NCT06622486

First-in-human Trial of EGL-001 in Patients with Selected Advanced And/or Metastatic Solid Tumors

First-in-human Phase 1/2 Trial of EGL-001 in Adult Patients with Selected Advanced And/or Metastatic Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Egle Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This multicenter, open-label, first-in-human, Phase 1/2 study consists of a Part 1 (Phase 1) open-label dose escalation of EGL-001 administered as a single agent and in combination with an anti-PD(L)-1 treatment, followed by a Part 2 (Phase 2) open-label dose expansion of EGL-001 administered at the RP2D in patients with recurrent and/or metastatic solid tumors as monotherapy and/or combination therapy with anti-PD(L)-1.

Detailed description

In approximately 4 centers in France and 4 centers in Spain, 30 to 50 patients will be included in the dose escalation Part 1 of the trial. Number of participating countries and sites as well as patients will be defined based on Part 1 for Part 2 dose expansion phase.

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
DRUG	EGL-001	IV administration

Timeline

• Start date: 2024-09-27
• Primary completion: 2027-01-23
• Completion: 2027-01-23
• First posted: 2024-10-02
• Last updated: 2024-11-07

Locations

8 sites across 2 countries: France, Spain