Recruiting NCT07524348
A Trial to Investigate the Safety of E303 in Participants With Advanced Refractory Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: E303.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase I, Open-Label, Multi-Center, First-in-Human Trial to Investigate E303, in Participants With Advanced Refractory Solid Tumors
Overview
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
Interventions
- Drug E303
All participants will receive an intravenous (IV) infusion of E303
Primary outcome measures
- 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 [Time frame: 32 weeks]
Secondary outcome measures (9)
- Tumor response [Time frame: 32 weeks]
- Disease control rate [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)]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Research Site — Scottsdale
- Research Site — Fairfax
Australia · 2 centers
- Research Site — Adelaide
- Research Site — Melbourne
Spain · 2 centers
- Research Site — Barcelona
- Research Site — Madrid
Identifiers
NCT: NCT07524348 · E303-1001