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

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ClinicalTrials.gov Identifier: NCT06077877
Recruitment Status : Recruiting
First Posted : October 11, 2023
Last Update Posted : April 11, 2024
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Neoplasms Drug: GSK4524101 Drug: Niraparib Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Masking Description: This is an open-label non-blinded study
Primary Purpose: Treatment
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
Actual Study Start Date : October 24, 2023
Estimated Primary Completion Date : December 30, 2027
Estimated Study Completion Date : November 9, 2029

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Part 1 - GSK4524101 Monotherapy Drug: GSK4524101
GSK452101 will be administered.
Experimental: Part 1 - GSK4524101 plus Niraparib Drug: GSK4524101
GSK452101 will be administered.

Drug: Niraparib
Niraparib will be administered.
Experimental: Part 1 - GSK4524101 Food Effect Cohort Drug: GSK4524101
GSK452101 will be administered.
Experimental: Part 2 - GSK4524101 plus Niraparib Drug: GSK4524101
GSK452101 will be administered.

Drug: Niraparib
Niraparib will be administered.
Active Comparator: Part 2 - Niraparib Drug: Niraparib
Niraparib will be administered.


Outcome Measures
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Primary Outcome Measures :
  1. Part 1 - Number of Participants with Dose Limiting Toxicities (DLTs) during DLT Observation Period [ Time Frame: Up to 28 days ]
  2. Part 1 - Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) based on Severity during DLT Observation Period [ Time Frame: Up to 28 days ]
  3. Part 1 - Duration of Treatment Emergent AEs and SAEs (Days) during DLT Observation Period [ Time Frame: Up to 28 days ]
  4. Part 1 - Percentage of Participants who receive all Planned Doses during DLT Observation Period [ Time Frame: 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 [ Time Frame: Up to 28 days ]
  6. Part 2 - Confirmed Objective Response Rate (ORR) [ Time Frame: Up to approximately 52 weeks ]
    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


Secondary Outcome Measures :
  1. Part 1 - Area Under Curve (AUC) of GSK4364973 (Metabolite of GSK4524101) [ Time Frame: Up to 21 weeks ]
  2. Part 1 -Maximum Concentration (Cmax) of GSK4364973 (Metabolite of GSK4524101) [ Time Frame: Up to 21 weeks ]
  3. Part 1 - Time to Maximum Concentration of GSK4364973 (Metabolite of GSK4524101) [ Time Frame: Up to 21 weeks ]
  4. Part 1 - Half-life of GSK4364973 (Metabolite of GSK4524101) (Days) [ Time Frame: Up to 21 weeks ]
  5. Part 1 -Plasma Concentration of Niraparib [ Time Frame: Up to 21 weeks ]
  6. Part 1 - Number of Participants with TEAEs and SAEs based on Severity beyond DLT Observation Period [ Time Frame: Up to approximately 24 weeks ]
  7. Part 1 - Duration of TEAEs and SAEs (Days) beyond DLT Observation Period [ Time Frame: Up to approximately 24 weeks ]
  8. Part 2 - Number of Participants with TEAEs and SAEs based on Severity [ Time Frame: Up to approximately 52 weeks ]
  9. Part 2 - Duration of Treatment Emergent AEs and SAEs (Days) [ Time Frame: Up to approximately 52 weeks ]
  10. Part 2 - Progression-free Survival (PFS) [ Time Frame: Up to approximately 52 weeks ]
    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

  11. Part 2 - Duration of Response (DOR) [ Time Frame: Up to approximately 52 weeks ]
    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

  12. Part 2 -Maximum Concentration (Cmax) of GSK4364973 (Metabolite of GSK4524101) [ Time Frame: Up to 21 weeks ]
  13. Part 2 - Minimum Concentration (Cmin) of GSK4364973 (Metabolite of GSK4524101) [ Time Frame: Up to 21 weeks ]
  14. Part 2 -Plasma Concentration of Niraparib [ Time Frame: Up to 21 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06077877


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations
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United States, California
GSK Investigational Site Recruiting
San Francisco, California, United States, 94158
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Pamela N. Munster         
United States, Florida
GSK Investigational Site Recruiting
Miami, Florida, United States, 33136
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Pasquale Benedetto         
United States, Missouri
GSK Investigational Site Recruiting
Saint Louis, Missouri, United States, 63110
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Brian Van Tine         
United States, Texas
GSK Investigational Site Recruiting
Dallas, Texas, United States, 75230
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Minal Barve         
GSK Investigational Site Recruiting
Houston, Texas, United States, 77030
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Timothy Yap         
GSK Investigational Site Recruiting
San Antonio, Texas, United States, 78229
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: David Sommerhalder         
United States, Virginia
GSK Investigational Site Recruiting
Fairfax, Virginia, United States, 22031
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Alexander I. Spira         
Canada, Alberta
GSK Investigational Site Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Quincy Chu         
Canada, Ontario
GSK Investigational Site Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Arif Ali Awan         
GSK Investigational Site Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Philippe Bedard         
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT06077877    
Other Study ID Numbers: 219590
First Posted: October 11, 2023    Key Record Dates
Last Update Posted: April 11, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
URL: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
POLQi
Niraparib
GSK4524101
Additional relevant MeSH terms:
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Niraparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents