This clinical study evaluated the efficacy and safety of T3011 in combination with PD-1/PD-L1 inhibitors in subjects with advanced solid tumors
Subjects with advanced solid tumors;
At least one measurable lesion;
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
Expected survival > 12 weeks;
Subjects who have received other antitumor therapy within the prescribed time prior to the first dose;
Subjects with a history of other malignancies within the prescribed time prior to the start of study treatment.
At screening, subjects with a history or evidence of high risk cardiovascular disease;
Subjects with persistent or active infection requiring intravenous anti-infective therapy;
Single group
T3011 high dose
Biological/VaccineT3011 high dose： T3011 will be given intratumorally，Q2W； PD-1/PD-L1 inhibitor：Administered by intravenous infusion，3 mg/kg，Q2W
T3011 middle dose
Biological/VaccineT3011 middle dose： T3011 will be given intratumorally，Q2W； PD-1/PD-L1 inhibitor：Administered by intravenous infusion，3 mg/kg，Q2W
T3011 low dose
Biological/VaccineT3011 low dose： T3011 will be given intratumorally，Q2W； PD-1/PD-L1 inhibitor：Administered by intravenous infusion，3 mg/kg，Q2W
Incidence of Treatment-Emergent Adverse Events
Adverse event type, incidence, duration
Objective response rate(ORR)
Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1
Disease control rate (DCR)
DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease
Duration of remission (DOR)
DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response to the date of disease progression per RECIST v1.1 or death from any cause.
Progression-free survival (PFS)
From the start date of study treatment to the date of progression disease or death , whichever occurred first.
Overall Survival (OS)
Determination of the overall survival time of all patients
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