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

Open

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