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New pill combo takes aim at Hard-to-Treat cancers

NCT ID NCT06077877

Disease control Sponsor: GlaxoSmithKline Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tests an experimental oral drug called GSK4524101, either alone or combined with another drug (niraparib), in adults with advanced solid tumors that have stopped responding to standard treatments. The study has two parts: first, finding a safe dose, and second, seeing if the combination shrinks tumors in people with a specific type of breast cancer. Only 42 participants will be enrolled.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GSK4524101 (a DNA repair blocker) and niraparib (a PARP inhibitor)
What this could lead to
If it works, this could offer a new treatment option for people with advanced solid tumors, especially those with BRCA-mutated breast cancer.
What could go wrong
This is a very early (Phase 1/2) and small trial (42 people). The drug may not shrink tumors or could cause serious side effects. Success is far from guaranteed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

42 people

The number who actually took part.

Started

Oct 2023

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

metastatic malignant neoplasm neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neoplasms

Contacts and locations

Locations

  • GSK Investigational Site

    San Francisco, California, 94158, United States

  • GSK Investigational Site

    St Louis, Missouri, 63110, United States

  • GSK Investigational Site

    Dallas, Texas, 75230, United States

  • GSK Investigational Site

    Houston, Texas, 77030, United States

  • GSK Investigational Site

    San Antonio, Texas, 78229, United States

  • GSK Investigational Site

    Fairfax, Virginia, 22031, United States

  • GSK Investigational Site

    Edmonton, Alberta, T6G 1Z2, Canada

  • GSK Investigational Site

    Toronto, Ontario, M5G 2M9, Canada

  • GSK Investigational Site

    Montreal, Quebec, H4A 3J1, Canada

  • GSK Investigational Site

    Panama City, Panama

  • GSK Investigational Site

    Punta Pacifica Panama City Panama, Panama

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