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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCB-313 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCB-313 | Drug | 10mg group: Intraperitoneal injection single dose on Day 0, safety observation for 7 days, then 3 continuous doses on Day7, Day8, Day9, 21 days for 1 cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| MTD | MTD for single and multiple doses of SCB-313 | 28 days after first dosing |
| DLT | Dose Limiting Toxicity (DLT) | 28 days after first dosing |
| AE/SAE | The severity of the adverse events associated with SCB-313 treatment, the incidence of serious adverse events (SAE), and the severity and incidence of adverse events (TEAE) during the DLT-observation period developed in patients, and the classification is based on the National Cancer Institute General Adverse Event Terminology | 28 days after first dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity | Occurrence of binding and neutralizing anti-SCB-313 antibodies | Up to 28 days after first dosing |
| Pharmacokinetics (Cmax) | Maximum SCB-313 concentration |
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Inclusion Criteria:
Histologically or cytologically confirmed as malignant solid tumor.
Malignant ascites requiring puncture drainage evaluated by investigators, defined as:
Eastern Cooperative Oncology Group (ECOG) performance status: 0 to 3.
Life expectancy of at least 12 weeks.
Age ≥ 18 years.
Body weight ≥ 45 kg and body mass index (BMI) >17 kg/m2
Adequate hematological function, defined as: (a) Platelet count ≥100×109/L, (b) Prothrombin time and activated partial thromboplastin time ≤ 1.5 times the upper limit of normal (ULN), (c) Absolute neutrophil count ≥1.5×109/L, and (d) Hemoglobin ≥ 9 g/dL.
Adequate renal function, defined as serum creatinine ≤ 2.0 times ULN and creatinine clearance > 50 mL/minute.
Adequate liver function, defined as: (a) Aspartate aminotransferase and alanine aminotransferase ≤ 3 times ULN for patients without liver metastases, or ≤ 5 times ULN in the presence of liver metastases, and (b) Bilirubin ≤ 2.0 times ULN, unless patient has known Gilberts syndrome.
Albumin ≥ 2.8 g / dL (patient can use albumin to meet the standard)
If the serum pregnancy test of a female patient with fertility is negative within 7 days prior to the initial administration, and she is willing to use effective birth control/contraception method for contraception within 6 months after discontinuation of SCB-313.( Female patients with fertility exclude women who have undergone sterilization or menopause, which is defined as a menstrual period that lasts for one year or more without any other medical reason.) All male and female patients with reproductive potential must agree to take effective contraceptive measures during the study period and within 6 months after discontinuation of SCB-313.
Note: Contraceptive methods considered to be effective include: complete abstinence, intrauterine devices, double barrier contraceptive methods (such as condom plus spermicide diaphragm), implanted contraceptives, hormonal contraceptives (contraceptives, implants agent, transdermal patch, hormonal vaginal device or injection for extended release), or the partner has removed the vas deferens and confirmed that it is azoospermia
Willing to attend follow-up visits according to study protocol.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai East Hospital | Shanghai | Shanghai Municipality | 200126 | China |
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| Pre-dose(0 hour[hr]), 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr post-dose on Day 1 and Day 10 |
| Pharmacokinetics (tmax) | Time to Cmax of SCB-313 | Pre-dose(0 hour[hr]), 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr post-dose on Day 1 and Day 10 |
| Pharmacokinetics ([AUC]0-24) | Area under SCB-313 concentration time curve from zero to 24 hours | Pre-dose(0 hour[hr]), 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr post-dose on Day 1 and Day 10 |
| Pharmacokinetics (AUC 0-inf) | Area under curve from time 0 extrapolated to infinity | Pre-dose(0 hour[hr]), 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr post-dose on Day 1 and Day 10 |