Clinical trial NCT04380753: AMG 510 Ethnic Sensitivity Study (CodeBreaK 105).
Official title: 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Advanced/Metastatic Solid Tumors With KRAS p.G12C Mutation
Keywords: AMG510 phase 1
Chinese Descent
Advanced Solid Tumors
KRAS p.G12C Mutation
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2020-05-08
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Number of Participants With Dose-limiting Toxicities (DLT)
timeFrame: Day 1 to Day 21
measure: Number of Participants With Treatment-emergent AEs (TEAEs)
timeFrame: 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
measure: Maximum Observed Plasma Concentration (Cmax) of Sotorasib
timeFrame: Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Days 1 and 8
measure: Time to Achieve Cmax (Tmax) of Sotorasib
timeFrame: Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Days 1 and 8
measure: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24h) of Sotorasib
timeFrame: Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Days 1 and 8
Secondary outcomes:
measure: Objective Response (OR)
timeFrame: Day 1 until the end of study (approximately 12 months)
measure: Duration of Response (DoR)
timeFrame: Day 1 until the end of study (approximately 12 months)
measure: Progression-free Survival (PFS)
timeFrame: Day 1 until the end of study (approximately 12 months)
measure: Disease Control Rate (DCR)
timeFrame: Day 1 until the end of study (approximately 12 months)
measure: Time to Response (TTR)
timeFrame: Day 1 until the end of study (approximately 12 months)
measure: Duration of Stable Disease
timeFrame: Day 1 until the end of study (approximately 12 months)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: University of Hong Kong, Queen Mary Hospital
city: Shatin, New Territories
country: Hong Kong
facility: Prince of Wales Hospital
city: Taichung
country: Taiwan
facility: Veterans General Hospital - Taichung
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: