Pamufetinib (TAS-115) Clinical Trials

Size	Price	Qty
5mg	USD 197
100mg	USD 970

Clinical Trials

Sponsored by Taiho Pharmaceutical Co., Ltd., a Phase 1 clinical trial is actively recruiting participants to evaluate the safety and therapeutic potential of Pamufetinib (TAS-115) in novel AB122-based combination therapies. The study targets patients with advanced or metastatic solid tumors, specifically encompassing conditions such as pancreatic ductal adenocarcinoma, non-small cell lung cancer, colorectal cancer, gastric cancer, alveolar soft part sarcoma, esophageal cancer, head and neck cancer, and biliary tract cancer.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04999761	RECRUITING	Advanced or Metastatic Solid Tumor; Pancreatic Ductal Adenocarcinoma; Colorectal Cancer; Non-small Cell Lung Cancer; Gastric Cancer; Alveolar Soft Part Sarcoma; Esophageal Cancer; Head and Neck Cancer; Biliary Tract Cancer	Taiho Pharmaceutical Co., Ltd.	2021-06-01	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-05)

Check the Pamufetinib (TAS-115) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pamufetinib (TAS-115) functions as a potent dual inhibitor of VEGFR2 and MET receptor tyrosine kinases, binding to their kinase domains to suppress autophosphorylation and downstream oncogenic signaling pathways. By halting these critical biochemical cascades, the compound inhibits tumor angiogenesis and cancer cell proliferation, offering therapeutic relevance for the treatment of advanced or metastatic solid tumors, including non-small cell lung cancer and pancreatic ductal adenocarcinoma.

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>).