Trial Title:
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5733584 for Injection in Participants With Advanced Solid Tumors
NCT ID:
NCT06431594
Condition:
Solid Tumors
Neoplasms
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Solid Tumors
GSK5733584
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
GSK5733584
Description:
GSK5733584 will be administered
Arm group label:
Part 1: Dose Escalation
Arm group label:
Part 2: Dose Expansion
Summary:
The goal of this study is to assess the safety and tolerability of GSK5733584. The study
will also see how the levels of GSK5733584 change over time at different dose amount.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Males or females aged 18 years or older (≥18 years).
- Participants with pathologically confirmed advanced solid tumor (who have failed or
are intolerant to standard of care).
- Participants have at least one target lesion as assessed per the RECIST 1.1
- Tumor tissue from a newly obtained biopsy or archival tumor tissue is required for
retrospective detection of B7 homolog 4 (B7-H4) expression by Immunohistochemistry
(IHC) in central laboratory and other biomarker analysis. Tissue from a newly
obtained biopsy is preferred. If a newly obtained biopsy is not feasible, archival
tumor tissue within 2 years prior to the first dose of study drug is acceptable.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2 and
no deterioration within 2 weeks before the first dose.
- Have a life expectancy of at least 12 weeks.
Exclusion Criteria:
- Have received any of B7-H4-targeted therapies.
- Have received any of cytotoxic chemotherapy drugs, anti-tumor traditional Chinese
medicines or other anti-tumor drugs within 28 days prior to the first dose of study
drug; or need to continue these drugs during the study.
- Have received locoregional radiation therapy within 2 weeks prior to the first dose
of study drug; more than 30% of bone marrow irradiation or wide-field radiation
therapy within 4 weeks prior to the first dose of study treatment.
- Presence of pleural/abdominal effusion/ascites requiring clinical intervention;
presence of pericardial effusion
- Major surgery within 4 weeks prior to the first dose of study treatment.
- Evidence of brain metastasis unless asymptomatic.
- Has inadequate bone marrow reserve or hepatic/renal functions.
- Mean Fridericia-corrected QT interval (QTcF) > 470 millisecond (msec) on resting
ECG.
- Evidence of current clinically significant arrhythmias or ECG abnormalities
- Risk factors of prolonged QTc or arrhythmia events,
- Left ventricular ejection fraction (LVEF) < 50%.
- Have severe, uncontrolled or active cardiovascular disorders, serious or poorly
controlled hypertension, clinically significant bleeding symptoms or serious
arteriovenous thromboembolic events
- Any evidence of current Interstitial lung disease (ILD) or pneumonitis or a prior
history of ILD or pneumonitis requiring high-dose systemic glucocorticoids.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
GSK Investigational Site
Address:
City:
Lake Mary
Zip:
32746
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 Philipovskiy
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Boston
Zip:
02114
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:
Sara Bouberhan
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Boston
Zip:
02215
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:
Elizabeth Lee
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Detroit
Zip:
48201
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:
Ira Winer
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:
West Valley City
Zip:
84119
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:
William McKean
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Blacktown
Zip:
2148
Country:
Australia
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:
Phuong Dinh
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Macquarie University
Zip:
2109
Country:
Australia
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:
Dhanusha Sabanathan
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
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:
Toon Van Gorp
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Montreal
Zip:
H2X 0A9
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:
Diane Provencher
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:
Moira Katherine Rushton-Marovac
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
Facility:
Name:
GSK Investigational Site
Address:
City:
Helsinki
Zip:
00290
Country:
Finland
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:
Katriina Jalkanen
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Napoli
Zip:
80131
Country:
Italy
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:
Adriano Gravina
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Roma
Zip:
00168
Country:
Italy
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:
Vanda Salutari
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Rozzano MI
Zip:
20089
Country:
Italy
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:
Domenica Lorusso
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Shizuoka
Zip:
411-8777
Country:
Japan
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:
Kentaro Yamazaki
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Tokyo
Zip:
135-8550
Country:
Japan
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:
Shigehisa Kitano
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Amsterdam
Zip:
1066 CX
Country:
Netherlands
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:
Neeltje Steeghs
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
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:
Ana Oaknin
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Madrid
Zip:
28040
Country:
Spain
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:
Victor Moreno Garcia
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Pozuelo De AlarcOn Madr
Zip:
28223
Country:
Spain
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:
Valentina Boni
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Stockholm
Zip:
17164
Country:
Sweden
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:
Lisa Liu Burström
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Cambridge
Zip:
CB2 0QQ
Country:
United Kingdom
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:
Joo Ern Ang
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
London
Zip:
NW1 2BU
Country:
United Kingdom
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:
Rowan Miller
Email:
Principal Investigator
Start date:
July 2, 2024
Completion date:
January 21, 2027
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/NCT06431594
