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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20220209 | Other Identifier | NMPA |
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The goal of this clinical trial is to about in Patients With Advanced Solid Tumors. The main question[s] it aims to answer are:
Subjects will be administered BH002 intravenously. It is expected that there will be 2 to 4 dose groups, with 3 to 6 subjects enrolled in each group. The doses from low to high are 15 mg/m2,20 mg/m2,25 mg/m2,30 mg/m2,35 mg/m2. Subjects were injected with BH002 intravenously on the first day of each cycle, once during a 3-week period.
The dose escalation for this trial will be 20mg/m2 as the starting dose. According to the traditional "3+3" dose escalation principle, 3 subjects are planned to be enrolled in each dose group at the same time. Safety, tolerability, and dose-limiting toxicities (DLTs) will be assessed within 21 days of first dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BH002 | Experimental | Every 21 days constitutes a treatment cycle, and administration begins on the first day of each cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BH002 | Drug | Every 21 days constitutes a treatment cycle, and administration begins on the first day of each cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluating the tolerability of BH002 in Chinese patients with advanced solid tumors. | dose-limiting toxicity [DLT] | 21 days after first dose |
| Evaluating the tolerability of BH002 in Chinese patients with advanced solid tumors. | maximum tolerated dose [MTD] | 21 days after first dose |
| Obtain the pharmacokinetic characteristics of BH002 in Chinese patients with advanced solid tumors. | Maximum Plasma Concentration [Cmax], etc, | 216 hours after first dose |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety of BH002 in Chinese patients with advanced solid tumors. | Rates and severity of adverse events. | From first dose to 30 days after last dose |
| Evaluating the preliminary anti-tumor activity of BH002 in Chinese patients with advanced solid tumors |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dingwei Ye, PI | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Cancer Hospital | Changsha | Hunan | China | |||
| Fudan University Shanghai Cancer Center |
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Preliminary observation of the therapeutic effect of the drug. |
| From first dose to 30 days after last dose |
| Determination of recommended phase Ⅱ dose (RP2D) | Explore clinically applicable doses and dosage regimens in the next phase. | 21 days after first dose |
| Shanghai |
| Shanghai Municipality |
| China |