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

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ClinicalTrials.gov Identifier: NCT04148937

Recruitment Status : Not yet recruiting

First Posted : November 4, 2019

Last Update Posted : December 3, 2019

See Contacts and Locations

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

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

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

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

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

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:

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

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