E303: All participants will receive an intravenous (IV) infusion of E303
Study 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
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy 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
Primary outcome measure(s)
Incidence of adverse events and serious adverse events — Until trial completion (estimated 3 years)
Incidence of dose limiting toxicity — For the first cycle of treatment, through pre-dose Cycle 2 Day 1
Confirmed objective response rate — 32 weeks Efficacy endpoint per Blinded Independent Central Review (BICR), according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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