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

Samsung

Status and phase: Enrolling; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: E303

Study type: Interventional

Funder types: Industry

Identifiers

NCT07524348

E303-1001

Details and patient eligibility

About

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

Enrollment: 149 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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149 participants in 1 patient group

E303

Experimental group

Treatment:

Drug: E303