ONO-4578
Sponsors
Ono Pharmaceutical Co. Ltd., Ono Pharmaceutical Co., Ltd., Ono Pharmaceutical Co. Ltd
Conditions
Advanced or Metastatic Solid TumorsColorectal CancerEsophageal AdenocarcinomaEsophagogastric Junction CancerGastric CancerHER2-negative Breast CancerHormone Receptor-positive Breast CancerMetastatic Breast Cancer
Phase 1
Study of ONO-4578 With and Without ONO-4538 in Subjects Advanced or Metastatic Solid Tumors
Active, not recruitingNCT03155061
Start: 2017-04-19End: 2028-03-01Target: 183Updated: 2026-09-04
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
CompletedNCT06538207
Start: 2021-01-13End: 2025-01-30Updated: 2025-02-06
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
CompletedNCT06542731
Start: 2021-06-01End: 2025-10-30Updated: 2026-10-20
Study of ONO-4578 and XELOX/FOLFOX Plus Bevacizumab in Colorectal Cancer
Active, not recruitingNCT06547385
Start: 2021-01-13End: 2027-10-31Updated: 2026-10-22
ONO-4578-06:Phase I Study of ONO-4578 and Letrozole Plus CDK4 /6 Inhibitors in Breast Cancer
CompletedNCT06570031
Start: 2021-11-09End: 2026-04-30Updated: 2026-06-05
Phase 2
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)
Active, not recruitingNCT06256328
Start: 2024-01-10End: 2027-07-31Updated: 2026-03-13
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
RecruitingNCT06948448
Start: 2025-11-18End: 2028-10-01Target: 144Updated: 2026-07-16
A randomized, open label, multicenter, Phase 2 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 for first-line treatment of non-MSI-H/dMMR, PD-L1 positive advanced colorectal cancer.
RecruitingCTIS2024-519590-19-00
Start: 2025-11-25Target: 76Updated: 2025-10-09