NCT07367529招募中1 期
A Phase Ib/II Clinical Trial to Evaluate the Efficacy and Safety of TQB6411 for Injection in Patients With Advanced Lung Cancer
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 465
- 试验地点
- 31
- 主要终点
- Recommended Phase II Dosage for the Treatment (RP2D)
研究概览
简要总结
To evaluate the efficacy and safety of TQB6411 for injection in trial participant with advanced lung cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants 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 and amplification testing, unless the participant 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 participants must agree to use effective contraception during the study and for 6 months after study completion (see Section 5.5 for details).
排除标准
- •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 participants with HepatitisBvirus 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 participants (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 (participants with stable atrial fibrillation controlled solely by β-blockers may be included after investigator assessment);
- •Unstable angina;
- •Myocardial infarction within 12 months;
- •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);
- •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:
- •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;
- •National Medical Products Administration (NMPA)-approved traditional Chinese medicines with antitumor indications within 1 week prior to first dose;
- •Tumor invading major vessels or judged likely to cause fatal hemorrhage;
- •Uncontrolled effusions/ascites requiring recurrent drainage;
- •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 participant safety or study completion.
研究组 & 干预措施
TQB6411 for Injection
Experimental
TQB6411 for Injection is administered every 21 days as a treatment cycle. TQB6411 for injection is administered every 28 days as a treatment cycle.
干预措施: TQB6411 for Injection (Drug)
结局指标
主要结局
Recommended Phase II Dosage for the Treatment (RP2D)
时间窗: Baseline up to 21 days
Recommended phase II dosage for the treatment of advanced Lung Cancer.
Objective Response Rate (ORR)
时间窗: Baseline up to 6 mouths
Objective response rate for the treatment of advanced Lung Cancer.
次要结局
- 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)
- 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)(Before administration, 30 minuets, 15 minuets after administration)
- Plasma concentration at steady state (Cav, SS)(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)
研究者
研究点 (31)
Loading locations...
相似试验
招募中
1 期
To Evaluate the Tolerability and Pharmacokinetics of TQB3142 for Injection in Patients With Advanced Malignant TumorsNCT07338838Chia Tai Tianqing Pharmaceutical Group Co., Ltd.66
招募中
1 期
Assessment of the Efficacy and Safety of Injectable TQB2934 (Subcutaneous Injection) in Systemic Light Chain Amyloidosis PatientsNCT07266116Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.70
招募中
1 期
Clinical Trial of TQB2922 Injection (Subcutaneous Injection) in Patients With Advanced CancersNCT07260708Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.42
招募中
1 期
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TQB3122 Capsules in Subjects With Advanced Malignant TumorsNCT07269145Chia Tai Tianqing Pharmaceutical Group Co., Ltd.86
撤回
1 期
Bispecific T-Cell Engager Tarlatamab and TROP2 Targeted Antibody Drug Conjugate Sacituzumab Govitecan in Previously Treated Extensive-Stage Small Cell Lung Cancer and Extrapulmonary Neuroendocrine CancerSmall Cell CarcinomaExtensive-Stage Small Cell Lung CancerNCT07328490National Cancer Institute (NCI)120