Sotorasib Activity in Subjects With Advanced Solid Tumours With KRAS p.G12C Mutation (CodeBreak 101)

Official Title

A Phase 1b/2, Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Sotorasib Monotherapy and in Combination With Other Anti-cancer Therapies in Subjects With Advanced Solid Tumours With KRAS p.G12C Mutation (CodeBreak 101)

Summary:

To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumours.

Trial Description

Primary Outcome:

  • Phase 1b: Number of Participants with Dose Limiting Toxicities (DLTs)
  • Phase 1b: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
  • Phase 1b: Number of Participants with Treatment-related Adverse Events
  • Phase 1b: Number of Participants with Clinically Significant Changes in Vital Signs
  • Phase 1b: Number of Participants with Clinically Significant Changes in ECG Measurements
  • Phase 1b: Number of Participants with Clinically Significant Changes in Laboratory Test Values
  • Phase 2: Objective Response Rate
Secondary Outcome:
  • Phase 1b: Maximum Plasma Concentration (Cmax)
  • Phase 1b: Time to Maximum Plasma Concentration (Tmax)
  • Phase 1b: Area Under the Plasma Concentration-time Curve (AUC)
  • Phase 1b: Objective Response Rate
  • Phase 1b: Disease Control Rate
  • Phase 1b: Duration of Response
  • Phase 1b: Progression-free Survival
  • Phase 1b: Duration of Stable Disease
  • Phase 1b: Time to Response
  • Phase 1b: Overall Survival
  • Phase 1b: Sotorasib + EGFR Inhibitor +/- Chemotherapeutic Regimen Only: Quantification of Plasma Levels
  • Phase 1b: Sotorasib Monotherapy Only: Intracranial Objective Response Rate
  • Phase 1b: Sotorasib Monotherapy Only: Intracranial Disease Control Rate
  • Phase 1b: Sotorasib Monotherapy Only: Intracranial Duration of Response
  • Phase 1b: Sotorasib Monotherapy Only: Time to Intracranial Radiation Therapy
  • Phase 1b: Sotorasib Monotherapy Only: Intracranial Progression-free Survival (PFS)
  • Phase 1b: Sotorasib Monotherapy Only: Non-intracranial Progression-free Survival (PFS)
  • Phase 1b: Sotorasib Monotherapy Only: Overall Progression-free Survival (PFS)
  • Phase 1b: Sotorasib + TNO155 Only: Best Overall Response
  • Phase 2: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
  • Phase 2: Number of Participants with Grade ≥3 Treatment-emergent Adverse Events (TEAEs)
  • Phase 2: Maximum Plasma Concentration (Cmax)
  • Phase 2: Time to Maximum Plasma Concentration (Tmax)
  • Phase 2: Area Under the Plasma Concentration-time Curve (AUC)
  • Phase 2: Disease Control Rate
  • Phase 2: Duration of Response
  • Phase 2: Progression-free Survival
  • Phase 2: Time to Response
  • Phase 2: Overall Survival
  • Phase 1b: Sotorasib + Afatinib + Loperamide Only: Number of Participants with Dose Limiting Toxicities (DLTs)
  • Phase 1b: Sotorasib + Afatinib + Loperamide Only: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
  • Phase 1b: Sotorasib + Afatinib + Loperamide Only: Number of Participants with Treatment-related Adverse Events
  • Phase 1b: Sotorasib + Afatinib + Loperamide Only: Number of Participants with Clinically Significant Changes in Vital Signs
  • Phase 1b: Sotorasib + Afatinib + Loperamide Only: Number of Participants with Clinically Significant Changes in ECG Measurements
  • Phase 1b: Sotorasib + Afatinib + Loperamide Only: Number of Participants with Clinically Significant Changes in Laboratory Test Values

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society