Compass Gets FDA Go-Ahead for Phase 2 Cancer Trial

By Matt Grossman

Compass Therapeutics Inc. said Thursday that a decision from the U.S. Food and Drug Administration will allow the company to proceed with a global Phase 2 trial evaluating its drug designed to treat advanced biliary-tract cancers.

The Boston-based pharmaceutical company said the FDA has accepted its investigational-new-drug application for CTX-009, an antibody that Compass is developing for people whose biliary-tract cancer hasn't responded to other treatments.

Compass is already studying the drug in a Phase 2 study in South Korea. Data from that trial will be rolled into an expanded trial that includes U.S. sites following the FDA's clearance, Compass said.

The expanded second stage of the Phase 2 study is expected to begin in the second quarter of 2022, Compass said.

Write to Matt Grossman at [e-mail]

(END) Dow Jones Newswires

01-20-22 0858ET