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A Phase 2/3 Study of Evorpacept (ALX148) in Patients With Advanced HER2-Overexpressing Gastric/Gastroesophageal Junction Adenocarcinoma (ASPEN-06)

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Trial Profile

A Phase 2/3 Study of Evorpacept (ALX148) in Patients With Advanced HER2-Overexpressing Gastric/Gastroesophageal Junction Adenocarcinoma (ASPEN-06)

Status: Active, no longer recruiting
Phase of Trial: Phase II/III

Latest Information Update: 18 Jun 2025

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At a glance

  • Drugs Evorpacept (Primary) ; Paclitaxel (Primary) ; Ramucirumab (Primary) ; Trastuzumab (Primary)
  • Indications Adenocarcinoma; Gastric cancer; Oesophageal cancer; Solid tumours
  • Focus Proof of concept; Registrational; Therapeutic Use
  • Acronyms ASPEN-06
  • Sponsors ALX Oncology

Most Recent Events

  • 12 Jun 2025 Status changed from recruiting to active, no longer recruiting.
  • 08 May 2025 According to a ALX Oncology media release, Company will not pursue U.S. registrational path in gastric cancer following receipt of FDA feedback that accelerated approval pathway is not feasible based on ASPEN-06 due to standard-of-care evolving to ENHERTU.
  • 05 Mar 2025 According to a ALX Oncology media release, the company planning for discussion with the FDA regarding the registrational path in gastric cancer based on the ASPEN-06 data.

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