Clinical Trials

LY2780301 has been evaluated in several clinical trials across various oncological indications. Industry sponsor Eli Lilly and Company completed a Phase 1 monotherapy trial targeting advanced or metastatic neoplasms. Additionally, European academic centers sponsored combination therapy trials, including a terminated Phase 1b/2 study by Institut Paoli-Calmettes evaluating LY2780301 with paclitaxel in HER2-negative metastatic breast cancer and a completed Phase 1b trial by Gustave Roussy assessing its combination with gemcitabine in solid tumors and Non-Hodgkin's lymphoma.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01980277 TERMINATED
Breast Cancer
Institut Paoli-Calmettes
 2014-01 PHASE1; PHASE2
NCT02018874 COMPLETED
Solid Tumors and Non-Hodgkin's Lymphoma
Gustave Roussy, Cancer Campus, Grand Paris
 2013-09 PHASE1
NCT01115751 COMPLETED
Metastases, Neoplasm
Eli Lilly and Company
 2010-03 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-04-21)

Check the LY2780301 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

LY2780301 acts as a highly selective, adenosine triphosphate-competitive dual inhibitor that binds to Akt and p70S6K, suppressing enzymatic kinase activity and downstream signal transduction through the PI3K/Akt pathway. This target inhibition leads to reduced cellular proliferation and the induction of apoptosis, driving therapeutic efficacy against solid tumors, metastatic breast cancer, and Non-Hodgkin's lymphoma as investigated in clinical trials.

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>).

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Note: Technical data last updated: Sep 1, 2026.