Study on ASP546C for Adults with Gastroesophageal, Pancreatic, and Other Solid Tumors

Sponsor: Astellas Pharma Global Development, Inc.

Sponsor score: 60

ClinicalTrials ID:NCT07488676

This clinical trial is exploring the best dose of a new drug, ASP546C, for treating adults with certain types of cancer, including gastroesophageal, pancreatic, and other solid tumors. The study involves receiving the drug through an infusion every three weeks.

Patient Parameters

Program Overview

The study aims to find the most suitable dose of ASP546C for treating adults with gastric, gastroesophageal junction (GEJ), pancreatic, and other specific solid tumors. The GEJ is where the esophagus meets the stomach. The study has two parts. In Part 1, participants with gastric or GEJ cancer will receive either a higher or lower dose of ASP546C. In Part 2, participants with pancreatic or other solid tumors will receive the higher dose. Participants will visit the clinic for infusions and health checks, with the number of visits depending on their health and treatment status.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with gastroesophageal, pancreatic, or other specific solid tumors like colorectal or breast cancer.
  • Cancer confirmed by scans within 28 days before starting the study.
  • Have measurable or evaluable disease according to specific criteria.
  • Tumor must express a protein called CLDN18.2.
  • Have received at least one prior treatment for advanced cancer.
  • Be in good overall health with a performance status of 0 or 1.
  • Expected to live at least 12 more weeks.
  • Women must not be pregnant and agree to use contraception during and after the study.
  • Men must agree to use contraception and not donate sperm during and after the study.
  • Willing to provide a tumor sample for research.
  • Agree not to join another study while participating in this one.

Exclusion Criteria

  • Have a type of cancer not included in the study or have had more than two prior treatments for advanced cancer.
  • Have severe stomach issues like gastric outlet syndrome or significant bleeding.
  • Have untreated brain cancer or mental health issues that are hard to control.
  • Have unresolved lung inflammation or a history of certain lung diseases.
  • Have active infections like HIV or hepatitis.
  • Have other serious medical conditions or recent major surgeries.
  • Have received certain treatments or vaccines recently that could interfere with the study.
  • Have a known allergy to ASP546C or its components.
  • Have a significant heart condition or other medical issues that could affect treatment safety.

Locations

FACILITYZIPCITYSTATE
START Los Angeles90025Los AngelesCalifornia
START Midwest49546Grand RapidsMichigan
START New York10042Lake SuccessNew York
Duke Cancer Center Durham27710DurhamNorth Carolina
Next Oncology - Austin78758AustinTexas
Next Oncology - Houston77054HoustonTexas
Next Oncology - Dallas75039IrvingTexas
START San Antonio78229San AntonioTexas
START Mountain Region84119West Valley CityUtah

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