A Phase I Study of JS108 in Patients With Advanced Solid Tumors
- Conditions
- Advanced Solid Tumors
- Interventions
- Drug: JS108 (recombinant humanized anti-Trop2 mAb-Tub196 conjugate for injection)
- Registration Number
- NCT04601285
- Lead Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 25
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose Escalation JS108 (recombinant humanized anti-Trop2 mAb-Tub196 conjugate for injection) -
- Primary Outcome Measures
Name Time Method Number of participants with adverse events (AEs) Through study completion, an average of 1 year The adverse events will be evaluated in accordance with CTCAE v5.0. The investigator shall assess the relationship between the events and investigational product.
First Cycle Dose Limiting Toxicities (DLTs) In Order to Determine the Maximum Tolerated Dose(MTD) A minimum of 21 days after first infusion of study drug Number of participants that experienced dose limiting toxicities(DLTs) at given dose level.
- Secondary Outcome Measures
Name Time Method Maximum observed serum or plasma concentration (Cmax) Through study completion, an average of 1 year One of the pharmacokinetics parameters for JS108
Maximum serum drug time（Tmax） Through study completion, an average of 1 year One of the pharmacokinetics parameters for JS108
Area under the serum or plasma concentration time curve from 0 to infinity (AUC0-inf) Through study completion, an average of 1 year One of the pharmacokinetics parameters for JS108
Anti-drug antibodies (ADA) Through study completion, an average of 1 year To evaluate the immunogenicity of JS108 in patients with advanced solid tumors
Overall Survival (OS) 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 OS is defined as the time from the date of randomization to the date of death due to any cause.
Volume of distribution at steady state (Vss) Through study completion, an average of 1 year One of the pharmacokinetics parameters for JS108
Objective Response Rate (ORR) 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 As determined by the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, which will be complete response (CR) + partial response (PR)
Duration of response (DOR) 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 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.
Progression Free Survival (PFS) 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 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.
Terminal phase elimination half life (t½) Through study completion, an average of 1 year One of the pharmacokinetics parameters for JS108
Clearance (CL) Through study completion, an average of 1 year One of the pharmacokinetics parameters for JS108
Levels of Trop2 (trophoblast antigen 2) expression in tumor tissue Through study completion, an average of 1 year To investigate any potential correlations of Trop2 levels with responses and toxicity
Trial Locations
- Locations (3)
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
Shanghai Pulmonary Hospital
🇨🇳Shanghai, Shanghai, China