BAY 2965501 Clinical Trials

Size	Price	Qty
5mg	USD 297
25mg	USD 890

Clinical Trials

Sponsored by Bayer, several clinical trials are evaluating the early-stage development of BAY 2965501 in patients with advanced solid tumors. These Phase 1 protocols assess the safety, tolerability, dosing parameters, and maximum tolerated dose of the compound, with recruitment spanning both actively recruiting and active, non-recruiting statuses. Together, these studies aim to establish the preliminary therapeutic profile of BAY 2965501 to support its continued development against solid malignancies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05614102	ACTIVE_NOT_RECRUITING	Advanced Solid Tumors	Bayer	2022-11-04	PHASE1
NCT05614102	Recruiting	Advanced Solid Tumors	Bayer	2022-11-04	Phase 1

(data from https://clinicaltrials.gov, updated on 2026-07-07)

Check the BAY 2965501 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BAY 2965501 acts as a potent and selective inhibitor of diacylglycerol kinase zeta (DGKζ), preventing the phosphorylation of diacylglycerol and thereby restoring intracellular diacylglycerol levels in T-cells. This elevation in diacylglycerol induces downstream extracellular signal-regulated kinase (pERK) activation in anergic T-cells, enhancing immune cell reactivation to facilitate T-cell-mediated tumor cell killing 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>).