Adagene Gets FDA Clearance for Phase 1b/2 Trial in Solid Tumors

By Michael Dabaie

Adagene Inc. said it received Food and Drug Administration clearance to proceed with a trial of ADG126 in combination with pembrolizumab in solid tumors.

The global Phase 1b/2 trial will evaluate patients with advanced/metastatic solid tumors at multiple sites in the U.S. and Asia Pacific, the company, which is focused on antibody-based therapies, said.

The company said it expects the ADG126-P001 trial to dose the first patients soon. The trial will evaluate safety and tolerability, and determine the recommended Phase 2 dose for ADG126 in combination with pembrolizumab, it said.

The trial will begin with dose escalation, followed by dose expansion at the recommended dose for early efficacy evaluation. A combination cohort of ADG126 with anti-PD-1 therapy toripalimab is also being initiated in Australia, the company said.

Write to Michael Dabaie at michael.dabaie@wsj.com

(END) Dow Jones Newswires

March 16, 2022 07:44 ET (11:44 GMT)

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