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

  • End date
    Aug 29, 2024
  • participants needed
  • sponsor
Updated on 7 October 2022
measurable disease
primary cancer
solid neoplasm


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).

Condition Neoplasms
Treatment dostarlimab, GSK6097608, GSK4428859A (EOS884448)
Clinical Study IdentifierNCT04446351
Last Modified on7 October 2022


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 fresh tumor biopsies
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
Prolonged QT as measured by electrocardiogram
Recent history (within 6 months) of uncontrolled symptomatic ascites or pleural effusions
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
Receipt of live vaccine within 30 days of the start of study intervention
Allergen desensitization therapy within 4 weeks of starting 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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