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Safety Lead-In Study of a Repurposed Drug Added to the Combination of Len Plus Pem
Sponsor: Evergreen Therapeutics, Inc.
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.
Official title: A Phase 2, Open-Label, Safety Lead-In With Long Term Safety Study of EG-007, Added to the Combination of Lenvatinib Plus Pembrolizumab
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
28
Start Date
2026-08
Completion Date
2027-03
Last Updated
2025-12-08
Healthy Volunteers
No
Conditions
Interventions
EG-007
A Repurposed 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.
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.