The purpose of this study is to evaluate the safety, tolerance and Dose-Limiting Toxicity (DLT) of recombinant humanized PD-L1/4-1BB bispecific antibody (ES101) in patients with advanced solid tumors.
ES101 (INBRX-105; PDL1x4-1BB antibody) is a recombinant humanized bispecific IgG1 antibody targeting human PD-L1 and 4-1BB. This is an open-label, multicenter, dose-escalation and cohort expansion phase 1 clinical study to evaluate the safety and pharmacokinetic characteristics and preliminary anti-tumor activity of ES101 in patients with advanced malignant solid tumors whose disease has progressed despite standard therapy, or who has no further standard therapy, or who is unsuitable for available standard treatment options.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
ES101 is administered via intravenous infusion, once every 14 days, every 28 days as a treatment cycle.
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of of ES101
The MTD and/or RP2D of ES101 will be determined.
Time frame: Up to 2-3 years
Frequency of adverse events of ES101
Adverse events will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
Time frame: Up to 2-3 years
Severity of adverse events of ES101
Severity of 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: Up to 2-3 years
Area under the serum concentration time curve (AUC) of ES101
Area under the serum concentration time curve (AUC) of ES101 will be determined.
Time frame: Up to 2-3 years
Maximum observed serum concentration (Cmax) of ES101
Maximum observed serum concentration (Cmax) of ES101 will be determined.
Time frame: Up to 2-3 years
Trough observed serum concentration (Ctrough) of ES101
Trough observed serum concentration (Cmax) of ES101 will be determined.
Time frame: Up to 2-3 years
Time to Cmax (Tmax) of ES101
Time to Cmax (Tmax) of ES101 will be determined.
Time frame: Up to 2-3 years
Immunogenicity of ES101
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Frequency of anti-drug antibodies (ADA) against ES101 will be determined.
Time frame: Up to 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: Up to 2-3 years