NCT04380753 · CITED IN SOURCE DOCUMENTS

AMG 510 Ethnic Sensitivity Study (CodeBreaK 105).

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE1
Status at capture: COMPLETED
Registry last update: 2026-05-06

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Dose-limiting Toxicities (DLT)

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outcome · POSTED

Number of Participants With Treatment-emergent AEs (TEAEs)

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outcome · POSTED

Maximum Observed Plasma Concentration (Cmax) of Sotorasib

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outcome · POSTED

Time to Achieve Cmax (Tmax) of Sotorasib

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outcome · POSTED

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

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outcome · NOT POSTED

Objective Response (OR)

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outcome · NOT POSTED

Duration of Response (DoR)

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outcome · NOT POSTED

Progression-free Survival (PFS)

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outcome · NOT POSTED

Disease Control Rate (DCR)

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outcome · NOT POSTED

Time to Response (TTR)

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outcome · NOT POSTED

Duration of Stable Disease

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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
healthy Volunteers: false
maximum Age: 100 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Subjects will be enrolled and will receive AMG 510 PO QD.
intervention Names
Drug: AMG 510
label
Treatment Arm
type
EXPERIMENTAL

interventions

arm Group Labels
Treatment Arm
description
Subjects will be enrolled and will receive AMG 510 PO QD.
name
AMG 510
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 12
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Number of Participants With Dose-limiting Toxicities (DLT)
time Frame
Day 1 to Day 21
description
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.
measure
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
description
Pharmacokinetic (PK) parameters were determined from the concentration-time profile using standard non-compartmental approaches and considering the profile over the complete sampling interval.
measure
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
description
PK parameters were determined from the concentration-time profile using standard non-compartmental approaches and considering the profile over the complete sampling interval.
measure
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
description
PK parameters were determined from the concentration-time profile using standard non-compartmental approaches and considering the profile over the complete sampling interval.
measure
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

secondary Outcomes

description
Measured by computed tomography (CT) or magnetic resonance imaging (MRI). Assessed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines.
measure
Objective Response (OR)
time Frame
Day 1 until the end of study (approximately 12 months)
description
Measured by CT or MRI. Assessed per RECIST version 1.1 guidelines.
measure
Duration of Response (DoR)
time Frame
Day 1 until the end of study (approximately 12 months)
description
Measured by CT or MRI. Assessed per RECIST version 1.1 guidelines.
measure
Progression-free Survival (PFS)
time Frame
Day 1 until the end of study (approximately 12 months)
description
Measured by CT or MRI. Assessed per RECIST version 1.1 guidelines.
measure
Disease Control Rate (DCR)
time Frame
Day 1 until the end of study (approximately 12 months)
description
Measured by CT or MRI. Assessed per RECIST version 1.1 guidelines.
measure
Time to Response (TTR)
time Frame
Day 1 until the end of study (approximately 12 months)
description
Measured by CT or MRI. Assessed per RECIST version 1.1 guidelines.
measure
Duration of Stable Disease
time Frame
Day 1 until the end of study (approximately 12 months)

Full study description

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.

Source references