← Back to Search

Other

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

Study Summary

This trial is testing a new cancer treatment on patients with advanced solid tumors. There are two groups of patients, those receiving the new treatment alone and those receiving the new treatment with another cancer treatment. Doctors will closely monitor how patients respond to increasing doses of the new treatment.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determination of the Recommended Phase 2 Dose (RP2D) of DSP-0509 for the Dose Expansion part by assessing dose-limiting toxicities (DLTs)

Determine the MTD of DSP-0509 when given in combination pembrolizumab - by assessing DLTs.

Determine the maximum tolerated dose (MTD) of DSP-0509 by assessing dose-limiting toxicities (DLTs)

+2 more

Secondary outcome measures

DoR by iRECIST

Duration of response (DoR) by RECIST

Evaluate change in cytokine levels induced by DSP-0509 in combination with pembrolizumab.

+7 more

Other outcome measures

Evaluate the PFS rate as a potential evaluation of treatment benefit of DSP-0509 administered with Pembrolizumab. Combination Arm - Part C (Dose Expansion)

Evaluate the effect of DSP-0509 on cardiac parameters by assessing continuous 25-hour ECG recordings.

Exploratory pharmacodynamic evaluation as potential biomarkers capable of predicting the clinical efficacy or toxicity

+2 more

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

DSP-0509

2018

Completed Phase 2

~40

DSP-0509, Pembrolizumab

2018

Completed Phase 2

~40

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Sumitomo Pharma America, Inc.Lead Sponsor

236 Previous Clinical Trials

52,684 Total Patients Enrolled

Sumitomo Dainippon Pharma Oncology, IncLead Sponsor

41 Previous Clinical Trials

6,592 Total Patients Enrolled

Sumitomo Pharma Oncology, Inc.Lead Sponsor

44 Previous Clinical Trials

6,913 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what conditions is DSP-0509 typically administered?

"DSP-0509 can be used to remedy malignant neoplasms, intractable melanoma and patients with microsatellite instability high."

Answered by AI

What are the expected results from this research?

"This clinical trial, set to run for 4 weeks, seeks to establish the maximum tolerable dose (MTD) of DSP-0509 by observing any toxic reactions. Secondary goals include assessing objective response rate (ORR), duration of response (DoR), and evaluating pharmacokinetics for both DSP-0509 and pembrolizumab through plasma concentration measurements."

Answered by AI

What is the cap for enrollment in this clinical trial?

"100 individuals who meet the criteria for inclusion in this study are needed. Potential enrollees can be found at M.D. Anderson Cancer Center, The University of Texas in Houston and Fox Chase Cancer Centre in Philadelphia."

Answered by AI

How many healthcare centers are partaking in this research endeavor?

"This experiment is currently recruiting patients at M.D. Anderson Cancer Center (Houston, TX), Fox Chase Cancer Center (Philadelphia, PA) and the University of North carolina at Chapel Hill (Chapel Hill, NC). In addition to these well-known medical centres there are 4 other locations participating in this trial."

Answered by AI

Have any other experiments been carried out using DSP-0509?

"Back in 2010, DSP-0509 made its debut at City of Hope. Since then, over the course of 249 clinical trials, this medication has been tested extensively and there are currently 961 active studies taking place across Houston Texas."

Answered by AI

Is the recruitment phase of this research endeavor still accepting participants?

"The latest information posted on clinicaltrials.gov implies that this experiment is actively recruiting participants; the trial was initiated on June 1st 2018 and adjusted most recently on October 12th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2018. "A Study of DSP-0509 in Patients With Advanced Solid Tumors to Determine the Safety and the Pharmacokinetic Profile". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03416335.