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To evaluate the safety and tolerability of single dose of SCB-313 by intrapleural injection.To evaluate the safety and tolerability of repeated dose of SCB-313 by intrapleural injection once a day for 3 days, and to determine the maximum tolerated dose (MTD) of SCB-313.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCB-313 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCB-313 | Drug | SCB-313 Intrapleural injection, once daily. Single dose on Day 1 in Cycle 0 followed by 7-day safety assessment, then dose on Day 1,2,3 in Cycle 1 followed by 21-day observation . |
| Measure | Description | Time Frame |
|---|---|---|
| DLT | Dose Limiting Toxicity | 28 days after first dosing |
| Measure | Description | Time Frame |
|---|---|---|
| AEs | Occurrence of adverse events (AEs) and serious adverse events (SAEs) | 28 days after first dosing |
| Immunogenicity | Occurrence of binding and neutralizing anti-SCB-313 antibodies |
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Inclusion Criteria:
Histologically or cytologically confirmed cancer of any primary tumor type.
Malignant pleural effusion requiring drainage that is histologically or cytologically confirmed;
Eastern Cooperative Oncology Group (ECOG) performance status: 0 to 2. Patients with an ECOG performance status of 3 may be included if the Investigator determines that removal of pleural fluid would improve their performance status to 2 or better.
Life expectancy of at least 8 weeks.
Age ≥18 years and ≤ 75 years;.
Body weight ≥45 kg and body mass index ≥17 kg/m2.
Adequate hematologic function, defined as:
Adequate renal function, defined as serum creatinine ≤2.0 times ULN and creatinine clearance >50 mL/minute.
Adequate liver function, defined as:
Female patients of childbearing potential (excluding women who have undergone surgical sterilization or are menopausal, defined as no menstrual periods for 1 year or more without any other medical reasons) are eligible if they have negative serum pregnancy test result 7 days before the first dose of SCB-313 and are willing to use an effective method of birth control/contraception to prevent pregnancy until 6 months after discontinuation of SCB-313.
Both men and women of reproductive potential must agree to use effective contraception during the study and for 6 months after discontinuation of SCB 313.
Note: Contraceptive methods that are considered highly effective areas follows: total abstinence, intrauterine device, double barrier method (such as condom plus diaphragm with spermicide), contraceptive implant, hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices, or injections with prolonged release), or vasectomized partner with confirmed azoospermia.
Willing to attend follow-up visits according to study protocol.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospitial, Sichuan University | Chengdu | Sichuan | 610000 | China |
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| ID | Term |
|---|---|
| D016066 | Pleural Effusion, Malignant |
| ID | Term |
|---|---|
| D010997 | Pleural Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
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| up to 28 days after first dosing |
| D009369 |
| Neoplasms |
| D010996 | Pleural Effusion |
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |