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Objectives:To evaluate the safety and tolerability of BAT8008 for injection in patients with advanced solid tumors, explore the maximum tolerated dose (MTD), and provide the recommended dose for subsequent clinical trials.
In this multi-center, open, dose-increasing, dose-expanding Phase I clinical study, rapid titration and a "3+3" dose-increasing design were used to explore the safety, tolerability and PK characteristics of BAT8008 for injection in patients with advanced solid tumors. During the dose-escalation test, appropriate doses were selected for the extended study according to the previous study data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A/0.8mg/kg | Experimental | Drugļ¼BAT8008 for Injection,0.8mg/kg |
|
| B/1.2mg/kg | Experimental | Drugļ¼BAT8008 for Injection,1.2mg/kg |
|
| C/2.4mg/kg | Experimental | Drugļ¼BAT8008 for Injection,2.4mg/kg |
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| D/3.6mg/kg | Experimental | Drugļ¼BAT8008 for Injection,3.6mg/kg |
|
| E/4.8mg/kg | Experimental | Drugļ¼BAT8008 for Injection,4.8mg/kg |
|
| F/6.0mg/kg | Experimental | Drugļ¼BAT8008 for Injection,6.0mg/kg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAT8008 for Injection | Drug | Intravenous infusion, once every 2 weeks (Q2W). It is recommended that the infusion time of the first cycle should be ā„ 3 hours. If no infusion reaction occurs, the subsequent circulation can be completed within 1-2 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicity (DLT) | DLT was defined as grade 3 or higher toxicity associated with the investigational product that occurred within 21 days of the subject's initial administration | At the end of Cycle 1( first cycle is 21 days, subsequent cycles are 14 days) |
| Maximum tolerated dose (MTD) | MTD was defined as exploration in a dose group observed ā¤1/6 of subjects during the DLT evaluation period to the highest dose level of DLT. | At the end of Cycle 1( first cycle is 21 days, subsequent cycles are 14 days) |
| Measure | Description | Time Frame |
|---|---|---|
| AUC(0-inf)after cycle 6 administration | The area under the concentration-time curve extrapolated from time 0 to infinity | 91 days after first dose of BAT8008 |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of ADA/nentralizing antibodiesļ¼NAbsļ¼ | presence of anti-drug antibody/ nentralizing antibodies | 91 days after first dose of BAT8008 |
Inclusion Criteria:
All of the following items could be meet to be enrolled the study
Exclusion Criteria:
If you meet any of the following items, you will not be allowed to enroll this study :
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| WeiNing Li | Contact | 020-31702863ļ¼8028ļ¼ | wnli@bio-thera.com | |
| Zhaohe Wang | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Weier Song | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Cancer Hospital of Chongqing University | Recruiting | Chongqing | Chongqing Municipality | China |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| G/7.2mg/kg | Experimental | Drugļ¼BAT8008 for Injection,7.2mg/kg |
|
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| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | China |
|