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
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
NCT #
NCT06077877
Condition(s)
Solid Tumors
Molecular Target(s)
PARP-1, PARP-2
Drug Classification(s)
Small Molecule
Agents(s)
Niraparib/GSK4524101
Phase(s)
I/II
Mechanism of Action
GSK4524101 is a POLQ inhibitor
Purpose
- How much of the study drug can be given with an acceptable level of side effects• The effects of the study drug (good and bad)
- How much of the study drug is absorbed into the blood and how fast it is removed (pharmacokinetics)
- If research tests can be used in the future to predict who will benefit from GSK4524101
- How the study drug is acting on your body
- 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.
- Participant has not recovered (i.e., to Grade less than or equal to [≤1] or to baseline) from prior chemotherapy-induced AEs.
- First-line locally advanced or metastatic breast cancer with no prior chemotherapy
- Inflammatory breast cancer
- Prior treatment with a Poly (ADP [Adenosine Diphosphate]-ribose) polymerase inhibitors (PARPi)
- 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.
Prior treatment with a PARPi
Location
MCD
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