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.
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
- SECONDARY ID:
Keynote A57
- NCT ID:
NCT04148937
Conditions
Interventions
Drug | Synonyms | Arms |
---|
LY3475070 | | Cohort A LY3475070 |
Pembrolizumab | | Cohort 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
Name | Type | Description | Interventions |
---|
Cohort A LY3475070 | Experimental | LY3475070 administered orally. | |
Cohort B LY3475070 + Pembrolizumab | Experimental | LY3475070 administered orally and pembrolizumab administered intravenously (IV). | |
Cohort C1 LY3475070 + Pembrolizumab | Experimental | LY3475070 administered orally and pembrolizumab administered IV. | |
Cohort C2 LY3475070 | Experimental | LY3475070 administered orally. | |
Cohort D1 LY3475070 + Pembrolizumab | Experimental | LY3475070 administered orally and pembrolizumab administered IV. | |
Cohort D2 LY3475070 | Experimental | LY3475070 administered orally. | |
Cohort E LY3475070 + Pembrolizumab | Experimental | LY3475070 administered orally and pembrolizumab administered IV. | |
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
- In the expansion cohorts 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: | Active, not 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
Last Updated
May 21, 2021