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

No strong warning signs right now. The score counts warning signs; it is not a prediction.

Why this score

Score over time

What counts as success

The trial's main goal(s), called the “primary outcome.”

• Part 1 - Occurrence of dose limiting toxicities (DLTs)

  Measured over: During the DLT evaluation period (Cycle 1), i.e., the time of initiation of the first dose of investigational medicinal product (IMP) up to 21 days

• Occurrence of Treatment-emergent adverse events (TEAEs), Grade ≥3 TEAEs, serious adverse events (SAEs), treatment-related TEAEs, treatment-related Grade ≥3 TEAEs, and treatment-related SAEs

  Measured over: From the time of initiation of the first dose of IMP to 90 days after the last IMP dose

• Occurrence of dose interruption, reduction, and discontinuation due to TEAEs

  Measured over: From the time of initiation of the first dose of IMP to 90 days after the last IMP dose

• Part 2 - Objective response rate (ORR)

  Measured over: From the time of initiation of the first dose of IMP to last tumor assessment scan, i.e., up to 36 months.

Changes Tremor has spotted