Phase 1
Completed N=12
AMG 510 Ethnic Sensitivity Study (CodeBreaK 105).
Advanced/Metastatic Solid Tumors With KRAS p.G12C Mutation
Source: ClinicalTrials.gov NCT04380753 ↗
Enrolled (actual)
12
Serious AEs
50.0%
Results posted
Mar 2024
Primary outcomePrimary: Number of Participants With Dose-limiting Toxicities (DLT) — 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose-limiting Toxicities (DLT) |
— | — |
| PRIMARY Number of Participants With Treatment-emergent AEs (TEAEs) |
11; 4 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Sotorasib |
9010; 6330 | — |
| PRIMARY Time to Achieve Cmax (Tmax) of Sotorasib |
0.85; 0.96 | — |
| PRIMARY Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24h) of Sotorasib |
73200; 37400 | — |
| SECONDARY Objective Response (OR) |
— | — |
| SECONDARY Duration of Response (DoR) |
— | — |
| SECONDARY Progression-free Survival (PFS) |
— | — |
| SECONDARY Disease Control Rate (DCR) |
— | — |
| SECONDARY Time to Response (TTR) |
— | — |
| SECONDARY Duration of Stable Disease |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT04380753). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.