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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06827236 | A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer | PHASE1 | RECRUITING | 380 | — | — | Apr 23, 2025 | May 1, 2029 | May 15, 2026 | 41 | United States, Canada +7 |
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...