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NCT Number: NCT07524348

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

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

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Key information

Conditions

Advanced Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Adelaide, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

E303

Drug

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

Primary outcomes

  1. Incidence of adverse events and serious adverse events

    Time frame: Until trial completion (estimated 3 years)

  2. Incidence of dose limiting toxicity

    Time frame: For the first cycle of treatment, through pre-dose Cycle 2 Day 1

  3. Confirmed objective response rate

    Time frame: 32 weeks

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

Secondary outcomes

  1. Tumor response

    Time frame: 32 weeks

    Efficacy endpoint per BICR, according to RECIST v1.1

  2. Disease control rate

    Time frame: 32 weeks

    Efficacy endpoint per BICR, according to RECIST v1.1

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

    Time frame: Until trial completion (estimated 3 years)

  4. Maximum plasma/serum concentration of total E303

    Time frame: Until trial completion (estimated 3 years)

  5. Time to reach maximum plasma/serum concentration of total E303

    Time frame: Until trial completion (estimated 3 years)

  6. Plasma/serum concentration before the next dose of total E303

    Time frame: Until trial completion (estimated 3 years)

  7. Terminal half life of total E303

    Time frame: Until trial completion (estimated 3 years)

  8. Incidence and titer of anti-drug antibodies

    Time frame: Until trial completion (estimated 3 years)

  9. Incidence of neutralizing antibodies

    Time frame: Until trial completion (estimated 3 years)

Interested in participating?

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Interested in participating?

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Sponsors and collaborators

Lead sponsor

Samsung Bioepis Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Apr 13, 2026
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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