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This study is a phase Ia study of single drug BR101 for Advanced solid tumor. The main purpose of this study is to Evaluate the safety and tolerability of BR101monotherapy (single dose and multiple doses) in Subjects with Advanced Solid Tumors and determine the MTD if possible, and determine the RP2D.
The secondary purpose of this study is to explore the Pharmacokinetics, Immunogenicity, Antitumor Activity of BR101 monotherapy (single dose and multiple doses) in Subjects with Advanced Solid Tumors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BR101 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BR101 | Drug | BR101 injection was administered once for 28 days observation period and then weekly until the subject experienced unacceptable toxicity, disease progression, poor compliance, pregnancy, informed withdrawal, death, study interruption, and withdrawal from the study |
| Measure | Description | Time Frame |
|---|---|---|
| Safety, Tolerability,RP2D | The incidence and severity of various adverse events of DLT, evaluated per NCI CTCAE 5.0 standard, abnormal physical examination, vital signs, laboratory examination, 12-guided ECG, etc.; maximum tolerated dose (MTD)(if possible). Recommended Phase II clinical trial dose | up to 91 days after the last administration |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Cmax | From screening to 31 days after the last administration |
| Tmax | Tmax | From screening to 31 days after the last administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Zhejiang University Medical College | Hangzhou | Zhejiang | 310052 | China |
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| AUC0-last | AUC0-last | From screening to 31 days after the last administration |
| AUC0-tau | AUC0-tau | From screening to 31 days after the last administration |
| Cmin | Cmin | From screening to 31 days after the last administration |
| Immunogenicity assessment | Anti-drug antibody (ADA) level produced by subjects | From screening to 31 days after the last administration |
| DCR | DCR | up to end of day 71 |
| DoR | DoR | up to end of day 71 |
| TTR | TTR | up to end of day 71 |
| CR | CR | up to end of day 71 |
| PFS | PFS | up to end of day 71 |
| Objective response rate(ORR) | ORR | up to end of day 71 |
| Pharmacodynamic assessment | After administration, to evaluate Total/free CD73 level in peripheral blood, CD73 enzymatic activity in peripheral blood, CD73 level and CD73 occupancy of peripheral blood T lymphocytes, CD73 level and CD73 occupancy of tumor tissue, CD73 enzymatic activity in tumor tissue, CD8+ tumor infiltrating lymphocyte level in tumor tissue. | UP to end of day 102 |