This is a phase I, open-label, first-in-human clinical study designed to evaluate the safety, tolerability, PK profile and efficacy of JS108 for patients with advanced solid tumors. This study is divided into 3 periods: dose escalation period, dose expansion period, and clinical expansion period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Dose escalation period: JS108 is administered intravenously every three weeks (Q3W) at the dose corresponding to the enrolled dose cohort. Dose expansion period: JS108 is administered intravenously Q3W at the corresponding dose. Clinical expansion period: JS108 is administered intravenously Q3W at the recommended dose.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
First Cycle Dose Limiting Toxicities (DLTs) In Order to Determine the Maximum Tolerated Dose(MTD)
Number of participants that experienced dose limiting toxicities(DLTs) at given dose level.
Time frame: A minimum of 21 days after first infusion of study drug
Number of participants with adverse events (AEs)
The adverse events will be evaluated in accordance with CTCAE v5.0. The investigator shall assess the relationship between the events and investigational product.
Time frame: Through study completion, an average of 1 year
Maximum observed serum or plasma concentration (Cmax)
One of the pharmacokinetics parameters for JS108
Time frame: Through study completion, an average of 1 year
Maximum serum drug time（Tmax）
One of the pharmacokinetics parameters for JS108
Time frame: Through study completion, an average of 1 year
Area under the serum or plasma concentration time curve from 0 to infinity (AUC0-inf)
One of the pharmacokinetics parameters for JS108
Time frame: Through study completion, an average of 1 year
Volume of distribution at steady state (Vss)
One of the pharmacokinetics parameters for JS108
Time frame: Through study completion, an average of 1 year
Terminal phase elimination half life (t½)
One of the pharmacokinetics parameters for JS108
Time frame: Through study completion, an average of 1 year
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Clearance (CL)
One of the pharmacokinetics parameters for JS108
Time frame: Through study completion, an average of 1 year
Anti-drug antibodies (ADA)
To evaluate the immunogenicity of JS108 in patients with advanced solid tumors
Time frame: Through study completion, an average of 1 year
Objective Response Rate (ORR)
As determined by the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, which will be complete response (CR) + partial response (PR)
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year
Duration of response (DOR)
DOR is defined as the time from the date of the first documentation of response (confirmed CR or confirmed PR) to the date of the first documentation of PD or death due to any cause, whichever occurs first.
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year
Progression Free Survival (PFS)
PFS is defined as the time from the date of randomization to the earlier of the dates of the first documentation of progressive disease or death due to any cause.
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause.
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year
Levels of Trop2 (trophoblast antigen 2) expression in tumor tissue
To investigate any potential correlations of Trop2 levels with responses and toxicity
Time frame: Through study completion, an average of 1 year