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A Study of the CD73 Inhibitor LY3475070 Alone or in Combination With Pembrolizumab in Participants With Advanced Cancer

NCT04148937

Description:

The reason for this study is to see if the CD73 inhibitor LY3475070 alone or in combination with pembrolizumab is safe and effective in participants with advanced cancer.

Related Conditions:
  • Breast Carcinoma
  • Kidney Carcinoma
  • Lung Carcinoma
  • Melanoma
  • Ovarian Carcinoma
  • Pancreatic Carcinoma
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of the CD73 Inhibitor LY3475070 Alone or in Combination With Pembrolizumab in Participants With Advanced Cancer
  • Official Title: A Phase 1 Multicenter Global First in Human Study of the CD73 Inhibitor LY3475070 as Monotherapy or in Combination With Pembrolizumab in Patients With Advanced Solid Malignancies

Clinical Trial IDs

  • ORG STUDY ID: 17504
  • SECONDARY ID: J2I-MC-JZMA
  • SECONDARY ID: 2019-003270-64
  • NCT ID: NCT04148937

Conditions

  • Advanced Cancer

Interventions

DrugSynonymsArms
LY3475070Cohort A LY3475070
PembrolizumabCohort B LY3475070 + Pembrolizumab

Purpose

The reason for this study is to see if the CD73 inhibitor LY3475070 alone or in combination with pembrolizumab is safe and effective in participants with advanced cancer.

Trial Arms

NameTypeDescriptionInterventions
Cohort A LY3475070ExperimentalLY3475070 administered orally.
  • LY3475070
Cohort B LY3475070 + PembrolizumabExperimentalLY3475070 administered orally and pembrolizumab administered intravenously (IV).
  • LY3475070
  • Pembrolizumab
Cohort C1 LY3475070 + PembrolizumabExperimentalLY3475070 administered orally and pembrolizumab administered IV.
  • LY3475070
  • Pembrolizumab
Cohort C2 LY3475070ExperimentalLY3475070 administered orally.
  • LY3475070
Cohort D1 LY3475070 + PembrolizumabExperimentalLY3475070 administered orally and pembrolizumab administered IV.
  • LY3475070
  • Pembrolizumab
Cohort D2 LY3475070ExperimentalLY3475070 administered orally.
  • LY3475070
Cohort E LY3475070 + PembrolizumabExperimentalLY3475070 administered orally and pembrolizumab administered IV.
  • LY3475070
  • Pembrolizumab

Eligibility Criteria

        Inclusion Criteria:

          -  Participants must have certain types of cancer such as breast cancer, pancreatic
             cancer, lung cancer, kidney cancer, skin cancer (melanoma), prostate cancer, and
             ovarian cancer

          -  Participants must have stopped other forms of treatment for the cancer

          -  Participants must be able and willing to provide a sample of the tumor before
             beginning treatment and a sample during the treatment. For certain tumor types, the
             result of a test on the tumor sample may exclude the participant from the study

          -  Participants must not be pregnant, and must agree to use birth control

          -  Participants must have progressed through or be intolerant to therapies with known
             clinical benefit

        Exclusion Criteria:

          -  Participants must not have a current untreated tuberculosis, lung disease, heart
             disease, uncontrolled HIV, autoimmune disease, active hepatitis B or C virus infection
             or using corticosteroids

          -  Participant must not have cancer that has spread to the brain

          -  Participant must not have received a vaccine within the last 30 days

          -  Participant must not have had bowel obstruction within the last 6 months, or
             intestinal surgery

          -  Participant must not have an infection that is currently being treated
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Participants with Dose Limiting Toxicity (DLT)
Time Frame:Up to 28 Days
Safety Issue:
Description:Number of Participants with DLT

Secondary Outcome Measures

Measure:Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3475070
Time Frame:Predose Cycle 1 Day 1 through Predose Cycle 7 Day 1 (28 Day Cycles)
Safety Issue:
Description:PK: AUC of LY3475070
Measure:PK: Maximum Concentration (Cmax) of LY3475070
Time Frame:Predose Cycle 1 Day 1 through Predose Cycle 7 Day 1 (28 Day Cycles)
Safety Issue:
Description:PK: Cmax of LY3475070
Measure:PK: AUC of LY3475070 in Combination with Pembrolizumab
Time Frame:Predose Cycle 1 Day 1 through Predose Cycle 7 Day 1 (28 Day Cycles)
Safety Issue:
Description:PK: AUC of LY3475070 in Combination with Pembrolizumab
Measure:PK: Cmax of LY3475070 in Combination with Pembrolizumab
Time Frame:Predose Cycle 1 Day 1 through Predose Cycle 7 Day 1 (28 Day Cycles)
Safety Issue:
Description:PK: Cmax of LY3475070 in Combination with Pembrolizumab
Measure:Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR)
Time Frame:Baseline through Disease Progression or Death (Estimated at up to 2 Years)
Safety Issue:
Description:ORR: Percentage of Participants with CR or PR
Measure:Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, and Stable Disease
Time Frame:Baseline through Measured Progressive Disease (Estimated at up to 2 Years)
Safety Issue:
Description:DCR
Measure:Progression Free Survival (PFS)
Time Frame:Baseline to Objective Progression or Death Due to Any Cause (Estimated at up to 2 Years)
Safety Issue:
Description:PFS

Details

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

Trial Keywords

  • Triple Negative Breast Cancer
  • Pancreatic Cancer
  • Non-small Cell Lung Cancer
  • Renal Cell Carcinoma, Clear Cell
  • Cutaneous Melanoma
  • Castrate Resistant Prostate Cancer
  • Epithelial Ovarian Cancer
  • Metastatic Cancer

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