Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid Tumors

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 A - Occurrence of DLTs

  Measured over: Up to 28 days after initiating BNT317 administration on Day 1 of Cycle 1 or the day before Cycle 3 Day 1, whichever comes earlier (each cycle is 14 days)

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

  Measured over: From the first dose of BNT317 up to 100 days after last dose of IMP or until a new anticancer therapy is initiated

• All parts - Occurrence of dose interruption, reductions, and discontinuation of BNT317 due to TEAEs

  Measured over: From the first dose of BNT317 up to 100 days after last dose of IMP or until a new anticancer therapy is initiated

• Parts B1, B2 & B3: Objective Response Rate (ORR)

  Measured over: From the first dose of BNT317 up to 100 days after last dose of IMP or until a new anticancer therapy is initiated

Changes Tremor has spotted