NCT05106127

Safety Lead-In Study of a Repurposed Drug Added to the Combination of Len Plus Pem

A Phase 2, Open-Label, Safety Lead-In With Long Term Safety Study of EG-007, Added to the Combination of Lenvatinib Plus Pembrolizumab

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Evergreen Therapeutics, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2 trial Safety Lead-in trial conducted in 3 cohorts of patients. A safety lead-in study of the impact of adding the Repurposed Drugs a third agent will be conducted prior to opening enrollment into the compassionate use study. All patients enrolled in the safety lead-in study may continue long-term treatment under this protocol without interruption of dosing.

Conditions

• Advanced Endometrial Cancer

Interventions

Type	Name	Description
DRUG	EG-007	A Repurposed Drug
DRUG	Pembrolizumab 100 mg/4 mL (25 mg/ml) Injection	Pembrolizumab will be provided as a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution that requires dilution for intravenous infusion. Each vial contains 100 mg of pembrolizumab in 4 mL of solution.
DRUG	Lenvatinib Capsules	Lenvatinib will be provided as 4-mg and 10-mg capsules. Lenvatinib is formulated with calcium carbonate, mannitol, microcrystalline cellulose, hydroxypropyl cellulose, low-substituted hydroxypropylcellulose, and talc.

Timeline

• Start date: 2026-08-01
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2021-11-03
• Last updated: 2025-12-08

Regulatory

• FDA-regulated drug study