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NOT YET RECRUITING
NCT07030478
PHASE1/PHASE2

A Study to Evaluate the Safety and Tolerability of EP0089

Sponsor: Ellipses Pharma

View on ClinicalTrials.gov

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

Interventions

DRUG

EP0089-101

EP0089 will be initially administered by intravenous (IV) infusion once every 2 weeks (Q2W)