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A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Anticancer Activity of GSK4524101 Alone or With Niraparib in Participants With Solid Tumors

Neoplasms

The primary purpose of this study is to determine the maximum tolerated dose of GSK4524101 monotherapy (MTD) and GSK4524101 in combination with niraparib (MTDc). The study consists of two parts - Part 1 (Dose Escalation) and Part 2 (Dose Expansion).

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Participation Requirements

  • Sex:

    ALL
  • Eligible Ages:

    18 and up

Participation Criteria

Inclusion Criteria:

* More than or equal to (≥)18 years of age
* Eastern cooperative oncology group (ECOG) class 0-2
* Life expectancy of a minimum of 3 month
* Participant has histologically diagnosed advanced or metastatic solid tumor and has exhausted all standard of care treatment options.

Exclusion Criteria:

* Participant has not recovered (i.e., to Grade less than or equal to \[≤1\] or to baseline) from prior chemotherapy-induced AEs.
* Participant is currently participating in a treatment study or has participated in a study of any investigational agent within 4 weeks of the first dose of treatment.
* Participant has symptomatic uncontrolled brain or leptomeningeal metastases.
* Participant has a known additional malignancy that progressed or required active treatment within the last 2 years
* Participant has a known history of Myelodysplastic syndrome (MDS) or Acute myeloid leukemia (AML).
* Participant has uncontrolled hypertension with sustained systolic blood pressure (BP) \>140 millimetres of mercury (mmHg) or diastolic BP \>90 mmHg.

Study Location

GSK Investigational Site
GSK Investigational Site
Ottawa, Ontario
Canada

Contact Study Team

Backup Contact

EU GSK Clinical Trials Call Centre

[email protected]
020 8990 4466
Primary Contact

US GSK Clinical Trials Call Center

[email protected]
877-379-3718
GSK Investigational Site
GSK Investigational Site
Edmonton, Alberta
Canada

Contact Study Team

Primary Contact

US GSK Clinical Trials Call Center

[email protected]
877-379-3718
Backup Contact

EU GSK Clinical Trials Call Centre

[email protected]
020 8990 4466
GSK Investigational Site
GSK Investigational Site
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

US GSK Clinical Trials Call Center

[email protected]
877-379-3718
Backup Contact

EU GSK Clinical Trials Call Centre

[email protected]
020 8990 4466
Study Sponsored By
GlaxoSmithKline
Participants Required
More Information
Study ID: NCT06077877