Onvansertib (NMS-1286937, NMS-P937) Clinical Trials

Size	Price	Qty
10mg	USD 279
50mg	USD 790

Clinical Trials

Multiple clinical trials ranging from Early Phase 1 to Phase 2 evaluate onvansertib across various oncologic conditions, including metastatic colorectal cancer, pancreatic ductal adenocarcinoma, acute myeloid leukemia, triple-negative breast cancer, and small-cell lung cancer. Sponsored by organizations such as Cardiff Oncology, Mayo Clinic, and the University of Kansas Medical Center, these evaluations—some pairing onvansertib with chemotherapy in KRAS-mutated colorectal cancer or acute myeloid leukemia—currently span recruitment statuses of active not recruiting, recruiting, completed, and withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05450965	RECRUITING	Small-cell Lung Cancer; Small Cell Lung Carcinoma	University of Maryland, Baltimore	2022-07-19	PHASE2
NCT04005690	RECRUITING	Locally Advanced Pancreatic Ductal Adenocarcinoma; Metastatic Pancreatic Ductal Adenocarcinoma; Stage II Pancreatic Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Unresectable Pancreatic Ductal Adenocarcinoma; Borderline Resectable Pancreatic Ductal Adenocarcinoma; Resectable Pancreatic Ductal Adenocarcinoma	OHSU Knight Cancer Institute	2019-08-01	EARLY_PHASE1
NCT05549661	RECRUITING	Recurrent Chronic Myelomonocytic Leukemia; Refractory Chronic Myelomonocytic Leukemia; Myelodysplastic/Myeloproliferative Neoplasm, Not Otherwise Specified; Recurrent Atypical Chronic Myeloid Leukemia; Recurrent Myelodysplastic/Myeloproliferative Neoplasm; Refractory Myelodysplastic/Myeloproliferative Neoplasm	Mayo Clinic	2023-04-04	PHASE1
NCT05383196	ACTIVE_NOT_RECRUITING	Breast Cancer; Invasive Breast Cancer; Unresectable Breast Carcinoma; Locally Advanced Breast Cancer; Metastatic Breast Cancer; Inflammatory Breast Cancer; Triple Negative Breast Cancer (TNBC); Hormone Receptor/Growth Factor Receptor-Negative Breast Cancer; HER2-negative Breast Cancer; Hormone Receptor Negative Breast Carcinoma	Antonio Giordano, MD	2022-09-30	PHASE1; PHASE2
NCT06106308	ACTIVE_NOT_RECRUITING	Metastatic Colorectal Cancer; CRC; KRAS/NRAS Mutation	Cardiff Oncology	2024-02-27	PHASE2
NCT06736717	RECRUITING	Pancreatic Cancer	University of Kansas Medical Center	2025-02	PHASE1; PHASE2
NCT06398587	WITHDRAWN	Locally Advanced Pancreatic Ductal Adenocarcinoma; Metastatic Pancreatic Ductal Adenocarcinoma; Stage II Pancreatic Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Unresectable Pancreatic Adenocarcinoma	OHSU Knight Cancer Institute	2024-08-01	PHASE2
NCT04752696	COMPLETED	Pancreatic Ductal Adenocarcinoma	Cardiff Oncology	2021-05-25	PHASE2
NCT05593328	COMPLETED	Colorectal Cancer; Metastatic Colorectal Cancer	Cardiff Oncology	2023-03-17	PHASE2
NCT03829410	COMPLETED	Metastatic Colorectal Cancer; KRAS Gene Mutation	Cardiff Oncology	2019-06-24	PHASE1; PHASE2
NCT03414034	COMPLETED	Metastatic Castration-Resistant Prostate Cancer	Cardiff Oncology	2018-08-14	PHASE2
NCT05593328	Active not recruiting	Colorectal Cancer\|Metastatic Colorectal Cancer	Cardiff Oncology	2023-03-17	Phase 2
NCT03303339	COMPLETED	Acute Myeloid Leukemia	Cardiff Oncology	2017-11-17	PHASE1; PHASE2
NCT03829410	Completed	Metastatic Colorectal Cancer\|KRAS Gene Mutation	Cardiff Oncology	2019-05-06	Phase 1\|Phase 2
NCT03303339	Completed	Acute Myeloid Leukemia	Cardiff Oncology	2017-11-17	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2025-12-17)

Check the Onvansertib (NMS-1286937, NMS-P937) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Onvansertib selectively binds to Polo-like Kinase 1 (PLK1) to inhibit kinase activity, which prevents proper mitotic spindle assembly and triggers G2/M cell-cycle arrest and apoptosis in tumor cells. This targeted inhibition of cell division suppresses oncogenic growth, directly supporting its clinical evaluation in malignancies such as KRAS-mutated colorectal cancer, pancreatic ductal adenocarcinoma, and acute myeloid leukemia.

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>).