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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04148937
Ethics application status
Date submitted
31/10/2019
Date registered
4/11/2019

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: Phase 1a Cohort A LY3475070 (dose escalation) - Participants received 150 milligram (mg) once daily or 300 mg once daily or 300mg twice daily or 600mg once daily oral LY3475070 on a 21-day cycle until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.

Experimental: Phase 1a Cohort B LY3475070 + Pembrolizumab (dose escalation) - Participants received 150 mg once daily or 150 mg twice daily or 300 mg once daily or 300mg twice daily oral LY3475070 on a 21-day cycle in combination with an intravenous infusion of 200mg pembrolizumab on day 1 until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.

Experimental: Phase 1b Cohort C1 LY3475070 + Pembrolizumab (dose expansion) - LY3475070 administered orally and pembrolizumab administered IV.

Based on Sponsor decision, Phase 1b expansion cohorts were not initiated.

Experimental: Phase 1b Cohort C2 LY3475070 (dose expansion) - LY3475070 administered orally.

Based on Sponsor decision, Phase 1b expansion cohorts were not initiated.

Experimental: Phase 1b Cohort D1 LY3475070 + Pembrolizumab (dose expansion) - LY3475070 administered orally and pembrolizumab administered IV.

Based on Sponsor decision, Phase 1b expansion cohorts were not initiated.

Experimental: Phase 1b Cohort D2 LY3475070 (dose expansion) - LY3475070 administered orally.

Based on Sponsor decision, Phase 1b expansion cohorts were not initiated.

Experimental: Phase 1b Cohort E LY3475070 + Pembrolizumab (dose expansion) - LY3475070 administered orally and pembrolizumab administered IV.

Based on Sponsor decision, Phase 1b expansion cohorts were not initiated.


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 Toxicities (DLTs)
Timepoint [1] 0 0
Up to 28 days from the first dose
Secondary outcome [1] 0 0
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Eight Hours (AUC[0-8]) of LY3475070
Timepoint [1] 0 0
Cycle 1 Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8 hours post-dose)
Secondary outcome [2] 0 0
PK: Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUCtau) of LY3475070
Timepoint [2] 0 0
Cycle 2 Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose for the QD arms, Pre-dose, 0.5, 1, 2, 4, 6, 8 hours post-dose for the BID arms)
Secondary outcome [3] 0 0
PK: Maximum Concentration (Cmax) of LY3475070
Timepoint [3] 0 0
Day 1 of Cycles 1 and 2 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose for the QD arms; Pre-dose, 0.5, 1, 2, 4, 6, 8 hours post-dose for the BID arms)
Secondary outcome [4] 0 0
Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR)
Timepoint [4] 0 0
Baseline through Disease Progression or Death (Estimated at up to 10.4 Months)
Secondary outcome [5] 0 0
Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, and Stable Disease (SD)
Timepoint [5] 0 0
Baseline through Measured Progressive Disease (Estimated at up to 10.4 Months)
Secondary outcome [6] 0 0
Progression-Free Survival (PFS)
Timepoint [6] 0 0
Baseline to Objective Progression or Death Due to Any Cause (Estimated at up to 10.4 Months)

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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/01/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/06/2022
Sample size
Target
Accrual to date
Final
52
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
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Cambridgeshire
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Scotland
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Manchester
Country [11] 0 0
United Kingdom
State/province [11] 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 LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04148937