A Phase 1, Open-Label, Dose Escalation and Dose Expansion Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Effects of Orally Administered CB-5083 in Patients with Advanced Solid Tumors

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Investigator: Pamela N. Munster, MD
Sponsor: Cleave Biosciences, Inc

Location(s): United States

Description

This is a multicenter, open-label, phase 1 study of orally administered CB-5083 in adult patients with advanced solid tumors who have progressed or are non-responsive to available therapies and for which no standard therapy exists. The study will be conducted in 2 parts: an initial Dose Escalation Phase (phase 1a) of CB-5083 in patients with advanced solid tumors, followed by a dose expansion phase (phase 1b) which will include 2 parallel arms: one in patients with advanced pNETs and the second one in patients with advanced solid tumors carrying K RAS mutations.