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This is an open-label phase I/II study to evaluate the safety, tolerability, pharmacokinetics and initial efficacy of JS004 injection combined with toripalimab in patients with advanced lung cancer who have failed standard therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JS004 200 mg in combination with toripalimab 240 mg was administered every 3 weeks as planned | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JS004 in combination with toripalimab | Drug | Usage and dosage: 200mg of JS004 combined with 240mg of JS001 is given every 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of adverse events (AE) and serious adverse events (SAE) were assessed | Incidence and severity of adverse events (AE) and serious adverse events (SAE) as assessed according to NCI-CTCAE 5.0, as well as abnormalities in vital signs, electrocardiogram, and laboratory tests | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| OS | Duration of Response | 2 years |
| DOR | Duration of Response | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jilin Cancer Hospital | Changchun | Jilin | 130012 | China | ||
| Cancer Hospital of Chinese Academy of Medical Sciences |
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| ID | Term |
|---|---|
| C000656314 | toripalimab |
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|
| DCR |
Disease Control Rate |
| 2 years |
| PFS | Progression-free survival | 2 years |
| Cmax | Maximum Plasma Concentration | 2 years |
| Tmax | Time to Cmax | 2 years |
| AUC0-t | Area under the concentration versus time curve from time 0 to the last measurable concentration | 2 years |
| AUC0-inf | AUC from time 0 to infinity | 2 years |
| Kel | Elimination rate constant | 2 years |
| t1/2 | Elimination half life time | 2 years |
| CL/F | Clearance | 2 years |
| Vd/F | Apparent volume of distribution | 2 years |
| Rac | Accumulation factor | 2 years |
| Beijing |
| 100029 |
| China |