drugset / Trial / NCT07030478

A Study to Evaluate the Safety and Tolerability of EP0089

NCT07030478 ↗

Phase 1/2 Not yet recruiting 190 enrolled Ellipses Pharma
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-09
Primary completion
2028-03
Completion
2029-06

Drugs

EvaluationDrugModalityDoseRoute
Subject EP0089 Monoclonal antibody — Intravenous

Indications