Dysautonomia International

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

Arm	Description	Assigned 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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.