Recruiting
Phase 1

SBE303

Sponsor:

Samsung Bioepis Co., Ltd.

Code:

NCT07524348

Conditions

Advanced Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

E303

Study Details

Brief 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

Conditions

Advanced Solid Tumors

Study ID

NCT07524348

Start date

Mar 23, 2026

Status verified date

Aug, 2026

Completion date

Jul, 2030

Anticipated

Primary completion date

Jul, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

149 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: E303

Interventions

E303

All participants will receive an intravenous (IV) infusion of E303

Primary outcome measure

  • Incidence of adverse events and serious adverse events [ Time Frame: Until trial completion (estimated 3 years) ]
  • Incidence of dose limiting toxicity [ Time Frame: For the first cycle of treatment, through pre-dose Cycle 2 Day 1 ]
  • Confirmed objective response rate [ Time Frame: 32 weeks ]

Central Contacts and Locations

Central contacts

Samsung Bioepis

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

Locations

Research Site

Recruiting

Scottsdale, Arizona, United States, 85258

Research Site

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

Samsung Bioepis Co., Ltd.

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Samsung Bioepis Co., Ltd. on 2026-08-27.