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A Phase 1/1b Study of ASP2138 as Monotherapy and in Combination With Pembrolizumab and mFOLFOX6 or Ramucirumab and Paclitaxel in Participants With Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma and in Combination With mFOLFIRINOX in Participants With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma Whose Tumors Have Claudin (CLDN) 18.2 Expression

Trial Profile

A Phase 1/1b Study of ASP2138 as Monotherapy and in Combination With Pembrolizumab and mFOLFOX6 or Ramucirumab and Paclitaxel in Participants With Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma and in Combination With mFOLFIRINOX in Participants With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma Whose Tumors Have Claudin (CLDN) 18.2 Expression

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 28 May 2025

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At a glance

  • Drugs ASP 2138 (Primary) ; ASP 2138 (Primary)
  • Indications Adenocarcinoma; Gastric cancer; Oesophageal cancer; Pancreatic cancer
  • Focus Adverse reactions
  • Sponsors Astellas Pharma Global Development

Most Recent Events

  • 22 May 2025 Planned End Date changed from 31 May 2027 to 30 Jun 2027.
  • 22 May 2025 Planned primary completion date changed from 30 Nov 2026 to 31 Dec 2026.
  • 09 Apr 2025 Planned number of patients changed from 305 to 378.

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