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

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.

Who Can Participate?

Eligibility

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 Range

18-110
Looking for Healthy Participants
No

What is Involved?

Description

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.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

No

Spanish Materials Available

No

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
Strickler

Protocol Number

PRO00119707

NCT ID

NCT07488676

Phase

I/II

Enrollment Status

Open to Enrollment