A Study to Evaluate the Safety and Tolerability of EP0089
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEllipses Pharma
About this trial
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.
Eligibility criteria
Qualifiers
Must be ≥18 years of age (≥19 in South Korea) with documented recurrent, metastatic or unresectable solid tumours for whom no standard therapy exists or standard therapy has failed
ECOG performance status of 0 or 1 and life expectancy >3 months at screening
Ability to understand and provide written informed consent
Must be willing to comply with necessary contraceptive methods as required
Disqualifiers
Known active CNS metastases and/or leptomeningeal disease and/or carcinomatous meningitis.
Recent major surgery
Recent live or live-attenuated vaccine ≤ 30 days prior to the first dose
Current active, or history of, autoimmune disease that requires or required systemic treatment (ie, with disease modifying agents, corticosteroids, or immunosuppressive drugs) within 2 years prior to starting study treatment.
Trial design
Treatments tested in this trial
- EP0089-101
Treatment groups
190 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov