A Trial to Investigate the Safety of E303 in Participants... | NCT07524348

Studies
A Trial to Investigate the Safety of E303 in Participants With Advanced Refractory Solid Tumors

NCT07524348

Sponsor

Samsung Bioepis Co., Ltd.

Status

Recruiting

Last Update Posted

Jun 30, 2026Actual

Enrollment

149Estimated

Phase

Phase 1

Conditions

Advanced Solid Tumors

Interventions

E303

Countries

United States
Australia
Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 23, 2026Actual

Primary Completion Date

Jul 2030Estimated

Completion Date

Jul 2030Estimated

First Submitted Date

Mar 26, 2026

First Submission Date that Met QC Criteria

Apr 6, 2026

First Posted Date

Apr 13, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 28, 2026

Last Update Posted Date

Jun 30, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

149Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
E303	Experimental		Drug: E303

Interventions

Name	Type	Description	Arm Group Labels	Other Names
E303	Drug	All participants will receive an intravenous (IV) infusion of E303	E303

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	Efficacy enpoint per Blinded Independent Central Review (BICR), according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1	32 weeks

Secondary Outcomes

Measure	Description	Time Frame
Tumor response	Efficacy endpoint per BICR, according to RECIST v1.1	32 weeks
Disease control rate	Efficacy endpoint per BICR, according to RECIST v1.1

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Samsung Bioepis	Contact	+82-32-728-0114		bioepisinfo@samsung.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site	Recruiting	Scottsdale	Arizona	85258	United States
Research Site

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided