Lartesertib (M4076) Clinical Trials

Size	Price	Qty
1mg	USD 170
5mg	USD 490

Clinical Trials

Multiple clinical trials, primarily sponsored by EMD Serono Research & Development Institute and Merck KGaA, are currently evaluating lartesertib (M4076) as a monotherapy or in combination regimens. These Phase 1 and Phase 2 studies range from completed early-phase evaluations to active or recruiting protocols focusing on advanced solid tumors, metastatic or locally advanced unresectable solid tumors, and ovarian cancer. Together, these trials underscore the therapeutic potential of targeting ATM kinase across various solid malignancies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05396833	ACTIVE_NOT_RECRUITING	Metastatic or Locally Advanced Unresectable Solid Tumors	EMD Serono Research & Development Institute, Inc.	2022-06-07	PHASE1
NCT06433219	ACTIVE_NOT_RECRUITING	Ovarian Cancer	EMD Serono Research & Development Institute, Inc.	2024-10-30	PHASE2
NCT04882917	COMPLETED	Advanced Solid Tumors	EMD Serono Research & Development Institute, Inc.	2021-05-24	PHASE1
NCT05396833	Recruiting	Metastatic or Locally Advanced Unresectable Solid Tumors	EMD Serono Research & Development Institute Inc.\|Merck KGaA Darmstadt Germany\|EMD Serono	2022-06-07	Phase 1
NCT04882917	Completed	Advanced Solid Tumors	EMD Serono Research & Development Institute Inc.\|Merck KGaA Darmstadt Germany\|EMD Serono	2021-05-24	Phase 1

(data from https://clinicaltrials.gov, updated on 2026-05-28)

Check the Lartesertib (M4076) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lartesertib (M4076) selectively binds to and inhibits ataxia telangiectasia-mutated (ATM) kinase with sub-nanomolar potency, thereby blocking double-strand break DNA repair biochemistry and suppressing clonogenic tumor cell growth. This pharmacological blockade potentiates radiosensitivity and chemosensitivity, demonstrating therapeutic relevance for patients with advanced solid tumors, metastatic unresectable malignancies, and ovarian cancer.

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>).