Nedisertib (M3814) Clinical Trials

Size	Price	Qty
5mg	USD 259
25mg	USD 777

Clinical Trials

Several Phase 1 and Phase 1/2 clinical trials evaluate the safety and clinical utility of nedisertib as monotherapy and in combination regimens across healthy volunteers and oncology indications, including advanced solid tumors, soft tissue sarcomas, prostate carcinoma, and ovarian and fallopian tube neoplasms. Sponsored by industry entities such as Merck KGaA and EMD Serono alongside government organizations like the National Cancer Institute, these trials span multiple recruitment statuses, including active, recruiting, completed, suspended, and terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05687136	RECRUITING	Advanced Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm; Unresectable Malignant Solid Neoplasm	National Cancer Institute (NCI)	2024-06-07	PHASE1
NCT04172532	RECRUITING	Locally Advanced Pancreatic Adenocarcinoma; Stage III Pancreatic Cancer AJCC v8	National Cancer Institute (NCI)	2021-01-11	PHASE1; PHASE2
NCT04068194	ACTIVE_NOT_RECRUITING	Locally Advanced Malignant Solid Neoplasm; Locally Advanced Unresectable Cholangiocarcinoma; Locally Advanced Unresectable Gallbladder Carcinoma; Locally Advanced Unresectable Malignant Solid Neoplasm; Metastatic Cholangiocarcinoma; Metastatic Gallbladder Carcinoma; Metastatic Malignant Solid Neoplasm; Stage III Gallbladder Cancer AJCC v8; Stage IV Gallbladder Cancer AJCC v8; Unresectable Malignant Solid Neoplasm	National Cancer Institute (NCI)	2020-04-07	PHASE1; PHASE2
NCT03983824	ACTIVE_NOT_RECRUITING	Recurrent Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia	National Cancer Institute (NCI)	2020-05-05	PHASE1
NCT04071236	SUSPENDED	Metastatic Castration-Resistant Prostate Carcinoma; Metastatic Malignant Neoplasm in the Bone; Metastatic Malignant Neoplasm in the Lymph Nodes; Stage IVB Prostate Cancer AJCC v8	National Cancer Institute (NCI)	2020-10-14	PHASE1; PHASE2
NCT04750954	ACTIVE_NOT_RECRUITING	Neuroendocrine Neoplasm	National Cancer Institute (NCI)	2021-07-22	PHASE1
NCT05711615	RECRUITING	Metastatic Dedifferentiated Liposarcoma; Metastatic Leiomyosarcoma; Metastatic Myxofibrosarcoma; Metastatic Sarcoma; Metastatic Synovial Sarcoma; Metastatic Undifferentiated Pleomorphic Sarcoma; Unresectable Dedifferentiated Liposarcoma; Unresectable Leiomyosarcoma; Unresectable Myxofibrosarcoma; Unresectable Sarcoma; Unresectable Synovial Sarcoma; Unresectable Undifferentiated Pleomorphic Sarcoma	National Cancer Institute (NCI)	2024-02-06	PHASE1
NCT04092270	ACTIVE_NOT_RECRUITING	Endometrial High Grade Endometrioid Adenocarcinoma; Fallopian Tube Clear Cell Adenocarcinoma; Fallopian Tube Endometrioid Adenocarcinoma; Fallopian Tube High Grade Serous Adenocarcinoma; Fallopian Tube Malignant Mixed Mesodermal (Mullerian) Tumor; Fallopian Tube Mucinous Adenocarcinoma; Fallopian Tube Transitional Cell Carcinoma; Fallopian Tube Undifferentiated Carcinoma; FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma; FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma; Ovarian High Grade Serous Adenocarcinoma; Ovarian Seromucinous Carcinoma; Ovarian Undifferentiated Carcinoma; Platinum-Sensitive Ovarian Carcinoma; Primary Peritoneal Carcinosarcoma; Primary Peritoneal High Grade Serous Adenocarcinoma; Primary Peritoneal Transitional Cell Carcinoma; Primary Peritoneal Undifferentiated Carcinoma; Recurrent Fallopian Tube Carcinoma; Recurrent Low Grade Fallopian Tube Serous Adenocarcinoma; Recurrent Ovarian Carcinoma; Recurrent Ovarian Clear Cell Adenocarcinoma; Recurrent Ovarian Endometrioid Adenocarcinoma; Recurrent Ovarian Low Grade Serous Adenocarcinoma; Recurrent Ovarian Malignant Mixed Mesodermal (Mullerian) Tumor; Recurrent Ovarian Mucinous Adenocarcinoma; Recurrent Ovarian Transitional Cell Carcinoma; Recurrent Primary Peritoneal Carcinoma; Recurrent Primary Peritoneal Low Grade Serous Adenocarcinoma	National Cancer Institute (NCI)	2020-05-07	PHASE1
NCT03724890	COMPLETED	Oncology; Solid Tumors	EMD Serono Research & Development Institute, Inc.	2018-11-27	PHASE1
NCT03770689	COMPLETED	Locally Advanced Rectal Cancer	EMD Serono Research & Development Institute, Inc.	2019-03-20	PHASE1; PHASE2
NCT02516813	COMPLETED	Advanced Solid Tumors	EMD Serono Research & Development Institute, Inc.	2015-09-15	PHASE1
NCT04702698	Completed	Healthy	Merck Healthcare KGaA Darmstadt Germany an affiliate of Merck KGaA Darmstadt Germany	2021-01-14	Phase 1
NCT03116971	TERMINATED	Small Cell Lung Cancer	EMD Serono Research & Development Institute, Inc.	2017-05-25	PHASE1
NCT02316197	COMPLETED	Advanced Solid Tumors; Chronic Lymphocytic Leukemia	Merck KGaA, Darmstadt, Germany	2014-12-31	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-24)

Check the Nedisertib (M3814) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Nedisertib potently and selectively inhibits DNA-dependent protein kinase, thereby blocking non-homologous end joining repair of double-strand DNA breaks and disrupting cancer cell genomic integrity. This impairment of DNA repair mechanisms sensitizes malignant cells to DNA-damaging interventions, impairing tumor progression in advanced solid tumors, sarcomas, and gynecologic carcinomas evaluated in clinical trials.

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>).