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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04148937
Registration number
NCT04148937
Ethics application status
Date submitted
31/10/2019
Date registered
4/11/2019
Date last updated
5/04/2024
Titles & IDs
Public title
A Study of the CD73 Inhibitor LY3475070 Alone or in Combination With Pembrolizumab in Participants With Advanced Cancer
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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
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Secondary ID [1]
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J2I-MC-JZMA
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Secondary ID [2]
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17504
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Cancer
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Dose Limiting Toxicities (DLTs)
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Assessment method [1]
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A DLT is defined as an adverse event that is likely related to the study medication or combination, and fulfils any one of the following criteria, graded according to the NCI-CTCAE (National Cancer Institute-Common Terminology Criteria for Adverse Events) version 5.0:
Grade 3 thrombocytopenia associated with clinically significant bleeding and requiring platelet transfusion or Grade 4 thrombocytopenia of any duration.
Grade =3 febrile neutropenia
Grade =3 anemia requiring a blood transfusion
Other Grade =4 toxicities, excluding few nonhematologic Toxicities
Any other significant toxicity deemed by the investigatory to be dose-limiting, such as: any toxicity that is possibly related to the study medication that requires the withdrawal of the participant from the study during 28-day DLT observation period), persistent Grade >2 toxicities causing a delay of LY3475070 study treatment >14 days during the 28-day DLT observation period.
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Timepoint [1]
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Up to 28 days from the first dose
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Secondary outcome [1]
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Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Eight Hours (AUC[0-8]) of LY3475070
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Assessment method [1]
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PK: AUC[0-8] of LY3475070.
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Timepoint [1]
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Cycle 1 Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8 hours post-dose)
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Secondary outcome [2]
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PK: Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUCtau) of LY3475070
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Assessment method [2]
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PK: AUCtau of LY3475070
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Timepoint [2]
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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)
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Secondary outcome [3]
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PK: Maximum Concentration (Cmax) of LY3475070
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Assessment method [3]
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PK: Cmax of LY3475070
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Timepoint [3]
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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)
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Secondary outcome [4]
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Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR)
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Assessment method [4]
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ORR is the best overall tumor response of complete response (CR) or partial response (PR) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.
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Timepoint [4]
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Baseline through Disease Progression or Death (Estimated at up to 10.4 Months)
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Secondary outcome [5]
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Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, and Stable Disease (SD)
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Assessment method [5]
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DCR is the percentage of participants with a best overall response of CR, PR or SD as defined by RECIST v1.1. CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
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Timepoint [5]
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Baseline through Measured Progressive Disease (Estimated at up to 10.4 Months)
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Secondary outcome [6]
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Progression-Free Survival (PFS)
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Assessment method [6]
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PFS is defined as the time from the date of start of treatment to the first date of the observed clinical or radiologically documented progressive disease or death due to any cause, whichever occurs first, was estimated and reported for all evaluable participants. For participants who were not known to have died or progressed as of the data-inclusion cut-off date, PFS time was censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systematic anticancer therapy.
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Timepoint [6]
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Baseline to Objective Progression or Death Due to Any Cause (Estimated at up to 10.4 Months)
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/01/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
20/06/2022
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Sample size
Target
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Accrual to date
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Final
52
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment postcode(s) [1]
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3000 - Melbourne
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Recruitment outside Australia
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United States of America
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State/province [1]
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Colorado
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United States of America
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Florida
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United States of America
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Michigan
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United States of America
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State/province [4]
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Missouri
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Country [5]
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United States of America
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State/province [5]
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Ohio
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Country [6]
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United States of America
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State/province [6]
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Tennessee
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Country [7]
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United States of America
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Texas
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Country [8]
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United Kingdom
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State/province [8]
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Cambridgeshire
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Country [9]
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United Kingdom
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State/province [9]
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Scotland
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Country [10]
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United Kingdom
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State/province [10]
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Manchester
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Country [11]
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United Kingdom
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State/province [11]
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Sutton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eli Lilly and Company
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Merck Sharp & Dohme LLC
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Address [1]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04148937
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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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)
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Address
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Eli Lilly and Company
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04148937
Download to PDF