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The Phase I Clinical Trials of JSI-1187 is an open-label, multi-center dose-increasing and extended clinical study that assesses the safety, tolerance, pharmacokinetics, pharmacological dynamics, and clinical efficacy of JSI-1187 in patients with recurrent, refractory solid tumors carrying MAPK mutations.
the clinical study consists of three stages: 1) JSI-1187 single-drug dose climbing stage for solid tumor patients; 2) JSI-1187 and BRAF inhibitor Dalafini combined dose climbing; 3) extended study of patients with tumors carrying specific gene mutations.
no ERK kinase inhibitors have been approved for market worldwide, and the fastest-moving projects are in Phase II, including BioMed Valley Discoveries/Vertex, LY3214996 (Lilly), LTT462 (Novartis).
JSI-1187 was granted a clinical application by the FDA in January 2020 and a phase I clinical trial (clinical trial registration number: NCT04418167) was launched in the United States in June 2020.
Source: NextPharma Note: Original: Original:
