E303 safety in people with advanced refractory solid tumors
Official title: A Phase I, Open-Label, Multi-Center, First-in-Human Trial to Investigate E303, in Participants With Advanced Refractory Solid Tumors
Run by Samsung Bioepis Co., Ltd. · NCT07524348 · Data updated 2026-11-12
This Phase I trial will test whether the drug E303 is safe and tolerable in people with advanced solid tumors who have not responded to or cannot receive standard treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 149 (estimated) |
| Sponsor | Samsung Bioepis Co., Ltd. Industry-sponsored |
| Locations | 7 sites (Scottsdale, Arizona and 6 other locations) |
| Status | Recruiting |
| Started | March 23, 2026 |
| Main results expected | July 2030 |
| Study ends | July 2030 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT07524348 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with histologically confirmed unresectable or metastatic solid tumors that have recurred or progressed during or after standard therapy, are intolerant of standard therapy, have refused standard therapy, or have no available standard options are candidates for this trial.
✕Probably not a fit
Patients with active central nervous system metastases, leptomeningeal disease, recent thromboembolic or significant bleeding events, significant cardiovascular disease, or active autoimmune disease are excluded and unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase I, multicenter, open-label trial gives E303 (also referred to as SBE303), a nectin-4–targeting antibody-drug conjugate, to adults with unresectable or metastatic solid tumors that progressed after or are not eligible for standard therapy. The study uses a dose-escalation design to determine safety, tolerability, and recommended dose while monitoring for dose-limiting toxicities and adverse events. Secondary assessments typically include pharmacokinetics and preliminary anti-tumor activity using standard imaging and response criteria. Enrollment focuses on patients whose disease is refractory to available treatments and who meet protocol eligibility and safety requirements.
Why it matters
Potential benefit: If successful, E303 could provide a new targeted treatment option that helps shrink tumors or control disease in some patients with advanced nectin-4–expressing solid tumors.
How similar studies have gone: Other nectin-4–targeting antibody-drug conjugates (for example enfortumab vedotin in urothelial cancer) have shown clinical benefit, so the general approach has precedent though E303 itself is being tested for the first time in this setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Research Site
Scottsdale, Arizona, United States Recruiting -
Research Site
Fairfax, Virginia, United States Recruiting -
Research Site
Adelaide, Australia Recruiting -
Research Site
Melbourne, Australia Recruiting -
Research Site
Seoul, South Korea Recruiting -
Research Site
Barcelona, Spain Recruiting
Show 1 more location
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Research Site
Madrid, Spain Recruiting
Study contacts
- Study coordinator: Samsung Bioepis
- Email: bioepisinfo@samsung.com
- Phone: +82-32-728-0114
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.