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

NCT07043751 | Recruiting Phase 1

• 1 other identifier: TQB6411-I-01
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 19

Brief 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.

Conditions

Advanced Malignant Tumors

Outcome Measures

Primary Outcomes (4)

• 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.

  Up to24 months

• Maximum Tolerated Dose

  Defined as the highest dose in less than 33% of subjects with dose-limiting toxicity (DLT).

  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.

  Up to24 months

• Rate and severity of adverse events

  Rate and severity of adverse events

  Up to24 months

Secondary Outcomes (9)

• Peak drug concentration (Cmax)

  Within 14 days after administration

• Area under the concentration-time curve from time zero to the last measurable concentration time t (AUC0-t)

  Within 14 days after administration

• Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞)

  Within 14 days after administration

• Peak time (Tmax)

  Within 14 days after administration

• Overall response rate (ORR)

  Up to 24 months

Study Arms (1)

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.

Drug: TQB6411 injection

Interventions

TQB6411 injection DRUG

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.

TQB6411 injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subjects voluntarily joined the study, signed an informed consent form, and had good compliance;
• 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;

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

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

Study Sites (19)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

NOT YET RECRUITING

Dongguan People's Hospital

Dongguan, Guangdong, 523059, China

NOT YET RECRUITING

ZhuJiang Hospital of Southern Medical University

Guangdong, Guangdong, 510000, China

NOT YET RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 519041, China

NOT YET RECRUITING

Anyang Tumor Hospital

Anyang, Henan, 455100, China

NOT YET RECRUITING

The Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

NOT YET RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

Zhongnan Hospital Of Wuhan University

Wuhan, Hubei, 430071, China

NOT YET RECRUITING

the Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

NOT YET RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

NOT YET RECRUITING

The First Hospital of China Medical University

Shenyang, Liaoning, 110000, China

NOT YET RECRUITING

Jining First People's Hospital

Jining, Shandong, 272002, China

NOT YET RECRUITING

Shanghai Jiaotong University School of Medicine, Renji Hospital

Shanghai, Shanghai Municipality, 200000, China

NOT YET RECRUITING

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200000, China

NOT YET RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

NOT YET RECRUITING

Sichuan Cancer Hospital

Chengdu, Sichuan, 610041, China

NOT YET RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

NOT YET RECRUITING

Mianyang Central Hospital

Mianyang, Sichuan, 621000, China

NOT YET RECRUITING

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

NOT YET RECRUITING

Central Study Contacts

Shengxiang Ren, Doctor

CONTACT

13816756732; harry_ren@126.com

Feng Wang, Doctor

CONTACT

13938244776; fengwang010@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: June 29, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: January 21, 2026

Record last verified: 2025-03

Locations

CN (19)