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

NCT07367529 | Recruiting Phase 1

• 1 other identifier: TQB6411-Ib/II-02
• Study Type: interventional
• Target: 465
• Locations: 1 country
• Sites: 37

Brief Summary

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

Conditions

Advanced Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Recommended Phase II Dosage for the Treatment (RP2D)

  Recommended phase II dosage for the treatment of advanced Lung Cancer.

  Baseline up to 21 days

• Objective Response Rate (ORR)

  Objective response rate for the treatment of advanced Lung Cancer.

  Baseline up to 6 mouths

Secondary Outcomes (8)

• Disease Control Rate (DCR)

  Baseline up to 6 mouths

• Duration of Relief (DOR)

  Baseline up to 2 years

• Progression-Free Survival

  Baseline up to 2 years

• Overall Survival (OS)

  Baseline up to 3 years

• Adverse Events (AE)

  Baseline up to 2 years

Study Arms (1)

TQB6411 for Injection

EXPERIMENTAL

TQB6411 for Injection is administered every 21 days as a treatment cycle.

Drug: TQB6411 for Injection

Interventions

TQB6411 for Injection DRUG

TQB6411 for Injection is administered every 21 days as a treatment cycle.

TQB6411 for 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:

• 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):
• Hemoglobin (HGB) ≥ 90 g/L;
• Absolute neutrophil count (NEUT) ≥ 1.5×10⁹/L;
• Platelet count (PLT) ≥ 90×10⁹/L;
• Total bilirubin (TBIL) ≤ 1.5×Upper Limit of Normal (ULN);
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN (≤ 5×ULN if liver metastases are present);
• Serum creatinine (CR) ≤ 1.3×ULN or creatinine clearance rate (CCR) ≥ 50 mL/min;
• 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;

You may not qualify if:

• 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:
• Cardiac dysfunction ≥New York Heart Association (NYHA) class II or Left Ventricular Ejection Fractions (LVEF) \<50% by echocardiography;
• 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);

Sponsors & Collaborators

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

Study Sites (37)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Beijing Chest Hospital，Capital Medical University

Beijing, Beijing Municipality, 101100, China

NOT YET RECRUITING

Chongqing University Affiliated Three Gorges Hospital

Chongqing, Chongqing Municipality, 404000, China

NOT YET RECRUITING

The first affiliated hospital of Guangzhou medical university

Guangzhou, Guangdong, 510120, China

NOT YET RECRUITING

The first affiliated hospital of Guangzhou medical university

Guanzhou, Guangdong, 510120, China

NOT YET RECRUITING

Zhongshan City People's Hospital

Zhongshan, Guangdong, 528445, China

NOT YET RECRUITING

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, 53000, China

NOT YET RECRUITING

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, 53000, China

NOT YET RECRUITING

Cangzhou Central hospital

Cangzhou, Hebei, 61000, China

NOT YET RECRUITING

Cangzhou Central hospital

Cangzhou, Hebei, 61000, China

NOT YET RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150000, China

NOT YET RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150000, China

NOT YET RECRUITING

Anyang People's Hospital

Anyang, Henan, 455000, China

NOT YET RECRUITING

Luoyang Central Hospital (Zhengzhou University Affiliated Luoyang Central Hospital)

Luoyang, Henan, 471000, China

NOT YET RECRUITING

Nanyang Second General Hospital

Nanyang, Henan, 473012, China

NOT YET RECRUITING

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

NOT YET RECRUITING

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

NOT YET RECRUITING

Jiangsu Provincial Hospital of Traditional Chinese Medicine

Nanjin, Jiangsu, 210019, China

NOT YET RECRUITING

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210000, China

NOT YET RECRUITING

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 225000, China

NOT YET RECRUITING

Affiliated Zhongshan Hospital Of dalian University

Dalian, Liaoning, 116001, China

NOT YET RECRUITING

Affiliated Zhongshan Hospital Of dalian University

Dalian, Liaoning, 116001, China

NOT YET RECRUITING

Liaoning Cancer Research Institute

Shenyang, Liaoning, 110000, China

NOT YET RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710000, China

NOT YET RECRUITING

Shandong First Medical University Affiliated Tumor Hospital

Jinan, Shandong, 250117, China

NOT YET RECRUITING

Shandong First Medical University Affiliated Tumor Hospital

Jinan, Shandong, 250117, China

NOT YET RECRUITING

Linyi cancer Hospital

Linyi, Shandong, 276034, China

NOT YET RECRUITING

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

NOT YET RECRUITING

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

NOT YET RECRUITING

First Hospital of Shangxi Medical University

Taiyuan, Shangxi, 030001, China

NOT YET RECRUITING

Shanxi Cancer hospital

Taiyuan, Shanxi, 030000, China

NOT YET RECRUITING

Shanxi Cancer hospital

Taiyuan, Shanxi, 030000, China

NOT YET RECRUITING

The Second Affiliated Hospital of Air Force Medical University

Xi’an, Shanxi, 710000, China

NOT YET RECRUITING

Sichuan cancer hosipital

Chengdu, Sichuan, 610040, China

NOT YET RECRUITING

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300000, China

NOT YET RECRUITING

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

NOT YET RECRUITING

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, 317000, China

NOT YET RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Shengxiang Ren, Doctor

CONTACT

13816756732; harry_ren@126.com

Zhijie Wang, Doctor

CONTACT

13466323860; wangzj@cicams.ac.cn

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: January 16, 2026
• First Posted: January 26, 2026
• Study Start: February 26, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-03

Locations

CN (37)