Advanced Malignant TumorsPhase 1NCT07043751
A Clinical Trial Evaluating Injection of TQB6411 in Subjects With Advanced Malignant Tumors
A Phase 1 study testing TQB6411 injection in people with Advanced Malignant Tumors, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 19 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Malignant Tumors
- What is being tested?
- TQB6411 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 19 sitesChina
- Study dates
- 15 Jul 2025to Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subjects voluntarily joined the study, signed an informed consent form, and had good compliance;
- 18 years old≤age age≤75 years old (calculated based on the date of signing the informed consent form);
- Eastern Cooperative Oncology Group (ECOG) score 0~1 point;
- Expected survival is greater than 12 weeks;
- According to the RECIST v1.1 standard, there is at least one evaluable tumor lesion in the dose escalation stage, and at least one measurable lesion in the dose expansion stage;
- Laboratory examination standards that meet the program requirements (no use of hematopoietic stimulator drugs for correction within 7 days);
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- Subjects who failed or were intolerant of standard treatment;
- Subject requirements for the dose expansion stage: advanced NSCLC; metastatic colon cancer; recurrent/metastatic esophageal squamous cell carcinoma; recurrent/metastatic nasopharyngeal carcinoma; advanced malignant solid tumor;
- Can provide tumor tissue specimens that meet the requirements for immunohistochemical testing;
- Women of childbearing age should agree that effective contraception must be adopted during the study period and within 6 months after the end of the study, and that the serum or urine pregnancy test will be negative within 7 days before the study enrollment; men should agree that effective contraception must be adopted within 6 months after the end of the study period;
Who cannot join
- Have appeared or are currently suffering from other malignant tumors;
- There are diseases that affect intravenous injection and intravenous blood collection;
- The adverse reactions of previous treatments failed to recover to CTCAE V5.0 grade score ≤1, except for toxicity without safety risk, such as grade 2 hair loss, grade 2 peripheral nerve toxicity, grade 2 anemia, non-clinical significance and asymptomatic grade 2 laboratory abnormalities, stable hypothyroidism with hormone replacement therapy;
- Those who have received major surgical treatment, obvious traumatic injury or major surgery during the expected study treatment within 4 weeks before the first medication (except for the surgery stipulated in the program), or have long-term uncured wounds or fractures;
- Subjects with any bleeding or bleeding events ≥CTC AE grade 3 within 4 weeks before the first dose;
- Arterial/venous thrombosis events occurred within 6 months before the first dose;
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- People with active viral hepatitis and poor control;
- People infected with active syphilis who need treatment;
- There is a history of active tuberculosis, idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia/radio-pneumonia that needs treatment, or active pneumonia with obvious clinical symptoms, and interstitial lung disease (ILD) that needs treatment, or currently associated with interstitial lung disease;
- Those with a history of abuse of psychotropic substances and cannot quit or have mental disorders;
- Preparing for or having previously received allogeneic bone marrow transplants or solid organ transplants;
- Have a history of hepatic brain disease;
- Suffering from major cardiovascular disease;
- Severe infection that is active or uncontrollable (≥CTC AE grade 2 infection);
- People who require hemodialysis or peritoneal dialysis if renal failure is required;
- Have a history of immunodeficiency, including HIV-positive or other acquired, congenital immunodeficiency diseases;
- Subjects who have poorly controlled autoimmune diseases and need to use immunosuppressive agents or systemic hormones to achieve immunosuppressive purposes and still need to continue using them within 7 days before the first dose (except for daily dose of glucocorticoid <10 mg prednisone or other therapeutic hormones);
- People with epilepsy and need treatment;
- Poor diabetes control [fasting blood sugar (FBG) > 10mmol/L];
- Tumor-related symptoms and treatment: subjects who have received chemotherapy, immunotherapy, small molecule targeted drugs, etc. within 3 weeks before the first dose, or are still in the 5 half-life of the drug; within 1 week before the first dose, they have received Chinese patent medicine treatment with anti-tumor indications in the National Medical Products Administration (NMPA) approved drug instructions; imaging (CT or MRI) shows that the tumor has invaded important blood vessels or the researchers judged that the tumor is very likely to invade important blood vessels during the subsequent study and causing fatal major bleeding; if it is not controlled, pleural effusion, pericardial effusion or moderate and severe ascites that still require repeated drainage; known to suffer from spinal cord compression, meningeal metastasis/cancer meningitis, accompanied by brain metastasis symptoms or symptoms/image control time is less than 4 weeks;
- Known allergies to research drugs or excipients;
- Have received previous treatment for Epidermal Growth Factor Receptor (EGFR)/c-Mesenchymal-epithelial transition dual anti-ADC drugs;
- Those who participated in and used other anti-tumor clinical trial drugs within 4 weeks before the first medication;
- According to the researcher's judgment, there are situations that seriously endanger the safety of the subject or affect the subject's completion of the study.
