A Study to Evaluate the Safety and Tolerability of EP0089

Launched by ELLIPSES PHARMA · Jun 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called EP0089 for adults with advanced solid tumors—these are cancers that form solid lumps in the body. The goal of this early-phase study is to find out if EP0089 is safe and well-tolerated when given through an IV infusion every two weeks. The study is for patients whose cancer has not responded to standard treatments or for whom no standard treatment options are available. A special safety team will regularly review the results to make sure participants remain safe throughout the study.

To join the trial, patients must be adults with certain types of solid tumors that can be measured, have a good overall health status, and expect to live more than three months. Patients with active brain cancer spread, recent major surgery, or certain immune or neurological conditions may not be eligible. If accepted, participants will receive EP0089 infusions every two weeks and undergo regular tests and check-ups to monitor their health and how they respond to the treatment. This study is not yet recruiting, but it aims to help find new options for people with difficult-to-treat cancers.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Applicable to all patients:
• • 1. 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
• • 2. ECOG performance status of 0 or 1 and life expectancy \>3 months at screening
• • 3. Ability to understand and provide written informed consent
• • 4. Must be willing to comply with necessary contraceptive methods as required
• • 5. Willing and able to comply with the scheduled study treatment plan, laboratory tests, and other study procedures.
• • 6. Adequate hepatic, haematological and renal function as assessed by protocol-defined criteria.
• • 7. Additional cohort/disease specific criteria apply
• • 8. Measurable disease per RECIST v1.1
• Exclusion Criteria:
• • 1. Known active CNS metastases and/or leptomeningeal disease and/or carcinomatous meningitis.
• • 2. Recent major surgery
• • 3. Recent live or live-attenuated vaccine ≤ 30 days prior to the first dose
• • 4. 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.
• • 5. Prior severe hypersensitivity reaction to mAbs
• • 6. Previous \> Grade 2 peripheral neuropathy.
• • 7. Significant neurological condition eg stroke, transient ischaemic attack (in the last 12 months), epilepsy, head trauma, brain surgery or prior history of any significant psychiatric disorder
• • 9. Current active, or history of, autoimmune disease that requires or required continuous treatment within 2 years prior to starting study treatment
• • 10. Receiving chronic systemic steroid therapy (\> 10 mg /day of prednisone or equivalent) or any other form of immunosuppressive therapy ≤ 7 days prior the first dose of study drug. Topical or inhaled steroids are permitted.
• • 11. Any prior immune-mediated or immune-related adverse events related to treatment with immune-modulatory agents that caused permanent discontinuation of the agent, that were ≥ Grade 3 in severity or in the opinion of the Investigator would otherwise jeopardise patient safety in this study.
• • 12. One or more clinically significant (ie, active) cardiovascular diseases, myocardial infarction, or unstable angina (≤ 6 months prior to first administration of study drug)