TAS0728 Clinical Trials

Size	Price	Qty
5mg	USD 359
25mg	USD 970

Clinical Trials

A Phase 1 clinical trial sponsored by Taiho Oncology Inc. evaluated the safety, pharmacokinetics, and preliminary efficacy of the oral inhibitor TAS0728 in patients with advanced solid tumors harboring HER2 or HER3 genetic abnormalities. However, recruitment for this early-stage study was terminated, and no active clinical trials investigating TAS0728 are presently recorded.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03410927	Terminated	Advanced Solid Tumors With HER2 Abnormalities\|Advanced Solid Tumors With HER3 Abnormalities	Taiho Oncology Inc.	2018-04-06	Phase 1

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

Check the TAS0728 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

TAS0728 selectively and covalently binds to human epidermal growth factor receptor 2 (HER2), thereby blocking downstream oncogenic signal transduction and suppressing cellular proliferation. By irreversibly inhibiting HER2 activity, this compound impairs tumor development, establishing its therapeutic relevance in treating advanced solid tumors with HER2 or HER3 abnormalities.

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>).