Advanced/Metastatic Solid Tumors With KRAS p.G12C MutationPhase 1NCT04380753
AMG 510 Ethnic Sensitivity Study (CodeBreaK 105).
A Phase 1 study testing AMG 510 in people with Advanced/Metastatic Solid Tumors With KRAS p.G12C Mutation, run by Amgen at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Advanced/Metastatic Solid Tumors With KRAS p.G12C Mutation
- What is being tested?
- AMG 510
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 28 Apr 2020to 9 Feb 2026
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Hong Kong2 sites
University of Hong Kong, Queen Mary Hospital
Hong Kong
Prince of Wales Hospital
Shatin, New Territories
Taiwan2 sites
Veterans General Hospital - Taichung
Taichung, 40705
National Taiwan University Hospital
Taipei, 10002
About this study
Official 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)
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.
- Being tested
- AMG 510
- Keywords
- AMG510 phase 1, Chinese Descent, Advanced Solid Tumors, KRAS p.G12C Mutation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 510Drug
Subjects will be enrolled and will receive AMG 510 PO QD.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Subjects will be enrolled and will receive AMG 510 PO QD. Receives: Drug: AMG 510 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured by computed tomography (CT) or magnetic resonance imaging (MRI). Assessed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines.
Measured: Day 1 until the end of study (approximately 12 months)
Duration of Response (DoR)
Measured by CT or MRI. Assessed per RECIST version 1.1 guidelines.
Measured: Day 1 until the end of study (approximately 12 months)
Progression-free Survival (PFS)
Measured by CT or MRI. Assessed per RECIST version 1.1 guidelines.
Measured: Day 1 until the end of study (approximately 12 months)
Disease Control Rate (DCR)
Measured by CT or MRI. Assessed per RECIST version 1.1 guidelines.
Measured: Day 1 until the end of study (approximately 12 months)
Time to Response (TTR)
Measured by CT or MRI. Assessed per RECIST version 1.1 guidelines.
Measured: Day 1 until the end of study (approximately 12 months)
Duration of Stable Disease
Measured by CT or MRI. Assessed per RECIST version 1.1 guidelines.
Measured: Day 1 until the end of study (approximately 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start28 Apr 2020
- Primary completion31 Dec 2021
- Study completion9 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced/Metastatic Solid Tumors With KRAS p.G12C MutationStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04380753
- Sponsor's protocol ID
- 20190147
- Status last verified
- Apr 2026
- First submitted
- 6 May 2020
- Last updated
- 6 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT04380753
- Acronym / sponsor ID
- 20190147
- Keywords
- AMG510 phase 1, Chinese Descent, Advanced Solid Tumors, KRAS p.G12C Mutation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 9 Feb 2026 (actual)
- First posted
- 8 May 2020 (actual)
- Results
- Posted 22 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: AMG 510Subjects will be enrolled and will receive AMG 510 PO QD. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMG 510Subjects will be enrolled and will receive AMG 510 PO QD. | Drug | Treatment Arm |
Primary outcome
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.
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.
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.
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.
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.
6 secondary outcomes
Objective Response (OR)
Time frame: Day 1 until the end of study (approximately 12 months)
Duration of Response (DoR)
Time frame: Day 1 until the end of study (approximately 12 months)
Progression-free Survival (PFS)
Time frame: Day 1 until the end of study (approximately 12 months)
Disease Control Rate (DCR)
Time frame: Day 1 until the end of study (approximately 12 months)
Time to Response (TTR)
Time frame: Day 1 until the end of study (approximately 12 months)
Duration of Stable Disease
Time frame: Day 1 until the end of study (approximately 12 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AMG 510 in people with Advanced/Metastatic Solid Tumors With KRAS p.G12C Mutation, run by Amgen at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Hong Kong, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Dose-limiting Toxicities (DLT) (time frame: Day 1 to Day 21). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.