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

  • STATUS
    Recruiting
  • participants needed
    100
  • sponsor
    GlaxoSmithKline
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Updated on 19 February 2024
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measurable disease
ejection fraction
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. This study will be used to define the recommended Phase 2 dose (RP2D). The study comprises 3 phases; screening phase (28 days prior to first dose), treatment phase (until disease progression, unacceptable toxicity, death, or withdrawal of consent) and follow-up phase (90 days). Approximately 100 adult participants with locally advanced, recurrent, or metastatic solid tumors will be enrolled.

Details
Condition Cancer
Age 18years - 100years
Treatment GSK6097608, Dostarlimab
Clinical Study IdentifierNCT04446351
SponsorGlaxoSmithKline
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Adults 18 years of age or older
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 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

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
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
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
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)
Prolonged QT corrected for heart rate according to Fridericia's formula as measured by electrocardiogram
History of hypersensitivity to monoclonal antibodies. For combination therapy, history of hypersensitivity to dostarlimab or its excipients
History or evidence of significant cardiovascular (CV) risk
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
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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