Phase 1
Completed N=52
A Study of the CD73 Inhibitor LY3475070 Alone or in Combination With Pembrolizumab in Participants With Advanced Cancer
Source: ClinicalTrials.gov NCT04148937 ↗Enrolled (actual)
52
Serious AEs
26.9%
Results posted
Apr 2024
Primary outcomePrimary: Number of Participants With Dose Limiting Toxicities (DLTs) — 0; 0; 0; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose Limiting Toxicities (DLTs) |
0; 0; 0; 0; 0; 1 | — |
| SECONDARY Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Eight Hours (AUC[0-8]) of LY3475070 |
5880; 6580; 10700; 16000; 2990; 3680 | — |
| SECONDARY PK: Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUCtau) of LY3475070 |
7950; 8320; 19600; 26200; 3180; 3280 | — |
| SECONDARY PK: Maximum Concentration (Cmax) of LY3475070 |
1750; 2060; 2960; 4320; 1100; 974 | — |
| SECONDARY Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, and Stable Disease (SD) |
50; 33.3; 16.7; 0; 66.7; 27.3 | — |
| SECONDARY Progression-Free Survival (PFS) |
2.71; 1.91; 0.89; 1.33; 2; 0.53 | — |
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
Data sourced from ClinicalTrials.gov (NCT04148937). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.