NCT04380753

AMG 510 Ethnic Sensitivity Study (CodeBreaK 105).

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	AMG 510	Subjects will be enrolled and will receive AMG 510 PO QD.

Timeline

• Start date: 2020-04-28
• Primary completion: 2021-12-31
• Completion: 2026-02-09
• First posted: 2020-05-08
• Last updated: 2026-03-25
• Results posted: 2024-03-22

Locations

4 sites across 2 countries: Hong Kong, Taiwan

Regulatory

• FDA-regulated drug study