A Clinical Study to Test if an Investigational Treatment Called BNT314 When Used in Combination With Another Investigational Treatment Pumitamig (BNT327) and Chemotherapy, is Beneficial and Safe for Patients With Advanced Colorectal 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.”

• Phase I - Part A: Occurrence of dose limiting toxicities (DLTs) during the DLT observation period

  Measured over: Up to 28 days after Day 1, Cycle 1

• Phase I - Part A: Occurrence of treatment emergent adverse events (TEAEs) and treatment related adverse events (TRAEs)

  Measured over: From initiation of the first dose of BNT314 + pumitamig until 90 days after last dose of investigational medicinal product (IMP)

• Phase I - Part A: Occurrence of dose interruption or discontinuation of study treatment due to TEAEs

  Measured over: From initiation of the first dose of BNT314 + pumitamig until 90 days after last dose of IMP

• Phase I - Part B: Occurrence DLTs during the DLT observation period for the first five participants in each dose cohort

  Measured over: Up to 42 days after Day 1, Cycle 1

• Phase I - Part B: Occurrence of TEAEs and TRAEs

  Measured over: From initiation of the first dose of BNT314 + pumitamig + SoC chemotherapy until 90 days after last dose of IMP

• Phase I - Part B: Occurrence of dose interruption or discontinuation of study treatment due to TEAEs

  Measured over: From initiation of the first dose of BNT314 + pumitamig + SoC chemotherapy until 90 days after last dose of IMP

• Phase I - Part B: Objective response rate (ORR)

  Measured over: From the time of initiation of the first dose of IMP to end of study, up to 57 months

• Phase II - Part C: Progression free survival

  Measured over: From the time of initiation of the first dose of IMP to end of study, up to 57 months

Changes Tremor has spotted