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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
EP0089-101
DrugEP0089 will be initially administered by intravenous (IV) infusion once every 2 weeks (Q2W)
Treatment groups
190 Participants
are divided into 1 treatment groupGroup A: Dose EscalationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety and Tolerability of EP0089
The study's main goal is to find the highest safe dose of EP0089 and the best dose for future testing.
Time frame
126 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: