Phase
Condition
Neoplasms
Treatment
GSK6097608
Dostarlimab
GSK4428859A (EOS884448)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adults 18 years of age or older (or >=20 years of age in Arm-A Japan, Arm-D Japan,Arm E-Japan, Arm F-Japan, and Arm G-Japan)
Female participants of childbearing potential must agree to use a highly effectiveform of contraception
Histological or cytological documentation of locally advanced, recurrent, ormetastatic solid malignancy. Enrollment in PK/PD cohorts will be restricted toparticipants with histologically or cytologically confirmed diagnosis of 1 or moreof the following: non-small-cell lung cancer (NSCLC), head and neck squamous cellcarcinoma (HNSCC), endometrial cancer (EC), colorectal cancer (CRC) (includingspecified molecular subtypes of these) or an alternative immunogenic tumor type withmedical monitor approval
Disease that has progressed after standard therapy for the specific tumor type, orfor which standard therapy has proven to be ineffective, intolerable, or isconsidered inappropriate, or if no further standard therapy exists
Participants in a PK/PD cohort (Arms A, B, E and F) must provide fresh tumorbiopsies. Biopsies are not required from participants enrolled in Arm D, Arm E, (non-PK/PD cohorts only), Arm F (non-PK/PD cohort only), Arm G or any participantenrolled in mainland China
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, Arm F-Japan, and Arm G-Japan only: lives inJapan and is racially Japanese, defined as all biological grandparents beingJapanese
Arm A-China, Arm B-China, Arm D-China, Arm E-China and Arm F-China only (excludingPK/PD cohorts in Arm E and Arm F): is of Chinese descent and lives in China
Arm D, Arm E, Arm F, and Arm G only: has been deemed suitable for assigned treatmentbased on assessment by the investigator
Exclusion
Exclusion Criteria:
Prior anti-cancer treatment including investigational agents, immune checkpointinhibitors, chemotherapy, targeted therapy, and biological therapy: within 4 weeksor 5 half-lives of the drug, whichever is shorter
Prior allogenic or autologous bone marrow transplantation or other solid organtransplantation
Toxicity from previous anticancer treatment, including; greater than or equal to (>=) Grade 3 immune-mediated toxicity considered related to prior immunotherapy andthat led to treatment discontinuation; or toxicity related to prior treatment thathas not resolved; or history of myocarditis of any grade during a previous treatmentwith immunotherapy
Known additional malignancy that progressed or required active treatment within thelast 2 years
Uncontrolled or symptomatic central nervous system (CNS) metastases and/orcarcinomatous meningitis
Active autoimmune disease that has required systemic disease-modifying orimmunosuppressive treatment within the last 2 years
Concurrent medical condition requiring the use of systemic immunosuppressivetreatment
Cirrhosis or current unstable liver or biliary disease per investigator assessment
Active infection requiring systemic treatment, known human immunodeficiency virusinfection, or positive test for hepatitis B surface antigen (HBsAg) or hepatitis Cvirus (HCV)
Prolonged QT as measured by electrocardiogram
Allergen desensitization therapy within 4 weeks of starting study intervention
History of hypersensitivity to any of the study interventions or their excipients
Has a history or evidence of cardiac abnormalities within the 6 months prior toenrolment
Recent history (within 6 months) of uncontrolled symptomatic ascites or pleuraleffusions
History of idiopathic pulmonary fibrosis; interstitial lung disease; organizingpneumonia; 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-stimulatingfactors 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
Study Design
Connect with a study center
GSK Investigational Site
Ottawa, Ontario K1H 8L6
CanadaSite Not Available
GSK Investigational Site
Toronto, Ontario M5G 1Z5
CanadaSite Not Available
GSK Investigational Site
Chiba, 277-8577
JapanSite Not Available
GSK Investigational Site
Tokyo, 104-0045
JapanSite Not Available
GSK Investigational Site
Seoul, 03080
Korea, Republic ofSite Not Available
GSK Investigational Site
Los Angeles, California 90025
United StatesSite Not Available
GSK Investigational Site
Boston, Massachusetts 02215
United StatesSite Not Available
GSK Investigational Site
Dallas, Texas 75230
United StatesSite Not Available
GSK Investigational Site
Houston, Texas 77030-4009
United StatesSite Not Available
GSK Investigational Site
San Antonio, Texas 78229
United StatesSite Not Available
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