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
China19 sites, 19 recruiting
- Not yet recruiting
Anyang Tumor Hospital
Anyang, Henan, 455100
Jin Xia, Doctor, 15890750990, 15890750990@126.com
- Not yet recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Bangwei Cao, Doctor, 13021161027, zlgcp2019@163.com
- Not yet recruiting
the Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Fang Ma, Doctor, 13975806788, dr_fma@126.com
Pingfei Fang, Doctor, 13517491647, fangpingfei@163.com
- Not yet recruiting
Sichuan Cancer Hospital
Chengdu, Sichuan, 610041
Hua Xie, Master, 17740223621, xiehua101@126.com
Yongdong Jin, Doctor, 18908190337, cccjin@163.com
- Not yet recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Lei Liu, Doctor, 18980606231, clinical_liu66@163.com
- Not yet recruiting
Dongguan People's Hospital
Dongguan, Guangdong, 523059
Zhigang Liu, Doctor, 13712645531, 85172626@qq.com
- Not yet recruiting
ZhuJiang Hospital of Southern Medical University
Guangdong, Guangdong, 510000
Jian Zhang, Doctor, 13925091863, blacktiger@139.com
- Not yet recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 519041
Dong Ma, Bachelor, Dr.madong@163.com
- Not yet recruiting
Jining First People's Hospital
Jining, Shandong, 272002
Jie Li, Doctor, 13964921790, 13964921790@139.com
Weixiang Kong, Master, 13705472797, kwx2797@163.com
- Not yet recruiting
Mianyang Central Hospital
Mianyang, Sichuan, 621000
Yu Zhang, Doctor, 15228700888, 543703371@qq.com
- Not yet recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Yanhong Gu, 13813908678, guyanhong@jsph.org.cn
- Not yet recruiting
Shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai, Shanghai Municipality, 200000
Qiang Xia, Doctor, 13661889035, Xiaqiang@medmail.com.cn
- Not yet recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200000
Shengxiang Ren, Doctor, 13816756732, harry_ren@126.com
- Not yet recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
ZhengFei Zhu, Doctor, 13764088764, zfeizhu@aliyun.com
- Not yet recruiting
The First Hospital of China Medical University
Shenyang, Liaoning, 110000
Xiujuan Qv, Doctor, 13604031355, xjqu@cmu.edu.cn
- Not yet recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Qingsong Pang, Doctor, 18622221203, pangqingsong2013@163.com
- Not yet recruiting
Zhongnan Hospital Of Wuhan University
Wuhan, Hubei, 430071
Yu Liu, Doctor, 13667148436
- Not yet recruiting
The Henan Cancer Hospital
Zhengzhou, Henan, 450008
Yanqiu Zhao, Master, 13938252350, 13938252350@163.com
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Feng Wang, Doctor, 13938244776, fengwang010@163.com
About this study
Official title: A Phase I Clinical Trial Evaluating the Tolerance, Pharmacokinetics and Preliminary Efficacy of Injection TQB6411 in Subjects With Advanced Malignant Tumors
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
- Advanced Malignant Tumors
- Being tested
- TQB6411 injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB6411 injectionDrug
TQB6411 for injection is an antibody-conjugated drug (ADC) targeting EGFR/c-Met. After injecting intravenously, the antibody part of this product binds to the EGFR and c-Met on the surface of tumor cells to block the activation of EGFR and c-Met signaling pathways. The ADC is enrolled and transported to the lysosome through cells. The linker releases toxins after enzyme cleavage, resulting in DNA damage and cell death.
| Study group | Role | What they receive |
|---|---|---|
| TQB6411 injection | Experimental | Intravenous injection, the dosage begins on the first day of each cycle, and one treatment cycle every 3 weeks; the dose group is between 0.8 mg/kg-8 mg/kg. Receives: Drug: TQB6411 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity
Dosage-limiting toxicity refers to any of the following events that researchers and sponsors believe to be related to the treatment of TQB6411 for injection (including positively related, likely related, and possible related) (except for special instructions, the degree of adverse events is evaluated in accordance with National Cancer Institute (NCI) Common Terminology Criteria (CTC) for Adverse Events (AE) v5.0.
Measured: Up to24 months
Maximum Tolerated Dose
Defined as the highest dose in less than 33% of subjects with dose-limiting toxicity (DLT).
Measured: Up to24 months
Phase II recommended dose
The recommended dose for subsequent phase II studies will be determined based on Maximum Tolerated Dose (MTD), Pharmacokinetics (PK), preliminary efficacy and safety.
Measured: Up to24 months
Rate and severity of adverse events
Rate and severity of adverse events
Measured: Up to24 months
Secondary outcomes (9)
Peak drug concentration (Cmax)
It refers to the highest blood drug concentration achieved after administration of TQB6411 for injection.
Measured: Within 14 days after administration
Area under the concentration-time curve from time zero to the last measurable concentration time t (AUC0-t)
Area under the concentration-time curve from time zero to the last measurable concentration time t (AUC0-t).
Measured: Within 14 days after administration
Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞)
Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞).
Measured: Within 14 days after administration
Peak time (Tmax)
It refers to the time when the maximum blood drug concentration is reached after administration of TQB6411 for injection.
