or death from any cause, whichever occurs first.
Defined as the proportion of participants with a CR or PR (per RECIST v1.1) as best overall response with confirmation.
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
By dose level.
In Part 1 by dose level. In Part 2 by cohort and arm.
In Part 1 by dose level. In Part 2 by cohort and arm.
ORR defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) (per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\] based on the investigator's assessment) is observed as best overall response. By cohort and arm.
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 |
|---|---|---|
| Cohort 1 (HER2 IHC score 1+ or 2+): BNT323/DB-1303 | EXPERIMENTAL | - |
| Cohort 1 - Doxorubicin or paclitaxel (or docetaxel) | ACTIVE_COMPARATOR | Single agent chemotherapy (either doxorubicin or paclitaxel) per investigator's choice. Participants with contraindications to paclitaxel may receive docetaxel as an alternative (if available at the site). |
| Cohort 2 (HER2 IHC score 3+) - BNT323/DB-1303 | EXPERIMENTAL | - |
| 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. |
| Part1 - BNT323 + BNT327 combination therapy | EXPERIMENTAL | Escalating dose levels (DLs) of BNT323 and BNT327 to define RP2D. Six DLs are planned, i.e., DL0-1, DL1-1, DL2-1, DL0-0, DL1-0, DL2-0, a combination of three different DLs for BNT323 (DL0, DL1, and DL2) and two DLs for BNT327 (DL0 and DL1). |
| Part 2 Cohort 1 - Arm 1 - RP2D of BNT323 + BNT327 | EXPERIMENTAL | - |
| Part 2 Cohort 1 - Arm 2 - BNT323 + BNT327 | EXPERIMENTAL | - |
| Part 2 Cohort 1 - Arm 3 - BNT323 monotherapy | EXPERIMENTAL | BNT323 monotherapy at a fixed dose |
| Part 2 Cohort 1 - Arm 4 - BNT327 monotherapy | EXPERIMENTAL | BNT327 monotherapy at a fixed dose |
| Part 2 Cohort 2 - RP2D of BNT323 + BNT327 | EXPERIMENTAL | - |
| Part 2 Cohort 3 - RP2D of BNT323 + BNT327 | EXPERIMENTAL | - |
| Part 2 Cohort 4 - RP2D of BNT323 + BNT327 | EXPERIMENTAL | - |
| 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 |
|---|---|---|
| BNT323/DB-1303 | DRUG | intravenous (IV) infusion |
| Doxorubicin | DRUG | IV bolus or infusion |
| Paclitaxel | DRUG | IV infusion |
| Docetaxel | DRUG | IV infusion |
| DB-1303/BNT323 | DRUG | Administered I.V. |
| T-DM1 | DRUG | Administered I.V. |
| Capecitabine | DRUG | Oral |
| Nab-paclitaxel | DRUG | IV |
| BNT323 | DRUG | Intravenous infusion |
| BNT327 | DRUG | Intravenous infusion |
| Pertuzumab Injection | DRUG | Administered IV |
| Ritonavir | DRUG | Administered oral |
| Itraconazole | DRUG | Administered oral |
Key Inclusion Criteria: * Are female adults (defined as ≥18 years of age or acceptable age according to local regulations at the time of voluntarily giving informed consent). * Have histologically confirmed endometrial cancer that: * Is recurrent, * Has a HER2 IHC score of 1+, 2+ (Cohort 1), o...
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BNT323 is an investigational HER2-targeted small molecule developed by BioNTech SE for HER2-expressing cancers. It is being studied in endometrial cancer, HER2-positive advanced solid tumors, HER2-positive breast cancer, and locally advanced or metastatic breast cancer. BNT323 holds FDA Breakthrough Therapy and Fast Track designations and is in Phase 3 development.
BNT323 targets HER2, a protein receptor found on the surface of certain cancer cells. By binding HER2, the small molecule is designed to act on tumors that express this target. The clinical program selects patients based on HER2 biomarker status, including HER2-positive and HER2-low breast cancer populations.
BNT323 is developed by BioNTech SE, which trades on Nasdaq under the ticker BNTX. BioNTech is running the Phase 3 program for BNT323 across endometrial cancer and breast cancer indications, including a study comparing BNT323 with T-DM1 in HER2-positive breast cancer.
BNT323 is in Phase 3 clinical development. It is investigational and is being evaluated in randomized, active-controlled trials, including a Phase 3 study in recurrent endometrial cancer and Phase 3 studies in HER2-positive and HER2-low metastatic breast cancer. It also holds FDA Breakthrough Therapy and Fast Track designations.
BNT323 is being studied in several trials, including NCT06340568, a Phase 3 study in recurring uterine cancer, and NCT06265428, a Phase 3 comparison with T-DM1 in HER2-positive breast cancer. Other studies include NCT06018337 (DYNASTY-Breast02) in HER2-low metastatic breast cancer and NCT06827236, a Phase 1 combination study with BNT327 in advanced breast cancer.
Yes, BNT323 is also known as DB-1303, and the asset appears in trial listings as DB-1303/BNT323 or BNT323/DB-1303. BioNTech SE develops it under the BNT323 name, while the DB-1303 designation is used in several study titles, so readers searching either name are looking at the same investigational HER2-targeted therapy.