TQB6411 injection for advanced EGFR/c‑Met–expressing solid tumors

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

This phase 1 trial tests TQB6411, an antibody–drug that targets EGFR and c‑Met, to try to kill tumor cells in adults with advanced solid tumors who have exhausted standard treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 216 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, prednisone
• Locations: 19 sites (Beijing, Beijing Municipality and 18 other locations)
• Trial ID: NCT07043751 on ClinicalTrials.gov

What this trial studies

TQB6411 is an antibody–drug conjugate that binds EGFR and c‑Met on tumor cells, is internalized, and releases a cytotoxic payload in lysosomes to cause DNA damage and cell death. The program is a first‑in‑human phase 1 trial with a dose‑escalation stage to define safety and a dose‑expansion stage in specific tumor types including advanced NSCLC, metastatic colorectal cancer, esophageal squamous cell carcinoma, and nasopharyngeal carcinoma. Eligible adults must have ECOG 0–1, measurable disease per RECIST v1.1, expected survival >12 weeks, and prior progression or intolerance to standard therapies. The trial is being run at several hospitals in China and focuses on safety, tolerability, pharmacokinetics, and selecting a recommended phase 2 dose.

Who should consider this trial

Good fit: Adults aged 18–75 with ECOG 0–1, measurable advanced malignant solid tumors who have progressed on or are intolerant to standard treatments and can provide required tumor tissue are the intended participants.

Not a fit: Patients with poor performance status (ECOG ≥2), very limited life expectancy (≤12 weeks), no measurable disease, or who cannot provide tumor tissue are unlikely to benefit from this phase 1 protocol.

Why it matters

Potential benefit: If successful, TQB6411 could provide a new targeted treatment option for patients with advanced tumors that express EGFR and c‑Met and who have limited standard options.

How similar studies have performed: Other antibody–drug conjugates targeting surface receptors have shown benefit in some cancers, but dual EGFR/c‑Met–targeting ADCs are relatively novel and their clinical effectiveness remains to be established.

Eligibility criteria

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;
* 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.

Where this trial is running

Beijing, Beijing Municipality and 18 other locations

• Beijing Friendship Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Dongguan People's Hospital — Dongguan, Guangdong, China (Not_yet_recruiting)
• ZhuJiang Hospital of Southern Medical University — Guangdong, Guangdong, China (Not_yet_recruiting)
• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Anyang Tumor Hospital — Anyang, Henan, China (Not_yet_recruiting)
• The Henan Cancer Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)
• Zhongnan Hospital Of Wuhan University — Wuhan, Hubei, China (Not_yet_recruiting)
• the Second Xiangya Hospital of Central South University — Changsha, Hunan, China (Not_yet_recruiting)
• Jiangsu Province Hospital — Nanjing, Jiangsu, China (Not_yet_recruiting)
• The First Hospital of China Medical University — Shenyang, Liaoning, China (Not_yet_recruiting)
• Jining First People's Hospital — Jining, Shandong, China (Not_yet_recruiting)
• Shanghai Jiaotong University School of Medicine, Renji Hospital — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• Shanghai Pulmonary Hospital — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• Sichuan Cancer Hospital — Chengdu, Sichuan, China (Not_yet_recruiting)
• West China Hospital, Sichuan University — Chengdu, Sichuan, China (Not_yet_recruiting)
• Mianyang Central Hospital — Mianyang, Sichuan, China (Not_yet_recruiting)
• Tianjin Medical University Cancer Institute & Hospital — Tianjin, Tianjin Municipality, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Shengxiang Ren, Doctor

Conditions Advanced Malignant Tumors