A First-in-Human Phase I Trial to Determine the Safety and the Pharmacokinetic Profile of DSP-0509 a Synthetic Toll-Like Receptor 7 (TLR-7) Agonist in Adult Patients With Advanced Solid Tumors

Study Overview

This is a Phase 1, open label, multi-center study of intravenously administered DSP-0509 in adult subjects with advance solid tumors that are refractory to standard treatment.

Study Description

The study consists of two stages: an initial dose escalation phase utilizing a 3 + 3 design to determine maximum tolerated dose followed by a dose expansion phase in up to 14 additional subjects. Study participants will initially receive DSP-0509 intravenously once a week in induction phase, and once every two weeks in a maintenance phase. If clinical benefit is seen, treatment can continue until disease progression.

Additional Information

Participants will not be paid for their participation.

  • IRB Number: 1804027965 (BBI-DSP0509-101)
  • Research Study Identifier: TX8859
  • Principal Investigator: Shadia Jalal, MD

Recruitment Status


Contact the research team to learn more about this study.

Fields marked with asterisk (*) are required

Please verify that you are not a bot.

By clicking "Contact Research Team", your contact information will be sent securely to the research staff associated with the study. You will also receive a copy of this email in your inbox, as well as other notifications to determine your participation status in the study.

Volunteer Sign up

Volunteer Registry

Create your profile and be matched to research opportunities

Register Now!

Contact Us

If you need help finding a study or have any questions, please contact us at inhealth@iu.edu or by phone at (888) 264-0005.