Triple-negative Breast Cancer
Conditions
Brief 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.
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
DRUGJS207 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)
DRUGJS207 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).
Sponsors
Shanghai Junshi Bioscience Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
None(open label)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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；
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | 2years | Objective response rate（ORR） evaluated based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DOR | 2years | Duration of response (DoR) evaluated based on RECIST v1.1 |
| DCR | 2years | Disease control rate (DCR) evaluated based on RECIST v1.1 |
| PFS | 2years | Progression-free survival (PFS) evaluated based on RECIST v1.1 |
| OS | 3years | The time from first dose to death from any cause |
| AE | 2years | Incidence and severity of Adverse Events(AEs)according to NCI-CTCAE v5.0 |
| Plasma concentrations | 2years | Plasma concentrations of JS207 and 9MW2821. |
| ADA | 2years | The incidence and titer of anti-drug antibodies (ADA) of JS207 and 9MW2821 |
| Nab | 2years | The incidence of Nab(if applicable) of JS207 and 9MW2821 |
| PD-L1 | 2years | The correlation between PD-L1 expression in tumor tissue and therapeutic efficacy |
Countries
China
Contacts
CONTACTChaoqiang Yang, Master
Outcome results
None listed