A Phase 1/2 open-label, multi-center, safety, preliminary efficacy and pharmacokinetic (PK) study of isatuximab (SAR650984) in combination with atezolizumab or isatuximab alone in patients with advanced malignancies - ACT15377

Sanofi-aventis0 个研究点目标入组 24 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

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•- Patients must have a known diagnosis of either unresectable hepatocellular carcinoma (HCC), platinum-refractory recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN), platinum-resistant/refractory epithelial ovarian cancer (EOC) with evidence of measurable disease;or recurrent glioblastoma multiforme (GBM).;- *18 years of age.;-For patients with HCC: Documentation of progressive disease (PD) during or after treatment with either sorafenib or lenvatinib, or intolerance to the therapy.;-For patients with SCCHN: Received and failed up to 2 lines of prior systemic anti-cancer therapy with documentation of tumor recurrence or PD within 6 months of last platinum-based therapy in primary, recurrent, or metastatic setting.;-For patients with EOC: Received and failed up to 3 lines of prior platinum-containing therapy when the disease was platinum-sensitive, and the patients should not have received any systemic therapy for platinum-resistant/refractory disease.;-For patients with GBM: Documentation of PD or first recurrence during or after temozolomide maintenance therapy for newly diagnosed GBM treated with 1st line radiotherapy plus concurrent temozolomide.

•- Prior exposure to agent that blocks CD38 or participation in clinical studies with isatuximab;- For patients with HCC, SCCHN, EOC or GBM prior exposure to any agent (approved or investigational) that blocks the PD-1/PD-L1 pathway.;- Evidence of other immune related disease /conditions.;- History of non-infectious pneumonitis requiring steroids or current pneumonitis; history of the thoracic radiation.;- Has received a live-virus vaccination within 28 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.;- Prior solid organ or bone marrow transplantation.;- Eastern Cooperative Oncology Group performance status (PS) *2 for patients with HCC, SCCHN or EOC or Karnofsky performance score * 70 for patients with GBM;- Poor bone marrow reserve.;- Poor organ function.

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