August 2025

ONCOLOGY
UROLOGY

FOR46: FIRST-IN-HUMAN TRIAL SHOWS PROMISE IN TREATING METASTATIC CASTRATION-RESISTANT PROSTATE CANCER

A phase 1, dose-escalation clinical trial conducted at Northwestern Medicine and four other locations involving David VanderWeele, MD, PhD, investigated FOR46, a novel antibody-drug conjugate designed to target CD46, a protein overexpressed in metastatic castration-resistant prostate cancer (mCRPC).

The study enrolled 56 patients with advanced disease that had progressed after prior treatments.

Key Highlights
  • FOR46 attacks cancer cells by targeting CD46 while boosting immune system activity.
  • The drug's safe dosage was established at 2.7 mg/kg, with common side effects like neutropenia and fatigue but no treatment-related deaths.

Effectiveness
  • 36% of participants achieved reduction of prostate-specific antigen levels by 50% or more.
  • Tumors shrank in five out of 25 RECIST-evaluable participants.
  • Median progression-free survival was 8.7 months.
  • Patients who responded showed increased activation of CD8+ immune cells.

These early results show that FOR46 provides a manageable safety profile and encouraging efficacy.
David VanderWeele, MD, PhD, Associate Professor of Hematology and Oncology at Northwestern Medicine

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