Study on the Safety and Effects of GSK4524101 Alone or with Niraparib in Patients with Solid Tumors

Sponsor: GlaxoSmithKline

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06077877

Provider View

This clinical trial is exploring the safety and effects of a new drug, GSK4524101, used alone or in combination with another drug, Niraparib, in patients with advanced solid tumors. The study aims to find the best dose that patients can tolerate.

Patient Parameters

Program Overview

The main goal of this study is to find out the highest dose of GSK4524101 that patients can safely take, both on its own and when combined with Niraparib. The study is divided into two parts: Part 1, where the dose is gradually increased to find the maximum safe dose, and Part 2, where the effects of the drug at this dose are further explored.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a performance status score of 0 to 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have a life expectancy of at least 3 months.
  • Have an advanced or metastatic solid tumor and have tried all standard treatment options without success.

Exclusion Criteria

  • Have not fully recovered from side effects of previous chemotherapy.
  • Are currently in another treatment study or have been in one within the last 4 weeks.
  • Have uncontrolled brain or spinal cord cancer spread.
  • Have another cancer that has worsened or needed treatment in the last 2 years.
  • Have a history of certain blood disorders like Myelodysplastic syndrome (MDS) or Acute myeloid leukemia (AML).
  • Have uncontrolled high blood pressure.

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