A Clinical Trial on the Efficacy and Safety of TQB6411 for Injection

April 29, 2026 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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

To evaluate the efficacy and safety of TQB6411 for Injection in subjects with advanced lung cancer

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

465

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100021
        • Recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Contact:
      • Beijing, Beijing Municipality, China, 101100
        • Not yet recruiting
        • Beijing Chest Hospital,Capital Medical University
        • Contact:
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 404000
        • Not yet recruiting
        • Chongqing University Affiliated Three Gorges Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Not yet recruiting
        • The First Affiliated Hospital of Guangzhou Medical University
        • Contact:
      • Guanzhou, Guangdong, China, 510120
        • Not yet recruiting
        • The First Affiliated Hospital of Guangzhou Medical University
        • Contact:
      • Zhongshan, Guangdong, China, 528445
        • Not yet recruiting
        • Zhongshan City People's Hospital
        • Contact:
          • Guinan Lin, Master
          • Phone Number: 13631147364
          • Email: lgn83@163.com
    • Guangxi
      • Nanning, Guangxi, China, 53000
        • Not yet recruiting
        • Guangxi Medical University Cancer Hospital
        • Contact:
    • Hebei
      • Cangzhou, Hebei, China, 61000
        • Not yet recruiting
        • Cangzhou Central Hospital
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • Not yet recruiting
        • Harbin Medical University Cancer Hospital
        • Contact:
    • Henan
      • Anyang, Henan, China, 455000
        • Not yet recruiting
        • Anyang People's Hospital
        • Contact:
      • Luoyang, Henan, China, 471000
        • Not yet recruiting
        • Luoyang Central Hospital (Zhengzhou University Affiliated Luoyang Central Hospital)
        • Contact:
      • Nanyang, Henan, China, 473012
        • Not yet recruiting
        • Nanyang Second General Hospital
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430071
        • Not yet recruiting
        • Zhongnan Hospital of Wuhan University
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410000
        • Not yet recruiting
        • The Third Xiangya Hospital of Central South University
        • Contact:
    • Jiangsu
      • Nanjin, Jiangsu, China, 210019
        • Not yet recruiting
        • Jiangsu Provincial Hospital of Traditional Chinese Medicine
        • Contact:
      • Nanjing, Jiangsu, China, 210000
        • Not yet recruiting
        • Nanjing Drum Tower Hospital
        • Contact:
      • Yangzhou, Jiangsu, China, 225000
        • Not yet recruiting
        • Northern Jiangsu People's Hospital
        • Contact:
    • Liaoning
      • Dalian, Liaoning, China, 116001
        • Not yet recruiting
        • Affiliated Zhongshan Hospital Of Dalian University
        • Contact:
      • Shenyang, Liaoning, China, 110000
        • Not yet recruiting
        • Liaoning Cancer Research Institute
        • Contact:
    • Shaanxi
      • Xi'an, Shaanxi, China, 710000
        • Not yet recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
          • Yu Yang
    • Shandong
      • Jinan, Shandong, China, 250117
        • Not yet recruiting
        • Shandong First Medical University Affiliated Tumor Hospital
        • Contact:
      • Linyi, Shandong, China, 276034
        • Not yet recruiting
        • LinYi Cancer Hospital
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200433
        • Not yet recruiting
        • Shanghai Pulmonary Hospital
        • Contact:
    • Shangxi
      • Taiyuan, Shangxi, China, 030001
        • Not yet recruiting
        • First Hospital of Shangxi Medical University
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China, 030000
        • Not yet recruiting
        • Shanxi Cancer Hospital
        • Contact:
      • Xi’an, Shanxi, China, 710000
        • Not yet recruiting
        • The Second Affiliated Hospital of Air Force Medical University
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610040
        • Not yet recruiting
        • Sichuan cancer hosipital
        • Contact:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300000
        • Not yet recruiting
        • Tianjin Medical University Cancer Institute & Hospital
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Not yet recruiting
        • Sir Run Run Shaw Hospital Zhejiang University School of Medicine
        • Contact:
      • Taizhou, Zhejiang, China, 317000
        • Not yet recruiting
        • Taizhou Hospital of Zhejiang Province
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TQB6411 for Injection
TQB6411 for Injection is administered every 21 days as a treatment cycle.
Drug: TQB6411 for Injection
TQB6411 for Injection is administered every 21 days as a treatment cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recommended Phase II Dosage for the Treatment (RP2D)
Time Frame: Baseline up to 21 days
Recommended phase II dosage for the treatment of advanced Lung Cancer.
Baseline up to 21 days
Objective Response Rate (ORR)
Time Frame: Baseline up to 6 mouths
Objective response rate for the treatment of advanced Lung Cancer.
Baseline up to 6 mouths

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Control Rate (DCR)
Time Frame: Baseline up to 6 mouths
Disease control rate for the treatment of advanced Lung Cancer.
Baseline up to 6 mouths
Duration of Relief (DOR)
Time Frame: Baseline up to 2 years
Duration of relief for the treatment of advanced Lung Cancer.
Baseline up to 2 years
Progression-Free Survival
Time Frame: Baseline up to 2 years
Progression-free survival for the treatment of advanced Lung Cancer.
Baseline up to 2 years
Overall Survival (OS)
Time Frame: Baseline up to 3 years
Overall survival for the treatment of advanced Lung Cancer.
Baseline up to 3 years
Adverse Events (AE)
Time Frame: Baseline up to 2 years
Numbers of participant with incidence and severity of adverse events, serious adverse events, and adverse events associated with investigational drugs (including investigational drugs and control drugs), as well as abnormal laboratory indicators were evaluated.
Baseline up to 2 years
Incidence of Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb)
Time Frame: Cycle 1 day 1, Cycle 4 day 1, Cycle 6 day 1, Cycle 12 daye 1: 60 minutes before administration (21 days as a treatment cycle)
Immunogenicity in patients with advanced lung cancer, Incidence of Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb).
Cycle 1 day 1, Cycle 4 day 1, Cycle 6 day 1, Cycle 12 daye 1: 60 minutes before administration (21 days as a treatment cycle)
Peak concentration (Cmax)
Time Frame: Before administration, 30 minuets, 15 minuets after administration
The plasma concentration at which the rate of administration and rate of elimination are in equilibrium.
Before administration, 30 minuets, 15 minuets after administration
Plasma concentration at steady state (Cav, SS)
Time Frame: Pre-dose of day 1 on multiple dose and 2, 6, 24, 72 hours, 7, 14 days post-dose on multiple dose of day 1
The plasma concentration at which the rate of administration and rate of elimination are in equilibrium.
Pre-dose of day 1 on multiple dose and 2, 6, 24, 72 hours, 7, 14 days post-dose on multiple dose of day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

January 16, 2026

First Submitted That Met QC Criteria

January 18, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TQB6411-Ib/II-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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