A Study to Evaluate the Tolerance and Pharmacokinetics of TQB3474 Injection
NCT ID: NCT04144855
Last Updated: 2019-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
40 participants
INTERVENTIONAL
2018-11-27
2021-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TQB3474 injection
Participants receive TQB3474 injection by intravenous (IV) infusion on Day 1, 8, 15, 22 of each 28 day cycle.
TQB3474 injection
This is a kind of heat shock protein (HSP90) inhibitor.
Interventions
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TQB3474 injection
This is a kind of heat shock protein (HSP90) inhibitor.
Eligibility Criteria
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Inclusion Criteria
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
2. Hypersensitivity to TQB3474 or its excipient.
3. Has factors that impact on intravenous infusion of drugs and venous blood collection.
4. Has severe gastrointestinal disease within 4 weeks before the first dose.
5. Has severe eye disease.
6. Breastfeeding or pregnant women.
7. Has brain metastases.
8. HCV antibody and HCV-RNA positive; Syphilis positive; HBsAg positive and HBV DNA positive (≥1000 copies /mL).
9. Has infection that need systemic treatment during screening.
10. Has participated in any other clinical trial within 4 weeks before the first dose.
11. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
18 Years
70 Years
ALL
No
Sponsors
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
Guizhou Cancer Hospital
Guiyang, Guizhou, China
Yongsheng
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TQB3474-I-01
Identifier Type: -
Identifier Source: org_study_id
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