E303 safety in people with advanced refractory solid tumors
A Phase I, Open-Label, Multi-Center, First-in-Human Trial to Investigate E303, in Participants With Advanced Refractory Solid Tumors
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 |
| Enrollment | 149 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Samsung Bioepis Co., Ltd. Industry-sponsored |
| Locations | 3 sites (Scottsdale, Arizona and 2 other locations) |
| Trial ID | NCT07524348 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Scottsdale, Arizona and 2 other locations
- Research Site — Scottsdale, Arizona, United States (Recruiting)
- Research Site — Fairfax, Virginia, United States (Recruiting)
- Research Site — Adelaide, Australia (Recruiting)
Study contacts
- Study coordinator: Samsung Bioepis
- Email: bioepisinfo@samsung.com
- Phone: +82-32-728-0114
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.