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A First-in-Human Phase I Trial to Determine the Safety and the Pharmacokinetic Profile of DSP-0509 a Synthetic Toll-Like Receptor 7 (TLR-7) Agonist in Adult Patients With Advanced Solid Tumors

Investigational Treatment for Advanced Solid Tumors

Recruiting
18 years and older
All
Phase N/A

This study investigates an investigational medication given through a vein to adults with advanced solid tumors. These tumors are those that cannot be removed by surgery or have spread to other parts of the body and do not respond to standard treatments. The study aims to find the best dose of this investigational medication, which will be given first once a week and then every two weeks to see if it helps control the disease.

Participants in this study will receive the investigational medication in two phases: an induction phase with weekly doses and a maintenance phase with doses every two weeks. The study will determine how well people tolerate the medication and how it affects their tumors. The investigational medication is given through an intravenous line, which means it is delivered directly into a vein.

  • Who can participate: Adults with histologically or cytologically confirmed advanced solid tumors that are metastatic or cannot be removed by surgery are eligible. Participants must have adequate blood, kidney, and liver function and must not have received certain treatments recently. Individuals with certain medical conditions or who are pregnant or breastfeeding are excluded.
  • Study details: Participants will receive the investigational medication through an intravenous line. The study includes two phases with different dosing schedules. A placebo is not used in this study.
Study details
    Neoplasms

TX8859

19 February 2024

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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