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Sponsor has adjusted study development plan and terminated this clinical study.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JS108 (recombinant humanized anti-Trop2 mAb-Tub196 conjugate for injection) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed serum or plasma concentration (Cmax) | One of the pharmacokinetics parameters for JS108 | Through study completion, an average of 1 year |
| Maximum serum drug time（Tmax） | One of the pharmacokinetics parameters for JS108 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China | ||
| Fudan University Shanghai Cancer Center |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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|
| 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 | Through study completion, an average of 1 year |
| Volume of distribution at steady state (Vss) | One of the pharmacokinetics parameters for JS108 | Through study completion, an average of 1 year |
| Terminal phase elimination half life (t½) | One of the pharmacokinetics parameters for JS108 | Through study completion, an average of 1 year |
| Clearance (CL) | One of the pharmacokinetics parameters for JS108 | Through study completion, an average of 1 year |
| Anti-drug antibodies (ADA) | To evaluate the immunogenicity of JS108 in patients with advanced solid tumors | 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) | 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. | 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. | 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. | 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 | Through study completion, an average of 1 year |
| Shanghai |
| Shanghai Municipality |
| 200032 |
| China |
| Shanghai Pulmonary Hospital | Shanghai | Shanghai Municipality | 200433 | China |