Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Phase
Phase 2
Started
2024-08-06
Last updated
2025-11-20
Condition(s) studied
Non-Small Cell Lung Cancer
Investigational drug(s) / intervention(s)
TQB2102 for injectionTQB2102 for injection combined with Benmelstobart injection
TQB2102 for injection: HER2 dual-antibody-drug Conjugate (ADC).
TQB2102 for injection combined with Benmelstobart injection: TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC); Benmelstobart injection is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1).
Study summary
TQB2102 is an antibody-drug conjugate comprised of a humanised antibody against Human Epidermal Growth Factor Receptor 2 (HER2), a enzyme-cleavable linker, and a topoisomerase I inhibitor payload, which combine the ability of antibodies to specifically target tumour cells with the highly potent killing activity of drugs with payloads too toxic for systemic administration. This is a Phase 2 study to evaluate the efficacy,and safety of TQB2102 for injection in locally advanced or metastatic non-small cell lung cancer with HER2 gene abnormality.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* Subjects voluntarily participate in this study and sign informed consent;
* Between the ages of 18-75 years (subject to the date of signing the informed consent); Eastern cooperative oncology group (ECOG) score 0-1; estimated survival time ≥3 months;
* Patients with locally advanced, metastatic, or recurrent non-small cell lung cancer that is cytologically or histologically proven to be inoperable and cannot be treated with radical concurrent chemoradiotherapy;
* Previous standard treatments failed;
* At least one measurable lesion (based on Response Evaluation Criteria In Solid Tumors 1.1);
* Female participants of childbearing age should agree to use contraception during the study period and for 6 months after the end of the study; Have a negative serum pregnancy test within 7 days prior to study enrollment and must be a non-lactating subject; Male participants should agree that contraception must be used during the study period and for 6 months after the end of the study period.
Exclusion Criteria:
* Has diagnosed and/or treated additional malignancy within 3 years prior to take medication;
* Adverse effects due to any prior treatment have not been restored to CommonTerminology Criteria for Adverse Events (CTCAE) 5.0 ≤ level 1 (Excluding hair loss);
* Major surgical treatment, incision biopsy, or significant traumatic injury were received within 28 days prior to study treatment,and minor traumatic surgery (biopsy, bronchoscopy, and chest drainage) within 7 days;
* Long-term unhealed wounds or fractures;
* History of interstitial lung disease, radiation pneumonia, and immune-related pneumonia treated with steroids in the past, or active non-infectious pneumonia with interstitial changes such as interstitial lung disease, radiation pneumonia, and immune-related pneumonia in the screening period, active pulmonary tuberculosis, pneumoconiosis, or other types of pneumonia ≥ grade 2, or severe impairment of lung function confirmed by pulmonary function examination;
* Arterial/deep vein thrombosis events occurred within 6 months prior to treatment, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism;
* Patients who have a history of psychotropic substance abuse and are unable to abstain or have mental disorders;
* Patients with any severe and/or uncontrolled disease;
* Any anticancer therapy or any other investigational drug treatment within 28 days or 5 half-lives prior to the first dosing of this study;
* Within 1 week prior to the first administration of this study, the Chinese patent drugs with anti-tumor indications clearly stated in the National MedicalProducts Administration approved drug instructions were treated;
* Local focal palliative radiotherapy was received within 2 weeks before the first dose;
* Patients with serous effusion requiring repeated drainage to relieve clinical symptoms or who have received serous effusion drainage for therapeutic purposes within 2 weeks prior to treatment;
* There is symptomatic or progressive exacerbation of central nervous system metastatic or cancerous meningitis with diffuse spread. Subjects with a history of brain metastases may be considered for inclusion if they are clinically stable;
* Severe bone injury caused by tumor bone metastasis, including pathological fractures and spinal cord compression that occurred within 6 months or are likely to occur in the near future;
* Pain associated with uncontrolled bone metastases;
* Allergic to humanized monoclonal antibody products;
* Allergic to any investigational drug or to any ingredient or excipient in the drug;
* Persons who have received live attenuated vaccine within 4 weeks prior to treatment;
* Subjects who, in the investigator's judgment, have concomitant diseases that seriously endanger the safety of subjects or interfere with the completion of the study, or who are deemed unsuitable for enrollment for other reasons.
Primary outcome measure(s)
Overall Response Rate (ORR) — Baseline up to 8 months ORR defined as percentage of participants achieving complete response (CR) and partial response (PR).
Trial sites (25)
Facility
City
Region
Status
Fujian Cancer Hospital
Fuzhou
Fujian
Recruiting
Foshan First People's Hospital
Foshan
Guangdong
Not Yet Recruiting
Sun Yat-sen University Cancer Center
Guangzhou
Guangdong
Not Yet Recruiting
Jiangmen Central Hospital
Jiangmen
Guangdong
Not Yet Recruiting
The Second People's Hospital of Shenzhen
Shenzhen
Guangdong
Not Yet Recruiting
Guangxi Medical University Cancer Hospital
Nanning
Guangxi
Not Yet Recruiting
The Second Affiliated Hospital of Zunyi Medical University
Zunyi
Guizhou
Not Yet Recruiting
Harbin Medical University cancer hospital
Harbin
Heilongjiang
Not Yet Recruiting
Henan Cancer Hospital
Zhengzhou
Henan
Not Yet Recruiting
Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Hubei
Not Yet Recruiting
Hunan Provincial Tumor Hospital
Changsha
Hunan
Not Yet Recruiting
Jiangsu Provincial People's Hospital
Nanjing
Jiangsu
Not Yet Recruiting
First Affiliated Hospital of Gannan Medical University
Ganzhou
Jiangxi
Not Yet Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang
Jiangxi
Not Yet Recruiting
Jilin Cancer Hospital
Changchun
Jilin
Not Yet Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an
Shaanxi
Not Yet Recruiting
Affiliated Cancer Hospital of Shandong First Medical University
Jinan
Shandong
Not Yet Recruiting
Sichuan Provincial People's Hospital
Chengdu
Sichuan
Not Yet Recruiting
Sichuan Cancer Hospital
Chengdu
Sichuan
Not Yet Recruiting
Leshan People's Hospital
Leshan
Sichuan
Not Yet Recruiting
Xinjiang Uygur Autonomous Region Cancer Hospital
Ürümqi
Xinjiang
Not Yet Recruiting
The 1th School of Medicine,School of Information and Engineering.The 1th Affiliated Hospital of WMU
Wenzhou
Zhejiang
Not Yet Recruiting
Beijing Cancer Hospital
Beijing
China
Not Yet Recruiting
Fudan University Shanghai Cancer Center
Shanghai
China
Not Yet Recruiting
Tianjin Medical University Cancer Institute&Hpspital
Tianjin
China
Not Yet Recruiting
More Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. trials in China
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