Health TrialsbyHealthPanel

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

ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSamsung Bioepis Co., Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • E303

    Drug

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

Treatment groups

149 Participants
are divided into 1 treatment group
Group A: E303Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of adverse events and serious adverse events

Time frame
Until trial completion (estimated 3 years)
2

Incidence of dose limiting toxicity

Time frame
For the first cycle of treatment, through pre-dose Cycle 2 Day 1
3

Confirmed objective response rate

Efficacy endpoint per Blinded Independent Central Review (BICR), according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Time frame
32 weeks

Secondary outcomes

1

Tumor response

Efficacy endpoint per BICR, according to RECIST v1.1

Time frame
32 weeks
2

Disease control rate

Efficacy endpoint per BICR, according to RECIST v1.1

Time frame
32 weeks
3

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

Time frame
Until trial completion (estimated 3 years)
4

Maximum plasma/serum concentration of total E303

Time frame
Until trial completion (estimated 3 years)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Samsung Bioepis Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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