Advanced and/or Metastatic Solid Tumors
Conditions
Brief summary
Dose-limiting toxicities (DLTs) when patients are receiving weekly administration of EGL-001 and proportion of patients with adverse events (AEs), treatment-emergent AEs (TEAEs), and serious AEs (SAEs) between the first dose of study drug and up to 90 days after the last dose of study drug., Proportion of patients with complete response (CR) or partial response (PR).
Detailed description
Efficacy assessment based on Overall response rate (ORR), Disease control rate (DCR), Duration of overall response (DoR), Progression-free survival (PFS), Overall survival (OS)., The proportion of patients with adverse events (AEs), treatment-emergent adverse events (TEAEs), and Serious adverse Events (SAEs) between the first dose of study drug and up to 90 days after the last dose of study drug.
Interventions
DRUGEGL-001
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
Sponsors
Egle Therapeutics
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicities (DLTs) when patients are receiving weekly administration of EGL-001 and proportion of patients with adverse events (AEs), treatment-emergent AEs (TEAEs), and serious AEs (SAEs) between the first dose of study drug and up to 90 days after the last dose of study drug., Proportion of patients with complete response (CR) or partial response (PR). | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy assessment based on Overall response rate (ORR), Disease control rate (DCR), Duration of overall response (DoR), Progression-free survival (PFS), Overall survival (OS)., The proportion of patients with adverse events (AEs), treatment-emergent adverse events (TEAEs), and Serious adverse Events (SAEs) between the first dose of study drug and up to 90 days after the last dose of study drug. | — |
Countries
France, Spain
Outcome results
None listed