Astellas- Drug ASP546C for CLDN18.2-expressing solid tumors (546C-CL-0201) - Clinical Trial

What is the Purpose of this Study?

If you join this study, you will receive a medicine called ASP546C through a vein every three weeks. You will also give blood and urine samples so doctors can check your health and how your body responds to the treatment. During the study, you will have regular scans such as CT or MRI to see how your cancer is changing.

What is the Condition Being Studied?

CLDN18.2-Expressing Cancers

Who Can Participate in the Study?

People can join this study if they are adults who have cancer that has spread or grown and cannot be cured with surgery. The cancer must have a special marker called CLDN 18.2. They must have already tried at least one treatment before. The study includes several types of cancer, such as cancers of the stomach and food tube, pancreas, bile ducts, colon, lungs, ovaries, and breast.

Age Group
Adults

What is Involved?

The purpose of this study is to see if a new medicine called ASP546C is safe and works well for certain cancers. These cancers have a special marker called CLDN18.2. Researchers want to learn if the medicine can help treat these cancers and improve patient health.

Study Details

Full Title
[546C-CL-0201] A Phase 1b/2 Open-label Study to Assess the Safety and Efficacy of ASP546C in Participants with CLDN18.2-expressing Locally Advanced Unresectable or Metastatic Gastroesophageal Adenocarcinoma, Pancreatic Adenocarcinoma or Other Solid Tumor Types
Principal Investigator
John H. Strickler, MD
Medical Oncologist
Protocol Number
IRB: PRO00119707
NCT: NCT07488676
Phase
Phase I/II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
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