Advanced Solid TumorsPhase 1NCT07524348
A Trial to Investigate the Safety of E303 in Participants With Advanced Refractory Solid Tumors
A Phase 1 study testing E303 in people with Advanced Solid Tumors, run by Samsung Bioepis Co., Ltd. at 7 sites in 4 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- E303
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 23 Mar 2026to Jul 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
7 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 4 countries
United States2 sites, 2 recruiting
- Recruiting
Research Site
Fairfax, Virginia, 22031
- Recruiting
Research Site
Scottsdale, Arizona, 85258
Australia2 sites, 2 recruiting
- Recruiting
Research Site
Adelaide
- Recruiting
Research Site
Melbourne
Spain2 sites, 2 recruiting
- Recruiting
Research Site
Barcelona
- Recruiting
Research Site
Madrid
About this study
Official title: A Phase I, Open-Label, Multi-Center, First-in-Human Trial to Investigate E303, in Participants With Advanced Refractory Solid Tumors
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
- Conditions
- Advanced Solid Tumors
- Being tested
- E303
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E303Drug
All participants will receive an intravenous (IV) infusion of E303
| Study group | Role | What they receive |
|---|---|---|
| E303 | Experimental | Not described Receives: Drug: E303 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events and serious adverse events
Measured: Until trial completion (estimated 3 years)
Incidence of dose limiting toxicity
Measured: 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
Measured: 32 weeks
Secondary outcomes (9)
Tumor response
Efficacy endpoint per BICR, according to RECIST v1.1
Measured: 32 weeks
Disease control rate
Efficacy endpoint per BICR, according to RECIST v1.1
Measured: 32 weeks
Area under the plasma/serum concentration vs time curve of total E303
Measured: Until trial completion (estimated 3 years)
Maximum plasma/serum concentration of total E303
Measured: Until trial completion (estimated 3 years)
Time to reach maximum plasma/serum concentration of total E303
Measured: Until trial completion (estimated 3 years)
Plasma/serum concentration before the next dose of total E303
Measured: Until trial completion (estimated 3 years)
Terminal half life of total E303
Measured: Until trial completion (estimated 3 years)
Incidence and titer of anti-drug antibodies
Measured: Until trial completion (estimated 3 years)
Incidence of neutralizing antibodies
Measured: Until trial completion (estimated 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start23 Mar 2026
- Primary completionJul 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 149 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Bioepis Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07524348
- Sponsor's protocol ID
- E303-1001
- Status last verified
- Sep 2026
- First submitted
- 26 Mar 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Multi-Center, First-in-Human Trial to Investigate E303, in Participants With Advanced Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT07524348
- Acronym / sponsor ID
- E303-1001
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 149 participants (estimated)
- Lead sponsor
- Samsung Bioepis Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| E303 | Experimental | Drug: E303 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E303All participants will receive an intravenous (IV) infusion of E303 | Drug | E303 |
Primary outcome
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
Efficacy endpoint per Blinded Independent Central Review (BICR), according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
9 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing E303 in people with Advanced Solid Tumors, run by Samsung Bioepis Co., Ltd. at 7 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Australia, Spain, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samsung Bioepis (+82-32-728-0114, bioepisinfo@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events and serious adverse events (time frame: Until trial completion (estimated 3 years)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.