Tuxobertinib (BDTX-189) Clinical Trials

Size	Price	Qty
5mg	USD 159
25mg	USD 477

Clinical Trials

Several clinical trials sponsored by Black Diamond Therapeutics, Inc. have evaluated tuxobertinib (BDTX-189) across Phase 1 and Phase 1/2 protocols for the management of solid tumor malignancies. These investigations were designed to assess the safety, tolerability, pharmacokinetics, and potential antitumor activity of the small-molecule inhibitor in human subjects. According to available registry data, these clinical trials currently report a terminated recruitment status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04209465	TERMINATED	Solid Tumor	Black Diamond Therapeutics, Inc.	2019-12-19	PHASE1
NCT04209465	Terminated	Solid Tumor	Black Diamond Therapeutics Inc.	2019-12-19	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2025-04-17)

Check the Tuxobertinib (BDTX-189) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tuxobertinib (BDTX-189) selectively binds to and inhibits allosteric oncogenic mutants of EGFR and HER2, blocking downstream receptor phosphorylation and dysregulated intracellular signaling pathways to impair cancer cell proliferation. By suppressing these mutant-driven kinase pathways, the compound exerts antitumor effects relevant to its clinical investigation 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>).