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NCT04185883 · CITED IN SOURCE DOCUMENTS

Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

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
ACTIVE NOT RECRUITING
Registry last update
2025-10-22

To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced 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.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
Inclusion Criteria: * Men or women greater than or equal to 18 years old. * Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing performed according to in-country requirements. In the United States, this test must be performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory. Exclusion Criteria: * Primary brain tumor. * Spinal cord compression, or untreated, or symptomatic, or active brain metastases, or leptomeningeal disease 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
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Experimental: Sotorasib + trametinib + panitumumab Dose Exploration and Dose Expansion * Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors. * Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors.
    intervention Names
    1. Drug: Sotorasib
    2. Drug: Trametinib
    3. Drug: Panitumumab
    label
    Sotorasib + trametinib + panitumumab
    type
    EXPERIMENTAL
  2. description
    Experimental: Sotorasib + RMC-4630 Dose Exploration and Dose Expansion * Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors. * Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants, with KRAS p.G12C mutant advanced solid tumors.
    intervention Names
    1. Drug: Sotorasib
    2. Drug: RMC-4630
    label
    Sotorasib + RMC-4630
    type
    EXPERIMENTAL
  3. description
    Experimental: Sotorasib + afatinib Dose Exploration and Dose Expansion * Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer. * Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer.
    intervention Names
    1. Drug: Sotorasib
    2. Drug: Afatinib
    label
    Sotorasib + afatinib
    type
    EXPERIMENTAL
  4. description
    Experimental: Sotorasib + panitumumab +/- chemotherapy Dose Exploration and Dose Expansion * Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced colorectal cancer. * Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors.
    intervention Names
    1. Drug: Sotorasib
    2. Drug: Panitumumab
    3. Drug: IV Chemotherapy (Regimen 1)
    label
    Sotorasib + panitumumab +/- chemotherapy
    type
    EXPERIMENTAL
  5. description
    Experimental: Sotorasib + atezolizumab Dose Exploration and Dose Expansion * Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer. * Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer.
    intervention Names
    1. Drug: Sotorasib
    2. Drug: Atezolizumab
    label
    Sotorasib + atezolizumab
    type
    EXPERIMENTAL
  6. description
    Experimental: Sotorasib + carboplatin, pemetrexed, docetaxel, paclitaxel, pembrolizumab Dose Exploration and Dose Expansion * Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer. * Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer.
    intervention Names
    1. Drug: Sotorasib
    2. Drug: Pembrolizumab
    3. Drug: Carboplatin, pemetrexed, docetaxel, paclitaxel
    label
    Sotorasib + carboplatin, pemetrexed, docetaxel, paclitaxel, pembrolizumab
    type
    EXPERIMENTAL
  7. description
    Experimental: Sotorasib only Dose Exploration and Dose Expansion * Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer with brain metastases. * Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer with brain metastases.
    intervention Names
    1. Drug: Sotorasib
    label
    Sotorasib Monotherapy
    type
    EXPERIMENTAL
  8. description
    Experimental: Sotorasib + palbociclib Dose Exploration and Dose Expansion * Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced solid tumor. * Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumor.
    intervention Names
    1. Drug: Sotorasib
    2. Drug: Palbociclib
    label
    Sotorasib + palbociclib
    type
    EXPERIMENTAL
  9. description
    Experimental: Sotorasib + pembrolizumab Dose Exploration and Dose Expansion * Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant non small cell lung cancer. * Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS P.G12C mutant non small cell lung cancer.
    intervention Names
    1. Drug: Sotorasib
    2. Drug: Pembrolizumab
    label
    Sotorasib + pembrolizumab
    type
    EXPERIMENTAL
  10. description
    Experimental: Sotorasib + MVASI® (bevacizumab-awwb)+ chemotherapy Dose Exploration and Dose Expansion * Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced colorectal cancer. * Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced colorectal cancer.
