AZD3965 Clinical Trials

Size	Price	Qty
1mg	USD 147
5mg	USD 297

Clinical Trials

Multiple Phase I clinical trials have evaluated the monocarboxylate transporter inhibitor AZD3965 to establish its safety, dosage, and early therapeutic potential in patients with advanced malignancies, including adult solid tumors, diffuse large B-cell lymphoma, and Burkitt lymphoma. Sponsored by Cancer Research UK in collaboration with AstraZeneca, these studies aimed to define key tolerability parameters. All clinical trials for this compound have completed recruitment.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01791595	COMPLETED	Adult Solid Tumor; Diffuse Large B Cell Lymphoma; Burkitt Lymphoma	Cancer Research UK	2013-04-23	PHASE1
NCT01791595	Completed	Adult Solid Tumor\|Diffuse Large B Cell Lymphoma\|Burkitt Lymphoma	Cancer Research UK\|AstraZeneca	2013-04-23	Phase 1

(data from https://clinicaltrials.gov, updated on 2022-04-11)

Check the AZD3965 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AZD3965 selectively binds to monocarboxylate transporter 1 (MCT1) with a binding affinity of 1.6 nM, effectively blocking transmembrane lactate transport and disrupting glycolytic flux alongside intracellular pH homeostasis in cancer cells. This metabolic inhibition impairs cell proliferation and induces apoptosis, offering potential anti-tumor efficacy against MCT1-dependent malignancies such as adult solid tumors, diffuse large B-cell lymphoma, and Burkitt lymphoma.

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>).