BCH Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 387

Clinical Trials

Multiple clinical trials are currently evaluating conditions including solid malignancies, breast, kidney, and lung cancers, melanoma, and catheter-related complications, with diagnostic protocols utilizing specialized imaging probes across oncology indications. These studies encompass Early Phase 1, Phase 2, and unassigned phase designs, featuring recruitment statuses of recruiting, not yet recruiting, and completed. The portfolio is sponsored primarily by academic medical centers and research institutes, including Peking University Cancer Hospital & Institute, Allegheny Health Network Research Institute, and Boston Children's Hospital.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06548529	RECRUITING	HER2 Positive or Suspicious Positive Tumors	Peking University Cancer Hospital & Institute	2024-06-01
NCT06115486	RECRUITING	Breast Cancer; Breast Carcinoma in Situ; Breast Cancer Female	Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)	2024-01-09
NCT07590310	RECRUITING	Kidney Cancers	Peking University Cancer Hospital & Institute	2025-03-01	EARLY_PHASE1
NCT06909604	RECRUITING	Breast Cancer	Peking University Cancer Hospital & Institute	2025-01-01
NCT05761366	RECRUITING	Malignancy	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	2022-10-13	PHASE2
NCT06454955	RECRUITING	B7H3; CD276 Affibody; PET/CT Imaing	Peking University Cancer Hospital & Institute	2024-01-01	EARLY_PHASE1
NCT05948878	COMPLETED	Dislodged Catheter; Catheter Related Complication	Boston Children's Hospital	2023-07-28

(data from https://clinicaltrials.gov, updated on 2024-08-23)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

BCH acts as a selective and competitive inhibitor of system L amino acid transporter 1 (LAT1), blocking the transport of essential neutral amino acids and suppressing downstream cellular nutrient signaling pathways. This intracellular nutrient deprivation triggers apoptotic cell death, leading to tumor growth inhibition in LAT1-overexpressing solid malignancies such as breast cancer, 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>).