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This study is to characterize the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of B1962, a PD-L1/VEGF bispecific antibody fusion protein, as a single agent in adult subjects with advanced solid tumor malignancies. The study consists of two parts: a once-weekly (QW) dosing phase and a biweekly (Q2W) dosing phase, which will explore the possibility of Q2W dosing of B1962 based on the PK data obtained in the QW phase. The study will determine the maximum tolerated dose (MTD), or recommended Phase 2 dose (RP2D) for B1962 as a single agent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | B1962 0.035mg Open Lable |
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| Cohort 2 | Experimental | B1962 0.12mg Open Lable |
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| Cohort 3 | Experimental | B1962 0.4mg Open Lable |
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| Cohort 4 | Experimental | B1962 1.2mg Open Lable |
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| Cohort 5 | Experimental | B1962 4mg Open Lable |
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| Cohort 6 | Experimental | B1962 8mg Open Lable |
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| Cohort 7 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B1962 | Drug | B1962 is a PD-L1/VEGF bispecific antibody fusion protein. |
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| Measure | Description | Time Frame |
|---|---|---|
| DLT Assessment | Toxicity associated with the treatment of the investigational drug B1962 | From Day1 to Day15 after first dose of B1962 |
| AE Assessment | The frequency of AE | From first dose of B1962 until 28 days after the last dose of B1962. |
| 12-lead ECG Assessment | Changes of 12-lead ECG from baseline | From first dose of B1962 until 28 days after the last dose of B1962. |
| Eastern Cooperative Oncology Group score Assessment | Changes of Eastern Cooperative Oncology Group score from baseline | From first dose of B1962 until 28 days after the last dose of B1962. |
| Determine the maximum tolerated dose (MTD) | From first dose of B1962 until 28 days after the last dose of B1962 | |
| Determine the recommended phase II dose (RP2D) | From first dose of B1962 until 28 days after the last dose of B1962 |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) Analysis | From first dose of B1962 through 7 days of deciding to stop research treatment by subjects | |
| Area under the plasma concentration versus time curve (AUC) Analysis | From first dose of B1962 through 7 days of deciding to stop research treatment by subjects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kongli zhu, Master | Contact | +8615800363686 | tsl-zhukongli@tasly.com |
| Name | Affiliation | Role |
|---|---|---|
| Kongli zhu, Master | Tasly Biopharmaceuticals Co., Ltd. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Pulmonary Hospital | Shanghai | Shanghai Municipality | 200082 | China |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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B1962 11mg Open Lable |
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| Cohort 8 | Experimental | B1962 15mg Open Lable |
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| Cohort 9 | Experimental | B1962 20mg Open Lable |
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| Cohort 10 | Experimental | B1962 25mg Open Lable |
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| Terminal elimination half-life(t1/2) Analysis | From first dose of B1962 through 7 days of deciding to stop research treatment by subjects |
| Time to reach the maximum observed concentration(Tmax) Analysis | From first dose of B1962 through 7 days of deciding to stop research treatment by subjects |
| Number of subjects who develop detectable anti-drug antibodies (ADAs) | From first dose of B1962 until 28 days after the last dose of B1962 |