Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : December 3, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE October 31, 2019
First Posted Date  ICMJE November 4, 2019
Last Update Posted Date December 3, 2019
Estimated Study Start Date  ICMJE December 4, 2019
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2019)
Number of Participants with Dose Limiting Toxicity (DLT) [ Time Frame: Up to 28 Days ]
Number of Participants with DLT
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04148937 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2019)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the CD73 Inhibitor LY3475070 Alone or in Combination With Pembrolizumab in Participants With Advanced Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Cancer
Intervention  ICMJE
  • Drug: LY3475070
    Administered orally
  • Drug: Pembrolizumab
    Administered IV
Study Arms  ICMJE
  • Experimental: Cohort A LY3475070
    LY3475070 administered orally.
    Intervention: Drug: LY3475070
  • Experimental: Cohort B LY3475070 + Pembrolizumab
    LY3475070 administered orally and pembrolizumab administered intravenously (IV).
    Interventions:
    • Drug: LY3475070
    • Drug: Pembrolizumab
  • Experimental: Cohort C1 LY3475070 + Pembrolizumab
    LY3475070 administered orally and pembrolizumab administered IV.
    Interventions:
    • Drug: LY3475070
    • Drug: Pembrolizumab
  • Experimental: Cohort C2 LY3475070
    LY3475070 administered orally.
    Intervention: Drug: LY3475070
  • Experimental: Cohort D1 LY3475070 + Pembrolizumab
    LY3475070 administered orally and pembrolizumab administered IV.
    Interventions:
    • Drug: LY3475070
    • Drug: Pembrolizumab
  • Experimental: Cohort D2 LY3475070
    LY3475070 administered orally.
    Intervention: Drug: LY3475070
  • Experimental: Cohort E LY3475070 + Pembrolizumab
    LY3475070 administered orally and pembrolizumab administered IV.
    Interventions:
    • Drug: LY3475070
    • Drug: Pembrolizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 1, 2019)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 20, 2022
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Australia,   France,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04148937
Other Study ID Numbers  ICMJE 17504
J2I-MC-JZMA ( Other Identifier: Eli Lilly and Company )
2019-003270-64 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date December 1, 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP