Project description:open-label single-arm pilot phase II clinical trial of Regorafenib as a single agent in Frail Patients With Metastatic Colorectal Cancer. Blood samples for determination of serum miRNAs were taken on entry into the study and at the time of disease progression.
Project description:High-througput transcriptome analysis by RNA-seq of multiple myeloma tumor samples (CD138+ cells) in subjects treated with pomalidomide, daily low dose oral cyclophosphamide and dexamethasone in the context of a phase II clinical trial. Samples were collected at baseline as a correlative study to determine whether gene expression profiles could distinguish patients with (un)favorable response to treatment.
Project description:The intestinal microbiome has been associated with response to immune checkpoint inhibitors (ICI) in humans, and causally implicated in ICI responsiveness in animal models. Therapeutic augmentation of the microbiome in ICI recipients is being investigated in multiple ongoing human clinical trials. We conducted an early phase clinical trial of a cultivated, orally-delivered 30-species microbial consortium (microbial ecosystem therapeutic-4, MET4) designed for co-administration with ICIs and assessed safety, tolerability and ecological responses in patients with advanced solid tumors.
Project description:MicroRNA profiling was performed on baseline bloods using the NanoString nCounter platform in a serial liquid biopsies obtained at baseline in chemo-refractory mCRC patients treated with regorafenib in a phase II clinical trial (PROSPECT-R n=40; NCT03010722).
Project description:The pre-clinical efficacy and safety data support the initiation of a phase I/II clinical trial for β-globin gene correction in patient-derived hematopoietic stem cells for the treatment of sickle cell disease.
Project description:Matrices of TPM-normalized counts from RNAseq data for the three phase II clinical trials (IMvigor210, POPLAR, IMmotion150) and the phase I clinical trial PCD4989g.