Clinical Trials

Betta Pharmaceuticals Co., Ltd. is currently sponsoring a clinical trial evaluating the targeted TEAD inhibitor BPI-460372 in patients with advanced solid tumors. This active and recruiting early-phase study aims to assess the drug's safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy. Furthermore, the trial intends to define appropriate dosing parameters for treating advanced malignancies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05789602 RECRUITING
Advanced Solid Tumor
Betta Pharmaceuticals Co., Ltd.
 2023-04-24 PHASE1

(data from https://clinicaltrials.gov, updated on 2025-01-27)

Check the BPI-460372 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BPI-460372 acts as a covalent, irreversible inhibitor of TEAD 1/3/4 that binds to the conserved cysteine residue within the TEAD palmitoylation pocket, thereby preventing protein palmitoylation and blocking downstream TEAD-mediated transcriptional activation. By suppressing TEAD-dependent oncogenic gene expression, this compound inhibits tumor cell proliferation and survival, providing a direct mechanistic basis for its therapeutic evaluation in patients with advanced solid tumors.

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.