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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04148937
Recruitment Status : Not yet recruiting
First Posted : November 4, 2019
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced Cancer Drug: LY3475070 Drug: Pembrolizumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 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
Estimated Study Start Date : December 4, 2019
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : December 20, 2022


Arm Intervention/treatment
Experimental: Cohort A LY3475070
LY3475070 administered orally.
Drug: LY3475070
Administered orally

Experimental: Cohort B LY3475070 + Pembrolizumab
LY3475070 administered orally and pembrolizumab administered intravenously (IV).
Drug: LY3475070
Administered orally

Drug: Pembrolizumab
Administered IV

Experimental: Cohort C1 LY3475070 + Pembrolizumab
LY3475070 administered orally and pembrolizumab administered IV.
Drug: LY3475070
Administered orally

Drug: Pembrolizumab
Administered IV

Experimental: Cohort C2 LY3475070
LY3475070 administered orally.
Drug: LY3475070
Administered orally

Experimental: Cohort D1 LY3475070 + Pembrolizumab
LY3475070 administered orally and pembrolizumab administered IV.
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.
Drug: LY3475070
Administered orally

Drug: Pembrolizumab
Administered IV




Primary Outcome Measures :
  1. Number of Participants with Dose Limiting Toxicity (DLT) [ Time Frame: Up to 28 Days ]
    Number of Participants with DLT


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Progression Free Survival (PFS) [ Time Frame: Baseline to Objective Progression or Death Due to Any Cause (Estimated at up to 2 Years) ]
    PFS



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

Locations
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United States, California
Cedars Sinai Medical Center Not yet recruiting
Los Angeles, California, United States, 90048
Contact    310-967-2700      
Principal Investigator: Heather L McArthur         
United States, Colorado
Sarah Cannon Research Institute at HealthOne Not yet recruiting
Denver, Colorado, United States, 80218
Contact    720-754-2610      
Principal Investigator: Shiraj Sen         
United States, Tennessee
Sarah Cannon Research Institute SCRI Not yet recruiting
Nashville, Tennessee, United States, 37203
Principal Investigator: SMO Sarah Cannon Research Inst.         
United States, Texas
University of Texas MD Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Contact    713-745-6754      
Principal Investigator: Sarina A Piha-Paul         
France
Gustave Roussy Not yet recruiting
Villejuif Cedex, France, 94805
Contact    33142114385      
Principal Investigator: Antoine Hollebecque         
United Kingdom
Royal Marsden Hospital Not yet recruiting
Sutton, United Kingdom, SM2 5PT
Contact    +442086426011      
Principal Investigator: Johann De Bono         
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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

Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04148937     History of Changes
Other Study ID Numbers: 17504
J2I-MC-JZMA ( Other Identifier: Eli Lilly and Company )
2019-003270-64 ( EudraCT Number )
First Posted: November 4, 2019    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 15, 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
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
Additional relevant MeSH terms:
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Neoplasms
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents