JS207 in combination with 9MW2821JS207 in combination with Albumin paclitaxel
JS207 in combination with 9MW2821: JS207 will be administered intravenously at a dose of 10 mg/kg (D1, Q3W), 9MW2821 will be administered intravenously at a dose of 1.25 m.g/kg (D1 and D8, Q3W)
JS207 in combination with Albumin paclitaxel: JS207 will be administered intravenously at a dose of 10 mg/kg (D1, Q3W), Albumin paclitaxel will be administered intravenously at a dose of 125 mg/m2 (D1 and D8, Q3W).
Study summary
This is an open-label, multi-center, phase II clinical study to preliminarily evaluate the efficacy and safety of JS207 combined with 9MW2821 or albumin paclitaxel as first-line therapy in patients with recurrent or metastatic TNBC.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Male or female age 18 - 75 years old;
2. Voluntary participation in clinical study;
3. Histologically confirmed unresectable, locally advanced or metastatic triple-negative breast cancer(absence of HER2, ER, and PR expression);
4. No prior systemic antitumor therapy for locally advanced or Metastatic TNBC;
5. Prior use of systemic anti-tumor therapy in the neoadjuvant and/or adjuvant phase is allowed, but must meet the following conditions: (1) the time interval between the end of neoadjuvant/adjuvant therapy and the occurrence of recurrence/metastasis is ≥6 months; (2) Arm2: if taxane is used in the neoadjuvant/adjuvant phase, the DFI must be ≥12 months;
6. Adequate organ function;
7. ECOG performance status of 0 or 1;
8. Life expectancy 12 weeks;
9. Measurable disease, as defined by RECIST v1.1;
Exclusion Criteria:
1. Untreated or active central nervous system (CNS) metastases;
2. Uncontrolled pleural effusion, pericardial effusion or ascites;
3. Tumor encasement of important vessels or significant necrosis and cavitation that may cause a risk of hemorrhage;
4. History of significant bleeding tendency or severe coagulation disorder;
5. Uncontrolled hypertension;
6. Active autoimmune diseases requiring systemic treatmen within 2 years prior to the first dose;
7. History of interstitial lung disease or previous Noninfectious pneumonitis treated with corticosteroids, or evidence of active Pneumonia in radiology on screening period;
8. Eye disorders or symptoms: severe xerophthalmia, keratoconjunctivitis sicca, severe exposure keratitis, or other conditions;
9. Severe cardiovascular disease;
10. Serious infection (CTCAE 5.0 Grade\>2) within 28 days prior to the first dose of study drug;
11. Previous treatment with anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs targeting other stimulatory or co-inhibitory T cell receptors (e.g., CTLA-4, OX-40, CD137) in (new) adjuvant therapy is allowed, if DFI is ≥6 months previously treated with Antibody-Drug Conjugates conjugated with MMAE and/or targeting Nectin-4, such as Enfortumab Vedotin is not allowed;
12. History of another malignancy within 5 years before the first dose of study drug;
13. Not suitable to receive study treatment for other conditions as per investigator;
Primary outcome measure(s)
ORR — 2years Objective response rate(ORR) evaluated based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria
Trial sites (22)
Facility
City
Region
Status
Anhui Provincial Cancer Hospital
Hefei
Anhui
Not Yet Recruiting
Peking University People's Hospital
Beijing
Beijing Municipality
Recruiting
The Fifth Medical Center of PLA General Hospital
Beijing
Beijing Municipality
Recruiting
Guangdong women and children's hospital and health institute
Guangzhou
Guangdong
Not Yet Recruiting
Affiliated Hospital of Hebei University
Baoding
Hebei
Recruiting
Harbin Medical University Affiliated Cancer Hospital
Harbin
Heilongjiang
Not Yet Recruiting
Harbin Medical University Affiliated Cancer Hospital
Harbin
Heilongjiang
Not Yet Recruiting
Henan Cancer Hospital
Zhangzhou
Henan
Recruiting
Hubei Cancer Hospital
Wuhan
Hubei
Recruiting
Jiangsu Cancer Hospital
Nanjing
Jiangsu
Recruiting
Jiangsu Province Hospital
Nanjing
Jiangsu
Not Yet Recruiting
Nanchang People'S Hospital
Nanchang
Jiangxi
Not Yet Recruiting
Jilin University First Hospital
Changchun
Jilin
Recruiting
The Second Hospital of Dalian Medical University
Dalian
Liaoning
Recruiting
The First Hospital of China Medical University
Shenyang
Liaoning
Recruiting
Liaoning Cancer Hospital&Institute
Shenyang
Liaoning
Recruiting
Ceneral Hosipital of Ningxia Medical University
Yinchuan
Ningxia
Not Yet Recruiting
The Affiliated Hospital of Qingdao University
Qingdao
Shandong
Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xian
Shanxi
Recruiting
Xi'an International Medical Center Hospital
Xian
Shanxi
Recruiting
Affiliated Tumor Hospital of Xinjiang Medical University
Ürümqi
Xinjiang Uygur Autonomous Region
Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou
Zhejiang
Not Yet Recruiting
More Shanghai Junshi Bioscience Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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