Advanced Solid Tumors
Conditions
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
Interventions
DRUGE303
All participants will receive an intravenous (IV) infusion of E303
Sponsors
Samsung Bioepis Co., Ltd.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 32 weeks | Efficacy endpoint per Blinded Independent Central Review (BICR), according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumor response | 32 weeks | Efficacy endpoint per BICR, according to RECIST v1.1 |
| Disease control rate | 32 weeks | Efficacy endpoint per BICR, according to RECIST v1.1 |
| 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) | — |
| Plasma/serum concentration before the next dose of total E303 | Until trial completion (estimated 3 years) | — |
| Terminal half life of total E303 | Until trial completion (estimated 3 years) | — |
| Incidence and titer of anti-drug antibodies | Until trial completion (estimated 3 years) | — |
| Incidence of neutralizing antibodies | Until trial completion (estimated 3 years) | — |
Countries
Australia, South Korea, Spain, United States
Contacts
CONTACTSamsung Bioepis
Outcome results
None listed