Trial Title:
A Clinical Trial of TQB3006 Tablets in Patients With Advanced Malignant Cancer
NCT ID:
NCT06344351
Condition:
Advanced Malignant Neoplasm
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TQB3006 tablets
Description:
TQB3006 is an inhibitor protein.
Arm group label:
TQB3006 tablets
Summary:
This study includes two stage: dose escalation and dose extension, with a single dose and
a multiple dose study. This is a single-center, open, non-randomized, single arm, study
to evaluate the safety, tolerability and pharmacokinetics of TQB3006 tables in patients
with advanced malignant cancer.
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;
- Female patient had no plans to become pregnant and voluntarily took effective
contraceptive measures during the study period to at least 6 months after the last
dose of study drug.
Exclusion Criteria:
- There were other malignant tumors within 3 years;
- Has multiple factors affecting oral medication;
- Unalleviated toxicity ≥ grade 1 of 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 including active hepatitis, a
history of immunodeficiency, etc.;
- Tumor-related symptoms and treatment:
1. Has known symptomatic central nervous system metastases and/or cancerous
meningitis;
2. Thoracic/abdominal/pericardial effusion with clinical symptoms or requiring
repeated drainage, or drainage for the purpose of receiving treatment within 1
month after receiving the investigational drug for the first time;
3. 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:
Anhui Provincial Hospital
Address:
City:
Hefei
Zip:
230000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Lianxin Liu, Doctor
Phone:
18096656677
Email:
liulx@ustc.edu.cn
Facility:
Name:
Peking University Shougang Hospital
Address:
City:
Beijing
Zip:
100144
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Liping Ma, Master
Phone:
18500878517
Email:
applemary18@163.com
Contact backup:
Last name:
Xiaodong Wang, Doctor
Phone:
15601155688
Email:
xdwang2000@163.com
Facility:
Name:
Chongqing university Cancer Hospital
Address:
City:
Chongqing
Zip:
400015
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yi Gong, Doctor
Phone:
13228685295
Email:
gongyi_95@163.com
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Harbin
Zip:
150000
Country:
China
Status:
Recruiting
Contact:
Last name:
Tongsen Zheng, Doctor
Phone:
15134569619
Email:
zhengtongsen@126.com
Facility:
Name:
The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450003
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Ning Li, Doctor
Phone:
13526501903
Email:
lining97@126.com
Start date:
April 25, 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/NCT06344351
