Advanced Cancer Clinical Trial
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
Verified date | April 2024 |
Source | Eli Lilly and Company |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 52 |
Est. completion date | June 20, 2022 |
Est. primary completion date | May 12, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Australia | Peter MacCallum Cancer Centre | Melbourne | Victoria |
United Kingdom | Addenbrookes Hospital | Cambridge | Cambridgeshire |
United Kingdom | Beatson West of Scotland Cancer Center | Glasgow | Scotland |
United Kingdom | Christie NHS Foundation Trust | Manchester | |
United Kingdom | Royal Marsden NHS Trust | Sutton | |
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | Sarah Cannon Research Institute at HealthOne | Denver | Colorado |
United States | START Midwest | Grand Rapids | Michigan |
United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
United States | Florida Cancer Specialists ORLANDO/DDU | Lake Mary | Florida |
United States | Sarah Cannon Research Institute SCRI | Nashville | Tennessee |
United States | Washington University Medical School | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Eli Lilly and Company | Merck Sharp & Dohme LLC |
United States, Australia, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Dose Limiting Toxicities (DLTs) | 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. |
Up to 28 days from the first dose | |
Secondary | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Eight Hours (AUC[0-8]) of LY3475070 | PK: AUC[0-8] of LY3475070. | Cycle 1 Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8 hours post-dose) | |
Secondary | PK: Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUCtau) of LY3475070 | PK: AUCtau of LY3475070 | 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 | PK: Maximum Concentration (Cmax) of LY3475070 | PK: Cmax of LY3475070 | 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 | Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) | 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. | Baseline through Disease Progression or Death (Estimated at up to 10.4 Months) | |
Secondary | Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, and Stable Disease (SD) | 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. | Baseline through Measured Progressive Disease (Estimated at up to 10.4 Months) | |
Secondary | Progression-Free Survival (PFS) | 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. | Baseline to Objective Progression or Death Due to Any Cause (Estimated at up to 10.4 Months) |
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