AMG 510 (pINN) Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)
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ClinicalTrials.gov Identifier: NCT04185883 |
Recruitment Status :
Recruiting
First Posted : December 4, 2019
Last Update Posted : March 1, 2021
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Solid Tumors Kirsten Rat Sarcoma (KRAS) pG12C Mutation | Drug: Sotorasib Drug: PD1 inhibitor Drug: MEK inhibitor Drug: SHP2 allosteric inhibitor Drug: Pan-ErbB tyrosine kinase inhibitor Drug: PD-L1 inhibitor Drug: EGFR inhibitor Drug: Chemotherapeutic regimen Drug: PD-1 inhibitor Drug: mTOR inhibitor Drug: CDK inhibitor | Phase 1 |
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1003 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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) |
Actual Study Start Date : | December 17, 2019 |
Estimated Primary Completion Date : | May 30, 2023 |
Estimated Study Completion Date : | July 4, 2027 |

Arm | Intervention/treatment |
---|---|
Experimental: Sotorasib + MEK inhibitor
Experimental: Sotorasib + MEK inhibitor Dose Exploration and Dose Expansion
|
Drug: Sotorasib
Sotorasib administered orally as a tablet. Drug: MEK inhibitor MEK inhibitor administered orally as a tablet. |
Experimental: Sotorasib + PD1 inhibitor
Experimental: Sotoasib + PD1 inhibitor Dose Exploration and Dose Expansion
|
Drug: Sotorasib
Sotorasib administered orally as a tablet. Drug: PD1 inhibitor PD1 inhibitor administered as an intravenous (IV) infusion. |
Experimental: Sotorasib + SHP2 allosteric inhibitor
Experimental: Sotorasib + SHP2 allosteric inhibitor Dose Exploration and Dose Expansion
|
Drug: Sotorasib
Sotorasib administered orally as a tablet. Drug: SHP2 allosteric inhibitor SHP2 allosteric inhibitor administered orally as a capsule. |
Experimental: Sotorasib + Pan-ErbB tyrosine kinase inhibitor
Experimental:Sotorasib + pan-ErbB tyrosine kinase inhibitor Dose Exploration and Dose Expansion
|
Drug: Sotorasib
Sotorasib administered orally as a tablet. Drug: Pan-ErbB tyrosine kinase inhibitor Pan-ErbB tyrosine kinase inhibitor administered orally as a tablet. |
Experimental: Sotorasib + PD-L1 inhibitor
Experimental: Sotorasib + PD-L1 inhibitor Dose Exploration and Dose Expansion
|
Drug: Sotorasib
Sotorasib administered orally as a tablet. Drug: PD-L1 inhibitor PD-L1 inhibitor administered as an intravenous (IV) infusion. |
Experimental: Sotorasib + EGFR inhibitor +/- Chemotherapeutic regimen
Experimental: Sotorasib + EGFR inhibitor +/- Chemotherapeutic regimen Dose Exploration and Dose Expansion
|
Drug: Sotorasib
Sotorasib administered orally as a tablet. Drug: EGFR inhibitor EGFR inhibitor administered as an intravenous (IV) infusion. Drug: Chemotherapeutic regimen Chemotherapeutic regimen administered as an intravenous (IV) infusion. |
Experimental: Sotorasib + PD-1 inhibitor
Sotorasib + PD-1 inhibitor Dose Exploration and Dose Expansion
|
Drug: Sotorasib
Sotorasib administered orally as a tablet. Drug: PD-1 inhibitor PD-1 inhibitor administered as an intravenous (IV) injection. |
Experimental: Sotorasib + Chemotherapeutic regimen
Experimental: Sotorasib + Chemotherapeutic regimen Dose Exploration and Dose Expansion
|
Drug: Sotorasib
Sotorasib administered orally as a tablet. Drug: Chemotherapeutic regimen Chemotherapeutic regimen administered as an intravenous (IV) infusion. |
Experimental: Sotorasib Monotherapy
Experimental: Sotorasib only Dose Exploration and Dose Expansion
|
Drug: Sotorasib
Sotorasib administered orally as a tablet. |
Experimental: Sotorasib + CDK inhibitor
Experimental: Sotorasib + CDK inhibitor Dose Exploration and Dose Expansion
|
Drug: Sotorasib
Sotorasib administered orally as a tablet. Drug: CDK inhibitor CDK inhibitor administered orally as a tablet. |
Experimental: Sotorasib + mTOR inhibitor
Experimental: Sotorasib + mTOR inhibitor Dose Exploration and Dose Expansion
|
Drug: Sotorasib
Sotorasib administered orally as a tablet. Drug: mTOR inhibitor mTOR inhibitor administered orally. |
Experimental: Sotorasib + MEK inhibitor + EGFR inhibitor
Experimental: Sotorasib + MEK inhibitor + EGFR inhibitor Dose Exploration and Dose Expansion
|
Drug: Sotorasib
Sotorasib administered orally as a tablet. Drug: MEK inhibitor MEK inhibitor administered orally as a tablet. Drug: EGFR inhibitor EGFR inhibitor administered as an intravenous (IV) infusion. |
- Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: 12 months ]
- Number of Participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: 12 months ]
- Number of Participants with Treatment-related Adverse Events [ Time Frame: 12 months ]
- Number of Participants with Clinically Significant Changes in Vital Signs. [ Time Frame: 12 months ]
