> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Pheast Gets Fast Track for Ovarian Cancer Drug
- URL: https://www.fdaweb.com/pheast-gets-fast-track-for-ovarian-cancer-drug/
- Published: 2025-06-09T12:00:00.000Z
- Updated: 2026-09-14T15:13:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159323

FDA has granted Pheast Therapeutics a fast-track designation for PHST001 and its use in treating patients with advanced platinum-resistant ovarian cancer or in combination with chemotherapy in platinum-sensitive ovarian cancer. The company describes PHST001 as an investigational anti-CD24 monoclonal antibody designed to enhance innate immune recognition and anti-tumor activity in solid tumors.

The company is currently recruiting patients for its open-label [Phase 1 clinical study](https://www.pheast.com/pheast-therapeutics-announces-first-patient-treated-in-phase-1-clinical-trial-of-phst001-for-patients-with-advanced-solid-tumors/?ref=fdaweb.com) of PHST001 in patients with advanced relapsed and/or refractory solid tumors (ClinicalTrials.gov Identifier: [NCT06840886](https://clinicaltrials.gov/study/NCT06840886?ref=fdaweb.com)). The study’s primary objectives include evaluating the safety and tolerability of PHST001 and establishing the recommended Phase 2 dose, with secondary endpoints assessing pharmacokinetics and early signs of anti-tumor activity, Pheast says.