Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BNT327 Dose Level 1 · 2 trials · 5 indications
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.
In the combination treatment regimen according to the (US) National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0). 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.
| 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 | - |
| Cohort 1 Arm 1 - BNT327 DL1 + carboplatin + etoposide | EXPERIMENTAL | Participants with ES-SCLC without prior systemic anticancer therapy received in the ES setting |
| Cohort 1 Arm 2 - BNT327 DL2 + carboplatin + etoposide | EXPERIMENTAL | Participants with ES-SCLC without prior systemic anticancer therapy received in the ES setting |
| Cohort 2 Arm 1 - BNT327 DL1 + paclitaxel | EXPERIMENTAL | Participants with SCLC who have disease progression/relapse |
| Cohort 2 Arm 2 - BNT327 DL2 + paclitaxel | EXPERIMENTAL | Participants with SCLC who have disease progression/relapse |
| Cohort 3 Arm 1 - BNT327 DL1 + topotecan | EXPERIMENTAL | Participants with SCLC who have disease progression/relapse |
| Cohort 3 Arm 2 - BNT327 DL2 + topotecan | EXPERIMENTAL | Participants with SCLC who have disease progression/relapse |
| 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 |
| BNT327 Dose Level 2 (DL2) | DRUG | IV infusion |
| Etoposide | DRUG | IV infusion |
| Topotecan | DRUG | IV infusion or oral capsules |
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...
BNT327 Dose Level 1 is an investigational small molecule being studied for extensive-stage small-cell lung cancer and locally advanced breast cancer, including triple negative breast cancer. It is in Phase 2 clinical development and is not yet approved by regulatory authorities.
BNT327 Dose Level 1 is being developed by BioNTech SE, a biotechnology company traded on NASDAQ under the ticker BNTX. The company is conducting Phase 2 clinical trials to evaluate the drug's safety and preliminary effectiveness in oncology indications.
BNT327 Dose Level 1 is in Phase 2 clinical development. It is an investigational therapy, meaning it has not been approved by the FDA or other regulatory agencies. The drug is being studied in active but not recruiting clinical trials for lung and breast cancers.
BNT327 Dose Level 1 is being evaluated in two Phase 2 trials. NCT06449209 studies the drug with chemotherapy in extensive-stage small-cell lung cancer with 110 participants. NCT06449222 studies it with chemotherapy in locally advanced and metastatic triple negative breast cancer with 83 participants.
BNT327 Dose Level 1 is a specific dose level of the investigational drug BNT327. The clinical trials listed under NCT06449209 and NCT06449222 evaluate BNT327 at this dose level in combination with chemotherapy for lung and breast cancer indications.