FDA releases draft guidance for early-phase first-in-human studies of solid-tumor therapies

The U.S. Food and Drug Administration has issued draft guidance to help sponsors design early-phase first-in-human IND studies for investigational drugs and biologics targeting solid tumors.

The guidance is part of the agency’s Operation TrialBlazer initiative, which seeks to streamline the development of new cancer therapies and enhance patient safety.

Sponsors are encouraged to use the document to align trial designs with FDA expectations, potentially shortening development timelines and improving regulatory interactions.