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.
Adults aged ≥18 years with life expectancy ≥12 weeks
ECOG performance status 0-1
Adequate recovery from prior therapy-related toxicities (Grade ≤1, with exceptions)
Adequate bone marrow, renal, and hepatic function per protocol-defined thresholds
Prior solid organ or allogeneic hematopoietic cell transplant
Active or untreated symptomatic CNS metastases (with limited exceptions)
Clinically significant cardiovascular disease, including uncontrolled arrhythmias or prolonged QTc
Active interstitial lung disease or pneumonitis
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Treatment groupsSee each treatment group below.
Novartis Pharmaceuticals
Lead sponsor