Trial Title:
A Clinical Trial of TQB2102 for Injection in Non-small Cell Lung Cancer With HER2 Gene Abnormality
NCT ID:
NCT06496490
Condition:
Non-Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TQB2102 for injection
Description:
HER2 dual-antibody-drug Conjugate (ADC).
Arm group label:
7.5 mg/kg of TQB2102 for injection
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Status:
Recruiting
Contact:
Last name:
Haipeng Xu, Doctor
Phone:
13675007687
Email:
penghaixu@163.com
Facility:
Name:
Foshan First People's Hospital
Address:
City:
Foshan
Zip:
528000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jun Jiang, Master
Phone:
18038865018
Email:
2290836829@qq.com
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Li Zhang, Doctor
Phone:
020-87343458
Email:
Zhangli6@mail.sysu.edu.cn
Facility:
Name:
Jiangmen Central Hospital
Address:
City:
Jiangmen
Zip:
529000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Daren Lin, Bachelor
Phone:
13802607246
Email:
ldrdy@sina.com
Contact backup:
Last name:
Min Ye, Bachelor
Phone:
13902889916
Email:
yeminzhangcuiyuan@126.com
Facility:
Name:
The Second People's Hospital of Shenzhen
Address:
City:
Shenzhen
Zip:
518035
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Hao Wu, Doctor
Phone:
13828810320
Email:
haowudr@hotmail.com
Facility:
Name:
Harbin Medical University cancer hospital
Address:
City:
Harbin
Zip:
150081
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Baogang Liu, Doctor
Phone:
13804552752
Email:
liubaogang1962@sina.com
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Qiming Wang, Doctor
Phone:
13783590691
Email:
qimingwang1006@126.com
Facility:
Name:
Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Rui Meng, Doctor
Phone:
13995612493
Email:
mengruivip@163.com
Facility:
Name:
Hunan Provincial Tumor Hospital
Address:
City:
Changsha
Zip:
410031
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xingxiang Pu, Doctor
Phone:
15874180022
Email:
puxingxiang@hnca.org.cn
Contact backup:
Last name:
Lemeng Zhang, Doctor
Phone:
18684689890
Email:
zhanglemeng@hnca.org.cn
Facility:
Name:
Jiangsu Provincial People's Hospital
Address:
City:
Nanjing
Zip:
210000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Renhua Guo, Doctor
Phone:
13585145540
Email:
guorenhua@csco.ac.cn
Facility:
Name:
The First Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Zip:
330006
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Longhua Sun, Doctor
Phone:
18279110112
Email:
48570887@qq.com
Facility:
Name:
Jilin Cancer Hospital
Address:
City:
Changchun
Zip:
130012
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Shuang Zhang, Doctor
Phone:
13074321168
Email:
zhangshuangphy@126.com
Facility:
Name:
The First Affiliated Hospital of Xi'an Jiaotong University
Address:
City:
Xi'an
Zip:
710000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yu Yang, Doctor
Phone:
13572101611
Email:
Oncology_yao@163.com
Facility:
Name:
Affiliated Cancer Hospital of Shandong First Medical University
Address:
City:
Jinan
Zip:
250117
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Linlin Wang, Doctor
Phone:
13793187739
Email:
wanglinlinatjn@163.com
Facility:
Name:
Xinjiang Uygur Autonomous Region Cancer Hospital
Address:
City:
Ürümqi
Zip:
830001
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
ChunLing Liu, Master
Phone:
13899931987
Email:
liudeyouxiang66@163.com
Facility:
Name:
The 1th School of Medicine,School of Information and Engineering.The 1th Affiliated Hospital of WMU
Address:
City:
Wenzhou
Zip:
325015
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yuping Li, Master
Phone:
13587600968
Email:
wzliyp@163.com
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jian Fang, Doctor
Phone:
010-88196479
Email:
fangjian5555@yeah.net
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Junhua Zhang, Doctor
Phone:
18017317850
Email:
zhangjunhua20005@163.com
Facility:
Name:
Tianjin Medical University Cancer Institute&Hpspital
Address:
City:
Tianjin
Zip:
300181
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Dingzhi Huang, Doctor
Phone:
18622221232
Email:
zlyyfnkdoc@163.com
Start date:
August 6, 2024
Completion date:
February 2026
Lead sponsor:
Agency:
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06496490
