The purpose of this study is to evaluate the safety, RP2D and PK/pharmacodynamic profile of ES101 monotherapy in patients with advanced NSCLC and to further evaluate the antitumor efficacy of ES101 in advanced malignant thoracic tumors, including NSCLC and SCLC.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
The active ingredient of ES101 is a recombinant, humanized, bispecific IgG antibody that targets the human programmed death-ligand 1 (PD-L1) receptor and the human 4-1BB receptor.
Phase 1b: Frequency and severity of adverse events of ES101
Adverse events will be assessed and assigned by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
Time frame: 1-2 years
Phase 1b: Recommended Phase 2 Dose (RP2D) of of ES101
RP2D of ES101 will be determined.
Time frame: 6 months
Phase 2: Objective response rate (ORR)
Tumor response will be determined by the revised Response Evaluation Criteria in Solid Tumors version 1.1 (RECISTv1.1).
Time frame: 2-3 years
Anti-tumor activity of ES101
Tumor response will be determined by the revised Response Evaluation Criteria in Solid Tumors version 1.1 (RECISTv1.1).
Time frame: 2-4 years
PK profile of ES101
Assess the relationship between ES101 exposure and efficacy/adverse events.
Time frame: 2-4 years
Immunogenicity of ES101
Frequency of anti-drug antibodies (ADA) against ES101 will be determined.
Time frame: 2-4 years
Pharmacodynamic markers
Assess PD-L1 receptor occupancy and cytokines
Time frame: 2-4 years
PD-L1 expression
Assess PD-L1 expression status of tumor tissues
Time frame: 2-4 years
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