A Phase 1/2 Study of DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas
Novartis Pharmaceuticals
Summary
The purpose of this open-label, first-in-human (FIH) trial is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of DZR123 (Tulmimetostat, CPI-0209), both as monotherapy and in combination with enzalutamide, in patients with advanced solid tumors and lymphomas.
Description
The study is divided into Phase 1 and Phase 2. Phase 1: Dose Escalation (Monotherapy) The initial phase of the study consists of a dose escalation period using a traditional 3+3 design. Adult patients with advanced, relapsed, or refractory solid tumors or lymphomas are enrolled to receive escalating doses of DZR123 (also known as Tulmimetostat, CPI-0209) as monotherapy. The primary objective of this phase is to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of DZR123. Dose escalation proceeds until the maximum tolerated dose or a suitable recommended Pha…