Exarafenib (KIN-2787) Clinical Trials

Size	Price	Qty
5mg	USD 199
25mg	USD 470

Clinical Trials

The clinical development of Exarafenib (KIN-2787) currently includes a clinical trial evaluating the agent across specific oncology indications. Conducted by Kinnate Biopharma, this industry-sponsored, Phase I open-label study is actively recruiting adult patients diagnosed with solid tumors, non-small cell lung cancer, or melanoma. This initial investigation assesses the safety, tolerability, pharmacokinetics, and therapeutic antitumor activity of the compound.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04913285	Recruiting	Solid Tumor Adult\|Non-small Cell Lung Cancer\|Melanoma	Kinnate Biopharma	2021-08-04	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Exarafenib (KIN-2787) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Exarafenib is a selective pan-RAF inhibitor that binds to and inhibits RAF1, BRAF, and ARAF kinases, thereby suppressing downstream mitogen-activated protein kinase (MAPK) pathway signaling. By halting aberrant MAPK signaling to impede cancer cell proliferation, this mechanistic blockade reduces tumor burden in patients with RAF-dependent solid tumors, non-small cell lung cancer, and melanoma.

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>).