NL-OMON49712已完成不适用
A Phase Ib, multicenter, open-label dose escalation and expansion platform study of select immunotherapy combinations in adult patients with triple negative breast cancer - CADPT01A12101C
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •ECOG Performance Status * 1
- •Patients with advanced/metastatic TNBC with measurable disease as determined by
- •RECIST version 1.1
- •Documented disease progression or intolerance to no more than 2 prior lines of
- •chemotherapy for advanced disease. Prior treatment with targeted agents or
- •checkpoint inhibitors will not count as a line of prior therapy unless
- •chemotherapy was administered concurrently.
- •Patients must have received prior systemic treatment that included taxane-based
- •chemotherapy for neoadjuvant or metastatic disease.
- •Patients must have a site of disease amenable to core needle biopsy, and be a
- •candidate for tumor biopsy according to the treating institution*s guidelines.
- •Patients must be willing to undergo a new tumor biopsy at screening, and during
- •therapy on the study.
- •See for more details protocol section 5.1
排除标准
- •Dose expansion arm(s), checkpoint- inhibitor-naive group only: Prior checkpoint
- •inhibitor therapy.
- •Presence of symptomatic central nervous system (CNS) metastases, or CNS
- •metastases that require local CNS-directed therapy (such as radiotherapy or
- •surgery), or increasing doses of corticosteroids within 2 weeks prior to
- •initiating study treatment.
- •Patients with treated brain metastases should be neurologically stable for at
- •least 4 weeks prior to study entry and off steroids for at least 2 weeks before
- •administration of any study treatment.
- •Out of range laboratory values:
- •- Creatinine clearance < 40 mL/min
- •- Total bilirubin > 1.5 x ULN, except for patients with Gilbert*s syndrome if
- •total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULN
- •- ALT and AST > 3 x ULN
- •- Absolute neutrophil count < 1.0 x 109/L
- •- Platelet count < 75 x 109/L
- •- Hemoglobin < 9 g/dL
- •- Potassium, magnesium, calcium or phosphate abnormality > CTCAE grade 1
- •despite appropriate replacement therapy
- •Impaired cardiac function or clinically significant cardiac disease
- •Cardiac Troponin T (cTnT) or Cardiac Troponin I (cTnI) elevation > Grade 1
- •History or current diagnosis of myocarditis.
- •Subjects assigned to the canakinumab arm are required to be tested using
- •Interferon-* release assay.
- •For patients assigned to the the MCS110 arm, active tuberculosis requiring
- •systemic antibiotic
- •therapy is excluded.
- •Other exclusion criteria may apply (see protocol section 5.2)
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