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Also known as BNT323
BNT323/DB-1303 · 1 trial · 1 indication
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.
| 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 | - |
| Name | Type | Description |
|---|---|---|
| BNT323/DB-1303 | DRUG | intravenous (IV) infusion |
| Doxorubicin | DRUG | IV bolus or infusion |
| Paclitaxel | DRUG | IV infusion |
| Docetaxel | DRUG | IV infusion |
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 oncology therapy being studied for endometrial cancer and locally advanced breast cancer. It is also known as BNT323/DB-1303 and is being developed by BioNTech SE (BNTX). The drug is currently in clinical development and has not been approved by the FDA.
BNT323 targets HER2, a protein found on the surface of some cancer cells. By targeting HER2, the drug is designed to interfere with cancer cell growth and survival. This mechanism is being evaluated in clinical trials for HER2-expressing cancers, including endometrial and breast cancers.
BNT323 is being developed by BioNTech SE, a biotechnology company traded on the Nasdaq under the ticker BNTX. BioNTech is conducting clinical trials to evaluate the safety and efficacy of BNT323 in patients with certain types of cancer.
BNT323 is in Phase 1 clinical development, with an active Phase 1 trial recruiting patients. The drug has received Breakthrough Therapy and Fast Track designations from the FDA, reflecting its potential to address serious conditions. It remains investigational and is not yet approved.
BNT323 is being studied in two clinical trials. NCT06340568 is a Phase 3 trial in endometrial cancer with 480 participants, and NCT06827236 is a Phase 1 trial in advanced breast cancer with 380 participants. Both trials are currently recruiting patients.
Yes, BNT323 is also known as BNT323/DB-1303. The drug is referred to by this alternative name in some clinical and research contexts. Both names refer to the same investigational therapy being developed by BioNTech SE.