A Phase 1, Study of the CD73 Inhibitor LY3475070
Research type
Research Study
Full 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
IRAS ID
273031
Contact name
Johann De Bono
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2019-003270-64
Duration of Study in the UK
3 years, 0 months, 9 days
Research summary
Medications that target the immune system help to treat some types of cancer. Approximately 50 to 80% of patients with advanced cancers experience progressive disease (PD) as their best response to a group of medications called immune checkpoint inhibitors (ICI). This suggests that some tumours may become resistant to treatment with ICIs, as most patients whose tumour initially responded to ICI eventually develop PD.
A number of chemical reactions occur within tumours that suppress the immune system and result in tumour growth. One of the chemicals involved in tumour growth is adenosine, and a molecule called CD73 is involved in the production of adenosine within tumour cells. Therefore, medications that target/inhibit CD73 have the potential to become new cancer treatments.LY3475070 is an orally available drug that works by binding/inhibiting a protein on the outside of the CD73 molecule. LY3475070 has been studied in laboratory and animal trials. Studies on other CD73 inhibitors suggest that the treatment is well tolerated in patients.
JZMA is a Phase 1a/1b first in human study of LY3475070. The aim of this study is to determine a safe dose of LY3475070 alone and in combination with Pembrolizumab (1a) and to determine a recommended dose for future studies (1b). JZMA will target triple negative breast cancer, pancreatic cancer, non-small cell lung cancer, renal cell carcinoma, melanoma and prostate cancer. Depending on when you enrol and what type of cancer you have you will participate in Phase 1a or 1b.Patients in each of the phases will receive LY3475070 orally once a day. In addition to this, some patients will also receive Pembrolizumab. There will be approximately 180 patients globally participating in the study including approximately 8 patients in the UK.
REC name
London - Chelsea Research Ethics Committee
REC reference
19/LO/1768
Date of REC Opinion
20 Dec 2019
REC opinion
Further Information Favourable Opinion