AMG 510 Ethnic Sensitivity Study (CodeBreaK 105).

Amgen

Status and phase: Active, not recruiting; Phase 1

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

Treatments: Drug: AMG 510

Study type: Interventional

Funder types: Industry

Identifiers

NCT04380753

20190147

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Treatment Arm

Experimental group

Description:

Subjects will be enrolled and will receive AMG 510 PO QD.

Treatment:

Drug: AMG 510