NCT07030478

A Study to Evaluate the Safety and Tolerability of EP0089

A Phase I/IIa Study to Evaluate the Safety and Tolerability of Monoclonal Antibody EP0089 in Patients With Advanced Solid Tumours

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 190 (estimated)
• Sponsor: Ellipses Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a first-in-human (FIH), first-in-class, Phase I/IIa, open-label study designed to evaluate the safety and tolerability of EP0089 (study drug). Study drug will initially be given via intravenous (IV) infusion once every 2 weeks (Q2W), with one treatment cycle defined as 14 days. The study will enroll patients with advanced solid tumours for whom no standard therapy exists or for whom standard therapy has failed. An independent Safety Monitoring Committee (SMC) will review safety data at regular intervals to ensure participant safety and support dose escalation decisions.

Conditions

• Solid Cancers
• Solid Tumours

Interventions

Type	Name	Description
DRUG	EP0089-101	EP0089 will be initially administered by intravenous (IV) infusion once every 2 weeks (Q2W)

Timeline

• Start date: 2025-09-01
• Primary completion: 2028-03-01
• Completion: 2029-06-01
• First posted: 2025-06-22
• Last updated: 2025-06-22