Actively Recruiting
A Clinical Trial Evaluating Injection of TQB6411 in Subjects With Advanced Malignant Tumors
Led by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Updated on 2026-01-21
216
Participants Needed
19
Research Sites
150 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
TQB6411 for injection is an antibody-conjugated drug (ADC) targeting EGFR/c-Met. After injecting blood intravenously, the antibody part of this product binds to the surface of EGFR and c-Met on tumor cells to block the activation of EGFR and c-Met signaling pathways. The ADC is enzymatically transported to the lysosome. The linker releases toxins after enzyme cleavage, resulting in DNA damage and cell death. TQB6411 for injection is intended for the treatment of advanced malignant tumors.
CONDITIONS
Official Title
A Clinical Trial Evaluating Injection of TQB6411 in Subjects With Advanced Malignant Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects voluntarily join the study, sign informed consent, and comply well
- Age between 18 and 75 years
- ECOG performance status of 0 to 1
- Expected survival longer than 12 weeks
- At least one evaluable tumor lesion per RECIST v1.1 criteria
- Laboratory test results meet study requirements without recent hematopoietic stimulators
- Previously failed or intolerant to standard treatments
- For dose expansion: diagnosis of advanced NSCLC, metastatic colon cancer, recurrent/metastatic esophageal squamous cell carcinoma, recurrent/metastatic nasopharyngeal carcinoma, or other advanced malignant solid tumors
- Ability to provide tumor tissue specimens for immunohistochemical testing
- Women of childbearing potential agree to effective contraception during study and 6 months after, with negative pregnancy tests before enrollment; men agree to contraception for 6 months after study
You will not qualify if you...
- Current or past other malignant tumors
- Diseases affecting intravenous injection or blood collection
- Unresolved adverse reactions from previous treatments above CTCAE grade 1, except certain non-safety risks
- Major surgery or trauma within 4 weeks before first dose, or long-term untreated wounds or fractures
- Bleeding events grade 3 or higher within 4 weeks before first dose
- Arterial/venous thrombosis events within 6 months before first dose
- Active viral hepatitis or poorly controlled infections
- Active syphilis requiring treatment
- History or presence of active tuberculosis, interstitial lung disease, organizing pneumonia, drug-induced pneumonia, or active pneumonia with symptoms
- History of psychotropic substance abuse or uncontrolled mental disorders
- Prior allogeneic bone marrow or solid organ transplant
- History of hepatic encephalopathy
- Major cardiovascular diseases
- Severe active or uncontrolled infections grade 2 or higher
- Renal failure requiring dialysis
- History of immunodeficiency including HIV
- Poorly controlled autoimmune diseases requiring immunosuppressants within 7 days before first dose
- Epilepsy requiring treatment
- Poorly controlled diabetes with fasting blood sugar over 10 mmol/L
- Recent chemotherapy, immunotherapy, targeted drugs, or anti-tumor traditional medicines within specified washout periods
- Tumor invading important blood vessels or causing severe symptoms like pleural effusion requiring drainage
- Known spinal cord compression, meningeal metastasis, brain metastasis symptoms or recent symptom control
- Known allergies to study drug or excipients
- Previous treatment with EGFR/c-Met dual anti-ADC drugs
- Participation in other anti-tumor drug trials within 4 weeks before first dose
- Any condition judged by investigators to endanger safety or study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100050
Not Yet Recruiting
2
Dongguan People's Hospital
Dongguan, Guangdong, China, 523059
Not Yet Recruiting
3
ZhuJiang Hospital of Southern Medical University
Guangdong, Guangdong, China, 510000
Not Yet Recruiting
4
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 519041
Not Yet Recruiting
5
Anyang Tumor Hospital
Anyang, Henan, China, 455100
Not Yet Recruiting
6
The Henan Cancer Hospital
Zhengzhou, Henan, China, 450008
Not Yet Recruiting
7
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Actively Recruiting
8
Zhongnan Hospital Of Wuhan University
Wuhan, Hubei, China, 430071
Not Yet Recruiting
9
the Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410011
Not Yet Recruiting
10
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
Not Yet Recruiting
11
The First Hospital of China Medical University
Shenyang, Liaoning, China, 110000
Not Yet Recruiting
12
Jining First People's Hospital
Jining, Shandong, China, 272002
Not Yet Recruiting
13
Shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai, Shanghai Municipality, China, 200000
Not Yet Recruiting
14
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China, 200000
Not Yet Recruiting
15
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Not Yet Recruiting
16
Sichuan Cancer Hospital
Chengdu, Sichuan, China, 610041
Not Yet Recruiting
17
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Not Yet Recruiting
18
Mianyang Central Hospital
Mianyang, Sichuan, China, 621000
Not Yet Recruiting
19
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300060
Not Yet Recruiting
Research Team
S
Shengxiang Ren, Doctor
CONTACT
F
Feng Wang, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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