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Phase I-II

A Phase 1b, Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 510 (pINN) Sotorasib Monotherapy and in Combination With Other Anti-cancer Therapies in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

  • Study HIC#:2000026544
  • Last Updated:11/14/2023

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

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    For more information about this study, including how to volunteer, contact:

    Jennifer Pope

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    Trial Purpose and Description

    Primary Outcome Measures  :

    1. Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: 12 months ]
    2. Number of Participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: 12 months ]
    3. Number of Participants with Treatment-related Adverse Events [ Time Frame: 12 months ]
    4. Number of Participants with Clinically Significant Changes in Vital Signs. [ Time Frame: 12 months ]
    5. Number of Participants with Clinically Significant Changes of ECG Measurement [ Time Frame: 12 months ]
    6. Number of Participants with Clinically Significant Laboratory Values [ Time Frame: 12 months ]

    Secondary Outcome Measures  :

    1. Maximum Plasma Concentration (Cmax) [ Time Frame: 12 months ]
    2. Time to Maximum Plasma Concentration (Tmax) [ Time Frame: 12 months ]
    3. Area Under the Plasma Concentration-time Curve (AUC) [ Time Frame: 12 months ]
    4. Disease Control Rate [ Time Frame: 12 months ]
    5. Duration of Response [ Time Frame: 12 Months ]
    6. Progression-free Survival [ Time Frame: 12 months ]
    7. Duration of Stable Disease [ Time Frame: 12 Months ]
    8. Objective Response Rate [ Time Frame: 12 months ]
    9. Time to Response [ Time Frame: 12 Months ]
    10. Overall Survival [ Time Frame: 12 Months ]

    Eligibility Criteria

    Inclusion Criteria:

    • Men or women greater than or equal to 18 years old.
    • Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing.

    Exclusion Criteria:

    • Primary brain tumor.
    • Spinal cord compression, or untreated, or symptomatic, or active brain metastases, or leptomeningeal disease from non-brain tumors.
    • Myocardial infarction within 6 months of study day 1.
    • Gastrointestinal (GI) tract disease causing the inability to take oral medication.