Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
With
23andMe, Inc.
iTeos Therapeutics
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 effective form of contraception
Histological or cytological documentation of locally advanced, recurrent, or metastatic solid malignancy. Enrollment in PK/PD cohorts will be restricted to participants with histologically or cytologically confirmed diagnosis of 1 or more of the following: non-small-cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), endometrial cancer (EC), colorectal cancer (CRC) (including specified molecular subtypes of these) or an alternative immunogenic tumor type with medical monitor approval
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 (Arms A, B, E and F) must provide fresh tumor biopsies. 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 participant enrolled 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 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 (excluding PK/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 treatment based on assessment by the investigator
You may not be if
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; or history of myocarditis of any grade during a previous treatment with immunotherapy
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 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 to enrolment
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
Clareo Health | Study of the Safety and Effectiveness of GSK6097608 in Participants With Advanced Solid Tumors
