Status:
ACTIVE_NOT_RECRUITING
AMG 510 Ethnic Sensitivity Study (CodeBreaK 105).
Lead Sponsor:
Amgen
Conditions:
Advanced/Metastatic Solid Tumors With KRAS p.G12C Mutation
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
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
- 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
Exclusion
Key Trial Info
Start Date :
April 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 16 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04380753
Start Date
April 28 2020
End Date
June 16 2026
Last Update
July 23 2025
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Hong Kong, Queen Mary Hospital
Hong Kong, Hong Kong
2
Prince of Wales Hospital
Shatin, New Territories, Hong Kong
3
Veterans General Hospital - Taichung
Taichung, Taiwan, 40705
4
National Taiwan University Hospital
Taipei, Taiwan, 10002