Actively Recruiting
A Phase I Clinical Trial Evaluating the Tolerance, Pharmacokinetics, and Preliminary Efficacy of TQB6411 Injection in Patients 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
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating TQB6411 injection, an antibody-conjugated drug that targets EGFR and c-Met proteins on tumor cells, in people with advanced malignant tumors. The study aims to assess how well patients tolerate the treatment, understand how the drug moves through the body, and observe early signs of its effects. This phase I clinical trial focuses on patients who have advanced cancer and have not responded to or cannot tolerate standard treatments. TQB6411 is given by intravenous injection every three weeks, with doses ranging from 0.8 mg/kg to 8 mg/kg at the start of each treatment cycle. The antibody in TQB6411 binds to cancer cells to block important growth signals, and then releases toxins inside the cells to cause DNA damage and cell death. The study includes a dose escalation stage to find the maximum tolerated dose and a dose expansion stage for specific tumor types such as advanced non-small cell lung cancer and metastatic colon cancer. Participants will have regular blood tests and tumor imaging to monitor safety and treatment effects for up to 24 months. Researchers will track dose-limiting toxicities, adverse events, drug levels in the blood, tumor response rates, and survival outcomes. Women of childbearing potential must use effective contraception during and for six months after the study. The trial includes careful monitoring to assess the body's reaction to the drug and to gather information for future studies.
CONDITIONS
Brief Title
A Clinical Trial Evaluating Injection of TQB6411 in Subjects With Advanced Malignant Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 18 to 75 years
- Voluntarily signed informed consent with good compliance
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival greater than 12 weeks
- At least one evaluable or measurable tumor lesion according to RECIST v1.1
- Laboratory test results meeting study requirements without recent use of hematopoietic stimulators
- 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 tumor
- Ability to provide tumor tissue specimens for immunohistochemical testing
- Women of childbearing potential agreeing to effective contraception during the study and for 6 months after, with negative pregnancy test before enrollment; men agreeing to effective contraception for 6 months after study end
You will not qualify if you...
- Current or previous other malignant tumors
- Conditions affecting intravenous injection or blood collection
- Unresolved adverse reactions from prior treatments above CTCAE grade 1, excluding certain non-safety risk toxicities
- Major surgery, traumatic injury, or unhealed wounds within 4 weeks before first dose
- Bleeding events of grade 3 or higher within 4 weeks before first dose
- Arterial or venous thrombosis events within 6 months before first dose
- Active or poorly controlled viral hepatitis
- Active syphilis infection requiring treatment
- History or current active interstitial lung diseases or pneumonia requiring treatment
- History of substance abuse or mental disorders
- Previous allogeneic bone marrow or solid organ transplant
- History of hepatic brain disease
- Major cardiovascular disease
- Active or uncontrolled severe infections (grade 2 or higher)
- Requirement for dialysis due to renal failure
- History of immunodeficiency including HIV
- Poorly controlled autoimmune diseases requiring immunosuppressive drugs within 7 days before first dose
- Epilepsy requiring treatment
- Poor diabetes control (fasting blood sugar above 10 mmol/L)
- Recent chemotherapy, immunotherapy, or targeted therapies within 3 weeks before first dose
- Recent use of Chinese patent medicines with anti-tumor effects within 1 week
- Tumor invasion of important blood vessels or risk of fatal bleeding
- Uncontrolled pleural or pericardial effusions or ascites requiring repeated drainage
- Known spinal cord compression, meningeal metastasis, or brain metastases with symptoms or recent control
- Allergies to study drug or components
- Previous treatment with EGFR/c-Met dual anti-ADC drugs
- Participation in other anti-tumor drug trials within 4 weeks before first dose
- Safety or study completion concerns as judged by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive intravenous injections of TQB6411 every 3 weeks in treatment cycles, targeting advanced malignant tumors.
Visits every 3 weeks for each treatment cycle
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
F
Feng Wang, Doctor
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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