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Clinical trial

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)

ID
Name
20190147
Description
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.
Trial arms
Trial start
2020-04-28
Estimated PCD
2021-12-31
Trial end
2024-07-15
Status
Active (not recruiting)
Phase
Early phase I
Treatment
AMG 510
Subjects will be enrolled and will receive AMG 510 PO QD.
Arms:
Treatment Arm
Size
12
Primary endpoint
Number of Participants With Dose-limiting Toxicities (DLT)
Day 1 to Day 21
Number of Participants With Treatment-emergent AEs (TEAEs)
Day 1 until the end of study (or primary data cut-off date for ongoing participants); median [min, max] duration was 5.57 [1.5, 13.7] months
Maximum Observed Plasma Concentration (Cmax) of Sotorasib
Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Days 1 and 8
Time to Achieve Cmax (Tmax) of Sotorasib
Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Days 1 and 8
Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24h) of Sotorasib
Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Days 1 and 8
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 12, 'type': 'ACTUAL'}}
Updated at
2024-03-22

1 organization

1 product

1 indication

Organization
Amgen
Product
AMG 510
Indication
Solid Tumors with KRAS p.G12C Mutation