LY-3475070 Clinical Trials

Size	Price	Qty
5mg	USD 309
25mg	USD 927

Clinical Trials

Multiple Phase I clinical trials are evaluating the small-molecule CD73 inhibitor LY-3475070 as a monotherapy and in combination with pembrolizumab for patients with advanced cancer. Sponsored by industry pharmaceutical entities including Eli Lilly and Company and Merck Sharp & Dohme LLC, these early-stage investigations assess safety, tolerability, and preliminary efficacy. Within this clinical program, a primary multicenter global first-in-human trial has completed recruitment.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04148937	COMPLETED	Advanced Cancer	Eli Lilly and Company	2020-01-16	PHASE1
NCT04148937	Completed	Advanced Cancer	Eli Lilly and Company\|Merck Sharp & Dohme LLC	2020-01-16	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-04-05)

Check the LY-3475070 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

LY-3475070 selectively binds to and inhibits the ecto-5'-nucleotidase enzyme CD73, preventing the enzymatic conversion of extracellular adenosine monophosphate into immunosuppressive adenosine. By suppressing adenosine accumulation in the tumor microenvironment, the compound reactivates cytotoxic immune cell function to enhance antitumor immunity, thereby providing therapeutic potential for treating advanced cancer.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).