A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100)

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.”

• Primary: Number of subjects with treatment-emergent adverse events

  Measured over: 24 Months

• Primary: Number of subjects with treatment-related adverse events

  Measured over: 24 Months

• Primary: Number of subjects with grade ≥3 treatment-emergent adverse events

  Measured over: 24 Months

• Primary: Number of subjects with serious adverse events

  Measured over: 24 Months

• Primary: Number of subjects with adverse events of interest

  Measured over: 24 Months

• Primary: Number of subjects with clinically significant changes in vital signs

  Measured over: Baseline to 24 Months

• Primary: Number of subjects with clinically significant changes in physical examination results

  Measured over: Baseline to 24 Months

• Primary: Number of subjects with clinically significant changes on electrocardiograms (ECGs)

  Measured over: Baseline to 24 Months

• Primary: Number of subjects with clinically significant changes in clinical laboratory values

  Measured over: Baseline to 24 Months

• Primary: Number of subjects with dose-limiting toxicities (DLTs)

  Measured over: 21 Days

• Primary: Objective response rate (ORR) as assessed by RECIST 1.1 criteria

  Measured over: 24 Months

• Primary: Duration of response (DOR) as assessed by RECIST 1.1 criteria

Changes Tremor has spotted