AMG 510 Ethnic Sensitivity Study (CodeBreaK 105).

NCT04380753 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 20190147
• Study Type: interventional
• Target: 12
• Locations: 2 countries
• Sites: 4

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.

Conditions

Advanced/Metastatic Solid Tumors With KRAS p.G12C Mutation

Keywords

AMG510 phase 1; Chinese Descent; Advanced Solid Tumors; KRAS p.G12C Mutation

Outcome Measures

Primary Outcomes (5)

• Number of Participants With Dose-limiting Toxicities (DLT)

  DLTs were defined as any of the following adverse events (AEs) where a relationship to sotorasib could not be ruled out. Hematological toxicity * febrile neutropenia * neutropenic infection * grade 4 neutropenia * grade ≥ 3 thrombocytopenia for \> 7 days * grade 3 thrombocytopenia with grade ≥ 2 bleeding * grade 4 thrombocytopenia * grade 4 anemia. Non-hematological toxicity * grade ≥ 4 vomiting or diarrhea * grade 3 diarrhea or grade 3 vomiting lasting more than 3 days despite optimal medical support * grade ≥ 3 nausea for 3 days or more despite optimal medical support * any other grade ≥ 3 adverse event.

  Day 1 to Day 21

• Number of Participants With Treatment-emergent AEs (TEAEs)

  An AE was any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. A TEAE was defined as an AE starting on or after first dose of study treatment. Treatment-related TEAEs were any TEAEs considered related to investigational product by the investigator. If relationship was missing, the event was assumed treatment-related. Clinically significant changes from the participant's baseline values in vital signs, 12-lead electrocardiograms, and clinical laboratory safety tests were reported as AEs.

  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

• Maximum Observed Plasma Concentration (Cmax) of Sotorasib

  Pharmacokinetic (PK) parameters were determined from the concentration-time profile using standard non-compartmental approaches and considering the profile over the complete sampling interval.

  Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Days 1 and 8

• Time to Achieve Cmax (Tmax) of Sotorasib

  PK parameters were determined from the concentration-time profile using standard non-compartmental approaches and considering the profile over the complete sampling interval.

  Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Days 1 and 8

• Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24h) of Sotorasib

  PK parameters were determined from the concentration-time profile using standard non-compartmental approaches and considering the profile over the complete sampling interval.

  Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Days 1 and 8

Secondary Outcomes (6)

• Objective Response (OR)

  Day 1 until the end of study (approximately 12 months)

• Duration of Response (DoR)

  Day 1 until the end of study (approximately 12 months)

• Progression-free Survival (PFS)

  Day 1 until the end of study (approximately 12 months)

• Disease Control Rate (DCR)

  Day 1 until the end of study (approximately 12 months)

• Time to Response (TTR)

  Day 1 until the end of study (approximately 12 months)

Study Arms (1)

Treatment Arm

EXPERIMENTAL

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

Drug: AMG 510

Interventions

AMG 510 DRUG

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

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (4)

University of Hong Kong, Queen Mary Hospital

Hong Kong, Hong Kong

Location

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

Location

Veterans General Hospital - Taichung

Taichung, 40705, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Interventions

sotorasib

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 8, 2020
• Study Start: April 28, 2020
• Primary Completion: December 31, 2021
• Study Completion: February 9, 2026
• Last Updated: May 6, 2026
• Results First Posted: March 22, 2024

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.

Locations

TW (2); HK (2)