Clinical Trials /

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

NCT04185883

Description:

To evaluate the safety and tolerability of AMG 510 administered in investigational regimens in adult subjects with KRAS p.G12C mutant advanced solid tumors

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: 20190135
  • NCT ID: NCT04185883

Conditions

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

Interventions

DrugSynonymsArms
AMG 510AMG 510+ MEKi
PD1 inhibitorAMG510+ PD1 inhibitor

Purpose

To evaluate the safety and tolerability of AMG 510 administered in investigational regimens in adult subjects with KRAS p.G12C mutant advanced solid tumors

Trial Arms

NameTypeDescriptionInterventions
AMG 510+ MEKiExperimentalExperimental: AMG510 + MEK inhibitor Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible subjects with KRAS P.G12C mutant advanced solid tumors. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of subjects with KRAS p.G12C mutant advanced solid tumors.
  • AMG 510
AMG510+ PD1 inhibitorExperimentalExperimental: AMG510 + PD-1inhibitor Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible subjects with KRAS P.G12C mutant advanced solid tumors. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of subjects with KRAS p.G12C mutant advanced solid tumors.
  • PD1 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.G12Cmutation identified through molecular testing.

        Exclusion Criteria:

          -  Primary brain tumor.

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

Primary Outcome Measures

Measure:Number of Participants with Abnormal Laboratory Values
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:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Amgen

Last Updated

December 3, 2019