Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BNT323 · 1 trial · 3 indications
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.
| Arm | Type | Description |
|---|---|---|
| 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 | - |
| Name | Type | Description |
|---|---|---|
| BNT323 | DRUG | Intravenous infusion |
| BNT327 | DRUG | Intravenous infusion |
Key Inclusion Criteria (applicable to all participants and all parts unless otherwise specified): * Have pathologically documented BC that: * Is locally advanced, unresectable or metastatic. * Has a confirmed HER2 status as determined by the local laboratory as standard of care testing prior t...
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.