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This is a study to evaluate the tolerance, dose-limiting toxicity (DLT), phase II recommended dose (RP2D), and maximum tolerated dose (MTD) of single and multiple oral doses of TQB3474 in patients with advanced malignant tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB3474 injection | Experimental | Participants receive TQB3474 injection by intravenous (IV) infusion on Day 1, 8, 15, 22 of each 28 day cycle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB3474 injection | Drug | This is a kind of heat shock protein (HSP90) inhibitor. |
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| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity (DLT) | Subjects appear the following toxic reaction relate to the drug after treatment within 28 days :III °or above of non-hematological toxicity, IV° hematological toxicity , III ° neutropenia associated with fever, III ° thrombocytopenia with bleeding. | Baseline up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Cmax is the maximum plasma concentration of TQB3474 or metabolite(s). | 0hour, 0.5hour, end of infusion, 5minutes, 15minutes, 0.5hour, 1hour, 2hour, 4hour, 7hour, 12hour, 24hour, 48hour, 144hour after infusion of day 1 and day 22; Hour 0, end of infusion of day 8 and day 15, hour 0 of day 29. |
| Tmax |
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Inclusion Criteria:
1.18 and 70 years old.
2. Histologically or cytologically confirmed advanced solid tumors.
3. Has the surgery more than 4 weeks before the first dose.
4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
5. Life expectancy ≥12 weeks.
6. Adequate organ system function.
7. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study.
8. Understood and signed an informed consent form.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongsheng Wang, Doctor | Contact | 028-85422707 | licdzk@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chongqing Cancer Hospital | Not yet recruiting | Chongqing | Chongqing Municipality | 400000 | China |
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To characterize the pharmacokinetics of TQB3474 by assessment of time to reach maximum plasma concentration. |
| 0hour, 0.5hour, end of infusion, 5minutes, 15minutes, 0.5hour, 1hour, 2hour, 4hour, 7hour, 12hour, 24hour, 48hour, 144hour after infusion of day 1 and day 22; Hour 0, end of infusion of day 8 and day 15, hour 0 of day 29. |
| AUC0-t | To characterize the pharmacokinetics of TQB3474 by assessment of area under the plasma concentration time curve from zero to infinity. | 0hour, 0.5hour, end of infusion, 5minutes, 15minutes, 0.5hour, 1hour, 2hour, 4hour, 7hour, 12hour, 24hour, 48hour, 144hour after infusion of day 1 and day 22; Hour 0, end of infusion of day 8 and day 15, hour 0 of day 29. |
| Guizhou Cancer Hospital | Not yet recruiting | Guiyang | Guizhou | 550008 | China |
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| Yongsheng | Recruiting | Chengdu | Sichuan | 610000 | China |
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