Study of the Safety and Effectiveness of GSK6097608 in Participants With Advanced Solid Tumors

STATUS

Recruiting
End date

Aug 29, 2024
participants needed

178
sponsor

GlaxoSmithKline

Updated on 6 May 2022

See if I qualify

measurable disease

primary cancer

solid neoplasm

Summary

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 and in combination with GSK6097608 and with GSK4428859A (EOS884448) in Japanese and Chinese participants. Drug name mentioned as GSK4428859A and EOS884448 are interchangeable for the same compound. In the rest of the document, the drug will be referred to as GSK4428859A (EOS884448).

Details

Condition	Neoplasms
Treatment	dostarlimab, GSK6097608, GSK4428859A (EOS884448)
Clinical Study Identifier	NCT04446351
Sponsor	GlaxoSmithKline
Last Modified on	6 May 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Adults 18 years of age or older (or >=20 years of age in Arm-A Japan, Arm-D Japan, Arm E-Japan, and Arm F-Japan)
	Female participants of childbearing potential must agree to use a highly effective form of contraception
	Histological or cytological documentation of locally advanced, recurrent, or metastatic solid malignancy
	Disease that has progressed after standard therapy for the specific tumor type, or for which standard therapy has proven to be ineffective, intolerable, or is considered inappropriate, or if no further standard therapy exists
	Participants in a PK/PD cohort must provide a tumor biopsy during the screening period from a tumor lesion and agree to an additional on-treatment biopsy
	Measurable disease per RECIST 1.1
	Eastern cooperative oncology group (ECOG) performance status (PS) 0 to 1
	Life expectancy of at least 12 weeks
	Adequate organ function as determined by laboratory assessments
	Adequate cardiac ejection fraction as measured by echocardiogram
	Arm A-Japan, Arm D-Japan, Arm E-Japan, and Arm F-Japan only: lives in Japan and is racially Japanese, defined as all biological grandparents being Japanese
	Arm A-China, Arm B-China, Arm D-China, Arm E-China and Arm F-China only: is of Chinese descent and lives in China
	Arm D, Arm E, and Arm F only: has been deemed suitable for assigned treatment based on assessment by the investigator
Exclusion Criteria
	Prior anti-cancer treatment including investigational agents, immune checkpoint inhibitors, chemotherapy, targeted therapy, and biological therapy: within 4 weeks or 5 half-lives of the drug, whichever is shorter
	Prior allogenic or autologous bone marrow transplantation or other solid organ transplantation
	Known additional malignancy that progressed or required active treatment within the last 2 years
	Uncontrolled or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis
	Toxicity from previous anticancer treatment, including; greater than or equal to Grade 3 immune-mediated toxicity considered related to prior immunotherapy and that led to treatment discontinuation; or toxicity related to prior treatment that has not resolved; or myocarditis of any grade considered related to prior immuno-oncology therapy that led to treatment discontinuation
	Active autoimmune disease that has required systemic disease-modifying or immunosuppressive treatment within the last 2 years
	Concurrent medical condition requiring the use of systemic immunosuppressive treatment
	Cirrhosis or current unstable liver or biliary disease per investigator assessment
	Active infection requiring systemic treatment, known human immunodeficiency virus infection, or positive test for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
	History or evidence of significant cardiovascular (CV) risk
	Recent history (within 6 months) of uncontrolled symptomatic ascites or pleural effusions
	Prolonged QT as measured by electrocardiogram
	History of idiopathic pulmonary fibrosis; interstitial lung disease; organizing pneumonia; noninfectious pneumonitis that required steroids, or evidence of active, noninfectious pneumonitis
	Pregnant or lactating woman
	Allergen desensitization therapy within 4 weeks of starting study intervention
	Receipt of live vaccine within 30 days of the start of study intervention
	History of hypersensitivity to any of the study interventions or their excipients
	Receipt of transfusion of blood products or administration of colony-stimulating factors within 14 days before the first dose of study intervention
	Major surgery less than 4 weeks before the first dose of study intervention
	Known drug or alcohol abuse

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Study of the Safety and Effectiveness of GSK6097608 in Participants With Advanced Solid Tumors