A Trial to Investigate the Safety of E303 in Participants With Advanced Refractory Solid Tumors

Purpose

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

Condition

  • Advanced Solid Tumors

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
E303
  • Drug: E303
    All participants will receive an intravenous (IV) infusion of E303

Recruiting Locations

Research Site
Scottsdale, Arizona 85258

Research Site
Fairfax, Virginia 22031

More Details

Status
Recruiting
Sponsor
Samsung Bioepis Co., Ltd.

Study Contact

Samsung Bioepis
+82-32-728-0114
bioepisinfo@samsung.com