- Number of Participants with Clinically Significant Changes in ECG Measurement [ Time Frame: 12 months ]
- Number of participants with clinically significant changes in laboratory test values [ Time Frame: 12 months ]
- Maximum Plasma Concentration (Cmax) [ Time Frame: 12 months ]
- Time to Maximum Plasma Concentration (Tmax) [ Time Frame: 12 months ]
- Area Under the Plasma Concentration-time Curve (AUC) [ Time Frame: 12 months ]
- Disease Control Rate [ Time Frame: 12 months ]
- Duration of Response [ Time Frame: 12 Months ]
- Progression-free Survival [ Time Frame: 12 months ]
- Duration of Stable Disease [ Time Frame: 12 Months ]
- Objective Response Rate [ Time Frame: 12 months ]
- Time to Response [ Time Frame: 12 Months ]
- Overall Survival [ Time Frame: 12 Months ]
- Sotorasib Monotherapy Only: Intracranial Objective Response Rate [ Time Frame: 12 Months ]Intracranial objective response rate assessed per Response Assessment in Neuro-oncology Brain Metastases (RANO-BM).
- Sotorasib Monotherapy Only: Intracranial Disease Control Rate [ Time Frame: 12 Months ]Intracranial disease control rate assessed per Response Assessment in Neuro-oncology Brain Metastases (RANO-BM).
- Sotorasib Monotherapy Only: Intracranial Duration of Response [ Time Frame: 12 Months ]Intracranial duration of response assessed per Response Assessment in Neuro-oncology Brain Metastases (RANO-BM).
- Sotorasib Monotherapy Only: Time to Intracranial Radiation Therapy [ Time Frame: 12 Months ]
- Sotorasib Monotherapy Only: Central Nervous System Progression-free Survival [ Time Frame: 12 Months ]
- Sotorasib Monotherapy Only: Non-Central Nervous System Progression-free Survival [ Time Frame: 12 Months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04185883
Contact: Amgen Call Center | 866-572-6436 | medinfo@amgen.com |
United States, California | |
Research Site | Recruiting |
Duarte, California, United States, 91010 | |
Research Site | Recruiting |
La Jolla, California, United States, 92093 | |
Research Site | Recruiting |
Loma Linda, California, United States, 92354 | |
Research Site | Recruiting |
Sacramento, California, United States, 95817 | |
Research Site | Recruiting |
Santa Monica, California, United States, 90404 | |
United States, Connecticut | |
Research Site | Recruiting |
New Haven, Connecticut, United States, 06473 | |
Research Site | Recruiting |
Norwalk, Connecticut, United States, 06856 | |
United States, Georgia | |
Research Site | Recruiting |
Atlanta, Georgia, United States, 30322 | |
United States, Illinois | |
Research Site | Recruiting |
Chicago, Illinois, United States, 60637 | |
United States, Indiana | |
Research Site | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
United States, Maryland | |
Research Site | Recruiting |
Baltimore, Maryland, United States, 21287 | |
United States, Michigan | |
Research Site | Recruiting |
Ann Arbor, Michigan, United States, 48109 | |
United States, Missouri | |
Research Site | Recruiting |
Saint Louis, Missouri, United States, 63110 | |
United States, New York | |
Research Site | Recruiting |
New York, New York, United States, 10022 | |
Research Site | Recruiting |
New York, New York, United States, 10032 | |
United States, North Carolina | |
Research Site | Recruiting |
Durham, North Carolina, United States, 27710 | |
United States, Ohio | |
Research Site | Recruiting |
Cincinnati, Ohio, United States, 45219 | |
Research Site | Recruiting |
Cleveland, Ohio, United States, 44195 | |
United States, Pennsylvania | |
Research Site | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, South Carolina | |
Research Site | Recruiting |
Spartanburg, South Carolina, United States, 29303 | |
United States, Tennessee | |
Research Site | Recruiting |
Nashville, Tennessee, United States, 37203 | |
United States, Texas | |
Research Site | Recruiting |
Dallas, Texas, United States, 75230 | |
Research Site | Recruiting |
Houston, Texas, United States, 77030 | |
United States, Utah | |
Research Site | Recruiting |
Salt Lake City, Utah, United States, 84112 |
Study Director: | MD | Amgen |
Responsible Party: | Amgen |
ClinicalTrials.gov Identifier: | NCT04185883 |
Other Study ID Numbers: |
20190135 |
First Posted: | December 4, 2019 Key Record Dates |
Last Update Posted: | March 1, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) |
Time Frame: | Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study. |
Access Criteria: | Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below. |
URL: | http://www.amgen.com/datasharing |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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