A Study of the CD73 Inhibitor LY3475070 Alone or in Combination With Pembrolizumab in Participants With Advanced Cancer
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04148937 |
Recruitment Status :
Active, not recruiting
First Posted : November 4, 2019
Last Update Posted : March 10, 2022
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Condition or disease | Intervention/treatment | Phase |
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Advanced Cancer | Drug: LY3475070 Drug: Pembrolizumab | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | January 16, 2020 |
Actual Primary Completion Date : | May 12, 2021 |
Estimated Study Completion Date : | June 20, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Cohort A LY3475070
LY3475070 administered orally.
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Drug: LY3475070
Administered orally |
Experimental: Cohort B LY3475070 + Pembrolizumab
LY3475070 administered orally and pembrolizumab administered intravenously (IV).
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Drug: LY3475070
Administered orally Drug: Pembrolizumab Administered IV |
Experimental: Cohort C1 LY3475070 + Pembrolizumab
LY3475070 administered orally and pembrolizumab administered IV.
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Drug: LY3475070
Administered orally Drug: Pembrolizumab Administered IV |
Experimental: Cohort C2 LY3475070
LY3475070 administered orally.
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Drug: LY3475070
Administered orally |
Experimental: Cohort D1 LY3475070 + Pembrolizumab
LY3475070 administered orally and pembrolizumab administered IV.
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Drug: LY3475070
Administered orally Drug: Pembrolizumab Administered IV |
Experimental: Cohort D2 LY3475070
LY3475070 administered orally.
|
Drug: LY3475070
Administered orally |
Experimental: Cohort E LY3475070 + Pembrolizumab
LY3475070 administered orally and pembrolizumab administered IV.
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Drug: LY3475070
Administered orally Drug: Pembrolizumab Administered IV |
- Number of Participants with Dose Limiting Toxicity (DLT) [ Time Frame: Up to 28 Days ]Number of Participants with DLT
- 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) ]PK: AUC of LY3475070
- PK: Maximum Concentration (Cmax) of LY3475070 [ Time Frame: Predose Cycle 1 Day 1 through Predose Cycle 7 Day 1 (28 Day Cycles) ]PK: Cmax of LY3475070
- PK: AUC of LY3475070 in Combination with Pembrolizumab [ Time Frame: Predose Cycle 1 Day 1 through Predose Cycle 7 Day 1 (28 Day Cycles) ]PK: AUC of LY3475070 in Combination with Pembrolizumab
- PK: Cmax of LY3475070 in Combination with Pembrolizumab [ Time Frame: Predose Cycle 1 Day 1 through Predose Cycle 7 Day 1 (28 Day Cycles) ]PK: Cmax of LY3475070 in Combination with Pembrolizumab
- 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) ]ORR: Percentage of Participants with CR or PR
- 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) ]DCR
- Progression Free Survival (PFS) [ Time Frame: Baseline to Objective Progression or Death Due to Any Cause (Estimated at up to 2 Years) ]PFS

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04148937
United States, Colorado | |
Sarah Cannon Research Institute at HealthOne | |
Denver, Colorado, United States, 80218 | |
United States, Florida | |
Florida Cancer Specialists ORLANDO/DDU | |
Lake Mary, Florida, United States, 32746 | |
United States, Michigan | |
START Midwest | |
Grand Rapids, Michigan, United States, 49546 | |
United States, Missouri | |
Washington University Medical School | |
Saint Louis, Missouri, United States, 63110 | |
United States, Ohio | |
Cleveland Clinic Foundation | |
Cleveland, Ohio, United States, 44195 | |
United States, Tennessee | |
Sarah Cannon Research Institute SCRI | |
Nashville, Tennessee, United States, 37203 | |
United States, Texas | |
University of Texas MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 | |
Australia, Victoria | |
Peter MacCallum Cancer Centre | |
Melbourne, Victoria, Australia, 3000 | |
United Kingdom | |
Addenbrookes Hospital | |
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ | |
Beatson West of Scotland Cancer Center | |
Glasgow, Scotland, United Kingdom, G12 0YN | |
Christie NHS Foundation Trust | |
Manchester, United Kingdom, M20 4 BX | |
Royal Marsden NHS Trust | |
Sutton, United Kingdom, SM2 5PT |
Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Responsible Party: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT04148937 |
Other Study ID Numbers: |
17504 J2I-MC-JZMA ( Other Identifier: Eli Lilly and Company ) 2019-003270-64 ( EudraCT Number ) Keynote A57 ( Other Identifier: Merck ) |
First Posted: | November 4, 2019 Key Record Dates |
Last Update Posted: | March 10, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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 |
Neoplasms Pembrolizumab Antineoplastic Agents, Immunological Antineoplastic Agents |