TQB6411 injection for advanced lung cancer.

A Phase Ib/II Clinical Trial to Evaluate the Efficacy and Safety of TQB6411 for Injection in Patients With Advanced Lung Cancer

This trial will test whether TQB6411 injection is safe and can help people with advanced lung cancer.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 465 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (industry)
• Drugs / interventions: Chemotherapy, immunotherapy, radiation, prednisone
• Locations: 37 sites (Beijing, Beijing Municipality and 36 other locations)
• Trial ID: NCT07367529 on ClinicalTrials.gov

What this trial studies

This is a Phase 1/2, interventional, multicenter trial that gives participants TQB6411 by injection and monitors them for safety and signs of tumor response. Patients must have advanced lung cancer with at least one measurable lesion and meet baseline lab and performance-status requirements (ECOG 0–1). Dose escalation and/or expansion cohorts will identify a tolerated dose and look for preliminary anti-tumor activity using RECIST v1.1 and standard safety labs. The trial is being run at cancer centers in Beijing and Chongqing, China.

Who should consider this trial

Good fit: Adults aged 18–75 with advanced lung cancer, ECOG performance status 0–1, at least one measurable lesion, expected survival >12 weeks, and adequate blood, liver, and kidney function are the intended participants.

Not a fit: Patients with poor performance status (ECOG >1), very short life expectancy, major organ dysfunction, or no measurable disease are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, TQB6411 could become a new treatment option that shrinks tumors or slows disease progression for some patients with advanced lung cancer.

How similar studies have performed: This is an early-phase trial of a novel anti-cancer agent; similar Phase 1/2 oncology trials sometimes show initial tumor responses and acceptable safety but many investigational drugs remain unproven.

Eligibility criteria

Inclusion Criteria:

* Subjects voluntarily participate in this study, sign the informed consent form, and demonstrate good compliance;
* Age between 18 and 75 years (calculated based on the date of signing the informed consent form);
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
* Expected survival greater than 12 weeks;
* At least one measurable lesion according to RECIST v1.1 criteria;
* Laboratory test results meeting the following criteria (no blood transfusion within 14 days or hematopoietic growth factor administration within 7 days prior to screening):

  1. Hemoglobin (HGB) ≥ 90 g/L;
  2. Absolute neutrophil count (NEUT) ≥ 1.5×10⁹/L;
  3. Platelet count (PLT) ≥ 90×10⁹/L;
  4. Total bilirubin (TBIL) ≤ 1.5×Upper Limit of Normal (ULN);
  5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN (≤ 5×ULN if liver metastases are present);
  6. Serum creatinine (CR) ≤ 1.3×ULN or creatinine clearance rate (CCR) ≥ 50 mL/min;
  7. Prothrombin time (PT), activated partial thromboplastin time (APTT), and international normalized ratio (INR) ≤ 1.5×ULN (no anticoagulant therapy within the past 2 weeks);
* Lung cancer confirmed by histology or cytology；
* Willing to provide qualified tumor tissue samples for immunohistochemical testing, unless the subject has no eligible archived specimens and is unsuitable or refuses re-biopsy;
* Women of childbearing potential must agree to use effective contraception during the study and for 6 months after study completion, with a negative serum or urine pregnancy test within 7 days before enrollment; male subjects must agree to use effective contraception during the study and for 6 months after study completion (see Section 5.5 for details).

Exclusion Criteria:

