Trial Title:
A Study of TQB2102 for Injection in Patients With Recurrent/Metastatic Breast Cancer
NCT ID:
NCT06115902
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
Phase 1
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:
TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC)
Arm group label:
TQB2102 for injection
Summary:
TQB2102 is an antibody-drug conjugate comprised of a humanised antibody against Human
Epidermal Growth Factor Receptor 2 (HER2), an 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 1/Phase 2 study to
evaluate the effectiveness, safety, pharmacokinetics (PK) and anti-drug antibody (ADA) of
TQB2102 for injection in subjects with HER2-expressing relapsed/metastatic breast cancer.
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;
- Breast cancer patients diagnosed with HER2 expression by pathological examination,
with evidence of local focal recurrence or distant metastasis, are not suitable for
surgery or radiotherapy for cure;
- Disease progression or intolerance during or after the most recent treatment period
must be present before participating in clinical trials;
- At least one measurable lesion (based on Response Evaluation Criteria In Solid
Tumors 1.1);
- The main organs function are normally;
- 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:
- Concomitant disease and medical history:
1. Has diagnosed and/or treated additional malignancy within 3 years prior to
first administration of study drug;
2. Adverse effects due to any prior treatment have not been restored according to
CommonTerminology Criteria for Adverse Events (CTCAE) 5.0 ≤ level 1 (Excluding
hair loss);
3. Major surgical treatment, incision biopsy, or significant traumatic injury
received within 28 days prior to study treatment;
4. Long-term unhealed wounds or fractures;
5. Patients who have a prior history of interstitial lung disease/pneumonia
requiring steroid intervention, or who are present with interstitial lung
disease/pneumonia, or who are suspected of having interstitial lung
disease/pneumonia on screening imaging and cannot be ruled out;
6. Arterial/venous thrombosis events, such as cerebrovascular accident, deep vein
thrombosis, and pulmonary embolism, occurred within 6 months before the first
medication;
7. Patients who have a history of psychotropic substance abuse and are unable to
abstain or have mental disorders;
8. Patients with any severe and/or uncontrolled disease;
- Tumor related symptoms and treatment:
1. Patients who have been treated with other antitumor drug, such as chemotherapy,
radical radiotherapy, or immunotherapy, within 4 weeks prior to the first dose,
or who are still within 5 half-lives of the drug;
2. Received Chinese patent drugs with anti-tumor indications specified in the
National Medical Products Administration (NMPA) approved drug instructions
within 2 week before the study treatment;
3. Patients whose imaging shows that the tumor has invaded important blood vessels
or who are determined by the investigators to be highly likely to invade
important blood vessels during follow-up studies and cause fatal major
bleeding;
4. Uncontrolled pleural effusion, ascites, and moderate or higher pericardial
effusion requiring repeated drainage;
5. Known presence of cancerous meningitis or clinically active central nervous
system metastasis; Patients who have been stable for at least 4 weeks after
treatment and have been off corticosteroids for at least 2 weeks are excluded;
6. Patients with severe bone injury due to tumor bone metastasis;
- Study treatment related: people who are known to be allergic to the study drug or
its excipients, or to humanized monoclonal antibody products;
- Patients who participated in and used other anti-tumor clinical trials within 4
weeks before the first medication;
- In the judgment of the investigator, there is a situation that seriously endangers
the safety of the subjects or affects the completion of the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Anhui Pronvincial Cancer Hospital
Address:
City:
Hefei
Zip:
230000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Changlu Hu, Bachelor
Phone:
13955116061
Email:
13955116061@139.com
Facility:
Name:
Lu'an People's Hospital
Address:
City:
Lu'an
Zip:
237008
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Feng Rong, Master
Phone:
13635649383
Email:
wazhl1996@163.com
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Science
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Peng Yuan, Doctor
Phone:
13501270834
Email:
yuanpeng01@hotmail.com
Facility:
Name:
Chongqing University Cancer Hospital
Address:
City:
Chongqing
Zip:
400030
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xiaohua Zeng, Doctor
Phone:
18986340992
Email:
zxiaohuacqu@126.com
Facility:
Name:
Sun Yat-Sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Shusen Wang, Doctor
Phone:
13926168469
Email:
wangshs@sysucc.org.cn
Facility:
Name:
Jiangmen Central Hospital
Address:
City:
Jiangmen
Zip:
529000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xiaoping Li, Doctor
Phone:
18933183766
Email:
13600033922@188.com
Facility:
Name:
Guangxi Medical University Cancer Hospital
Address:
City:
Nanning
Zip:
530021
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
WeiMin Xie, Doctor
Phone:
13907861028
Email:
xieweimin3358@163.com
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Harbin
Zip:
150081
Country:
China
Status:
Recruiting
Contact:
Last name:
Qingyuan Zhang, Doctor
Phone:
+8613312612989
Email:
13313612989@163.com
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410031
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Quchang OuYang, Doctor
Phone:
13973135318
Email:
oyqc1969@126.com
Facility:
Name:
Ganzhou People's Hospital
Address:
City:
Ganzhou
Zip:
341000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Chen Wang, Master
Phone:
13807078925
Email:
goestbaby@163.com
Facility:
Name:
Jilin Cancer Hospital
Address:
City:
Changchun
Zip:
130012
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Chunjiao Wu, Master
Phone:
13643112151
Email:
2956519672@qq.com
Facility:
Name:
Liaoning Cancer Hospital & Institute
Address:
City:
Shenyang
Zip:
110000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Tao Sun, Doctor
Phone:
13940404526
Email:
Inzlrxnsy@163.com
Facility:
Name:
The First Hospital of China Medical University
Address:
City:
Shenyang
Zip:
110001
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xiujuan Qu, Doctor
Phone:
13604031355
Email:
quxiujuan@hotmail.com
Facility:
Name:
Cancer Hospital Affiliated to Shandong First Medical University
Address:
City:
Jinan
Zip:
250117
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Huihui Li, Doctor
Phone:
+86 17653115650
Email:
17653115650@163.com
Facility:
Name:
Linyi Cancer Hospital
Address:
City:
Linyi
Zip:
276034
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jingfen Wang, Master
Phone:
15963976026
Email:
2298641960@qq.com
Facility:
Name:
The First Affiliated Hospital of Xi'an Jiaotong University School of Medicine
Address:
City:
Xi'an
Zip:
710089
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jin Yang, Doctor
Phone:
18991232383
Email:
1473106133@qq.com
Facility:
Name:
Shanxi Cancer Hospital
Address:
City:
Taiyuan
Zip:
030000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Fei Luo, Master
Phone:
13835101051
Email:
2435654439@qq.com
Facility:
Name:
Suining Central Hospital
Address:
City:
Suining
Zip:
629000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Hongwei Yang, Master
Phone:
18008258079
Email:
snsyhw@163.com
Facility:
Name:
Tianjin Medical University Cancer Institute & Hospital
Address:
City:
Tianjin
Zip:
300202
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yehui Shi, Doctor
Phone:
18622221183
Email:
shiyehui@tjmuch.com
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310022
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yabing Zheng, Master
Phone:
13858065353
Email:
zhengyabing@sina.com
Start date:
November 17, 2023
Completion date:
December 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/NCT06115902
