Actively Recruiting
A Study of TQB2102 for Injection in Patients With Recurrent/Metastatic Breast Cancer
Led by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Updated on 2023-11-29
150
Participants Needed
20
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of TQB2102 for Injection in Patients With Recurrent/Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteers who provide informed consent
- Age between 18 and 75 years at time of consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Estimated survival time of at least 3 months
- Diagnosed with HER2-positive breast cancer confirmed by pathology
- Evidence of local recurrence or distant metastasis not suitable for surgery or radiotherapy
- Disease progression or intolerance during or after the most recent treatment
- At least one measurable lesion according to RECIST 1.1 criteria
- Normal functioning of major organs
- Female participants of childbearing age must agree to contraception during the study and for 6 months after
- Negative serum pregnancy test within 7 days before enrollment and not breastfeeding
- Male participants must agree to use contraception during the study and for 6 months after
You will not qualify if you...
- Diagnosis or treatment of another malignancy within the past 3 years
- Unresolved adverse effects from prior treatments greater than CTCAE grade 1 (except hair loss)
- Major surgery, incision biopsy, or significant injury within 28 days before study treatment
- Presence of long-term unhealed wounds or fractures
- History or current interstitial lung disease or pneumonia requiring steroids, or suspected cases not ruled out
- Arterial or venous thrombosis events within 6 months before starting treatment
- History of psychotropic substance abuse or mental disorders preventing abstinence
- Severe or uncontrolled diseases
- Antitumor treatments including chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to first dose or still within 5 half-lives
- Use of Chinese patent antitumor drugs within 2 weeks before treatment
- Tumor invading important blood vessels or high risk of fatal bleeding
- Uncontrolled pleural effusion, ascites, or moderate or higher pericardial effusion needing repeated drainage
- Known cancerous meningitis or active CNS metastasis; stable patients must be off corticosteroids for at least 2 weeks
- Severe bone injury from bone metastasis
- Allergy to study drug, its components, or humanized monoclonal antibodies
- Participation in other antitumor clinical trials within 4 weeks before first dose
- Any condition judged by investigators to endanger safety or study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
Anhui Pronvincial Cancer Hospital
Hefei, Anhui, China, 230000
Not Yet Recruiting
2
Lu'an People's Hospital
Lu'an, Anhui, China, 237008
Not Yet Recruiting
3
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, China, 100021
Not Yet Recruiting
4
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China, 400030
Not Yet Recruiting
5
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
6
Jiangmen Central Hospital
Jiangmen, Guangdong, China, 529000
Not Yet Recruiting
7
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China, 530021
Not Yet Recruiting
8
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081
Actively Recruiting
9
Hunan Cancer Hospital
Changsha, Hunan, China, 410031
Not Yet Recruiting
10
Ganzhou People's Hospital
Ganzhou, Jiangxi, China, 341000
Not Yet Recruiting
11
Jilin Cancer Hospital
Changchun, Jilin, China, 130012
Not Yet Recruiting
12
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China, 110000
Not Yet Recruiting
13
The First Hospital of China Medical University
Shenyang, Liaoning, China, 110001
Not Yet Recruiting
14
Cancer Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China, 250117
Not Yet Recruiting
15
Linyi Cancer Hospital
Linyi, Shandong, China, 276034
Not Yet Recruiting
16
The First Affiliated Hospital of Xi'an Jiaotong University School of Medicine
Xi'an, Shannxi, China, 710089
Not Yet Recruiting
17
Shanxi Cancer Hospital
Taiyuan, Shanxi, China, 030000
Not Yet Recruiting
18
Suining Central Hospital
Suining, Sichuan, China, 629000
Not Yet Recruiting
19
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300202
Not Yet Recruiting
20
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Not Yet Recruiting
Research Team
Q
Qingyuan Zhang, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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