A Clinical Trial of TQB3117 Tablets in Patients With Advanced Malignant Cancer
NCT ID: NCT06415903
Last Updated: 2024-05-16
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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NOT_YET_RECRUITING
PHASE1
59 participants
INTERVENTIONAL
2024-06-30
2026-08-31
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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TQB3117 tablets
TQB3117 tables is administered as a single dose or multiple dose, ranging from 20 to 180 mg once daily. Oral administration on fast condition, with each cycle lasting 21 days.
TQB3117 tablets
TQB3117 is a protein inhibitor.
Interventions
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TQB3117 tablets
TQB3117 is a protein inhibitor.
Eligibility Criteria
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Inclusion Criteria
* Age: 18 to 75 years old; an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
* Has at least one assessable lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria;
* The main organs function well;
* Female patient had no plans to become pregnant and voluntarily took effective contraceptive measures from agree with the study to at least 6 months after the last dose of study drug.
Exclusion Criteria
* Has multiple factors affecting oral medication;
* Unalleviated toxicity ≥ grade 1 above CTCAE v5.0 due to any previous therapy, excluding hair loss;
* Major surgical treatment, open biopsy and obvious traumatic injury were performed within 28 days before the study, or have not fully recovered from previous surgery, or are expected to require major surgical surgery during the study period;
* Arteriovenous thrombotic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism;
* Have a history of psychotropic drug abuse and can not quit or have mental disorders;
* Subjects with any severe and / or uncontrolled disease included: active hepatitis, have a history of immunodeficiency;
* Has known symptomatic central nervous system metastases and/or cancerous meningitis;
* Thoracic/abdominal/pericardial effusion with clinical symptoms or requiring repeated drainage, or drainage for the purpose of receiving treatment within one month after receiving the investigational drug for the first time;
* Has participated in other clinical trials within 4 weeks before first dose;
* According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
18 Years
75 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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The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TQB3117-I-01
Identifier Type: -
Identifier Source: org_study_id
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