LY3405105 Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Multiple clinical trials sponsored by Eli Lilly and Company have evaluated the compound LY3405105 in patients with advanced solid tumors. These Phase 1 and Phase 1a/1b studies were designed to assess safety and therapeutic potential. However, recruitment was ultimately terminated, halting the compound's early-stage clinical development prior to completion.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03770494	TERMINATED	Solid Tumor	Eli Lilly and Company	2019-01-31	PHASE1
NCT03770494	Terminated	Solid Tumor	Eli Lilly and Company	2019-01-31	Phase 1

(data from https://clinicaltrials.gov, updated on 2025-11-04)

Check the LY3405105 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

LY3405105 is an orally active cyclin-dependent kinase 7 (CDK7) inhibitor with an IC50 of 92.8 nM that selectively blocks CDK7 catalytic activity, thereby preventing downstream phosphorylation of RNA polymerase II and disrupting cell cycle progression. Consequently, this target inhibition suppresses cancer cell proliferation and promotes apoptosis, providing the biological rationale for its antineoplastic evaluation in patients with advanced solid tumors.

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>).