Clinical trial NCT04148937: A Study of the CD73 Inhibitor LY3475070 Alone or in Combination With Pembrolizumab in Participants With Advanced Cancer
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Cancer
Keywords: Triple Negative Breast Cancer
Pancreatic Cancer
Non-small Cell Lung Cancer
Renal Cell Carcinoma, Clear Cell
Cutaneous Melanoma
Castrate Resistant Prostate Cancer
Epithelial Ovarian Cancer
Metastatic Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2019-11-04
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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

Primary outcomes:
measure: Number of Participants With Dose Limiting Toxicities (DLTs)
timeFrame: Up to 28 days from the first dose
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Eight Hours (AUC[0-8]) of LY3475070
timeFrame: Cycle 1 Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8 hours post-dose)
measure: PK: Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUCtau) of LY3475070
timeFrame: 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)
measure: PK: Maximum Concentration (Cmax) of LY3475070
timeFrame: 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)
measure: Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR)
timeFrame: Baseline through Disease Progression or Death (Estimated at up to 10.4 Months)
measure: Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, and Stable Disease (SD)
timeFrame: Baseline through Measured Progressive Disease (Estimated at up to 10.4 Months)
measure: Progression-Free Survival (PFS)
timeFrame: Baseline to Objective Progression or Death Due to Any Cause (Estimated at up to 10.4 Months)
Other outcomes:
Locations:
city: Denver
country: United States
facility: Sarah Cannon Research Institute at HealthOne
state: Colorado
city: Lake Mary
country: United States
facility: Florida Cancer Specialists ORLANDO/DDU
state: Florida
city: Grand Rapids
country: United States
facility: START Midwest
state: Michigan
city: Saint Louis
country: United States
facility: Washington University Medical School
state: Missouri
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Nashville
country: United States
facility: Sarah Cannon Research Institute SCRI
state: Tennessee
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
state: Cambridgeshire
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Center
state: Scotland
city: Manchester
country: United Kingdom
facility: Christie NHS Foundation Trust
city: Sutton
country: United Kingdom
facility: Royal Marsden NHS Trust
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: