Clinical Trials /

A Study of LY3499446 in Participants With Advanced Solid Tumors With KRAS G12C Mutation

NCT04165031

Description:

The reason for this study is to see if the study drug LY3499446 is safe and effective in participants with solid tumors with KRAS G12C mutation.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of LY3499446 in Participants With Advanced Solid Tumors With KRAS G12C Mutation
  • Official Title: A Phase 1/2 Study of LY3499446 Administered to Patients With Advanced Solid Tumors With KRAS G12C Mutation

Clinical Trial IDs

  • ORG STUDY ID: 17501
  • SECONDARY ID: J2K-MC-JZKA
  • SECONDARY ID: 2019-003070-53
  • NCT ID: NCT04165031

Conditions

  • Advanced Solid Tumor
  • Non-Small Cell Lung Cancer
  • Colorectal Cancer

Interventions

DrugSynonymsArms
LY3499446LY3499446 Phase 1
AbemaciclibLY2835219LY3499446 + Abemaciclib Phase 1
CetuximabLY3499446 + Cetuximab Phase 1
ErlotinibLY3499446 + Erlotinib Phase 1
DocetaxelDocetaxel Phase 2

Purpose

The reason for this study is to see if the study drug LY3499446 is safe and effective in participants with solid tumors with KRAS G12C mutation.

Trial Arms

NameTypeDescriptionInterventions
LY3499446 Phase 1ExperimentalParticipants given LY3499446 monotherapy orally.
  • LY3499446
LY3499446 + Abemaciclib Phase 1ExperimentalParticipants given LY3499446 and abemaciclib orally.
  • LY3499446
  • Abemaciclib
LY3499446 + Cetuximab Phase 1ExperimentalParticipants given LY3499446 orally and cetuximab intravenously (IV).
  • LY3499446
  • Cetuximab
LY3499446 + Erlotinib Phase 1ExperimentalParticipants given LY3499446 and erlotinib orally.
  • LY3499446
  • Erlotinib
LY3499446 Phase 2ExperimentalParticipants given LY3499446 monotherapy orally.
  • LY3499446
LY3499446 + Abemaciclib Phase 2ExperimentalParticipants given LY3499446 and abemaciclib orally.
  • LY3499446
  • Abemaciclib
LY3499446 + Erlotinib Phase 2ExperimentalParticipants given LY3499446 and erlotinib orally.
  • LY3499446
  • Erlotinib
LY3499446 + Cetuximab Phase 2ExperimentalParticipants given LY3499446 orally and cetuximab IV.
  • LY3499446
  • Cetuximab
Docetaxel Phase 2Active ComparatorParticipants given docetaxel IV.
  • Docetaxel

Eligibility Criteria

        Inclusion Criteria:

          -  Participants must have diagnosis of a solid tumor with KRAS G12C mutation that did not
             respond to at least 1 line of standard therapy and has spread to other part(s) of the
             body

          -  For phase II, participants must be willing to have new tumor tissue biopsies (doctor
             removes a small amount of tissue) during the study if it does not cause undue risks to
             health

          -  Participants must be willing to use highly effective birth control

          -  Participants must have adequate organ function

          -  Participants must be able to swallow capsules

        Exclusion Criteria:

          -  Participants must not have certain infections such as hepatitis or tuberculosis or HIV
             that is not well controlled

          -  Participants must not have another serious medical condition including a serious heart
             condition, such as congestive heart failure, unstable angina pectoris, or heart attack
             within the last three months

          -  Participants must not have cancer of the central nervous system that is not stable

          -  Participants must not be pregnant or breastfeeding

          -  Participants must not use herbal supplements
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Phase 1: Number or Participants with Dose Limiting Toxicities (DLTs)
Time Frame:Cycle 1 (21 Day Cycle)
Safety Issue:
Description:Phase 1: Number or Participants with DLTs

Secondary Outcome Measures

Measure:Pharmacokinetics (PK): Average Concentration at Steady State of LY3499446
Time Frame:Predose Cycle 1 Day 1 through Cycle 3 Day 1 (21 Day Cycles)
Safety Issue:
Description:PK: Average Concentration at Steady State of LY3499446
Measure:PK: Average Concentration at Steady State of LY3499446 in Combination with Abemaciclib
Time Frame:Predose Cycle 1 Day 1 through Cycle 3 Day 1 (21 Day Cycles)
Safety Issue:
Description:PK: Average Concentration at Steady State of LY3499446 in Combination with Abemaciclib
Measure:PK: Average Concentration at Steady State of LY3499446 in Combination with Cetuximab
Time Frame:Predose Cycle 1 Day 1 through Cycle 3 Day 1 (21 Day Cycles)
Safety Issue:
Description:PK: Average Concentration at Steady State of LY3499446 in Combination with Cetuximab
Measure:PK: Average Concentration at Steady State of LY3499446 in Combination with Erlotinib
Time Frame:Predose Cycle 1 Day 1 through Cycle 3 Day 1 (21 Day Cycles)
Safety Issue:
Description:PK: Average Concentration at Steady State of LY3499446 in Combination with Erlotinib
Measure:Phase 1: ORR: Percentage of Participants Who Achieve CR or PR
Time Frame:Baseline through Measured Progressive Disease (Estimated up to 24 Months)
Safety Issue:
Description:Phase 1: ORR: Percentage of Participants Who Achieve CR or PR
Measure:Phase 1: PFS
Time Frame:Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 24 Months)
Safety Issue:
Description:Phase 1: PFS
Measure:Duration of Response (DoR)
Time Frame:Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 24 Months)
Safety Issue:
Description:DoR
Measure:Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, and SD
Time Frame:Baseline through Measured Progressive Disease (Estimated up to 24 Months)
Safety Issue:
Description:Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, and SD

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Eli Lilly and Company

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