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A Study of DSP-0509 in Patients With Advanced Solid Tumors to Determine the Safety and the Pharmacokinetic Profile
Phase 1 & 2
Waitlist Available
Research Sponsored by Sumitomo Pharma America, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new drug, DSP-0509, alone and with pembrolizumab, in patients with advanced solid tumors. It aims to find the best dose and see how well the drugs work together, especially in patients who haven't responded to other treatments. DSP-0509 helps the immune system attack cancer cells more effectively. Pembrolizumab is an immune checkpoint inhibitor first approved by the FDA in 2014 for the treatment of advanced melanoma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Determination of RP2D of DSP-0509 When Given in Combination With Pembrolizumab by Assessing DLTs
Determination of the MTD of DSP-0509 When Given in Combination With Pembrolizumab by Assessing Dose-limiting Toxicities (DLTs).
Preliminary Antitumor Activity of DSP-0509 in Combination With Pembrolizumab in Patients With Head & Neck Squamous Cell Carcinoma (HNSCC) Who Have Shown Primary or Acquired Resistance to Immune Checkpoint Inhibitors (ICIs)
Secondary study objectives
DoR by iRECIST
Duration of Response (DoR) by RECIST
Evaluate Change in Cytokine Levels Induced by DSP-0509 in Combination With Pembrolizumab.
+7 moreOther study objectives
Evaluate the Effect of DSP-0509 on Cardiac Parameters by Assessing Continuous 25-hour ECG Recordings.
Evaluate the PFS Rate as a Potential Evaluation of Treatment Benefit of DSP-0509 Administered With Pembrolizumab
Identification of Potential Metabolites of DSP-0509 in Plasma and Possibly in Urine.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Monotherapy Arm - Part AExperimental Treatment1 Intervention
Dose Escalation Drug DSP-0509
Group II: Combination arm - Part CExperimental Treatment1 Intervention
Dose Expansion, Drug DSP-0509, Pembrolizumab
Group III: Combination arm - Part BExperimental Treatment1 Intervention
Dose Escalation Drug DSP-0509, Pembrolizumab
Find a Location
Who is running the clinical trial?
Sumitomo Pharma America, Inc.Lead Sponsor
241 Previous Clinical Trials
51,410 Total Patients Enrolled
Sumitomo Dainippon Pharma Oncology, IncLead Sponsor
41 Previous Clinical Trials
6,733 Total Patients Enrolled
Sumitomo Pharma Oncology, Inc.Lead Sponsor
44 Previous Clinical Trials
7,054 Total Patients Enrolled
Syneos HealthOTHER
176 Previous Clinical Trials
68,619 Total Patients Enrolled