Clinical Trials

Multiple clinical trials have evaluated BGB-3245 across Phase 1 and Phase 1/2 studies for conditions such as advanced solid tumors, B-Raf mutant malignancies, colorectal cancer, and RAS-mutant pancreatic ductal cancers. Sponsored by entities including MapKure, LLC and SpringWorks Therapeutics, Inc., these studies assessed early-stage therapeutic efficacy in advanced disease settings. Currently, all of these clinical trials share a recruitment status of terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04249843 TERMINATED
Solid Tumor; B-Raf Mutation-Related Tumors
MapKure, LLC
 2020-02-10 PHASE1
NCT06194877 TERMINATED
Colorectal Cancer; Pancreatic Ductal Cancer; Advanced or Metastatic RAS Mutant Colorectal and Pancreatic Ductal Cancers
MapKure, LLC
 2024-04-18 PHASE1
NCT05580770 TERMINATED
Advanced Solid Tumor
SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany
 2023-02-03 PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-31)

Check the BGB-3245(Brimarafenib) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BGB-3245 selectively binds to and inhibits monomeric and dimeric RAF kinase isoforms, thereby blocking downstream mitogen-activated protein kinase pathway activation and signal transduction. This molecular blockade suppresses cancer cell proliferation and induces apoptosis, thereby conferring antitumor efficacy against B-Raf mutation-related tumors, advanced solid tumors, and RAS-mutant colorectal and pancreatic ductal cancers.

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.