New cancer Drug's dosing secrets explored in healthy volunteers

NCT ID NCT06385119

Completed Knowledge-focused Sponsor: Fore Biotherapeutics Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study in 28 healthy adults looks at how food and the drug cobicistat change the way plixorafenib (FORE8394) is processed by the body. Participants take single doses under different conditions—fasted, with low-fat or high-fat meals, and with or without cobicistat. The goal is to find the best way to give plixorafenib in future studies, while checking for side effects.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Plixorafenib (also known as FORE8394) and cobicistat (Tybost)
What this could lead to: If successful, this study will help determine the right dosing conditions for plixorafenib in future trials, potentially leading to better treatment options for certain cancers.
What could go wrong: This is an early Phase 1 study in only 28 healthy people, not patients. It tests drug levels and safety, not whether plixorafenib works against any disease. Results may not predict effects in sick patients.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HEALTHY PARTICIPANTS

Contacts and locations

Locations

PPD - Austin Research Unit

Austin, Texas, 78744, United States

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