NCT07524348

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P75+ for phase_1

Timeline
49mo left

Started Mar 2026

Longer than P75 for phase_1

Geographic Reach
3 countries

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Mar 2026Jul 2030

Study Start

First participant enrolled

March 23, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2030

Last Updated

June 1, 2026

Status Verified

May 1, 2026

Enrollment Period

4.3 years

First QC Date

March 26, 2026

Last Update Submit

May 28, 2026

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

  • 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 (9)

  • Tumor response

    32 weeks

  • Disease control rate

    32 weeks

  • Area under the plasma/serum concentration vs time curve of total E303

    Until trial completion (estimated 3 years)

  • Maximum plasma/serum concentration of total E303

    Until trial completion (estimated 3 years)

  • Time to reach maximum plasma/serum concentration of total E303

    Until trial completion (estimated 3 years)

  • +4 more secondary outcomes

Study Arms (1)

E303

EXPERIMENTAL
Drug: E303

Interventions

E303DRUG

All participants will receive an intravenous (IV) infusion of E303

E303

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Research Site

Scottsdale, Arizona, 85258, United States

RECRUITING

Research Site

Fairfax, Virginia, 22031, United States

RECRUITING

Research Site

Adelaide, Australia

RECRUITING

Research Site

Barcelona, Spain

RECRUITING

Central Study Contacts

Samsung Bioepis

CONTACT

+82-32-728-0114bioepisinfo@samsung.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2026

First Posted

April 13, 2026

Study Start

March 23, 2026

Primary Completion (Estimated)

July 1, 2030

Study Completion (Estimated)

July 1, 2030

Last Updated

June 1, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)ES(1)US(2)