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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04148937




Registration number
NCT04148937
Ethics application status
Date submitted
31/10/2019
Date registered
4/11/2019
Date last updated
17/09/2020

Titles & IDs
Public title
A Study of the CD73 Inhibitor LY3475070 Alone or in Combination With Pembrolizumab in Participants With Advanced Cancer
Scientific 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
Secondary ID [1] 0 0
J2I-MC-JZMA
Secondary ID [2] 0 0
17504
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LY3475070
Treatment: Drugs - Pembrolizumab

Experimental: Cohort A LY3475070 - LY3475070 administered orally.

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

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

Experimental: Cohort C2 LY3475070 - LY3475070 administered orally.

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

Experimental: Cohort D2 LY3475070 - LY3475070 administered orally.

Experimental: Cohort E LY3475070 + Pembrolizumab - LY3475070 administered orally and pembrolizumab administered IV.


Treatment: Drugs: LY3475070
Administered orally

Treatment: Drugs: Pembrolizumab
Administered IV

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Dose Limiting Toxicity (DLT) - Number of Participants with DLT
Timepoint [1] 0 0
Up to 28 Days
Secondary outcome [1] 0 0
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3475070 - PK: AUC of LY3475070
Timepoint [1] 0 0
Predose Cycle 1 Day 1 through Predose Cycle 7 Day 1 (28 Day Cycles)
Secondary outcome [2] 0 0
PK: Maximum Concentration (Cmax) of LY3475070 - PK: Cmax of LY3475070
Timepoint [2] 0 0
Predose Cycle 1 Day 1 through Predose Cycle 7 Day 1 (28 Day Cycles)
Secondary outcome [3] 0 0
PK: AUC of LY3475070 in Combination with Pembrolizumab - PK: AUC of LY3475070 in Combination with Pembrolizumab
Timepoint [3] 0 0
Predose Cycle 1 Day 1 through Predose Cycle 7 Day 1 (28 Day Cycles)
Secondary outcome [4] 0 0
PK: Cmax of LY3475070 in Combination with Pembrolizumab - PK: Cmax of LY3475070 in Combination with Pembrolizumab
Timepoint [4] 0 0
Predose Cycle 1 Day 1 through Predose Cycle 7 Day 1 (28 Day Cycles)
Secondary outcome [5] 0 0
Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR) - ORR: Percentage of Participants with CR or PR
Timepoint [5] 0 0
Baseline through Disease Progression or Death (Estimated at up to 2 Years)
Secondary outcome [6] 0 0
Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, and Stable Disease - DCR
Timepoint [6] 0 0
Baseline through Measured Progressive Disease (Estimated at up to 2 Years)
Secondary outcome [7] 0 0
Progression Free Survival (PFS) - PFS
Timepoint [7] 0 0
Baseline to Objective Progression or Death Due to Any Cause (Estimated at up to 2 Years)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Tennessee
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Cambridgeshire
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Scotland
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Manchester
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Merck Sharp & Dohme Corp.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT04148937
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Address 0 0
Country 0 0
Phone 0 0
1-317-615-4559
Fax 0 0
Email 0 0
ClinicalTrials.gov@lilly.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04148937