Study of the Safety and Effectiveness of GSK6097608 in Participants with Advanced Solid Tumors
Trial overview
Number of participants with dose-limiting toxicities (DLTs)
Timeframe: Up to Day 21
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Timeframe: Up to 2 years
Number of participants with clinically significant changes in laboratory parameters, vital signs, and 12-lead electrocardiogram (ECG) findings
Timeframe: Up to 2 years
Number of participants with dose reductions or delay
Timeframe: Up to 2 years
Number of participants withdrawn due to AEs
Timeframe: Up to 2 years
Overall response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Timeframe: Up to 2 years
Arms D, E, F, G: ORR based on modified Response Evaluation Criteria in Solid Tumors (iRECIST)
Timeframe: Up to 2 years
Arms D, E, F, G: Disease Control Rate (DCR) based on RECIST 1.1
Timeframe: Up to 2 years
Arms D, E, F, G: DCR based on iRECIST
Timeframe: Up to 2 years
Arms D, E, F, G: Time to response (TTR) based on RECIST 1.1
Timeframe: Up to 2 years
Arms D, E, F, G: TTR based on iRECIST
Timeframe: Up to 2 years
Arms D, E, F, G: Duration of response (DOR) based on RECIST 1.1
Timeframe: Up to 2 years
Arms D, E, F, G: DOR based on iRECIST
Timeframe: Up to 2 years
Arms D, E, F, G: Progression-free survival (PFS) based on RECIST 1.1
Timeframe: Up to 2 years
Arms D, E, F, G: PFS based on iRECIST
Timeframe: Up to 2 years
Arms A, B, F: Number of participants with positive anti-drug antibodies (ADAs) against GSK6097608
Timeframe: Up to 2 years
Arms A, B, F: Titers of ADAs against GSK6097608
Timeframe: Up to 2 years
Arms B, D, E, F, G: Number of participants with positive ADAs against dostarlimab
Timeframe: Up to 2 years
Arms B, D, E, F, G: Titers of ADAs against dostarlimab
Timeframe: Up to 2 years
Arms E, F: Number of participants with positive ADAs against belrestotug
Timeframe: Up to 2 years
Arms E, F: Titers of ADAs against belrestotug
Timeframe: Up to 2 years
Arm G: Number of participants with positive ADAs against cobolimab
Timeframe: Up to 2 years
Arm G: Titers of ADAs against cobolimab
Timeframe: Up to 2 years
Arms A, B, F: Maximum observed concentration (Cmax) for GSK6097608
Timeframe: Up to 2 years
Arms A, B, F: Minimum observed concentration (Cmin) for GSK6097608
Timeframe: Up to 2 years
Arms A, B, F: Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC[0-infinity]) for GSK6097608
Timeframe: Up to 2 years
Arms A, B, F: Area under the plasma concentration-time curve from time zero to time (AUC[0-t]) for GSK6097608
Timeframe: Up to 2 years
Arms A, B, F: Apparent terminal phase half-life (t1/2) for GSK6097608
Timeframe: Up to 2 years
Arms B, D, E, F, G: Cmax for dostarlimab
Timeframe: Up to 2 years
Arms B, D, E, F, G: Cmin for dostarlimab
Timeframe: Up to 2 years
Arms B, D, E, F, G: AUC(0-infinity) for dostarlimab
Timeframe: Up to 2 years
Arms B, D, E, F, G: AUC(0-t) for dostarlimab
Timeframe: Up to 2 years
Arms B, D, E, F, G: t1/2 for dostarlimab
Timeframe: Up to 2 years
Arms E, F: Cmax for belrestotug
Timeframe: Up to 2 years
Arms E, F: Cmin for belrestotug
Timeframe: Up to 2 years
Arms E, F: AUC(0-infinity) for belrestotug
Timeframe: Up to 2 years
Arms E, F: AUC(0-t) for belrestotug
Timeframe: Up to 2 years
Arms E, F: t1/2 for belrestotug
Timeframe: Up to 2 years
Arm G: Cmax for cobolimab
Timeframe: Up to 2 years
Arm G: Cmin for cobolimab
Timeframe: Up to 2 years
Arm G: AUC(0-infinity) for cobolimab
Timeframe: Up to 2 years
Arm G: AUC(0-t) for cobolimab
Timeframe: Up to 2 years
Arm G: t1/2 for cobolimab
Timeframe: Up to 2 years
- 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
- 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
•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
•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
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.