Clinical Trials /

AMG 510 (pINN) Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

NCT04185883

Description:

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

Related Conditions:
  • Malignant Solid Tumor
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: AMG 510 (pINN) Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)
  • Official Title: A Phase 1b, Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 510 (pINN) Sotorasib Monotherapy and in Combination With Other Anti-cancer Therapies in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

Clinical Trial IDs

  • ORG STUDY ID: 20190135
  • NCT ID: NCT04185883

Conditions

  • Advanced Solid Tumors
  • Kirsten Rat Sarcoma (KRAS) pG12C Mutation

Interventions

DrugSynonymsArms
SotorasibSotorasib + CDK inhibitor
PD1 inhibitorSotorasib + PD1 inhibitor
MEK inhibitorSotorasib + MEK inhibitor + EGFR inhibitor
SHP2 allosteric inhibitorSotorasib+ SHP2 allosteric inhibitor
Pan-ErbB tyrosine kinase inhibitorSotorasib+ Pan-ErbB tyrosine kinase inhibitor
PD-L1 inhibitorSotorasib + PD-L1 inhibitor
EGFR inhibitorSotorasib + MEK inhibitor + EGFR inhibitor
Chemotherapeutic regimenSotorasib+ EGFR inhibitor +/- Chemotherapeutic regimen
PD-1 inhibitorSotorasib + PD-1 inhibitor
Chemotherapeutic regimenSotorasib + Chemotherapeutic regimen
mTOR inhibitorSotorasib + mTOR inhibitor
CDK inhibitorSotorasib + CDK inhibitor

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Sotorasib+ MEK inhibitorExperimentalExperimental: Sotorasib + MEK inhibitor 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.
  • Sotorasib
  • MEK inhibitor
Sotorasib + PD1 inhibitorExperimentalExperimental: Sotoasib + PD1 inhibitor 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.
  • Sotorasib
  • PD1 inhibitor
Sotorasib+ SHP2 allosteric inhibitorExperimentalExperimental: Sotorasib + SHP2 allosteric inhibitor 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.
  • Sotorasib
  • SHP2 allosteric inhibitor
Sotorasib+ Pan-ErbB tyrosine kinase inhibitorExperimentalExperimental:Sotorasib + pan-ErbB tyrosine kinase inhibitor Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant 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.
  • Sotorasib
  • Pan-ErbB tyrosine kinase inhibitor
Sotorasib + PD-L1 inhibitorExperimentalExperimental: Sotorasib + PD-L1 inhibitor 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.
  • Sotorasib
  • PD-L1 inhibitor
Sotorasib+ EGFR inhibitor +/- Chemotherapeutic regimenExperimentalExperimental: Sotorasib + EGFR inhibitor +/- Chemotherapeutic regimen 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.
  • Sotorasib
  • EGFR inhibitor
  • Chemotherapeutic regimen
Sotorasib + PD-1 inhibitorExperimentalSotorasib + PD-1 inhibitor 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.
  • Sotorasib
  • PD-1 inhibitor
Sotorasib + Chemotherapeutic regimenExperimentalExperimental: Sotorasib + Chemotherapeutic regimen 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.
  • Sotorasib
  • Chemotherapeutic regimen
Sotorasib MonotherapyExperimentalExperimental: 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.
  • Sotorasib
Sotorasib + CDK inhibitorExperimentalExperimental: Sotorasib + CDK inhibitor 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.
  • Sotorasib
  • CDK inhibitor
Sotorasib + mTOR inhibitorExperimentalExperimental: Sotorasib + mTOR inhibitor 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.
  • Sotorasib
  • mTOR inhibitor
Sotorasib + MEK inhibitor + EGFR inhibitorExperimentalExperimental: Sotorasib + MEK inhibitor + EGFR inhibitor 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.
  • Sotorasib
  • MEK inhibitor
  • EGFR inhibitor

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.

        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.
      
Maximum Eligible Age:100 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Participants with Dose Limiting Toxicities (DLTs)
Time Frame:12 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Maximum Plasma Concentration (Cmax)
Time Frame:12 months
Safety Issue:
Description:
Measure:Time to Maximum Plasma Concentration (Tmax)
Time Frame:12 months
Safety Issue:
Description:
Measure:Area Under the Plasma Concentration-time Curve (AUC)
Time Frame:12 months
Safety Issue:
Description:
Measure:Disease Control Rate
Time Frame:12 months
Safety Issue:
Description:
Measure:Duration of Response
Time Frame:12 Months
Safety Issue:
Description:
Measure:Progression-free Survival
Time Frame:12 months
Safety Issue:
Description:
Measure:Duration of Stable Disease
Time Frame:12 Months
Safety Issue:
Description:
Measure:Objective Response Rate
Time Frame:12 months
Safety Issue:
Description:
Measure:Time to Response
Time Frame:12 Months
Safety Issue:
Description:
Measure:Overall Survival
Time Frame:12 Months
Safety Issue:
Description:
Measure:Sotorasib Monotherapy Only: Intracranial Objective Response Rate
Time Frame:12 Months
Safety Issue:
Description:Intracranial objective response rate assessed per Response Assessment in Neuro-oncology Brain Metastases (RANO-BM).
Measure:Sotorasib Monotherapy Only: Intracranial Disease Control Rate
Time Frame:12 Months
Safety Issue:
Description:Intracranial disease control rate assessed per Response Assessment in Neuro-oncology Brain Metastases (RANO-BM).
Measure:Sotorasib Monotherapy Only: Intracranial Duration of Response
Time Frame:12 Months
Safety Issue:
Description:Intracranial duration of response assessed per Response Assessment in Neuro-oncology Brain Metastases (RANO-BM).
Measure:Sotorasib Monotherapy Only: Time to Intracranial Radiation Therapy
Time Frame:12 Months
Safety Issue:
Description:
Measure:Sotorasib Monotherapy Only: Central Nervous System Progression-free Survival
Time Frame:12 Months
Safety Issue:
Description:
Measure:Sotorasib Monotherapy Only: Non-Central Nervous System Progression-free Survival
Time Frame:12 Months
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Amgen

Last Updated

November 12, 2020