Brief Summary
To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors.
Brief Title
Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
866-572-6436
Central Contact Email
medinfo@amgen.com
Completion Date
Completion Date Type
Estimated
Conditions
Advanced Solid Tumors
Kirsten Rat Sarcoma (KRAS) pG12C Mutation
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 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.
* 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.
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.
* 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.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
100 Years
Minimum Age
18 Years
NCT Id
NCT04185883
Org Class
Industry
Org Full Name
Amgen
Org Study Id
20190135
Overall Status
Recruiting
Phases
Phase 1
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
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)
Primary Outcomes
Outcome Measure
Number of Participants with Dose Limiting Toxicities (DLTs)
Outcome Time Frame
12 Months
Outcome Measure
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Outcome Time Frame
12 Months
Outcome Measure
Number of Participants with Treatment-related Adverse Events
Outcome Time Frame
12 Months
Outcome Measure
Number of Participants with Clinically Significant Changes in Vital Signs
Outcome Time Frame
12 Months
Outcome Measure
Number of Participants with Clinically Significant Changes in ECG Measurements
Outcome Time Frame
12 Months
Outcome Measure
Number of Participants with Clinically Significant Changes in Laboratory Test Values
Outcome Time Frame
12 Months
Secondary Ids
Secondary Id
2023-506794-35
Secondary Outcomes
Outcome Time Frame
12 Months
Outcome Measure
Maximum Plasma Concentration (Cmax)
Outcome Time Frame
12 Months
Outcome Measure
Time to Maximum Plasma Concentration (Tmax)
Outcome Time Frame
12 Months
Outcome Measure
Area Under the Plasma Concentration-time Curve (AUC)
Outcome Time Frame
12 Months
Outcome Measure
Objective Response Rate
Outcome Time Frame
12 Months
Outcome Measure
Disease Control Rate
Outcome Time Frame
12 Months
Outcome Measure
Duration of Response
Outcome Time Frame
12 Months
Outcome Measure
Progression-free Survival
Outcome Time Frame
12 Months
Outcome Measure
Duration of Stable Disease
Outcome Time Frame
12 Months
Outcome Measure
Time to Response
Outcome Time Frame
12 Months
Outcome Measure
Overall Survival
Outcome Time Frame
12 Months
Outcome Measure
Sotorasib + EGFR Inhibitor +/- Chemotherapeutic Regimen Only: Quantification of Plasma Levels
Outcome Description
Intracranial objective response rate assessed per Response Assessment in Neuro-oncology Brain Metastases (RANO-BM).
Outcome Time Frame
12 Months
Outcome Measure
Sotorasib Monotherapy Only: Intracranial Objective Response Rate
Outcome Description
Intracranial disease control rate assessed per RANO-BM.
Outcome Time Frame
12 Months
Outcome Measure
Sotorasib Monotherapy Only: Intracranial Disease Control Rate
Outcome Description
Intracranial duration of response assessed per RANO-BM.
Outcome Time Frame
12 Months
Outcome Measure
Sotorasib Monotherapy Only: Intracranial Duration of Response
Outcome Time Frame
12 Months
Outcome Measure
Sotorasib Monotherapy Only: Time to Intracranial Radiation Therapy
Outcome Description
Intracranial PFS assessed per RANO-BM.
Outcome Time Frame
12 Months
Outcome Measure
Sotorasib Monotherapy Only: Intracranial Progression-free Survival (PFS)
Outcome Description
Non-intracranial PFS assessed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Outcome Time Frame
12 Months
Outcome Measure
Sotorasib Monotherapy Only: Non-intracranial Progression-free Survival (PFS)
Outcome Description
Overall PFS assessed per RECIST 1.1 and RANO-BM.
Outcome Time Frame
12 Months
Outcome Measure
Sotorasib Monotherapy Only: Overall Progression-free Survival (PFS)
Outcome Time Frame
12 Months
Outcome Measure
Sotorasib + TNO155 Only: Best Overall Response
Outcome Time Frame
12 Months
Outcome Measure
Sotorasib + Afatinib + Loperamide Only: Number of Participants with Dose Limiting Toxicities (DLTs)
Outcome Time Frame
12 Months
Outcome Measure
Sotorasib + Afatinib + Loperamide Only: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Outcome Time Frame
12 Months
Outcome Measure
Sotorasib + Afatinib + Loperamide Only: Number of Participants with Treatment-related Adverse Events
Outcome Time Frame
12 Months
Outcome Measure
Sotorasib + Afatinib + Loperamide Only: Number of Participants with Clinically Significant Changes in Vital Signs
Outcome Time Frame
12 Months
Outcome Measure
Sotorasib + Afatinib + Loperamide Only: Number of Participants with Clinically Significant Changes in ECG Measurements
Outcome Time Frame
12 Months
Outcome Measure
Sotorasib + Afatinib + Loperamide Only: Number of Participants with Clinically Significant Changes in Laboratory Test Values
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
100
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Sanjay Goel
Investigator Email
sgoel@montefiore.org
Investigator Phone
718-405-8404