This is a Phase I study designed to evaluate if experimental anti-PD-1 and anti-TIM-3 bispecific antibody, LB1410, is safe, tolerable and efficacious in participants with advanced solid tumors or lymphoma.
This first time in patients, open-label, multi-centre study will have LB1410 administered intravenously (IV) to participants with advanced solid tumors or lymphoma. This study will have 2 parts: Part A which will have dose escalation cohorts and Part B which will have the dose expansion cohorts.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
anti-PD-1 and anti-TIM-3 bispecific antibody
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGIncidence and severity of treatment-emergent adverse events (TEAEs)
According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Time frame: up to 30 days following last dose.
Incidence and severity of serious adverse events (SAEs)
According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Time frame: up to 90 days following last dose.
AEs of special interest (immune-related AEs)
Incidence and severity of immune-related AEs.
Time frame: up to 90 days following last dose.
Incidence of DLTs
The DLT for this study is defined according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0 and will be evaluated in the dose escalation part, the first 28 days (Cycle 1) of treatment.
Time frame: in the first 28 days (Cycle 1).
Serum PK parameters
AUC0-t and so on.
Time frame: Up to finished treatment (each cycle is 28 days).
Overall response rate (ORR)
Evaluation Criteria in Solid Tumors (RECIST) v 1.1 and Immunotherapeutics Response Evaluation Criteria in Solid Tumors (iRECIST) and Response Evaluation Criteria in Lymphoma (2017) (RECIL 2017).
Time frame: through study completion, an average of 8 months.
Disease control rate (DCR)
Evaluation Criteria in Solid Tumors (RECIST) v 1.1 and Immunotherapeutics Response Evaluation Criteria in Solid Tumors (iRECIST) and Response Evaluation Criteria in Lymphoma (2017) (RECIL 2017).
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Time frame: through study completion, an average of 8 months.
Progression-free survival (PFS)
Evaluation Criteria in Solid Tumors (RECIST) v 1.1 and Immunotherapeutics Response Evaluation Criteria in Solid Tumors (iRECIST) and Response Evaluation Criteria in Lymphoma (2017) (RECIL 2017).
Time frame: through study completion, an average of 8 months.
Duration of response (DOR)
Evaluation Criteria in Solid Tumors (RECIST) v 1.1 and Immunotherapeutics Response Evaluation Criteria in Solid Tumors (iRECIST) and Response Evaluation Criteria in Lymphoma (2017) (RECIL 2017).
Time frame: through study completion, an average of 8 months.
Immunogenicity
Incidence of anti-drug anti-body (ADA) including the number and percentage of participants who develop detectable ADA.
Time frame: up to 90 days following last dose.