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A Study of ASP546C in Adults With Gastroesophageal Cancer, Pancreatic Cancer or Other Solid Tumors

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary endpoints: details revised at 2 of 8 entries Trial sites expanded: 17 → 21 locations · Eligibility criteria expanded, about 27 words · Secondary endpoints: details revised at 8 of 32 entries Show 3 more changesShow less
    • Trial sites expanded: 17 → 21 locations
    • Eligibility criteria expanded, about 27 words
    • Secondary endpoints: details revised at 8 of 32 entries
  2. Minor Trial sites expanded: 14 → 17 locationsv6
  3. Minor Study sites: 12 to 14v5
  4. Minor Trial sites expanded: 9 → 12 locationsv4
  5. Notable Start date: Mar 20, 2026 to May 4, 2026 Study sites: 8 to 9v3 Show 1 more changeShow less
    • Study sites: 8 to 9
  6. Notable Recruitment opened Trial sites expanded: 0 → 8 locations · Start date changed from estimate of Mar 31, 2026 to Mar 20, 2026 · Eligibility criteria expanded, about 35 wordsv2 Show 3 more changesShow less
    • Trial sites expanded: 0 → 8 locations
    • Start date changed from estimate of Mar 31, 2026 to Mar 20, 2026
    • Eligibility criteria expanded, about 35 words

    See this version in full on ClinicalTrials.gov ↗

  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study will help find the most suitable dose of ASP546C in people with gastric cancer, gastroesophageal junction (GEJ) cancer, pancreatic cancer, and other specific solid tumors. GEJ is where the food pipe (esophagus) joins the stomach. This study is in 2 parts. In both parts of the study, ASP546C will be given once in 3-week cycles. It will be given slowly through a tube into a vein. This is called an infusion. In Part 1, people with gastric cancer or GEJ cancer can take part. They will receive an infusion of either a higher dose or a lower dose of ASP546C. In Part 2, people with pancreatic cancer or who have one of the other solid tumors can take part. Part 2 doesn't include people with gastric cancer or GEJ cancer. All people in this part of the study will receive an infusion of the higher dose of ASP546C. People will visit the clinic on certain days to receive ASP546C and have health checks. The number of visits and checks done during the study will depend on the health of each person and whether they are still receiving infusions of ASP546C.
Trial Details
NCT Number NCT07488676
Lead Sponsor Astellas Pharma Global Development, Inc.
Conditions Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma, Pancreatic Adenocarcinoma
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov