Clinical Trials

Gilead Sciences exclusively sponsored several clinical trials evaluating the small-molecule inhibitor GS-4224 in patients with advanced solid tumors. Reaching Phase 1 and Phase 1b/2 development, these investigations aimed to assess safety profiles, tolerability, pharmacokinetics, and preliminary therapeutic efficacy. However, recruitment was ultimately terminated, limiting the clinical evaluation of GS-4224 to early-stage oncology studies that were halted before completion.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04049617 TERMINATED
Advanced Solid Tumors
Gilead Sciences
 2019-08-26 PHASE1
NCT04049617 Terminated
Advanced Solid Tumors
Gilead Sciences
 2019-08-26 Phase 1

(data from https://clinicaltrials.gov, updated on 2022-10-06)

Check the GS-4224 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

GS-4224 potent and selective binding to the human programmed cell death protein 1 / programmed death-ligand 1 (PD-1/PD-L1) interface directly disrupts this immune-checkpoint interaction, thereby overriding immunosuppressive signals and enhancing the production of interferon-gamma and Granzyme B in T lymphocytes. This revitalized cytotoxic T-cell activity restores host immune surveillance, providing the mechanistic rationale for evaluating GS-4224 as a targeted therapy against advanced solid tumors.

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>).

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