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This study is a Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of JS212 in Subjects with Advanced Malignant Solid Tumour. Patients will be enrolled in two stages: a dose-escalation stage and a dose expansion stage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JS212 | Experimental | If needed, additional descriptive information (including which interventions are administered in each arm) to differentiate each arm from other arms in the clinical trial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JS212 for Injection | Drug | JS212 for Injection is administered on the first day of the first cycle and every 3 weeks thereafter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| DLT | Incidence and severity of DLT events | Up to 1 years |
| Incidence and severity of Adverse Events | Abnormal changes in clinical symptoms, vital signs, physical examination, laboratory tests, electrocardiograph and other examinations. | Up to 2 years |
| MTD | Maximum tolerated dose | Up to 1 years |
| RP2D | Recommended phase II dose | Up to 1 years |
| ORR | Objective Response Rate (ORR) as Assessed by Investigator according to RECIST v1.1 | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| DOR | Duration of Objective Response (DOR) as Assessed by Investigator according to RECIST v1.1 | Up to 2 years |
| DCR | Investigator-assessed Duration of objective Response (DCR) according to RECIST v1.1 |
| Measure | Description | Time Frame |
|---|---|---|
| To explore the correlation between potential MARKERS and efficacy | To explore the correlation between potential MARKERS and efficacy | Up to 2 years |
| To explore the correlation between serum β-Glucuronidase Concentrations and efficacy |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhihao Jiang, Master | Contact | 86-15350403639 | zhihao_jiang@junshipharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
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| Up to 2 years |
| Progression-Free Survival (PFS) | Progression-Free Survival (PFS) as Determined by Investigator according to RECIST v1.1 | Up to 2 years |
| Overall Survival (OS) | Overall Survival (OS) | Up to 2 years |
| Pharmacokinetic (PK) | Patient blood concentrations and pharmacokinetic parameters after drug administration | About 6 months after first dosing |
| Immunogenicity | Incidence of antidrug antibodies (ADA) | About 6 months after first dosing |
To explore the correlation between serum β-Glucuronidase Concentrations and efficacy
| Up to 2 years |
| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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