Clinical Trials

Several Phase 1 and Phase 2 clinical trials sponsored by Incyte Corporation and Incyte Biosciences Japan GK have evaluated the safety, tolerability, pharmacokinetics, and clinical activity of INCB086550. These studies investigated the compound in healthy volunteers and patients with broad and specific solid tumor cohorts, including non-small cell lung cancer, urothelial cancer, renal cell carcinoma, hepatocellular carcinoma, and melanoma. Recruitment across these trials is currently marked as either completed or terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04629339 TERMINATED
Non Small Cell Lung Cancer; Urothelial Cancer; Renal Cell Carcinoma; Hepatocellular Carcinoma; Melanoma
Incyte Corporation
 2021-09-02 PHASE2
NCT03762447 COMPLETED
Solid Tumors
Incyte Corporation
 2018-12-10 PHASE1
NCT04674748 TERMINATED
Solid Tumors
Incyte Biosciences Japan GK
 2021-02-03 PHASE1
NCT05101369 COMPLETED
Healthy Volunteers
Incyte Corporation
 2022-01-21 PHASE1
NCT05101369 Completed
Healthy Volunteers
Incyte Corporation
 2022-01-21 Phase 1
NCT03762447 Completed
Solid Tumors
Incyte Corporation
 2018-12-10 Phase 1

(data from https://clinicaltrials.gov, updated on 2025-03-13)

Check the INCB086550 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

INCB086550 selectively binds to programmed death-ligand 1 (PD-L1) with an IC50 of 10 nM or less, blocking the PD-1/PD-L1 checkpoint interaction and inducing target dimerization and endocytic internalization. This disruption prevents immunosuppressive signaling to restore T-cell-mediated immune surveillance, thereby inhibiting tumor growth across solid malignancies including non-small cell lung cancer, renal cell carcinoma, 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>).

Jump to

Note: Technical data last updated: Sep 1, 2026.