Lifirafenib (BGB-283) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 490

Clinical Trials

Multiple clinical trials have evaluated lifirafenib (BGB-283) for the treatment of various advanced adult solid tumors. Sponsored by BeiGene, these completed Phase 1 and Phase 1a/1b dose-escalation and expansion studies evaluated safety, tolerability, pharmacokinetics, and preliminary antitumor efficacy. Collectively, these protocols reflect a focused effort to establish the therapeutic profile and optimal dosing of lifirafenib in patients with solid tumors.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03905148	COMPLETED	Solid Tumor, Adult	BeiGene	2019-05-01	PHASE1
NCT02610361	COMPLETED	Solid Tumors	BeiGene	2013-11-20	PHASE1
NCT03641586	COMPLETED	Solid Tumors	BeiGene	2015-10-12	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-01-07)

Check the Lifirafenib (BGB-283) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lifirafenib binds to and inhibits RAF family kinases as well as epidermal growth factor receptor (EGFR) mutants, thereby blocking downstream mitogen-activated protein kinase (MAPK) signaling and suppressing oncogenic cell proliferation. By shutting down these proliferative cascades, the compound promotes apoptosis and reduces tumor burden, which underlies its therapeutic application in targeting advanced adult solid tumors studied in Phase 1 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>).