Clinical Trials

Multiple Phase 1 clinical trials sponsored by industry entities, including EMD Serono Research & Development Institute and Merck KGaA, have evaluated the investigative small-molecule inhibitor M3541 for the treatment of solid tumors. These early-stage studies utilized dose-escalation protocols combining M3541 with palliative radiation therapy to assess the drug's safety profile and therapeutic viability. Patient recruitment for these Phase 1 investigations has since been terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03225105 TERMINATED
Solid Tumors
EMD Serono Research & Development Institute, Inc.
 2017-09-06 PHASE1
NCT03225105 Terminated
Solid Tumors
EMD Serono Research & Development Institute Inc.|Merck KGaA Darmstadt Germany|EMD Serono
 2017-09-06 Phase 1

(data from https://clinicaltrials.gov, updated on 2023-11-22)

Check the M3541 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

M3541 selectively binds to and inhibits ataxia telangiectasia mutated (ATM) kinase with nanomolar potency, thereby suppressing double-strand break repair pathways and blocking clonogenic cancer cell growth. By impairing the cellular DNA damage response, M3541 sensitizes malignant cells to ionizing radiation, providing a biological rationale for its clinical investigation in combination with radiotherapy for 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.