SoraTram is a multicenter, open-label, single-arm Phase I basket study evaluating combined CRAF and MEK inhibition using Sorafenib and Trametinib in advanced malignancies. The primary objective is to characterize the safety and tolerability of the combination therapy in the expansion part. Adult patients with metastatic malignancies harboring a BRAF mutation with impaired kinase activity are eligible for inclusion. Participants must have received prior standard therapy or been deemed ineligible for such treatment. Key secondary objectives include a preliminary assessment of the efficacy of the combination in these BRAF-mutated tumors.
SoraTram is an early-stage clinical trial (Phase I) investigating a combination of the drugs Sorafenib and Trametinib in adult patients with advanced or metastatic solid tumors. The study focuses on cancers with a specific BRAF gene alteration that causes resistance to standard BRAF inhibitors. The primary goal is to determine the maximum safe dose and tolerability of this new combination therapy for patients who have no further standard treatment options. This information will then enable a later assessment of the combination's overall effectiveness.
