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Trial Title:
A Clinical Trial of TQB3117 Tablets in Patients With Advanced Malignant Cancer
NCT ID:
NCT06415903
Condition:
Advanced Malignant Cancer
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TQB3117 tablets
Description:
TQB3117 is a protein inhibitor.
Arm group label:
TQB3117 tablets
Summary:
The study is divided into two phases: dose escalation and dose extension. The dosing
regimens include a single-dose study and a multiple-dose study. It adopts a
single-center, open-label, non-randomized, single-arm clinical trial design, where
patients with advanced malignant cancer are selected to orally take TQB3117 tablets. The
purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of
TQB3117 tablets in patients.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Evidence of a personally signed and dated informed consent document indicating that
the patient has been informed of all pertinent aspects of the study;
- 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:
- There were other malignant tumors in 3 years;
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Shandong First Medical University
Address:
City:
Jinan
Zip:
250117
Country:
China
Contact:
Last name:
Jinming Yu, Doctor
Phone:
13806406293
Email:
sdyujinming@126.com
Start date:
June 2024
Completion date:
August 2026
Lead sponsor:
Agency:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Agency class:
Industry
Source:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06415903