* History of or concurrent other malignancies, except for: other malignancies treated with surgery alone and achieving ≥5 years of disease-free survival (DFS); or cured carcinoma in situ of cervix, non-melanoma skin cancer, or superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading basement membrane)\].
* Diseases affecting intravenous injection or blood sampling.
* Adverse reactions from prior therapies not recovered to Common Terminology Criteria for Adverse Events (CTCAE) v6.0 grade ≤1, except for: grade 2 alopecia, grade 2 peripheral neuropathy, grade 2 anemia, non-clinically significant asymptomatic grade 2 laboratory abnormalities, hypothyroidism stabilized with hormone replacement, or other toxicities judged by investigator as non-safety risks.
* Major surgery (Grade 3 or above per National Surgical Classification Catalog 2022), significant traumatic injury within 4 weeks prior to first dose, planned major surgery during study (except protocol-specified procedures), or presence of unhealed wounds/fractures.
* Any bleeding or hemorrhagic events ≥CTCAE grade 3 within 4 weeks prior to first dose.
* Arterial/venous thromboembolic events within 6 months prior to first dose, including: cerebrovascular accidents (including transient ischemic attack (TIA), excluding lacunar infarction), deep vein thrombosis, or pulmonary embolism (implantable venous port- or catheter-related thrombosis or superficial venous thrombosis not considered "severe" thromboembolism).
* Active viral hepatitis with poor control, except: hepatitis B surface antigen (HBsAg)-positive subjects with Hepatitis B virus Deoxyribonucleic acid (HBV DNA) \<500 IU/mL (2500 copies/mL) who agree to receive anti-HBV therapy throughout study; or hepatitis C virus (HCV)-infected subjects (Hepatitis C Virus Antibody or Ribonucleic Acid positive) with hepatitis C virus Ribonucleic Acid (HCV RNA) ≤ULN continuing approved antiviral therapy.
* Active syphilis requiring treatment.
* Active tuberculosis, history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced/radiation pneumonitis requiring treatment, clinically significant active pneumonia, history of interstitial lung disease (ILD) requiring treatment, or current ILD.
* History of psychotropic drug abuse or mental disorders.
* Prior or planned allogeneic bone marrow or solid organ transplantation.
* History of hepatic encephalopathy.
* Significant cardiovascular diseases including:

  1. Cardiac dysfunction ≥New York Heart Association (NYHA) class II or Left Ventricular Ejection Fractions (LVEF) \<50% by echocardiography;
  2. Clinically significant ventricular arrhythmia history (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes) or arrhythmias requiring continuous antiarrhythmic therapy (subjects with stable atrial fibrillation controlled solely by β-blockers may be included after investigator assessment);
  3. Unstable angina;
  4. Myocardial infarction within 12 months;
  5. Cardio contraction time (QTc) \>450ms (male) or \>470ms (female) (if abnormal, measure three times at ≥2-minute intervals and average; corrected by Fridericia or Bazett method);
  6. Congenital long QT syndrome or family history.
* Active or uncontrolled severe infection (≥CTCAE grade 2).
* Renal failure requiring hemodialysis or peritoneal dialysis.
* Immunodeficiency including HIV positivity or other acquired/congenital immunodeficiency diseases.
* Uncontrolled autoimmune diseases requiring immunosuppressants or systemic corticosteroids (\>10mg prednisone/day equivalent) within 7 days prior to first dose.
* Epilepsy requiring treatment.
* Poorly controlled diabetes (fasting blood glucose \>10mmol/L).
* Tumor-related conditions and treatments:

  1. Chemotherapy, immunotherapy, or small-molecule targeted therapy within 3 weeks prior to first dose or within 5 half-lives (whichever shorter); prior local radiotherapy allowed if: completed \>4 weeks (\>2 weeks for brain) before study treatment, and target lesions are outside radiation field or show progression within field;
  2. National Medical Products Administration (NMPA)-approved traditional Chinese medicines with antitumor indications within 1 week prior to first dose;
  3. Tumor invading major vessels or judged likely to cause fatal hemorrhage;
  4. Uncontrolled effusions/ascites requiring recurrent drainage;
  5. Spinal cord compression, leptomeningeal metastases, or brain metastases with symptoms controlled \<4 weeks, or requiring steroids/dehydrating agents within 2 weeks before treatment.
* Known hypersensitivity to study drug or excipients.
* Prior treatment with: Epidermal Growth Factor Receptor/cellular-mesenchymal epithelial transition factor (EGFR/c-Met)-targeted antibody-drug conjugates (ADCs); or topoisomerase I inhibitors (Non-Small Cell Lung Cancer only) or topoisomerase I inhibitor-based ADCs.
* Prior EGFR/c-Met-targeted Monoclonal Antibody (mAbs)/bispecifics with: ≥grade 4 toxicity, permanent discontinuation due to toxicity, ≥grade 3 infusion reactions, or ≥grade 3 myalgia.
* Participation in other antitumor clinical trials within 4 weeks prior to first dose.
* Other conditions judged by investigator to jeopardize subject safety or study completion.

