Cintirorgon (LYC-55716) Clinical Trials

Size	Price	Qty
5mg	USD 217
25mg	USD 657

Clinical Trials

Multiple clinical trials sponsored by Lycera Corp. evaluate Cintirorgon (LYC-55716) in adult patients with advanced solid tumors and non-small cell lung cancer. This research includes a completed Phase 1/2 study in locally advanced or metastatic cancers, alongside a Phase 1 study of unknown recruitment status investigating the agent in combination with pembrolizumab. These early-phase trials serve to establish the safety profile and therapeutic potential of Cintirorgon across various oncological indications.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03396497	UNKNOWN	Non-small Cell Lung Cancer	Lycera Corp.	2018-08-03	PHASE1
NCT02929862	COMPLETED	Cancer	Lycera Corp.	2016-12	PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2019-09-25)

Check the Cintirorgon (LYC-55716) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cintirorgon (LYC-55716) selectively binds to and activates retinoic acid receptor-related orphan receptor gamma (RORγ), thereby modulating transcription of target genes involved in immune regulation. This activation enhances effector T-cell activity and cytokine production within the tumor microenvironment, driving anti-tumor immune responses in clinical settings such as advanced solid tumors and non-small cell lung cancer.

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>).