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RecruitingInterventionalPhase 1

A Phase I, Open-Label, Multi-Center, First-in-Human Trial to Investigate E303, in Participants With Advanced Refractory Solid Tumors

NCT ID: NCT07524348Sponsor: Samsung Bioepis Co., Ltd.Last updated: 2026-06-01

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

Arms & interventions

  • DrugE303

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

Outcome measures

Primary

  • 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

    Efficacy enpoint per Blinded Independent Central Review (BICR), according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Time frame: 32 weeks

Secondary

  • Tumor response

    Time frame: 32 weeks

  • Disease control rate

    Time frame: 32 weeks

  • Area under the plasma/serum concentration vs time curve of total E303

    Time frame: Until trial completion (estimated 3 years)

  • Maximum plasma/serum concentration of total E303

    Time frame: Until trial completion (estimated 3 years)

  • Time to reach maximum plasma/serum concentration of total E303

    Time frame: Until trial completion (estimated 3 years)

  • Plasma/serum concentration before the next dose of total E303

    Time frame: Until trial completion (estimated 3 years)

  • Terminal half life of total E303

    Time frame: Until trial completion (estimated 3 years)

  • Incidence and titer of anti-drug antibodies

    Time frame: Until trial completion (estimated 3 years)

  • Incidence of neutralizing antibodies

    Time frame: Until trial completion (estimated 3 years)

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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 locations (2)

Research Site

Scottsdale, Arizona, 85258

Recruiting

Research Site

Fairfax, Virginia, 22031

Recruiting