A Phase 1 interventional study of E303 in Advanced Solid Tumors, sponsored by Samsung Bioepis Co., Ltd.. Recruiting at 7 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Samsung Bioepis Co., Ltd. · Phase 1, Interventional, and Treatment
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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
Samsung Bioepis Co., Ltd. is the lead sponsor of 33 studies on the registry; 2 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: E303
All participants will receive an intravenous (IV) infusion of E303
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 endpoint per Blinded Independent Central Review (BICR), according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: 32 weeks
Tumor response
Efficacy endpoint per BICR, according to RECIST v1.1
Time frame: 32 weeks
Disease control rate
Efficacy endpoint per BICR, according to RECIST v1.1
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)
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Jul 2030, 52 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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