Clinical Trials

Sponsored by Bayer, multiple clinical trials evaluate BAY 2416964 primarily for the treatment of advanced solid tumors. These Phase 1 and Phase 1b open-label dose escalation and expansion studies—with recruitment statuses spanning completed, active not recruiting, and terminated—aim to assess safety, tolerability, pharmacokinetics, and maximum tolerated dosing. Overall, clinical evaluation remains focused on establishing preliminary safety and therapeutic parameters in patients with advanced solid malignancies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04999202 TERMINATED
Advanced Solid Tumors
Bayer
 2021-08-30 PHASE1
NCT04069026 COMPLETED
Advanced Solid Tumors
Bayer
 2019-08-15 PHASE1
NCT04999202 Active not recruiting
Advanced Solid Tumors
Bayer
 2021-08-30 Phase 1
NCT04069026 Completed
Advanced Solid Tumors
Bayer
 2019-08-15 Phase 1

(data from https://clinicaltrials.gov, updated on 2025-02-10)

Check the BAY 2416964 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BAY 2416964 functions as a potent, orally active antagonist of the aryl hydrocarbon receptor (AhR) with an IC50 of 341 nM, selectively binding AhR to block ligand-induced nuclear translocation and downstream gene transcription. By suppressing AhR-driven immunosuppressive metabolic pathways within the tumor microenvironment, this agent enhances anti-tumor immune responses to inhibit neoplastic growth in 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.