AMG 510 Ethnic Sensitivity Study (CodeBreaK 105).

Study Overview
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Brief Summary
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To evaluate safety, tolerability, PK, and preliminary efficacy of AMG 510 PO QD in subjects of Chinese descent with KRAS p.G12C-mutant advanced/metastatic solid tumors.

Official Title
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A Phase 1, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 510 in Subjects of Chinese Descent With Advanced/Metastatic Solid Tumors With KRAS p.G12C Mutation (CodeBreaK 105)

Conditions
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Advanced/Metastatic Solid Tumors With KRAS p.G12C Mutation

Intervention / Treatment
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* Drug: AMG 510


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Male or female subjects greater than or equal to 18 years old Subject is of Chinese ancestry Pathologically documented, advanced/metastatic solid tumor with KRAS p.G12C mutation identified Exclusion Criteria: Active brain metastases from non-brain tumors. Myocardial infarction within 6 months of study day 1. Gastrointestinal (GI) tract disease causing the inability to take oral medication

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br>Subjects will be enrolled and will receive AMG 510 PO QD. | Drug: AMG 510<br>* Subjects will be enrolled and will receive AMG 510 PO QD.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject incidence of Dose-limiting toxicities (DLT) |  | 6 to 12 months | 
| Number of participants with treatment-emergent adverse events |  | 6 to 12 months | 
| Number of participants with treatment-related adverse events |  | 6 to 12 months | 
| Number of participants with changes in vital signs | Vital signs include blood pressure, heart rate, temperature and pulse oximetry. | 6 to 12 months | 
| Number of participants with changes in electrocardiograms (ECGs) | ECG must include the following measurements: QRS, QT, QTc, RR, and PR intervals. | 6 to 12 months | 
| Number of participants with changes in clinical laboratory tests | Laboratory assessments include Chemistry, HbA1c, Hematology, Coagulation, Urinalysis, HIV, Hepatitis serology, pregnancy test, thyroid panel and lipid panel. | 6 to 12 months | 
| maximum observed plasma concentration (Cmax) of AMG 510. |  | 6 to 12 months | 
| time to achieve Cmax (tmax) of AMG 510 |  | 6 to 12 months | 
| area under the plasma concentration time curve (AUC) of AMG 510 |  | 6 to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response measured by computed tomography (CT) or magnetic resonance imaging (MRI) |  | 6 to 12 months | 
| Duration of response measured by computed tomography (CT) or magnetic resonance imaging (MRI) | Assessed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines | 6 to 12 months | 
| Progression-free survival (PFS) measured by computed tomography (CT) or magnetic resonance imaging (MRI) | Assessed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines | 6 to 12 months | 
| Disease control time measured by computed tomography (CT) or magnetic resonance imaging (MRI) | Assessed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines | 6 to 12 months | 
| Time to response (TTR) measured by computed tomography (CT) or magnetic resonance imaging (MRI) | Assessed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines | 6 to 12 months | 
| Duration of stable disease measured by computed tomography (CT) or magnetic resonance imaging (MRI) | Assessed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines | 6 to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AMG510 phase 1, Chinese Descent, Advanced Solid Tumors, KRAS p.G12C Mutation