A Phase I, Open-Label, Multi-Center, First-in-Human Trial to Investigate E303, in Participants With Advanced Refractory Solid Tumors
Study Identifier:
E303-1001
CT.gov Identifier:
EudraCT Identifier:
EU Trial (CTIS) Number:
N/A
Study Contact Information:
Recruiting
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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
To evaluate the safety, tolerability and efficacy of SBE303 in participants with advanced refractory solid tumors.
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Solid Tumor
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Female & Male
Age
18+ years
Study Drug
N/A
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting
Requirements information
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
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START Barcelona
Barcelona, Spain, 08023
Investigator
Roberto Martin Huertas
Status
Recruiting
Condition(s) Treated at Site
Solid Tumor