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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06449222 | Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy | PHASE2 | ACTIVE NOT_RECRUITING | 83 | — | — | Aug 26, 2024 | Jun 1, 2029 | Feb 25, 2026 | 31 | United States, Australia +2 |
In the combination treatment regimen according to the (US) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5.0 (CTCAE version 5.0). By treatment arm and overall.
By treatment arm and overall.
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 \[RECIST 1.1\] based on the investigator's assessment) is observed as best overall response. By treatment arm.
Based on the investigator's tumor assessment according to RECIST 1.1. Defined as the change from baseline in percent to the minimal tumor size until tumor progression/recurrence or death (whichever occurs first). By treatment arm.
Defined as ≥10% decrease in the pretreatment sum of diameters at first post-treatment tumor scan in target lesions. By treatment arm.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 Arm 1 - BNT327 DL1 + Nab-paclitaxel | EXPERIMENTAL | - |
| Cohort 1 Arm 2 - BNT327 DL2 + Nab-paclitaxel | EXPERIMENTAL | - |
| Cohort 2 Arm 1 - BNT327 Optimized dose + Paclitaxel | EXPERIMENTAL | - |
| Cohort 2 Arm 2 - BNT327 Equivalent Q3W dose + Gemcitabine + Carboplatin | EXPERIMENTAL | - |
| Cohort 2 Arm 3 - BNT327 Equivalent Q3W dose + Eribulin | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| BNT327 Dose Level 1 (DL1) | DRUG | Intravenous (IV) infusion |
| BNT327 Dose Level 1 (DL2) | DRUG | IV infusion |
| Nab-placlitaxel | DRUG | IV infusion |
| Carboplatin | DRUG | IV infusion |
| Gemcitabine | DRUG | IV infusion |
| Paclitaxel | DRUG | IV infusion |
| Eribulin | DRUG | IV infusion |
| BNT327 Optimized Dose | DRUG | IV infusion |
| BNT327 Equivalent Q3W Dose | DRUG | IV infusion |
Inclusion Criteria: * Have given informed consent by signing and dating an informed consent form before initiation of any study-specific procedures. * Male or female, aged ≥18 years at the time of giving informed consent. * Are willing and able to comply with scheduled visits, the treatment schedul...