Active — Not RecruitingPhase 1

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

United States, Australia, Austria610 participantsStarted 2019-12-17

Plain-language summary

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

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants with Dose Limiting Toxicities (DLTs)

Timeframe: 12 Months

Number of Participants with Treatment-emergent Adverse Events (TEAEs)

Timeframe: 12 Months

Number of Participants with Treatment-related Adverse Events

Timeframe: 12 Months

Number of Participants with Clinically Significant Changes in Vital Signs

Timeframe: 12 Months

Number of Participants with Clinically Significant Changes in ECG Measurements

Timeframe: 12 Months

Number of Participants with Clinically Significant Changes in Laboratory Test Values

Timeframe: 12 Months

Trial details

NCT IDNCT04185883

SponsorAmgen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-17

View on ClinicalTrials.gov More Advanced Solid Tumors trials

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants with Dose Limiting Toxicities (DLTs)

Timeframe: 12 Months

Number of Participants with Treatment-emergent Adverse Events (TEAEs)

Timeframe: 12 Months

Number of Participants with Treatment-related Adverse Events

Timeframe: 12 Months

Number of Participants with Clinically Significant Changes in Vital Signs

Timeframe: 12 Months

Number of Participants with Clinically Significant Changes in ECG Measurements

Timeframe: 12 Months

Number of Participants with Clinically Significant Changes in Laboratory Test Values

Timeframe: 12 Months