Clinical Trials

Several clinical trials evaluate belvarafenib across Phase I and Phase II studies for oncology indications, including advanced or metastatic melanoma, primary and metastatic brain tumors, and locally advanced solid malignancies. Sponsored by industry leaders and research institutions such as Genentech, Hanmi Pharmaceutical, Hoffmann-La Roche, and Samsung Medical Center, these investigations include actively recruiting studies assessing central nervous system efficacy and combination therapies, as well as active trials no longer recruiting. Together, these clinical investigations aim to establish the safety, pharmacokinetics, and therapeutic potential of belvarafenib as both monotherapy and combination treatment.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04589845 ACTIVE_NOT_RECRUITING
Solid Tumors
Hoffmann-La Roche
 2021-01-18 PHASE2
NCT07449754 RECRUITING
Advanced or Metastatic Melanoma
Hanmi Pharmaceutical Company Limited
 2026-02-12 PHASE2
NCT07688356 RECRUITING
Primary Brain Tumor; Metastatic Brain Tumor
Samsung Medical Center
 2026-06-15 PHASE2
NCT04835805 ACTIVE_NOT_RECRUITING
Melanoma
Genentech, Inc.
 2021-05-13 PHASE1
NCT04835805 Active not recruiting
Melanoma
Genentech Inc.
 2021-05-13 Phase 1
NCT03284502 Active not recruiting
Locally Advanced Solid Tumor|Metastatic Solid Tumor
Hanmi Pharmaceutical Company Limited
 2017-05-22 Phase 1

(data from https://clinicaltrials.gov, updated on 2026-09-04)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Belvarafenib acts as a selective pan-RAF kinase inhibitor by binding to wild-type BRAF, BRAF(V600E), and CRAF with IC50 values of 41 nM, 7 nM, and 2 nM, respectively, thereby suppressing downstream MAPK/ERK pathway signaling. This inhibition halts oncogenic cellular proliferation and survival, providing the mechanistic foundation for its evaluation in clinical trials targeting BRAF-altered solid tumors, including melanoma and primary or metastatic brain malignancies.

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.