JS207 Combination Therapy in Triple-negative Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: JS207 in combination with 9MW2821, JS207 in combination with Albumin paclitaxel.
- Who it may be relevant to
- Registry conditions: Triple-negative Breast Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
JS207 Combination Therapy in Recurrent or Metastatic Triple-negative Breast Cancer(TNBC)
Overview
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.
Detailed description
The study consists of Cohort A and Cohort B. Both cohorts include patients with recurrent or metastatic TNBC who have not received systemic anti-tumor therapy previously. Cohort A will receive JS207 combined with 9MW2821, and Cohort B will receive JS207 combined with albumin paclitaxel. Each cohort consists of two stages: safety run-in period and cohort expansion period.
Interventions
- Drug 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) - Drug 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).
Primary outcome measures
- ORR [Time frame: 2years]
Secondary outcome measures (9)
- DOR [Time frame: 2years]
- DCR [Time frame: 2years]
- PFS [Time frame: 2years]
- OS [Time frame: 3years]
- AE [Time frame: 2years]
- Plasma concentrations [Time frame: 2years]
- ADA [Time frame: 2years]
- Nab [Time frame: 2years]
- PD-L1 [Time frame: 2years]
Eligibility criteria
Inclusion criteria
- Male or female age 18 - 75 years old；
- Voluntary participation in clinical study；
- Histologically confirmed unresectable, locally advanced or metastatic triple-negative breast cancer(absence of HER2, ER, and PR expression);
- No prior systemic antitumor therapy for locally advanced or Metastatic TNBC；
- 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;
- Adequate organ function;
- ECOG performance status of 0 or 1;
- Life expectancy 12 weeks;
- Measurable disease, as defined by RECIST v1.1;
Exclusion criteria
- Untreated or active central nervous system (CNS) metastases；
- Uncontrolled pleural effusion, pericardial effusion or ascites；
- Tumor encasement of important vessels or significant necrosis and cavitation that may cause a risk of hemorrhage；
- History of significant bleeding tendency or severe coagulation disorder；
- Uncontrolled hypertension；
- Active autoimmune diseases requiring systemic treatmen within 2 years prior to the first dose；
- History of interstitial lung disease or previous Noninfectious pneumonitis treated with corticosteroids, or evidence of active Pneumonia in radiology on screening period；
- Eye disorders or symptoms: severe xerophthalmia, keratoconjunctivitis sicca, severe exposure keratitis, or other conditions；
- Severe cardiovascular disease；
- Serious infection (CTCAE 5.0 Grade>2) within 28 days prior to the first dose of study drug；
- 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；
- History of another malignancy within 5 years before the first dose of study drug；
- Not suitable to receive study treatment for other conditions as per investigator；
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 22 centers
- Anhui Provincial Cancer Hospital — Hefei
- Peking University People's Hospital — Beijing
- The Fifth Medical Center of PLA General Hospital — Beijing
- Guangdong women and children's hospital and health institute — Guangzhou
- Affiliated Hospital of Hebei University — Baoding
- Harbin Medical University Affiliated Cancer Hospital — Harbin
- Harbin Medical University Affiliated Cancer Hospital — Harbin
- Henan Cancer Hospital — Zhangzhou
- … and 14 more centers
Identifiers
NCT: NCT07045311 · JS207-008-II-TNBC