Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreaK 101)

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031210121

Enrollment

1200

Registered

2021-05-28

Start date

2019-12-17

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

None listed

Interventions

- Experimental: Sotorasib + panitumumab +/- chemotherapy Experimental: Sotorasib + panitumumab +/- chemotherapy Dose Exploration and Dose Expansion - Enrollment into the dose exploration cohort is

Eligibility

Sex/Gender

All

Inclusion 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 performed according to in-country requirements. In the United States, this test must be performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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 in ECG Measurements [Time Frame: 12 Months] 6. Number of Participants with Clinically Significant Changes in Laboratory Test Values [Time Frame: 12 Months]	—

Measure

Time frame

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 in ECG Measurements [Time Frame: 12 Months] 6. Number of Participants with Clinically Significant Changes in Laboratory Test Values [Time Frame: 12 Months]

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Secondary

Measure	Time frame
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. Objective Response Rate [Time Frame: 12 Months] 5. Disease Control Rate [Time Frame: 12 Months] 6. Duration of Response [Time Frame: 12 Months] 7. Progression-free Survival [Time Frame: 12 Months] 8. Duration of Stable Disease [Time Frame: 12 Months] 9. Time to Response [Time Frame: 12 Months] 10. Overall Survival [Time Frame: 12 Months] 11. Sotorasib + EGFR Inhibitor +/- Chemotherapeutic Regimen Only: Quantification of Plasma Levels [Time Frame: 12 Months]	—

Measure

Time frame

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. Objective Response Rate [Time Frame: 12 Months] 5. Disease Control Rate [Time Frame: 12 Months] 6. Duration of Response [Time Frame: 12 Months] 7. Progression-free Survival [Time Frame: 12 Months] 8. Duration of Stable Disease [Time Frame: 12 Months] 9. Time to Response [Time Frame: 12 Months] 10. Overall Survival [Time Frame: 12 Months] 11. Sotorasib + EGFR Inhibitor +/- Chemotherapeutic Regimen Only: Quantification of Plasma Levels [Time Frame: 12 Months]

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Countries

Australia, Austria, Belgium, Canada, Germany, Italy, Japan, Netherlands, South Korea, Spain, Taiwan, United Kingdom, United States

Contacts

Public ContactLocal Contact

Amgen K.K.

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

Outcome results