Clinical Trials /

A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of AMG 510 in Subjects With Solid Tumors With a Specific KRAS Mutation.

NCT03600883

Description:

Evaluate the safety and tolerability of AMG 510 in adult subjects with KRAS p.G12C mutant advanced solid tumors. Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with KRAS p.G12C mutant advanced solid tumors.

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

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of AMG 510 in Subjects With Solid Tumors With a Specific KRAS Mutation.
  • Official Title: A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 510 Monotherapy in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation and AMG 510 Combination Therapy in Subjects With Advanced NSCLC With KRAS p.G12C

Clinical Trial IDs

  • ORG STUDY ID: 20170543
  • NCT ID: NCT03600883

Conditions

  • KRAS p.G12C Mutant Advanced Solid Tumors

Interventions

DrugSynonymsArms
AMG 510Dose Exploration Part 1 monotherapy

Purpose

Evaluate the safety and tolerability of AMG 510 in adult subjects with KRAS p.G12C mutant advanced solid tumors. Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with KRAS p.G12C mutant advanced solid tumors.

Trial Arms

NameTypeDescriptionInterventions
Dose Exploration Part 1 monotherapyExperimentalEnrollment into the dose exploration cohorts may be from any eligible solid tumor type. Dose escalation will begin with 2-4 subjects treated at the lowest planned dose level of 180 mg. If no DLT is observed, dose escalation will continue to the next planned dose cohort
  • AMG 510
Dose Expansion Part 2 monotherapyExperimentalUpon completing the dose exploration part of the study and depending on data obtained, dose expansion may proceed with 2 groups consisting of subjects with KRAS p.G12C mutant advanced solid tumors Dose expansion in these 2 groups may be done concurrently.
  • AMG 510
Phase 2 monotherapyExperimentalAdditional subjects will be enrolled in the dose expansion to confirm the recommended phase 2 dose. Enrollment into phase 2 will be opened after confirmation of the recommended phase 2 dose
  • AMG 510
Combination arm with AMG 510 and anti PD-1/L1ExperimentalAdditional subjects will be enrolled into the combination arm with AMG 510 in combination with an anti (PD-1/L1)
  • AMG 510

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 DNA sequencing.

        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.
      
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:24 Months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Plasma concentration (Cmax)
Time Frame:24 Months
Safety Issue:
Description:
Measure:Time to achieve Cmax (tmax)
Time Frame:24 Months
Safety Issue:
Description:
Measure:Area under the plasma concentration-time curve (AUC)
Time Frame:24 Months
Safety Issue:
Description:
Measure:Objective response rate
Time Frame:24 months
Safety Issue:
Description:
Measure:Duration of overall response
Time Frame:24 Months
Safety Issue:
Description:
Measure:Progression-free survival
Time Frame:24 Months
Safety Issue:
Description:
Measure:Duration of stable disease
Time Frame:24 Months
Safety Issue:
Description:

Details

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

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