Navoximod Clinical Trials

Size	Price	Qty
5mg	USD 470
25mg	USD 1,470

Clinical Trials

Multiple Phase 1 clinical trials sponsored by industry leaders like Genentech Inc. and academic investigators including Dr. Jason Luke have evaluated navoximod (GDC-0919) for solid and advanced solid tumors. These early-stage investigations assessed the drug's safety, pharmacology, and therapeutic potential, with recruitment status varying across studies. Notably, a trial examining combination therapy with atezolizumab was completed, whereas a Phase 1 evaluation involving stereotactic body radiotherapy was withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05469490	WITHDRAWN	Advanced Solid Tumors	Luke, Jason, MD	2022-10	PHASE1
NCT02471846	Completed	Solid Tumor	Genentech Inc.	2015-07-28	Phase 1

(data from https://clinicaltrials.gov, updated on 2022-09-30)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Navoximod potently binds to and inhibits indoleamine-(2,3)-dioxygenase, blocking the enzymatic conversion of L-tryptophan into kynurenine and preventing local immunosuppressive metabolite accumulation in the tumor microenvironment. By reversing kynurenine-mediated immune suppression and promoting effector T-lymphocyte activity, navoximod restores host anti-tumor immunity, providing clinical relevance for its evaluation in patients with solid tumors and advanced solid malignancies.

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>).