GSK6097608
DrugGSK6097608 will be administered as an IV infusion.
NCT Number: NCT04446351
This first-time-in-human (FTIH) study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of escalating doses of GSK6097608 given as monotherapy and in combination with dostarlimab in participants with advanced solid tumors. In addition, dostarlimab will be given as monotherapy (Arm D); and in combination with belrestotug (Arm E); and with GSK6097608 + belrestotug (Arm F) in Japanese and Chinese participants. The study may assess the PK/PD cohorts for Arm E and/or Arm F in participants outside of China and Japan. Additionally, dostarlimab will be given in combination with cobolimab in Japanese participants. Drug name mentioned as belrestotug, GSK4428859A and EOS884448 are interchangeable for the same compound. In the rest of the document, the drug will be referred to as belrestotug.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 1
GSK Investigational Site, Ottawa, Ontario, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
GSK6097608 will be administered as an IV infusion.
Dostarlimab will be administered as an IV infusion.
Cobolimab will be administered as an IV infusion.
Belrestotug will be administered as an IV infusion.
Other names: GSK4428859A, EOS884448
Time frame: Up to Day 21
Time frame: Up to 2 years
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Time frame: Up to 2 years
GlaxoSmithKline
Industry
A Phase 1 First-Time-in-Human, Open-Label Study of GSK6097608 Administered as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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