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)

A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Sotorasib (AMG 510) Monotherapy in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation and Sotorasib (AMG 510) Combination Therapy in Subjects With Advanced NSCLC With KRAS p.G12C Mutation (CodeBreaK 100)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224746

Enrollment

793

Registered

2019-06-25

Start date

2018-08-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

KRAS p.G12C Mutant Advanced Solid Tumors

Interventions

- Phase 1 Dose Exploration Part 1monotherapy Cohorts with food effect and alternative dosing regimens Enrollment into the dose exploration cohorts may be from any eligible solid tumor type. Dose esca

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Men or women greater than or equal to 18 years old. 2. Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing.

Exclusion criteria

Exclusion criteria: 1. Active brain metastases from non-brain tumors. 2. Myocardial infarction within 6 months of study day 1. 3. Gastrointestinal (GI) tract disease causing the inability to take oral medication.

Design outcomes

Primary

Measure	Time frame
safety efficacy 1. Number of subjects with treatment-emergent adverse events [Time Frame: 24 Months] 2. Number of subjects with treatment-related adverse events [Time Frame: 24 Months] 3. Number of subjects with grade >=3 treatment-emergent adverse events [Time Frame: 24 Months] 4. Number of subjects with serious adverse events [Time Frame: 24 Months] 5. Number of subjects with adverse events of interest [Time Frame: 24 Months] 6. Number of subjects with clinically significant changes in vital signs [Time Frame: Baseline to 24 Months] 7. Number of subjects with clinically significant changes in physical examination results [Time Frame: Baseline to 24 Months] 8. Number of subjects with clinically significant changes on electrocardiograms (ECGs) [Time Frame: Baseline to 24 Months] 9. Number of subjects with clinically significant changes in clinical laboratory values [Time Frame: Baseline to 24 Months] 10. Number of subjects with dose-limiting toxicities (DLTs) [Time Frame: 21 Days] 11. Objective response rate (ORR) as assessed by RECIST 1.1 criteria [Time Frame: 24 Months] 12. Duration of response (DOR) as assessed by RECIST 1.1 criteria [Time Frame: 24 Months] 13. Disease control as assessed by RECIST 1.1 criteria [Time Frame: 24 Months] 14. Duration of stable disease (SD) as assessed by RECIST 1.1 criteria [Time Frame: 24 Months] 15. Time to response (TTR) as assessed by RECIST 1.1 criteria [Time Frame: 24 Months]	—

Measure

Time frame

safety efficacy 1. Number of subjects with treatment-emergent adverse events [Time Frame: 24 Months] 2. Number of subjects with treatment-related adverse events [Time Frame: 24 Months] 3. Number of subjects with grade >=3 treatment-emergent adverse events [Time Frame: 24 Months] 4. Number of subjects with serious adverse events [Time Frame: 24 Months] 5. Number of subjects with adverse events of interest [Time Frame: 24 Months] 6. Number of subjects with clinically significant changes in vital signs [Time Frame: Baseline to 24 Months] 7. Number of subjects with clinically significant changes in physical examination results [Time Frame: Baseline to 24 Months] 8. Number of subjects with clinically significant changes on electrocardiograms (ECGs) [Time Frame: Baseline to 24 Months] 9. Number of subjects with clinically significant changes in clinical laboratory values [Time Frame: Baseline to 24 Months] 10. Number of subjects with dose-limiting toxicities (DLTs) [Time Frame: 21 Days] 11. Objective response rate (ORR) as assessed by RECIST 1.1 criteria [Time Frame: 24 Months] 12. Duration of response (DOR) as assessed by RECIST 1.1 criteria [Time Frame: 24 Months] 13. Disease control as assessed by RECIST 1.1 criteria [Time Frame: 24 Months] 14. Duration of stable disease (SD) as assessed by RECIST 1.1 criteria [Time Frame: 24 Months] 15. Time to response (TTR) as assessed by RECIST 1.1 criteria [Time Frame: 24 Months]

