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Phase I

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:07/15/2021

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

  • Start Date07/31/2020
  • End Date12/15/2021
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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.
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Principal Investigator

Sub-Investigators

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