The purpose of this study is to evaluate the safety, tolerance, Dose-Limiting Toxicity (DLT), Maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of ES102 (OX40 agonist) in combination with JS001 (anti-PD-1 checkpoint inhibitor) in patients with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Jilin Cancer Hospital
Changchun, Jilin, China
MTD
Maximum Tolerated Dose (MTD) of ES102 in combination with JS001
Time frame: 2-4 years
Frequency and severity of adverse events of ES102 in combination with JS001
The safety profile of ES102 in combination with JS001 will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
Time frame: 2-4 years
RP2D
Recommended Phase 2 Dose (RP2D) of ES102 in combination with JS001
Time frame: 2-4 years
Area under the serum concentration time curve (AUC) of ES102 in combination with JS001
Area under the serum concentration time curve (AUC) of ES102 in combination with JS001 will be determined.
Time frame: 2-4 years
Maximum observed serum concentration of ES102 in combination with JS001
Maximum observed serum concentration of ES102 in combination with JS001 will be determined.
Time frame: 2-4 years
Trough observed serum concentration (Ctrough) of ES102 in combination with JS001
Trough observed serum concentration (Ctrough) of ES102 in combination with JS001 will be determined.
Time frame: 2-4 years
Time to Cmax (Tmax) of ES102 in combination with JS001
Time to Cmax (Tmax) of ES102 in combination with JS001 will be determined.
Time frame: 2-4 years
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Immunogenicity of ES102 in combination with JS001
Frequency of anti-drug antibodies (ADA) against ES102 in combination with JS001 will be determined.
Time frame: 2-4 years
Anti-tumor activity of ES102 in combination with JS001
Tumor response will be determined by the revised Response Evaluation Criteria in Solid Tumors version 1.1 (RECISTv1.1).
Time frame: 2-4 years