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NCT Number: NCT06077877

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

GSK Investigational Site, Edmonton, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 (Part 1).
  • Participant has metastatic, gBRCAmut, HER2-negative or HER2-low breast cancer who has completed at most 3 or more prior lines of therapy (Part 2).

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.

Treatment and study plan

GSK4524101

Drug

GSK452101 will be administered.

Niraparib

Drug

Niraparib will be administered.

Primary outcomes

  1. Part 1 - Proportion of Participants with Dose Limiting Toxicities (DLTs) during DLT Observation Period

    Time frame: Up to 28 days

  2. Part 1 - Proportion of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) based on Severity during DLT Observation Period

    Time frame: Up to 28 days

  3. Part 1 - Duration of Treatment Emergent AEs and SAEs (Days) during DLT Observation Period

    Time frame: Up to 28 days

  4. Part 1 - Percentage of Participants who receive all Planned Doses during DLT Observation Period

    Time frame: Up to 28 days

  5. Part 1 -Percentage of Participants who require dosage interruptions, dose reductions, and drug discontinuations due to adverse reactions during DLT Observation Period

    Time frame: Up to 28 days

  6. Part 2 - Confirmed Objective Response Rate (ORR)

    Time frame: Up to approximately 52 weeks

    ORR is the percentage of participants with an Investigator-assessed confirmed complete response and confirmed partial response to treatment, as assessed by Response Evaluation Criteria in Solid Tumor (RECIST) v1.1

Secondary outcomes

  1. Part 1 - Area Under Curve (AUC) of GSK4364973 (Metabolite of GSK4524101)

    Time frame: Up to 21 weeks

  2. Part 1 -Maximum Concentration (Cmax) of GSK4364973 (Metabolite of GSK4524101)

    Time frame: Up to 21 weeks

  3. Part 1 - Time to Maximum Concentration of GSK4364973 (Metabolite of GSK4524101)

    Time frame: Up to 21 weeks

  4. Part 1 - Half-life of GSK4364973 (Metabolite of GSK4524101) (Days)

    Time frame: Up to 21 weeks

  5. Part 1 -Plasma Concentration of Niraparib

    Time frame: Up to 21 weeks

  6. Part 1 - Number of Participants with TEAEs and SAEs based on Severity beyond DLT Observation Period

    Time frame: Up to approximately 24 weeks

  7. Part 1 - Duration of TEAEs and SAEs (Days) beyond DLT Observation Period

    Time frame: Up to approximately 24 weeks

  8. Part 2 - Number of Participants with TEAEs and SAEs based on Severity

    Time frame: Up to approximately 52 weeks

  9. Part 2 - Duration of Treatment Emergent AEs and SAEs (Days)

    Time frame: Up to approximately 52 weeks

  10. Part 2 - Progression-free Survival (PFS)

    Time frame: Up to approximately 52 weeks

    PFS is time from randomization to progressive disease or death from any cause, whichever is earlier, as assessed via RECIST v1.1 by Investigator assessment

  11. Part 2 - Duration of Response (DOR)

    Time frame: Up to approximately 52 weeks

    DOR is defined as time from first documented PR or better to disease progression (as assessed by RECIST v1.1 by investigator assessment) or death whichever is earlier for participants who have achieved a CR or PR

  12. Part 2 -Maximum Concentration (Cmax) of GSK4364973 (Metabolite of GSK4524101)

    Time frame: Up to 21 weeks

  13. Part 2 - Minimum Concentration (Cmin) of GSK4364973 (Metabolite of GSK4524101)

    Time frame: Up to 21 weeks

  14. Part 2 -Plasma Concentration of Niraparib

    Time frame: Up to 21 weeks

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Phase 1/2 First-Time-in-Human, Open-label, Multicenter, Dose Escalation and Expansion Study of the Oral DNA Polymerase Theta Inhibitor (POLQi) GSK4524101 and the PARP Inhibitor (PARPi) Niraparib in Adult Participants With Solid Tumors

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 11, 2023
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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