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RECRUITINGPHASE1

A Clinical Trial Evaluating Injection of TQB6411 in Subjects With Advanced Malignant Tumors

A Phase I Clinical Trial Evaluating the Tolerance, Pharmacokinetics and Preliminary Efficacy of Injection TQB6411 in Subjects With Advanced Malignant Tumors

NCT07043751•Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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. 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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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);
•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;

Exclusion Criteria

•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;
•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;
+14 more criteria

Locations (19)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Dongguan People's Hospital

Dongguan, Guangdong, China

ZhuJiang Hospital of Southern Medical University

Guangdong, Guangdong, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Anyang Tumor Hospital

Anyang, Henan, China

The Henan Cancer Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Zhongnan Hospital Of Wuhan University

Wuhan, Hubei, China

the Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Key Dates

Start Date

July 15, 2025

Primary Completion Date

December 1, 2027

Completion Date

June 1, 2028

Last Updated

January 21, 2026

Enrollment

216

ESTIMATED participants

Conditions

Advanced Malignant Tumors

Interventions

TQB6411 injection

DRUG

Contacts

Shengxiang Ren, Doctor

CONTACT

13816756732 harry_ren@126.com

Feng Wang, Doctor

CONTACT

13938244776 fengwang010@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 21, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Clinical Trial Evaluating Injection of TQB6411 in Subjects With Advanced Malignant Tumors

Inclusion Criteria

Exclusion Criteria

A Phase 1 Study of SSGJ-709 in Patients With Advanced Malignant Tumors

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