    intervention Names
    1. Drug: Sotorasib
    2. Drug: MVASI® (bevacizumab-awwb)
    3. Drug: IV Chemotherapy (Regimen 1)
    4. Drug: IV Chemotherapy (Regimen 2)
    label
    Sotorasib + MVASI® (bevacizumab-awwb)+ Chemotherapy
    type
    EXPERIMENTAL
  11. description
    Experimental: Sotorasib + TNO155 Dose Exploration and Dose Expansion * Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors. * Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors.
    intervention Names
    1. Drug: Sotorasib
    2. Drug: TNO155
    label
    Sotorasib + TNO155
    type
    EXPERIMENTAL
  12. description
    Experimental: Sotorasib + BI 1701963 Dose Exploration and Dose Expansion * Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors. * Upon completion of dose exploration part of the study the dose expansion cohort is for eligible participants with KRAS P.G12C mutant advanced non-small cell lung cancer and advanced colorectal cancer.
    intervention Names
    1. Drug: Sotorasib
    2. Drug: BI 1701963
    label
    Sotorasib + BI 1701963
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Sotorasib + AMG 404
    2. Sotorasib + BI 1701963
    3. Sotorasib + MVASI® (bevacizumab-awwb)+ Chemotherapy
    4. Sotorasib + RMC-4630
    5. Sotorasib + TNO155
    6. Sotorasib + afatinib
    7. Sotorasib + atezolizumab
    8. Sotorasib + carboplatin, pemetrexed, docetaxel, paclitaxel, pembrolizumab
    9. Sotorasib + everolimus
    10. Sotorasib + palbociclib
    11. Sotorasib + panitumumab +/- chemotherapy
    12. Sotorasib + pembrolizumab
    description
    Sotorasib administered orally as a tablet.
    name
    Sotorasib
    type
    DRUG
  2. arm Group Labels
    1. Sotorasib + trametinib + panitumumab
    description
    Trametinib administered orally as a tablet.
    name
    Trametinib
    type
    DRUG
  3. arm Group Labels
    1. Sotorasib + RMC-4630
    description
    RMC-4630 administered orally as a capsule.
    name
    RMC-4630
    type
    DRUG
  4. arm Group Labels
    1. Sotorasib + afatinib
    description
    afatinib administered orally as a tablet.
    name
    Afatinib
    type
    DRUG
  5. arm Group Labels
    1. Sotorasib + carboplatin, pemetrexed, docetaxel, paclitaxel, pembrolizumab
    2. Sotorasib + pembrolizumab
    description
    pembrolizumab administered as an intravenous (IV) infusion.
    name
    Pembrolizumab
    type
    DRUG
  6. arm Group Labels
    1. Sotorasib + panitumumab +/- chemotherapy
    2. Sotorasib + trametinib + panitumumab
    description
    Panitumumab administered as an IV infusion.
    name
    Panitumumab
    type
    DRUG
  7. arm Group Labels
    1. Sotorasib + carboplatin, pemetrexed, docetaxel, paclitaxel, pembrolizumab
    description
    Carboplatin, pemetrexed, docetaxel administered as an IV infusion.
    name
    Carboplatin, pemetrexed, docetaxel, paclitaxel
    type
    DRUG
  8. arm Group Labels
    1. Sotorasib + atezolizumab
    description
    Atezolizumab administered as an IV injection.
    name
    Atezolizumab
    type
    DRUG
  9. arm Group Labels
    1. Sotorasib + palbociclib
    description
    Palbociclib administered orally as a tablet.
    name
    Palbociclib
    type
    DRUG
  10. arm Group Labels
    1. Sotorasib + MVASI® (bevacizumab-awwb)+ Chemotherapy
    description
    MVASI® (bevacizumab-awwb) administered as an IV infusion.
    name
    MVASI® (bevacizumab-awwb)
    type
    DRUG
  11. arm Group Labels
    1. Sotorasib + TNO155
    description
    TNO155 administered orally as a capsule.
