A Phase1b multicenter open-label dose escalation and expansion platform study of select immunotherapy combinations in adult patients with triple negative breast cancer

Novartis Pharma KK1 个研究点目标入组 6 人开始时间: 待定最近更新: 2024年8月6日

试验速览

暂无简介。

研究类型: Interventional
干预模型: A Phase Ib, Multicenter, Open-label Dose Escalation And Expansion Platform Study.
主要目的: Treatment Purpose

•Patients with advanced/metastatic TNBC (defined as HER-2 negative with under 1% of tumor cell nuclei immunoreactive for estrogen receptor (ER) and progesterone receptor (PR), with measurable disease as determined by RECIST version 1.
•Patients should have documented disease progression following, or intolerance to, no more than 2 prior lines of chemotherapy for advanced or metastatic disease. Neoadjuvant and/or adjuvant chemotherapy administered with curative intent will count as one prior line of therapy, if disease recurred within 12 months of the last treatment.
•Patients must have received prior systemic treatment that included taxane-based chemotherapy for (neo)adjuvant 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 institutions guidelines.

•Patients with a history of treatment with anti-LAG-3, anti-PD-1, anti-PD-L1 or anti-PD-L2 antibodies.
•Presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require local CNS-directed therapy.
•History of severe hypersensitivity reactions to any ingredient of study drug(s) and other mAbs and/or their excipients.
•Impaired cardiac function or clinically significant cardiac disease.
•HIV infection.
•Patients with active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. For patients with inactive HBV or HCV infection (hepatitis controlled under antiviral therapy), see study drug-specific exclusion criteria. For dose expansion, patients whose disease is controlled under antiviral therapy should not be excluded.
•Active, known or suspected autoimmune disease.
•History of or current interstitial lung disease or pneumonitis over grade
•Subjects with tuberculosis (TB) (patients receiving MCS110 or canakinumab)

safety Incidence and severity of AEs and SAEs,Incidence and nature of DLTs in first cycle.

未报告次要终点

发起方

Loading locations...