DSP-0509 for Tumors

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

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.

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Other 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.