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Considering that the safety risk will affect the subsequent development, it is decided to terminate the test voluntarily
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The trial is divided into three periods. Dosing will be the first day of each cycle, 21 days per cycle. The first period is the day of first study drug delivery until the 21st day, that is, the first treatment cycle. The DLT observation, exploration of MTD, safety of single administration, tolerance and pharmacokinetics, immunity Original research will happen during this period. The second period is a 2-8 dosing cycle, with multiple doses of tolerance, pharmacokinetics, immunogenicity studies, and preliminary efficacy evaluations. After a 2-4 cycle study, patients with good tolerance and no tumor progression will continue to the 5-8 cycle dosing study. The third period is to expand the study. After exploring the MTD, the investigator and the sponsor can discuss to extend another 10-30 cases in a safe and effective dose group to further study the effectiveness and safety of BAT8003 and its pharmacokinetics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAT8003 0.2mg/kg | Experimental | BAT8003,0.2mg/kg,intravenous infusion, sample size 1-3 |
|
| BAT8003 0.5mg/kg | Experimental | BAT8003,0.5mg/kg,intravenous infusion, sample size 1-3 |
|
| BAT8003 1mg/kg | Experimental | BAT8003,1mg/kg,intravenous infusion, sample size 3 |
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| BAT8003 2mg/kg | Experimental | BAT8003,2mg/kg,intravenous infusion, sample size 3 |
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| BAT8003 4mg/kg | Experimental | BAT8003,4mg/kg,intravenous infusion, sample size 3 |
|
| BAT8003 6mg/kg | Experimental | BAT8003,6mg/kg,intravenous infusion, sample size 3 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAT8003 | Drug | Phase 1 dose titration study from BAT8003 0.2mg/kg to 10mg/kg, then choose a proper dose for amplification study based on DLT result |
|
| Measure | Description | Time Frame |
|---|---|---|
| dose-limiting toxicity (DLT) | safety and tolerability endpoint | 3weeks |
| maximum tolerated dose (MTD) | safety and tolerability endpoint | 3weeks |
| Area under the curve(AUC) | pharmacokinetic endpoint | no more than 24weeks |
| Maximum serum drug concentration(Cmax) | pharmacokinetic endpoint | no more than 24weeks |
| half-life period(t1/2) | pharmacokinetic endpoint | no more than 24weeks |
| Maximum serum drug time(Tmax) | pharmacokinetic endpoint | no more than 24weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| jian huang | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
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| BAT8003 8mg/kg | Experimental | BAT8003,8mg/kg,intravenous infusion, sample size 3 |
|
| BAT8003 10mg/kg | Experimental | BAT8003,10mg/kg,intravenous infusion, sample size 3 |
|
| Amplification group | Experimental | BAT8003,intravenous infusion,choose one proper dose from 0.2、0.5、1、2、4、6、8、10mg/kg |
|