Trial Title:
A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Anticancer Activity of GSK4524101 Alone or With Niraparib in Participants With Solid Tumors
NCT ID:
NCT06077877
Condition:
Neoplasms
Conditions: Official terms:
Niraparib
Conditions: Keywords:
POLQi
Niraparib
GSK4524101
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
This is an open-label non-blinded study
Intervention:
Intervention type:
Drug
Intervention name:
GSK4524101
Description:
GSK452101 will be administered.
Arm group label:
Part 1 - GSK4524101 Food Effect Cohort
Arm group label:
Part 1 - GSK4524101 Monotherapy
Arm group label:
Part 1 - GSK4524101 plus Niraparib
Arm group label:
Part 2 - GSK4524101 plus Niraparib
Intervention type:
Drug
Intervention name:
Niraparib
Description:
Niraparib will be administered.
Arm group label:
Part 1 - GSK4524101 plus Niraparib
Arm group label:
Part 2 - GSK4524101 plus Niraparib
Arm group label:
Part 2 - Niraparib
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).
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
GSK Investigational Site
Address:
City:
San Francisco
Zip:
94158
Country:
United States
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Pamela N. Munster
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Pasquale Benedetto
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Brian Van Tine
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Dallas
Zip:
75230
Country:
United States
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Minal Barve
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Timothy Yap
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
David Sommerhalder
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Alexander I. Spira
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Edmonton
Zip:
T6G 1Z2
Country:
Canada
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Quincy Chu
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Ottawa
Zip:
K1H 8L6
Country:
Canada
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Arif Ali Awan
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Philippe Bedard
Email:
Principal Investigator
Start date:
October 24, 2023
Completion date:
November 9, 2029
Lead sponsor:
Agency:
GlaxoSmithKline
Agency class:
Industry
Source:
GlaxoSmithKline
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06077877
