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GSK4524101A

Clinical trials are studying GSK4524101A in adults with advanced or metastatic solid tumors, and in a breast cancer expansion group. The research looks at safety, tolerability, how the body handles the treatment, and early signs of anticancer activity, both alone and with niraparib.

Table of contents

Trial overview

The clinical trial NCT06077877 studied GSK4524101A in adults with advanced or metastatic solid tumors, and it also studied GSK4524101A with niraparib.[1] The study was Phase 1/2 and was completed with 99 participants.[1]

The trial aimed to learn about safety, tolerability, pharmacokinetics (how the body handles a treatment), and early anticancer activity.[1] It also looked for a dose that could be used in the study setting based on safety, available PK, and available pharmacodynamic information.[1]

Who can join the study

In the dose-escalation part, the study enrolled adults with advanced or metastatic solid tumors who had already used all standard of care treatment options.[1] The study also preferred participants who might benefit based on the trial’s treatment approach.[1]

In the dose-expansion part, the study enrolled adults with metastatic breast cancer that was gBRCAmut, HER2-negative, or HER2-low.[1] These participants had completed at most 3 prior lines of therapy and were PARPi-naïve, which means they had not had a PARP inhibitor before.[1]

What the study measures

The first part of the trial measured dose-limiting toxicities, which are side effects that are serious enough to limit the dose that can be given.[1] It also measured treatment-emergent adverse events and serious adverse events, how long these events lasted, whether participants received all planned doses, and whether dose interruptions, dose reductions, or stopping treatment were needed because of side effects.[1]

In the second part, the main outcome was confirmed objective response rate.[1] This means the study checked how many participants had a confirmed tumor response, such as shrinkage of the cancer.[1]

Study phases and study groups

This was a dose escalation and dose expansion study.[1] Dose escalation means the researchers carefully tested increasing doses to find the maximum tolerated dose and the maximum tolerated dose for the combination with niraparib.[1]

The study also included a food effect cohort, which means one group was used to see whether food changed how the treatment was handled by the body.[1] The expansion part studied GSK4524101A with niraparib at a dose lower than, at, or near the tested combination dose, but not above it.[1]

Key medical terms

  • Solid tumors: cancers that form a lump or mass, rather than cancers of the blood.[1]
  • Metastatic: cancer that has spread to other parts of the body.[1]
  • Standard of care: the usual treatment doctors use for a disease.[1]
  • Pharmacokinetics: what the body does to a treatment after it is taken.[1]
  • Pharmacodynamic: how a treatment affects the body, as used in the trial description.[1]
  • Adverse event: any unwanted medical problem that happens during a study.[1]
  • Serious adverse event: an unwanted medical problem that is severe or needs urgent care.[1]
  • Objective response rate: the share of participants whose tumors respond in a confirmed way.[1]
Trial ID Phase Condition studied Status Enrollment
NCT06077877 Phase 1/2 Neoplasms; advanced or metastatic solid tumors; metastatic breast cancer Completed 99

FAQ

  • What is being studied in the GSK4524101A trials? The trials are studying the safety, tolerability, pharmacokinetics, and early anticancer activity of GSK4524101A. One part also studies GSK4524101A together with niraparib.
  • Who can join the main dose-escalation part of the study? Adults with advanced or metastatic solid tumors who have already used all standard treatment options may be able to join. The study also prefers people who may benefit based on the trial's targeted treatment approach.
  • Who can join the dose-expansion part of the study? This part is for adults with metastatic breast cancer that is gBRCAmut, HER2-negative, or HER2-low. They must have had at most 3 prior treatment lines and must be PARPi-naïve, meaning they have not had a PARP inhibitor before.
  • What phase is the GSK4524101A study? This is a Phase 1/2 study. Phase 1 mainly checks safety and the best dose, while Phase 2 looks more closely at early signs that the treatment may work.
  • What results are the researchers measuring? In the early part, the study measures dose-limiting toxicities, side effects, treatment interruptions, and whether planned doses are completed. In the later part, it measures confirmed objective response rate, which means how many people have a confirmed tumor response.

Ongoing Clinical Trials on GSK4524101A

  • A Study of GSK4524101 and Niraparib for Adults with Advanced Solid Tumors or Metastatic Breast Cancer with BRCA Gene Changes

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Czechia Denmark Estonia Greece Italy +2

Glossary

  • Advanced solid tumors: Solid cancers that have grown or spread and are no longer at an early stage.
  • Metastatic: Cancer that has spread from where it started to other parts of the body.
  • Safety: How well a treatment can be given without causing serious harm.
  • Tolerability: How well people can handle a treatment and its side effects.
  • Pharmacokinetics (PK): How the body absorbs, moves, breaks down, and removes a treatment.
  • Dose escalation: A study step where doses are raised carefully to find a dose that can be used safely.
  • Maximum tolerated dose (MTD): The highest dose that can be given without unacceptable side effects.
  • Dose expansion: A later study step that treats more people at selected doses to learn more about activity and safety.
  • Objective response rate (ORR): The percentage of participants whose tumors shrink or disappear in a confirmed way.
  • PARPi-naïve: A person who has not been treated with a PARP inhibitor before.
  • gBRCAmut: A cancer with a BRCA mutation found in the tumor or inherited background, as used in the study description.

References