Where this trial is running

Beijing, Beijing Municipality and 36 other locations

• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (RECRUITING)
• Beijing Chest Hospital，Capital Medical University — Beijing, Beijing Municipality, China (NOT_YET_RECRUITING)
• Chongqing University Affiliated Three Gorges Hospital — Chongqing, Chongqing Municipality, China (NOT_YET_RECRUITING)
• The first affiliated hospital of Guangzhou medical university — Guangzhou, Guangdong, China (NOT_YET_RECRUITING)
• The first affiliated hospital of Guangzhou medical university — Guanzhou, Guangdong, China (NOT_YET_RECRUITING)
• Zhongshan City People's Hospital — Zhongshan, Guangdong, China (NOT_YET_RECRUITING)
• Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China (NOT_YET_RECRUITING)
• Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China (NOT_YET_RECRUITING)
• Cangzhou Central hospital — Cangzhou, Hebei, China (NOT_YET_RECRUITING)
• Cangzhou Central hospital — Cangzhou, Hebei, China (NOT_YET_RECRUITING)
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (NOT_YET_RECRUITING)
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (NOT_YET_RECRUITING)
• Anyang People's Hospital — Anyang, Henan, China (NOT_YET_RECRUITING)
• Luoyang Central Hospital (Zhengzhou University Affiliated Luoyang Central Hospital) — Luoyang, Henan, China (NOT_YET_RECRUITING)
• Nanyang Second General Hospital — Nanyang, Henan, China (NOT_YET_RECRUITING)
• Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China (NOT_YET_RECRUITING)
• The Third Xiangya Hospital of Central South University — Changsha, Hunan, China (NOT_YET_RECRUITING)
• Jiangsu Provincial Hospital of Traditional Chinese Medicine — Nanjin, Jiangsu, China (NOT_YET_RECRUITING)
• Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (NOT_YET_RECRUITING)
• Northern Jiangsu People's Hospital — Yangzhou, Jiangsu, China (NOT_YET_RECRUITING)
• Affiliated Zhongshan Hospital Of dalian University — Dalian, Liaoning, China (NOT_YET_RECRUITING)
• Affiliated Zhongshan Hospital Of dalian University — Dalian, Liaoning, China (NOT_YET_RECRUITING)
• Liaoning Cancer Research Institute — Shenyang, Liaoning, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shaanxi, China (NOT_YET_RECRUITING)
• Shandong First Medical University Affiliated Tumor Hospital — Jinan, Shandong, China (NOT_YET_RECRUITING)
• Shandong First Medical University Affiliated Tumor Hospital — Jinan, Shandong, China (NOT_YET_RECRUITING)
• Linyi cancer Hospital — Linyi, Shandong, China (NOT_YET_RECRUITING)
• Shanghai Pulmonary Hospital — Shanghai, Shanghai Municipality, China (NOT_YET_RECRUITING)
• Shanghai Pulmonary Hospital — Shanghai, Shanghai Municipality, China (NOT_YET_RECRUITING)
• First Hospital of Shangxi Medical University — Taiyuan, Shangxi, China (NOT_YET_RECRUITING)
• Shanxi Cancer hospital — Taiyuan, Shanxi, China (NOT_YET_RECRUITING)
• Shanxi Cancer hospital — Taiyuan, Shanxi, China (NOT_YET_RECRUITING)
• The Second Affiliated Hospital of Air Force Medical University — Xi’an, Shanxi, China (NOT_YET_RECRUITING)
• Sichuan cancer hosipital — Chengdu, Sichuan, China (NOT_YET_RECRUITING)
• Tianjin Medical University Cancer Institute & Hospital — Tianjin, Tianjin Municipality, China (NOT_YET_RECRUITING)
• Sir Run Run Shaw Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (NOT_YET_RECRUITING)
• Taizhou Hospital of Zhejiang Province — Taizhou, Zhejiang, China (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Shengxiang Ren, Doctor

Conditions: Advanced Lung Cancer