Skip to main content
OpenTrials
Completed

NCT Number: NCT04380753

AMG 510 Ethnic Sensitivity Study (CodeBreaK 105).

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Advanced/Metastatic Solid Tumors With KRAS p.G12C Mutation

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Hong Kong, Queen Mary Hospital, Hong Kong

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AMG 510

Drug

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

Primary outcomes

  1. Number of Participants With Dose-limiting Toxicities (DLT)

    Time frame: Day 1 to Day 21

    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.

  2. Number of Participants With Treatment-emergent AEs (TEAEs)

    Time frame: 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

    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.

  3. Maximum Observed Plasma Concentration (Cmax) of Sotorasib

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

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

  4. Time to Achieve Cmax (Tmax) of Sotorasib

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

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

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

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

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

Secondary outcomes

  1. Objective Response (OR)

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

    Measured by computed tomography (CT) or magnetic resonance imaging (MRI). Assessed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines.

  2. Duration of Response (DoR)

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

    Measured by CT or MRI. Assessed per RECIST version 1.1 guidelines.

  3. Progression-free Survival (PFS)

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

    Measured by CT or MRI. Assessed per RECIST version 1.1 guidelines.

  4. Disease Control Rate (DCR)

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

    Measured by CT or MRI. Assessed per RECIST version 1.1 guidelines.

  5. Time to Response (TTR)

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

    Measured by CT or MRI. Assessed per RECIST version 1.1 guidelines.

  6. Duration of Stable Disease

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

    Measured by CT or MRI. Assessed per RECIST version 1.1 guidelines.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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)

Important dates

Study start
2020
Primary completion
2021
Study completion
2026
First posted
May 8, 2020
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.