3 active not recruiting, 3 completed, 1 not yet recruiting, 1 recruiting. 5 Phase 1, 2 Phase 2, 1 Phase 3.
By phase and status
Follow this drug Literature Review of ONO-4578 trials Research Report on ONO-4578
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|
A Trial of ONO-4578 Versus Placebo in Combination With Nivolumab and Chemotherapy in Participants With Gastric Cancer, Esophagogastric Junction Cancer, or Esophageal Adenocarcinoma
ONO-4578, Placebo, Nivolumab - Gastric Cancer, Esophagogastric Junction Cancer | Phase 3 | Not yet recruiting | Ono Pharmaceutical Co., Ltd. | 600 | 2027-02-01 | 2026-09-14 |
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
ONO-4578, Opdivo®, Oxaliplatin - Colorectal Cancer | Phase 2 | Recruiting | Ono Pharmaceutical Co., Ltd. | 144 | 2025-11-18 | 2026-07-16 |
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)
ONO-4578, Oxaliplatin, Capecitabine - Gastric Cancer | Phase 2 | Active not recruiting | Ono Pharmaceutical Co., Ltd. | 226 | 2024-01-10 | 2026-03-13 |
ONO-4578-06:Phase I Study of ONO-4578 and Letrozole Plus CDK4 /6 Inhibitors in Breast Cancer
ONO-4578, letrozole, Palbociclib - Hormone Receptor-positive Breast Cancer, HER2-negative Breast Cancer | Phase 1 | Completed | Ono Pharmaceutical Co., Ltd. | 46 | 2021-11-09 | 2026-06-05 |
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
ONO-4578, ONO-4538, Docetaxel - Non-small Cell Lung Cancer | Phase 1 | Completed | Ono Pharmaceutical Co., Ltd. | 42 | 2021-06-01 | 2026-10-20 |
Study of ONO-4578 and XELOX/FOLFOX Plus Bevacizumab in Colorectal Cancer
ONO-4578, ONO-4538, Capecitabine - Colorectal Cancer | Phase 1 | Active not recruiting | Ono Pharmaceutical Co., Ltd. | 40 | 2021-01-13 | 2024-08-09 |
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
ONO-4578, ONO-4538, Oxaliplatin - Metastatic Pancreatic Cancer | Phase 1 | Completed | Ono Pharmaceutical Co., Ltd. | 46 | 2021-01-13 | 2025-02-06 |
Study of ONO-4578 With and Without ONO-4538 in Subjects Advanced or Metastatic Solid Tumors
ONO-4578, ONO-4538 - Advanced or Metastatic Solid Tumors | Phase 1 | Active not recruiting | Ono Pharmaceutical Co., Ltd. | 183 | 2017-04-19 | 2026-09-04 |
Conditions studied
Colorectal Neoplasms (2) · Stomach Neoplasms (2) · Adenocarcinoma (1) · Adenocarcinoma Of Esophagus (1) · Breast Neoplasms (1) · Carcinoma, Non-Small-Cell Lung (1) · Neoplasm Metastasis (1) · Pancreatic Neoplasms (1) · Recurrence (1)
Sponsors
Ono Pharmaceutical Co., Ltd. (8)
Countries
Japan (7) · Canada (1) · France (1) · Italy (1) · South Korea (1) · Spain (1) · Taiwan (1) · United States (1)
Top investigators
Project Leader (7)
Results publications
PMID 36082616, PMID 40618725, PMID 42223130