A Study of DSP-0509 in Patients With Advanced Solid Tumors to Determine the Safety and the Pharmacokinetic Profile

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

June 1, 2018

Primary Completion Date

December 20, 2022

Study Completion Date

December 20, 2022

Conditions
Neoplasms
Interventions
DRUG

DSP-0509

Each patient treated will receive DSP-0509 at the dose fixed for that Part or cohort administered as a constant rate IV infusion over 10 minutes using a syringe pump.

DRUG

DSP-0509, Pembrolizumab

Each patient treated will receive DSP-0509 at the dose fixed for that Part or cohort administered as a constant rate IV infusion over 10 minutes using a syringe pump and is given in combination with pembrolizumab which should be administered following the dosing schedule of the approved label (200 mg IV q3w)

DRUG

DSP-0509, Pembrolizumab

Each patient treated will receive DSP-0509 at the Recommended Phase II Dose (RP2D) level as determined in Part B. It is given as a constant rate IV infusion over 10 minutes using a syringe pump and is given in combination with pembrolizumab which should be administered following the dosing schedule of the approved label (400 mg IV q6w)

Trial Locations (5)

19111

Fox Chase Cancer Center, Philadelphia

25799

University of North Carolina at Chapel Hill, Chapel Hill

37232

Henry-Joyce Cancer Center, Vanderbilt University, Nashville

46202

Indiana University Health Melvin and Bren Simon Cancer Center, Indianapolis

77030

M.D. Anderson Cancer Center, The University of Texas, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Syneos Health

OTHER

lead

Sumitomo Pharma America, Inc.

INDUSTRY