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ONO-4578

Ono Pharmaceutical Co., Ltd.

ONO-4578 is an oral, selective EP4 antagonist developed by Ono Pharmaceutical that blocks PGE2-mediated immunosuppression to potentiate PD-1 inhibition. The ONO

Gastric Cancer

Studies (7 shown)

NCT06948448PHASE2RECRUITING

A Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo®, in Combination With mFOLFOX6 and Bevacizumab Versus Standard of Care in Participants With Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer

Sponsor · Ono Pharmaceutical Co., Ltd.Condition · Colorectal CancerIntervention · ONO-4578, Opdivo®Updated May 2026
NCT06256328PHASE2ACTIVE_NOT_RECRUITING

A Study to Investigate the Efficacy and Safety of ONO-4578 in Combination With Nivolumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)

Sponsor · Ono Pharmaceutical Co., Ltd.Condition · Gastric CancerIntervention · ONO-4578, OxaliplatinUpdated Mar 2026
NCT06570031PHASE1ACTIVE_NOT_RECRUITING

ONO-4578-06:Phase I Study of ONO-4578 and Letrozole Plus CDK4 /6 Inhibitors in Breast Cancer

Sponsor · Ono Pharmaceutical Co., Ltd.Condition · Hormone Receptor-positive Breast Cancer, HER2-negative Breast CancerIntervention · ONO-4578, letrozoleUpdated Jul 2025
NCT03155061PHASE1ACTIVE_NOT_RECRUITING

Study of ONO-4578 With and Without ONO-4538 in Subjects Advanced or Metastatic Solid Tumors

Sponsor · Ono Pharmaceutical Co., Ltd.Condition · Advanced or Metastatic Solid TumorsIntervention · ONO-4578, ONO-4538Updated Jun 2025
NCT06547385PHASE1ACTIVE_NOT_RECRUITING

Study of ONO-4578 and XELOX/FOLFOX Plus Bevacizumab in Colorectal Cancer

Sponsor · Ono Pharmaceutical Co., Ltd.Condition · Colorectal CancerIntervention · ONO-4578, ONO-4538Updated Aug 2024
NCT06542731PHASE1ACTIVE_NOT_RECRUITING

An Open-label, Uncontrolled Study of ONO-4578 and ONO-4538 in Combination With Standard-of-care Docetaxel and Ramucirumab as Second-line Therapy in Patients With Advanced or Recurrent Non-small Cell Lung Cancer

Sponsor · Ono Pharmaceutical Co., Ltd.Condition · Non-small Cell Lung CancerIntervention · ONO-4578, ONO-4538Updated Aug 2024
NCT06538207PHASE1COMPLETED

An Open-label, Uncontrolled Study of ONO-4578 and ONO-4538 in Combination With Standard-of-care Modified FOLFIRINOX (mFFX) or Gemcitabine Plus Nab-paclitaxel (GnP) Therapy as First-line Treatment in Patients With Metastatic Pancreatic Cancer

Sponsor · Ono Pharmaceutical Co., Ltd.Condition · Metastatic Pancreatic CancerIntervention · ONO-4578, ONO-4538Updated Feb 2025
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