Clinical trial · Interventional
A Trial to Investigate the Safety of E303 in Participants With Advanced Refractory Solid Tumors
A Phase I, Open-Label, Multi-Center, First-in-Human Trial to Investigate E303, in Participants With Advanced Refractory Solid Tumors
NCT07524348CI-TRIAL-00124169recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| E303 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- E303
- interventionNames
- Drug: E303
Primary outcomes (3)
- measure
- Incidence of adverse events and serious adverse events
- timeFrame
- Until trial completion (estimated 3 years)
- measure
- Incidence of dose limiting toxicity
- timeFrame
- For the first cycle of treatment, through pre-dose Cycle 2 Day 1
- measure
- Confirmed objective response rate
- timeFrame
- 32 weeks
- description
- Efficacy endpoint per Blinded Independent Central Review (BICR), according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.