Sign in Subscribe
Cancer

FDA Grants Orphan Drug Designation to Adcentrx's ADRX-0405 for Gastric Cancer Treatment

Strategic Insights

— 1 min read

Adcentrx Therapeutics has announced that its antibody-drug conjugate, ADRX-0405, has received orphan drug designation from the US Food and Drug Administration (FDA) for the treatment of patients with gastric cancer. The STEAP1-targeting ADC demonstrated favorable preclinical results, including pharmacokinetics, safety, and efficacy in animal models. The agent is currently being evaluated in a phase 1a/b trial, which aims to assess its safety, tolerability, and efficacy in advanced solid tumors, including gastric cancer.

Key Takeaways:

  • ADRX-0405, a STEAP1 ADC, has received orphan drug designation from the FDA for the treatment of gastric cancer.
  • STEAP1 is meaningfully expressed as a target in gastric cancer, offering potential for future clinical development.
  • The agent demonstrated favorable preclinical results, including pharmacokinetics, safety, and efficacy in animal models.
  • ADRX-0405 is being evaluated in a phase 1a/b trial with an estimated enrollment of 68 patients.
  • The trial will assess the agent's safety, tolerability, and efficacy in advanced solid tumors, including gastric cancer.
  • The primary end point of the trial is the incidence of adverse events, while secondary end points include objective response rate and progression-free survival.
  • The trial is being conducted in the US, with 8 locations across California, Michigan, Minnesota, Texas, Utah, and Virginia.

Statistics:

  • Estimated trial completion date: December 2026.
  • Number of patients enrolled in the trial: 68.
  • Number of locations in the US: 8.
  • Total dose-escalation portion of the trial: N/A.
  • Number of patients with measurable disease per RECIST v1.1: 68.

Sources:

1. U.S. FDA grants orphan drug designation to Adcentrx Therapeutics' ADRX-0405 STEAP1 ADC for gastric cancer. News release. Adcentrx Therapeutics. July 8, 2025. Accessed July 9, 2025.

2. Adcentrx Therapeutics announces first patient dosed in the phase 1a/b study of ADRX-0405, a potential first-in-class ADC targeting STEAP1 for the treatment of advanced solid tumors. News release. Adcentrx Therapeutics. January 6, 2025. Accessed July 9, 2025.

3. A study of ADRX-0405 in subjects with select advanced solid tumors. ClinicalTrials.gov. Updated April 9, 2025. Accessed July 9, 2025.

Read more