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

NCT03416335 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-05-30

Study results available
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Summary

This is a multi-center, Phase 1 / 2 clinical study for patients with advanced solid tumors. The study consists of 2 treatment arms - a monotherapy arm and a combination arm. The monotherapy arm has 1 part: Dose Escalation (Part A). The combination arm has Dose Escalation (Part B) only.

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)

Sponsors & Collaborators

  • Syneos Health

    collaborator OTHER

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2022-12-20
Completion
2022-12-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03416335 on ClinicalTrials.gov