A Phase I, Open-Label, Multi-Center, First-in-Human Trial to Investigate E303, in Participants With Advanced Refractory Solid Tumors
Samsung Bioepis Co., Ltd.
Summary
This is a Phase I trial to evaluate the safety, tolerability and efficacy of nectin-4 targeting antibody-drug conjugate (SBE303) in participants with advanced solid tumors
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically-confirmed, locally advanced (unresectable) or metastatic solid tumors with recurrence or progression during or after standard therapy, intolerance to standard therapy, refused to receive standard therapy, or for whom no standard therapy is available. Exclusion Criteria: * Have spinal cord compression or clinically active central nervous system metastases * Have leptomeningeal disease * Have thromboembolic or clinically significant bleeding events * Have significant cardiovascular disease * Have an active autoimmune disease
Interventions
- DrugE303
All participants will receive an intravenous (IV) infusion of E303
Location
- Research SiteFairfax, Virginia