Onvansertib

Drug

Drug Profile

Onvansertib is an investigational oral enzyme inhibitor targeting PLK1 in oncology. Ongoing studies are evaluating it across multiple cancers, including small cell lung cancer and other solid tumors. It is currently in active clinical trial development and not approved as a marketed therapy.

Drug Class
Investigational PLK1 enzyme inhibitor (small molecule)
Approval Status
Investigational; active Phase II clinical trial status reported.
Mechanism of Action
Binds PLK1 to disrupt cell replication and induce tumor-cell death.
Indications
  • \Advanced-stage small cell lung cancer (investigational)\
  • \Triple-negative breast cancer (investigational)\
  • \CMML/MDS-MPN overlap neoplasms (investigational)\
  • \Pancreatic cancer (investigational)\

Related News

Related Clinical Trials

NCT ID Title Status Phase
NCT06736717

Onvansertib in Combination With NALIRIFOX for First Line Treatment of Advanced Pancreatic Cancer

RECRUITING PHASE1/PHASE2
NCT06398587

Onvansertib in Combination With Gemcitabine and Nab-paclitaxel for the Treatment of Patients With Locally-advanced, Unresectable, or Metastatic Pancreatic Ductal Adenocarcinoma

WITHDRAWN PHASE2
NCT06106308

Study of Onvansertib in Combination With FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab Versus FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab for First-Line Treatment of Metastatic Colorectal Cancer in Adult Participants With a KRAS or NRAS Mutation

ACTIVE_NOT_RECRUITING PHASE2
NCT05593328

Study of Onvansertib in Combination With FOLFIRI and Bevacizumab Versus FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer in Participants With a Kirsten Rat Sarcoma Virus Gene (KRAS) or Neuroblastoma-RAS (NRAS) Mutation

COMPLETED PHASE2
NCT05549661

Onvansertib for the Treatment of Recurrent or Refractory Chronic Myelomonocytic Leukemia and Myelodysplastic Syndrome/MPN Overlap Neoplasms

RECRUITING PHASE1
NCT05450965

Study of PLK1 Inhibitor, Onvansertib, in Relapsed Small Cell Lung Cancer

RECRUITING PHASE2
NCT05383196

Onvansertib + Paclitaxel In TNBC

ACTIVE_NOT_RECRUITING PHASE1/PHASE2
NCT04752696

Onvansertib in Combination With Nanoliposomal Irinotecan, Leucovorin, and Fluorouracil for Second-Line Treatment of Participants With Metastatic Pancreatic Ductal Adenocarcinoma

COMPLETED PHASE2
NCT04446793

Expanded Access of Onvansertib With FOLFIRI and Bevacizumab for the Second-Line Treatment of Participants With KRAS-Mutated Metastatic Colorectal Cancer

NO_LONGER_AVAILABLE
NCT04005690

Targeted Pathway Inhibition in Patients With Pancreatic Cancer

RECRUITING EARLY_PHASE1