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Secondary

Measure	Time frame
efficacy pharmacokinetics 1. Plasma concentration (Cmax) of Sotorasib [Time Frame:: 15 Weeks] 2. Plasma concentration (Cmax) of midazolam [Time Frame:: 16 Days] 3. Time to achieve Cmax (Tmax) of Sotorasib [Time Frame:: 15 Weeks] 4. Area under the plasma concentration-time curve (AUC) of Sotorasib [Time Frame:: 15 Weeks] 5. Area under the plasma concentration-time curve (AUC) of midazolam [Time Frame:: 16 Days] 6. Clearance of midazolam from the plasma [Time Frame:: 16 Days] 7. Terminal half-life (t1/2) of midazolam [Time Frame:: 16 Days] 8. Objective response rate (ORR) as assessed by RECIST 1.1 criteria [Time Frame:: 24 Months ] 9. Duration of response (DOR) as assessed by RECIST 1.1 criteria [Time Frame:: 24 Months ] 10. Disease control as assessed by RECIST 1.1 criteria [Time Frame:: 24 Months ] 11. Progression-free survival (PFS) as assessed by RECIST 1.1 criteria [Time Frame:: 24 Months] 12. Duration of stable disease (SD) as assessed by RECIST 1.1 criteria [Time Frame:: 24 Months] 13. Depth of response (best percentage change from baseline in lesion sum diameters) as assessed by RECIST 1.1 criteria [Time Frame:: Baseline to 24 Months] 14. Time to response (TTR) as assessed by RECIST 1.1 criteria [Time Frame:: 24 Months] 15. Overall survival (OS) [Time Frame:: 24 Months] 16. Sotorasib exposure and QTc interval relationship [Time Frame:: 24 Months] 17. Progression-free survival (PFS) at 6 months [Time Frame:: 6 Months] 18. Progression-free survival (PFS) at 12 months [Time Frame:: 12 Months] 19. Overall survival (OS) at 12 months [Time Frame:: 12 Months] 20. Number of subjects with treatment-emergent adverse events [Time Frame:: 24 Months] 21. Number of subjects with grade >=3 treatment-emergent adverse events [Time Frame:: 24 Months] 22. Impact of treatment on disease-related symptoms and health related quality of life (HRQOL) as assessed by EORTC QLQ-C30 [Time Frame:: 24 Months] 23. Impact of treatment on disease-related symptoms and HRQOL as assessed by disea	—

Measure

Time frame

efficacy pharmacokinetics 1. Plasma concentration (Cmax) of Sotorasib [Time Frame:: 15 Weeks] 2. Plasma concentration (Cmax) of midazolam [Time Frame:: 16 Days] 3. Time to achieve Cmax (Tmax) of Sotorasib [Time Frame:: 15 Weeks] 4. Area under the plasma concentration-time curve (AUC) of Sotorasib [Time Frame:: 15 Weeks] 5. Area under the plasma concentration-time curve (AUC) of midazolam [Time Frame:: 16 Days] 6. Clearance of midazolam from the plasma [Time Frame:: 16 Days] 7. Terminal half-life (t1/2) of midazolam [Time Frame:: 16 Days] 8. Objective response rate (ORR) as assessed by RECIST 1.1 criteria [Time Frame:: 24 Months ] 9. Duration of response (DOR) as assessed by RECIST 1.1 criteria [Time Frame:: 24 Months ] 10. Disease control as assessed by RECIST 1.1 criteria [Time Frame:: 24 Months ] 11. Progression-free survival (PFS) as assessed by RECIST 1.1 criteria [Time Frame:: 24 Months] 12. Duration of stable disease (SD) as assessed by RECIST 1.1 criteria [Time Frame:: 24 Months] 13. Depth of response (best percentage change from baseline in lesion sum diameters) as assessed by RECIST 1.1 criteria [Time Frame:: Baseline to 24 Months] 14. Time to response (TTR) as assessed by RECIST 1.1 criteria [Time Frame:: 24 Months] 15. Overall survival (OS) [Time Frame:: 24 Months] 16. Sotorasib exposure and QTc interval relationship [Time Frame:: 24 Months] 17. Progression-free survival (PFS) at 6 months [Time Frame:: 6 Months] 18. Progression-free survival (PFS) at 12 months [Time Frame:: 12 Months] 19. Overall survival (OS) at 12 months [Time Frame:: 12 Months] 20. Number of subjects with treatment-emergent adverse events [Time Frame:: 24 Months] 21. Number of subjects with grade >=3 treatment-emergent adverse events [Time Frame:: 24 Months] 22. Impact of treatment on disease-related symptoms and health related quality of life (HRQOL) as assessed by EORTC QLQ-C30 [Time Frame:: 24 Months] 23. Impact of treatment on disease-related symptoms and HRQOL as assessed by disea

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Countries

Australia, Austria, Belgium, Brazil, Canada, France, Germany, Greece, Hungary, Korea, Portugal, Romania, Spain, Switzerland, United States

Contacts

Public ContactContact Local

Amgen K.K

clinicaltrials_japan@amgen.com+81-80-7217-8592

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026