JS207 Combination Therapy in Triple-negative Breast Cancer

Официальное название

JS207 Combination Therapy in Recurrent or Metastatic Triple-negative Breast Cancer(TNBC)

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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)
• Препарат 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).

Первичные конечные точки

• ORR [Срок оценки: 2years]

Вторичные конечные точки (9)

• DOR [Срок оценки: 2years]
• DCR [Срок оценки: 2years]
• PFS [Срок оценки: 2years]
• OS [Срок оценки: 3years]
• AE [Срок оценки: 2years]
• Plasma concentrations [Срок оценки: 2years]
• ADA [Срок оценки: 2years]
• Nab [Срок оценки: 2years]
• PD-L1 [Срок оценки: 2years]

Критерии участия

Критерии включения

• 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;

Критерии исключения

• 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；

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 22 центра

• Anhui Provincial Cancer Hospital — Хэфэй
• Peking University People's Hospital — Пекин
• The Fifth Medical Center of PLA General Hospital — Пекин
• Guangdong women and children's hospital and health institute — Гуанчжоу
• Affiliated Hospital of Hebei University — Baoding
• Harbin Medical University Affiliated Cancer Hospital — Харбин
• Harbin Medical University Affiliated Cancer Hospital — Харбин
• Henan Cancer Hospital — Zhangzhou
• … и ещё 14 центров

Идентификаторы

NCT: NCT07045311 · JS207-008-II-TNBC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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