ONO-4578 (Not yet branded)

Other Medications

US Experimental EU Experimental ES Not available IV 2 Clinical Trials
Target not publicly disclosed

Description

ONO-4578 is a novel therapeutic agent being developed for metastatic colorectal cancer, specifically in patients with microsatellite instability-high (MSI-H) tumors. This compound is administered in combination regimens that include established therapies such as nivolumab (Opdivo), mFOLFOX6 chemotherapy, and bevacizumab for enhanced antitumor activity. Based on current clinical development, ONO-4578 appears to be designed to work synergistically with immunotherapy and standard chemotherapy combinations in the metastatic CRC setting.

Mechanism of Action

ONO-4578's specific molecular mechanism of action has not been fully disclosed in publicly available information. The drug is being studied in combination with immune checkpoint inhibitors and chemotherapy, suggesting it may modulate immune responses or enhance the efficacy of existing therapeutic approaches in MSI-H colorectal tumors.

Molecular Targets

Side Effects

Specific side effect profile not yet established Likely includes fatigue Nausea Diarrhea Neutropenia Peripheral neuropathy Hypertension Proteinuria Skin reactions

Not all side effects are listed. Side effects vary by individual. Always consult your oncologist.

Clinical Trials

NCT06948448 Phase 2
Recruiting
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
United States, Canada, France, Italy, Japan, Spain
NCT06547385 Phase 1
Active, not recruiting
Study of ONO-4578 and XELOX/FOLFOX Plus Bevacizumab in Colorectal Cancer
Japan