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| Name | Class |
|---|---|
| Peking University Cancer Hospital and Institute | OTHER |
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The goal of this clinical trial is to learn about the safety, tolerability and preliminary effectiveness of a treatment for patients with advanced melanoma,regardless of gender, aged between 18 and 75 years (inclusive).
Participants will receive the investigational product intravenously every two or three weeks. The treatment will continue for a maximum of two years for those who do not show signs of disease progression or experience intolerable side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dose escalation and expansion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BT02 | Drug | monoclonal antibody injection with intravenous administration every 2 or 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Through the study completion, an average of 2 years | |
| Dose limited toxicity(DLT) | Through the dose escalation phase, an average of 8 months | |
| Maximum tolerable dose(MTD) | Through the dose escalation phase, an average of 8 months | |
| Recommended phase 2 dose(RP2D) | Through the study completion, an average of 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) on tumor assessments | Through the study completion, an average of 2 years | |
| Progression-free survival (PFS) on tumor assessments | Through the study completion, an average of 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical development director | Contact | +86-18602185973 | clin.oper@biotroy.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jun Guo, MD | Peking University Cancer Hospital & Institute | Principal Investigator |
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| Overall survival (OS) | Through the study completion, an average of 2 years |
| Duration of response (DoR) on tumor assessments | Through the study completion, an average of 2 years |
| Disease control rate (DCR) on tumor assessments | Through the study completion, an average of 2 years |
| Mean and median Area under the curve (AUC) of BT02 following first dose and repeated administration at each dose level | Through the study completion, an average of 2 years |
| Mean and median Maximum concentration (Cmax) of BT02 following first dose and repeated administration at each dose level | Through the study completion, an average of 2 years |
| ADA and NAb incidence | Through the study completion, an average of 2 years |