A Phase I Study of DS-1062a in People with Advanced Digestive Cancers

Full Title

Phase 1, Two-part, Multicenter, Open-label, Multiple Dose, First-in-human Study of DS-1062a in Subjects with Advanced Solid Tumors

Purpose

Researchers in this study are evaluating the safety of the investigational drug DS-1062a in people with advanced, inoperable pancreatic, gastroesophageal (junction between the stomach and esophagus), esophageal, or colorectal cancers. DS-1062a targets a protein TROP2, which is found on the surface of cancer cells in large amounts. DS-1062a is expected to slow tumor growth by attaching to TROP2 and releasing a chemotherapy drug inside cancer cells, which is designed to kill them. DS-1062a is given intravenously (by vein).

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

• Participants must have advanced, inoperable pancreatic, HER2-negative gastroesophageal, esophageal, or colorectal cancer that cannot be successfully treated with other therapies.
• The serious side effects of prior treatments must go away before DS-1062a is given.
• Participants must be willing to have tissue biopsies during the study.
• Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
• This study is for people age 18 and older.

Contact

For more information about this study and to inquire about eligibility, please contact the office of Dr. Yelena Janjigian at 646-888-4186.