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A Study to Evaluate the Safety and Tolerability of EP0089

NCT07030478 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2025-06-22

No results posted yet for this study

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

Interventions

DRUG

EP0089-101

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

Sponsors & Collaborators

  • Ellipses Pharma

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2028-03-31
Completion
2029-06-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07030478 on ClinicalTrials.gov