A Study to Evaluate the Tolerance and Pharmacokinetics of TQB3474 Injection
- Conditions
- Advanced Solid Tumor
- Interventions
- Drug: TQB3474 injection
- Registration Number
- NCT04144855
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
1.18 and 70 years old.
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Histologically or cytologically confirmed advanced solid tumors.
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Has the surgery more than 4 weeks before the first dose.
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Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
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Life expectancy ≥12 weeks.
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Adequate organ system function.
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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.
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Understood and signed an informed consent form.
- Has received chemotherapy or radiotherapy within 4 weeks before the first dose.
- Hypersensitivity to TQB3474 or its excipient.
- Has factors that impact on intravenous infusion of drugs and venous blood collection.
- Has severe gastrointestinal disease within 4 weeks before the first dose.
- Has severe eye disease.
- Breastfeeding or pregnant women.
- Has brain metastases.
- HCV antibody and HCV-RNA positive; Syphilis positive; HBsAg positive and HBV DNA positive (≥1000 copies /mL).
- Has infection that need systemic treatment during screening.
- Has participated in any other clinical trial within 4 weeks before the first dose.
- According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TQB3474 injection TQB3474 injection Participants receive TQB3474 injection by intravenous (IV) infusion on Day 1, 8, 15, 22 of each 28 day cycle.
- Primary Outcome Measures
Name Time Method Dose-limiting toxicity (DLT) Baseline up to 28 days 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.
- Secondary Outcome Measures
Name Time Method AUC0-t 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. To characterize the pharmacokinetics of TQB3474 by assessment of area under the plasma concentration time curve from zero to infinity.
Tmax 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. To characterize the pharmacokinetics of TQB3474 by assessment of time to reach maximum plasma concentration.
Cmax 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. Cmax is the maximum plasma concentration of TQB3474 or metabolite(s).
Trial Locations
- Locations (3)
Guizhou Cancer Hospital
🇨🇳Guiyang, Guizhou, China
Yongsheng
🇨🇳Chendu, Sichuan, China
Chongqing Cancer Hospital
🇨🇳Chongqing, Chongqing, China