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The goal of this interventional study is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BAT8010 for injection in patients with advanced or metastatic solid tumors, explore the maximum tolerable dose. Participants will be given one of below dose once every three weeks: 0.8mg/kg, 1.2mg/kg, 2.4mg/kg, 3.6mg/kg, 4.8mg/kg, 6.0mg/kg, 7.2mg/kg, 8.4mg/kg. The dose escalation follow adopt accelerated titration and "3+3" dose increasing rule.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A/ Accelerated titration 0.8mg/kg of BAT8010 | Experimental | Drug: BAT8010, Dosage: 0.8mg/kg, Frequency: once every 3 weeks, Duration: 1year |
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| B/ Standard 3+3 1.2mg/kg of BAT8010 | Experimental | Drug: BAT8010, Dosage: 1.2mg/kg, Frequency: once every 3 weeks, Duration: 1year |
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| C/ Standard 3+3 2.4mg/kg of BAT8010 | Experimental | Drug: BAT8010, Dosage: 2.4mg/kg, Frequency: once every 3 weeks, Duration: 1year |
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| D/ Standard 3+3 3.6mg/kg of BAT8010 | Experimental | Drug: BAT8010, Dosage: 3.6mg/kg, Frequency: once every 3 weeks, Duration: 1year |
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| E/ Standard 3+3 4.8mg/kg of BAT8010 | Experimental | Drug: BAT8010, Dosage: 4.8mg/kg, Frequency: once every 3 weeks, Duration: 1year |
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| F/ Standard 3+3 6.0mg/kg of BAT8010 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAT8010 for Injection | Drug | Intravenous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity (DLT) | Grade 5 toxicity; Hematological toxicity: Grade 4 alanine-aminotransferase(ALT) or aspartate-aminotransferase(AST) increase: AST or ALT>5 times upper limit of normal value(ULN), with ≥ 2 levels of blood bilirubin increase; Hematological toxicity: Grade 4 neutropenia lasting>7 days. ≥Grade 3 neutropenia with fever (single body temperature>38.3 or continuous body temperature ≥ 38 ℃, more than 1 Hour). Grade 4 anemia. Grade 4 thrombocytopenia. ≥ Grade 3 thrombocytopenia and lasting>7 days. ≥ Grade 3 thrombocytopenia with bleeding; Other ≥Grade 3 non hepatic toxicity, non hematological toxicity. | 3 weeks |
| maximum tolerated dose (MTD) | MTD was defined as the highest dose level of DLT observed in ≤1/6 subjects in a dose group during the DLT evaluation period | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic | Cmax | every cycle until 18 weeks (one cycle equals 3 weeks)] |
| Immunogenicity | Presence of anti drug antibody (ADA)/Neutralizing antibodies (NAb) ADA, Nab |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chaohe Wang | Bio-Thera Solutions | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Experimental |
Drug: BAT8010, Dosage: 6.0mg/kg, Frequency: once every 3 weeks, Duration: 1year |
|
| G/ Standard 3+3 7.2mg/kg of BAT8010 | Experimental | Drug: BAT8010, Dosage: 7.2mg/kg, Frequency: once every 3 weeks, Duration: 1year |
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| H/ Standard 3+3 8.4mg/kg of BAT8010 | Experimental | Drug: BAT8010, Dosage: 8.4mg/kg, Frequency: once every 3 weeks, Duration: 1year |
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| every cycle until 18 weeks, every 4 cycles after 18 weeks (one cycle equals 3 weeks), up to 1 year |
| Objective response rate (ORR) | Refers to the proportion of patients whose tumors have shrunk to a certain amount and remained for a certain period of time, including CR and PR cases. Specifically divided into: 1.The ratio of patients with partial response (PR) or complete remission (CR) efficacy at the end of the first 6 cycles (18 weeks) of treatment. 2.The proportion of patients whose best response reached PR or CR during the entire study period. | through study completion, an average of 2 years |
| Duration of remission (DoR) | DoR is defined as the time between the first assessment of objective remission of a tumor and death from any cause before the first assessment of Disease progression (PD) , reflecting the duration of ORR. | Through study completion, an average of 2 years |
| Disease Control Rate (DCR) | The proportion of patients with reduced or stable tumors that remain for a certain period of time, including CR, PR, and Disease stability (SD) cases. | through study completion, an average of 2 years |
| Progression free survival (PFS) | The time from the first administration to the occurrence of objective tumor progression or all cause death | through study completion, an average of 2 years |
| Total survival period (OS) | The time from the date of first administration to the occurrence of death due to any cause. Subjects who were still alive at the time of analysis will use the date of their last contact as the deadline. | through study completion, an average of 2 years |