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

trialsTrialActive

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 trial of Niraparib in advanced solid tumours, run by GlaxoSmithKline, active and no longer recruiting.

Overview Connected4

Overview

A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Anticancer Activity of GSK4524101 Alone or With Niraparib in Participants With Solid Tumors is a phase 1/2 interventional study registered as NCT06077877 by GlaxoSmithKline, with 42 participants enrolled, started 2023-10-24 and due to reach its primary completion in 2026-06-30. Interventions recorded: GSK4524101 and Niraparib.

Setting

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

Phase

Phase 1/2

Sponsor

GlaxoSmithKline

Registry

Started

2023-10-24

Enrolled

42 enrolled

Connected

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cancers

Metastatic cancer (cancer that has spread)

technologies

PARP inhibitors

drugs

ApprovedSmall-molecule PARP inhibitor

Niraparib · Zejula

companies

Evidence strength21/100 · Preliminary

How much and what kind of evidence, not how big the benefit. Click for the breakdown.

Phase 1/2+8
42 enrolled+8
No structured primary endpoint0
Result: active0
No independent replication recorded0
A linked product is approved+5

Formula disclosed on the evidence page.

ProvenanceLast edited 2026-09-22 · Jude Gomila · Wave 2 corpus-only joins applied · diff · file

Sources & links

ClinicalTrials.gov NCT06077877

Data

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Cancers

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PARP inhibitors

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