AzTrials
AzTrials

NeoplasmsPhase 1/2NCT06077877

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

A Phase 1/2 study testing GSK4524101 and Niraparib in people with Neoplasms, run by GlaxoSmithKline at 11 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms
What is being tested?
GSK4524101 and Niraparib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
11 sitesin 3 countries
Study dates
24 Oct 2023to 30 Jun 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

11 sites in 3 countries.

11 sites in 3 countries

United States6 sites

  • GSK Investigational Site

    Dallas, Texas, 75230

  • GSK Investigational Site

    Fairfax, Virginia, 22031

  • GSK Investigational Site

    Houston, Texas, 77030

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    San Francisco, California, 94158

  • GSK Investigational Site

    St Louis, Missouri, 63110

Other trials in United States

Canada3 sites

  • GSK Investigational Site

    Edmonton, Alberta, T6G 1Z2

  • GSK Investigational Site

    Montreal, Quebec, H4A 3J1

  • GSK Investigational Site

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Panama2 sites

  • GSK Investigational Site

    Panama City

  • GSK Investigational Site

    Punta Pacifica Panama City Panama

Other trials in Panama

About this study

Official 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

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).

Conditions
Neoplasms
Being tested
GSK4524101, Niraparib
Keywords
POLQi, Niraparib, GSK4524101
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSK4524101Drug

    GSK452101 will be administered.

  • NiraparibDrug

    Niraparib will be administered.

Study groups in NCT06077877
Study groupRoleWhat they receive
Part 1 - GSK4524101 MonotherapyExperimentalNot described
Receives: Drug: GSK4524101
Part 1 - GSK4524101 plus NiraparibExperimentalNot described
Receives: Drug: GSK4524101; Drug: Niraparib
Part 1 - GSK4524101 Food Effect CohortExperimentalNot described
Receives: Drug: GSK4524101
Part 2 - GSK4524101 plus NiraparibExperimentalNot described
Receives: Drug: GSK4524101; Drug: Niraparib
Part 2 - NiraparibActive comparatorNot described
Receives: Drug: Niraparib

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 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

    Measured: Up to 28 days

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

    Measured: Up to 28 days

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

    Measured: 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

    Measured: Up to 28 days

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

    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

    Measured: Up to approximately 52 weeks

Secondary outcomes (14)

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

    Measured: Up to 21 weeks

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

    Measured: Up to 21 weeks

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

    Measured: Up to 21 weeks

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

    Measured: Up to 21 weeks

  5. Part 1 -Plasma Concentration of Niraparib

    Measured: Up to 21 weeks

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

    Measured: Up to approximately 24 weeks

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

    Measured: Up to approximately 24 weeks

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

    Measured: Up to approximately 52 weeks

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

    Measured: Up to approximately 52 weeks

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

    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

    Measured: Up to approximately 52 weeks

  11. Part 2 - Duration of Response (DOR)

    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

    Measured: Up to approximately 52 weeks

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

    Measured: Up to 21 weeks

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

    Measured: Up to 21 weeks

  14. Part 2 -Plasma Concentration of Niraparib

    Measured: Up to 21 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2023
  2. Study start24 Oct 2023
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06077877
Sponsor's protocol ID
219590
Status last verified
Apr 2026
First submitted
5 Oct 2023
Last updated
24 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GSK4524101 and Niraparib in people with Neoplasms, run by GlaxoSmithKline at 11 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States, Canada, Panama. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1 - Proportion of Participants with Dose Limiting Toxicities (DLTs) during DLT Observation Period (time frame: Up to 28 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06077877.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in