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this is a single-arm, open phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, pharmacokinetics, and preliminary efficacy of FS-8002 and combination therapy in patients with advanced solid tumors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose escalation | Experimental | 42patients for dose escalation ,total 6 dose group |
|
| Combination therapy-FS8002 and Toripalimab Injection | Experimental | Toripalimab Injection and FS8002 |
|
| Combination therapy-FS8002 and Toripalimab Injection and Chemotherapy | Experimental | Toripalimab Injection and FS8002 and Chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FS-8002 injection | Drug | Q3W or until the patient develops PD, intolerable toxicity, death, loss of follow-up, voluntary withdrawal, or the end of the study, whichever occurs first |
| Measure | Description | Time Frame |
|---|---|---|
| MTD | the maximum tolerated dose(MTD) | 1.5years |
| RP2D | the phase II recommended dose(RP2D) | 1.5years |
| DLT | incidence and serverity of DLT | 1 years |
| AE | incidence and serverity of adverse events(AE) | 2years |
| SAE | incidence and serverity of serious adverse events(SAE) | 2years |
| Measure | Description | Time Frame |
|---|---|---|
| peak concentration (Cmax) | the pharmacokinetic parameters of FS-8002: peak concentration (Cmax) | 1.5years |
| peak time (Tmax) | the pharmacokinetic parameters of FS-8002: peak time (Tmax) |
| Measure | Description | Time Frame |
|---|---|---|
| Cytokines | Cytokines: interferon gamma (IFN-γ), interleukin (IL) -2, IL-10, IL-12, and IL-15. | 1.5years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaojun Wang, Master | Contact | 021-50796193 | xiaojun_wang@junshipharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| Toripalimab Injection | Combination Product | Q3W or until the patient develops PD, intolerable toxicity, death, loss of follow-up, voluntary withdrawal, or the end of the study, whichever occurs first |
|
| Chemotherapy | Combination Product | Administrated per the chemotherapy chosed by the investigator until the patient develops PD, intolerable toxicity, death, loss of follow-up, voluntary withdrawal, or the end of the study, whichever occurs first |
|
| 1.5years |
| area under the plasma concentration-time curve (AUC) | the pharmacokinetic parameters of FS-8002: area under the plasma concentration-time curve (AUC) | 1.5years |
| T1/2 | the pharmacokinetic parameters of FS-8002: Terminal half-life | 1.5years |
| elimination rate constant | the pharmacokinetic parameters of FS-8002: elimination rate constant | 1.5years |
| ADA | Anti-drug antibody | 1.5years |
| objective response rate (ORR) | According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate objective response rate (ORR) | 1.5years |
| disease control rate (DCR) | According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate disease control rate (DCR) | 1.5years |
| duration of response (DOR) | According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate duration of response (DOR) | 1.5years |
| progression-free survival (PFS) | According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate progression-free survival (PFS) | 1.5years |
| overall survival (OS) | According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate overall survival (OS) | 1.5years |
| Fujian Cancer hospital | Recruiting | Fujian | Fuzhou | 350013 | China |
|
| The First Affiliated Hospital of Zhejiang Medical University | Recruiting | Zhejiang | Hangzhou | 310003 | China |
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| Harbin Medical University Cancer Hospital | Recruiting | Heilongjiang | Harbin | 150081 | China |
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| Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute,Shandong Cancer Hospital) | Recruiting | Shandong | Jinan | 250117 | China |
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| Meizhou People's Hospital | Recruiting | Guangdong | Meizhou | 514031 | China |
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| The First Affiliated Hospital of China Medical University | Recruiting | Shenyang | Shenyang | 110001 | China |
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| Hebei General Hospital | Recruiting | Hebei | Shijiazhuang | 050010 | China |
|
| Union Hospital, Tongji Medical College | Recruiting | Hubei | Wuhan | 430022 | China |
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| Hubei Cancer Hospital | Recruiting | Hubei | Wuhan | 430079 | China |
|
| ID | Term |
|---|---|
| C000656314 | toripalimab |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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