    name
    TNO155
    type
    DRUG
  12. arm Group Labels
    1. Sotorasib + MVASI® (bevacizumab-awwb)+ Chemotherapy
    2. Sotorasib + panitumumab +/- chemotherapy
    description
    Chemotherapy combination of leucovorin administered as an IV injection, 5-fluorouracil (5-FU) administered as IV bolus injection or IV continuous infusion (depending on dose), and irinotecan administered as IV injection.
    name
    IV Chemotherapy (Regimen 1)
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
SEQUENTIAL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
610
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Number of Participants with Dose Limiting Toxicities (DLTs)
    time Frame
    12 Months
  2. measure
    Number of Participants with Treatment-emergent Adverse Events (TEAEs)
    time Frame
    12 Months
  3. measure
    Number of Participants with Treatment-related Adverse Events
    time Frame
    12 Months
  4. measure
    Number of Participants with Clinically Significant Changes in Vital Signs
    time Frame
    12 Months
  5. measure
    Number of Participants with Clinically Significant Changes in ECG Measurements
    time Frame
    12 Months
  6. measure
    Number of Participants with Clinically Significant Changes in Laboratory Test Values
    time Frame
    12 Months
secondary Outcomes
  1. measure
    Maximum Plasma Concentration (Cmax)
    time Frame
    12 Months
  2. measure
    Time to Maximum Plasma Concentration (Tmax)
    time Frame
    12 Months
  3. measure
    Area Under the Plasma Concentration-time Curve (AUC)
    time Frame
    12 Months
  4. measure
    Objective Response Rate
    time Frame
    12 Months
  5. measure
    Disease Control Rate
    time Frame
    12 Months
  6. measure
    Duration of Response
    time Frame
    12 Months
  7. measure
    Progression-free Survival
    time Frame
    12 Months
  8. measure
    Duration of Stable Disease
    time Frame
    12 Months
  9. measure
    Time to Response
    time Frame
    12 Months
  10. measure
    Overall Survival
    time Frame
    12 Months
  11. measure
    Sotorasib + EGFR Inhibitor +/- Chemotherapeutic Regimen Only: Quantification of Plasma Levels
    time Frame
    12 Months
  12. description
    Intracranial objective response rate assessed per Response Assessment in Neuro-oncology Brain Metastases (RANO-BM).
    measure
    Sotorasib Monotherapy Only: Intracranial Objective Response Rate
    time Frame
    12 Months
Full study description
brief Summary
To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors.
Source references
references
  1. citation
    Kuboki Y, Fakih M, Strickler J, Yaeger R, Masuishi T, Kim EJ, Bestvina CM, Kopetz S, Falchook GS, Langer C, Krauss J, Puri S, Cardona P, Chan E, Varrieur T, Mukundan L, Anderson A, Tran Q, Hong DS. Sotorasib with panitumumab in chemotherapy-refractory KRASG12C-mutated colorectal cancer: a phase 1b trial. Nat Med. 2024 Jan;30(1):265-270. doi: 10.1038/s41591-023-02717-6. Epub 2024 Jan 4.
    pmid
    38177853
    type
    BACKGROUND
see Also Links
  1. label
    AmgenTrials clinical trials website
Source notices and limitations
    Discovery and provenance
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      occurrences
      1. context exact
        e toxicity in 549 patients with NSCLC with KRAS G12C mutation in the following trials: CodeBreaK 200 (NCT04303780), CodeBreaK 100 (NCT03600883), CodeBreaK 101 (NCT04185883) and CodeBreaK 105 (NCT04380753). Among these 549 patients who received LUMAKRAS, 44% were exposed for 6 months or longer and 21% were exposed for greater than
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        n combination with panitumumab in 126 patients who received LUMAKRAS in combination with panitumumab for mCRC in CodeBreaK 300 (NCT05198934) and CodeBreaK 101 (NCT04185883). Among the 126 patients who received LUMAKRAS 960 mg in combination with panitumumab, 40% were exposed for 6 months or longer and 10% were exposed for greater
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    Preserved source evidence · Not medical advice