Measured: Within 14 days after administration
Overall response rate (ORR)
Proportion of subjects with best response as Partial relief (PR), Complete Response (CR).
Measured: Up to 24 months
Disease Control Rate (DCR)
Proportion of subjects with best response as Complete Response (CR), Partial relief (PR), Stable Disease (SD).
Measured: Up to 24 months
Progression-free survival (PFS)
The time between the first dose of the trial drug and the date of first definite disease progression or death (from any cause), whichever occurs first.
Measured: Up to 24 months
Overall survival (OS)
Time from first dose of study drug to date of death from any cause.
Measured: Up to 24 months
The incidence of antibiotic-resistant antibodies (ADA) and neutralizing antibodies (NAbs)
The incidence of antibiotic-resistant antibodies (ADA) and neutralizing antibodies (NAbs)
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start15 Jul 2025
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant TumorsStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043751
- Sponsor's protocol ID
- TQB6411-I-01
- Status last verified
- Mar 2025
- First submitted
- 20 Jun 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial Evaluating the Tolerance, Pharmacokinetics and Preliminary Efficacy of Injection TQB6411 in Subjects With Advanced Malignant Tumors
- ClinicalTrials.gov ID
- NCT07043751
- Acronym / sponsor ID
- TQB6411-I-01
- Conditions
- Advanced Malignant Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQB6411 injection | Experimental | Drug: TQB6411 injectionIntravenous injection, the dosage begins on the first day of each cycle, and one treatment cycle every 3 weeks; the dose group is between 0.8 mg/kg-8 mg/kg. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The subjects voluntarily joined the study, signed an informed consent form, and had good compliance;
- 18 years old≤age age≤75 years old (calculated based on the date of signing the informed consent form);
- Eastern Cooperative Oncology Group (ECOG) score 0~1 point;
- Expected survival is greater than 12 weeks;
- According to the RECIST v1.1 standard, there is at least one evaluable tumor lesion in the dose escalation stage, and at least one measurable lesion in the dose expansion stage;
Key exclusion criteria (24 listed)
- Have appeared or are currently suffering from other malignant tumors;
- There are diseases that affect intravenous injection and intravenous blood collection;
- The adverse reactions of previous treatments failed to recover to CTCAE V5.0 grade score ≤1, except for toxicity without safety risk, such as grade 2 hair loss, grade 2 peripheral nerve toxicity, grade 2 anemia, non-clinical significance and asymptomatic grade 2 laboratory abnormalities, stable hypothyroidism with hormone replacement therapy;
- Those who have received major surgical treatment, obvious traumatic injury or major surgery during the expected study treatment within 4 weeks before the first medication (except for the surgery stipulated in the program), or have long-term uncured wounds or fractures;
- Subjects with any bleeding or bleeding events ≥CTC AE grade 3 within 4 weeks before the first dose;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQB6411 injectionTQB6411 for injection is an antibody-conjugated drug (ADC) targeting EGFR/c-Met. After injecting intravenously, the antibody part of this product binds to the EGFR and c-Met on the surface of tumor cells to block the activation of EGFR and c-Met signaling pathways. The ADC is enrolled and transported to the lysosome through cells. The linker releases toxins after enzyme cleavage, resulting in DNA damage and cell death. | Drug | TQB6411 injection |
Primary outcome
Dose-limiting toxicity
Time frame: Up to24 months
Dosage-limiting toxicity refers to any of the following events that researchers and sponsors believe to be related to the treatment of TQB6411 for injection (including positively related, likely related, and possible related) (except for special instructions, the degree of adverse events is evaluated in accordance with National Cancer Institute (NCI) Common Terminology Criteria (CTC) for Adverse Events (AE) v5.0.
Maximum Tolerated Dose
Time frame: Up to24 months
Defined as the highest dose in less than 33% of subjects with dose-limiting toxicity (DLT).
Phase II recommended dose
Time frame: Up to24 months
The recommended dose for subsequent phase II studies will be determined based on Maximum Tolerated Dose (MTD), Pharmacokinetics (PK), preliminary efficacy and safety.
Rate and severity of adverse events
Time frame: Up to24 months
Rate and severity of adverse events
9 secondary outcomes
Peak drug concentration (Cmax)
Time frame: Within 14 days after administration
Area under the concentration-time curve from time zero to the last measurable concentration time t (AUC0-t)
Time frame: Within 14 days after administration
Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞)
Time frame: Within 14 days after administration
Peak time (Tmax)
Time frame: Within 14 days after administration
Overall response rate (ORR)
Time frame: Up to 24 months
Disease Control Rate (DCR)
Time frame: Up to 24 months
Progression-free survival (PFS)
Time frame: Up to 24 months
Overall survival (OS)
Time frame: Up to 24 months
The incidence of antibiotic-resistant antibodies (ADA) and neutralizing antibodies (NAbs)
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TQB6411 injection in people with Advanced Malignant Tumors, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 19 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shengxiang Ren, Doctor (13816756732, harry_ren@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (time frame: Up to24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.