Trial Title:
A Study of GSK5764227 in Participants With Advanced Solid Tumors
NCT ID:
NCT06551142
Condition:
Neoplasms
Conditions: Official terms:
Neoplasms
Topotecan
Conditions: Keywords:
Solid Tumors
GSK5764227
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
GSK5764227
Description:
GSK5764227 will be administered
Arm group label:
Phase 1a: Dose escalation-GSK5764227
Arm group label:
Phase 1b: Dose expansion-GSK5764227
Intervention type:
Drug
Intervention name:
Topotecan
Description:
Topotecan will be administered
Arm group label:
Phase 1b: Dose expansion- Topotecan
Summary:
The goal of this study is to assess the safety, tolerability, clinical activity and
pharmacokinetics of GSK5764227. The study will also see how the levels of GSK5764227
change over time at different dose amounts.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Male or female participants at least 18 years of age (≥18 years)
- Participants with histologically confirmed advanced/metastatic solid tumors,
irrespective of mutational status, as defined per study phase and cohort, as
follows:
- Participants with advanced/metastatic tumors who have progressed on or are
intolerant to all available standard of care therapies.
- Participants with selected advanced/metastatic solid tumors who have progressed
on one or more prior lines of therapy.
- Has measurable disease (i.e., at least 1 target lesion) per RECIST v1.1, as
determined by the investigator.
- Has an ECOG performance status of 0 or 1, with no deterioration in the 2 weeks
before first dose.
- Has a life expectancy >12 weeks.
- Has adequate organ function. Specimens must be collected within 3 days prior to the
start of study intervention administration.
- Where available, participants should provide a formalin fixed and paraffin embedded
(FFPE) tumor sample from the most recent biopsy of primary cancer or from a
metastatic site for central testing. Tumor tissue (archival tumor tissue or a fresh
biopsy) is required unless an exemption is granted by the medical monitor. Tumor
tissue is necessary for retrospective detection of B7 homolog 3 protein (B7-H3)
expression by Immunohistochemistry (IHC) in central laboratory and other biomarker
analysis.
Exclusion Criteria:
- Has ongoing adverse reaction(s) from prior therapy that has(have) not recovered to
≤Grade 1 or to the baseline status preceding prior therapy.
- Prior treatment with orlotamab, enoblituzumab, I-Dxd, or other B7-H3 targeted
agents.
- Evidence of brain metastasis (unless meeting the following criteria at the same
time: asymptomatic; medically stable for at least 4 weeks prior to initial dosing;
no steroid treatment required for at least 2 weeks prior to initial dosing; and no
imaging evidence of severe edema located around the tumor lesion); or untreated
progression due to brain metastasis during or after the last treatment prior to
screening; or evidence of meningeal/brainstem metastasis; or evidence of spinal cord
compression (detected by radiographic examination, symptomatic or not).
- Any of the following cardiac examination abnormality:
- Has QT interval, corrected for heart rate (QTc) >450 msec or QTc >480 msec for
participants with bundle branch block.
- Evidence of current clinically significant arrhythmias or ECG abnormalities
(e.g., complete left bundle branch block, third-degree atrioventricular [AV]
block, second-degree AV block, PR interval >250 msec).
- Risk factors of prolonged QTc or arrhythmia events, such as heart failure,
refractory hypokalemia, congenital long QT syndrome, family history of long QT
syndrome, or unexplained sudden death of any direct relative under 40 years old
or any concomitant medications that prolong the QT interval.
- Left ventricular ejection fraction (LVEF) <50%.
- Has severe, uncontrolled or active CV 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 non-infectious pneumonitis requiring
high-dose glucocorticoids.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
GSK Investigational Site
Address:
City:
Denver
Zip:
80218
Country:
United States
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:
Gerald Falchook
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
New Haven
Zip:
06511
Country:
United States
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:
Patricia M Lorusso
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Detroit
Zip:
48201
Country:
United States
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:
Wasif Saif
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Nashville
Zip:
37203
Country:
United States
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:
Vivek Subbiah
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Dallas
Zip:
75230
Country:
United States
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:
Reva Elaine Schneider
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
San Antonio
Zip:
78229
Country:
United States
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:
Rosario
Zip:
S2002
Country:
Argentina
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:
Herman Perroud
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Viedma
Zip:
R8500ACE
Country:
Argentina
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:
Ruben Dario Kowalyszyn
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Montreal
Zip:
H4A 3J1
Country:
Canada
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:
Ramy Saleh
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Ottawa
Zip:
K1H 8L6
Country:
Canada
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:
John Hilton
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Sherbrooke
Zip:
J1H 5N4
Country:
Canada
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:
Michel Pavic
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Toronto
Zip:
M5G 1X6
Country:
Canada
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:
Albiruni Ryan Abdul Razak
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Bordeaux
Zip:
33076
Country:
France
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:
Antoine Italiano
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Lyon cedex 08
Zip:
69373
Country:
France
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 Cassier
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Milano
Zip:
20141
Country:
Italy
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:
Giuseppe Curigliano
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Napoli
Zip:
80131
Country:
Italy
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
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:
Gennaro Daniele
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Chiba
Zip:
277-8577
Country:
Japan
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:
Shigehiro Koganemaru
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Tokyo
Zip:
104-0045
Country:
Japan
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:
Noboru Yamamoto
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Madrid
Zip:
28034
Country:
Spain
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:
Maria Eugenia Olmedo Garcia
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Madrid
Zip:
28040
Country:
Spain
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:
Edinburgh
Zip:
EH4 2XU
Country:
United Kingdom
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:
Stefan Symeonides
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Glasgow
Zip:
G12 0YN
Country:
United Kingdom
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:
Jeff Evans
Email:
Principal Investigator
Start date:
August 30, 2024
Completion date:
June 9, 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/NCT06551142
