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A Study to Evaluate the Safety and Tolerability of EP0089
Sponsor: Ellipses Pharma
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.
Official title: A Phase I/IIa Study to Evaluate the Safety and Tolerability of Monoclonal Antibody EP0089 in Patients With Advanced Solid Tumours
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
190
Start Date
2025-09
Completion Date
2029-06
Last Updated
2025-06-22
Healthy Volunteers
No
Conditions
Interventions
EP0089-101
EP0089 will be initially administered by intravenous (IV) infusion once every 2 weeks (Q2W)