Phase 12 Study of Oral Tulmimetostat Alone and With Enzalutamide in Adults With Advanced Solid Tumors and Lymphomas

What this Trial Is About

Researchers are studying the safety, tolerability, pharmacokinetics, pharmacodynamics, and early antitumor effects of Tulmimetostat DZR123, alone and combined with enzalutamide, in adults with advanced solid tumors and lymphomas. This open-label trial includes Phase 1 dose-escalation and Phase 2 dose-expansion cohorts to determine optimal doses and evaluate treatment across tumor-specific groups, including those with certain genetic mutations and metastatic prostate cancer. Participants receive oral Tulmimetostat once daily in 28-day cycles, either as monotherapy or combined with enzalutamide for metastatic castration-resistant prostate cancer. Phase 1 focuses on dose escalation to find the maximum tolerated dose. Phase 2 includes disease-specific groups and dose optimization, a food-effect cohort, and combination therapy cohorts. Dose levels and combinations are carefully monitored and adjusted based on safety, pharmacokinetics, and initial antitumor activity. During the study, participants undergo regular safety assessments including laboratory tests, tumor evaluations, and monitoring for adverse events and second primary cancers. Follow-up includes survival tracking and malignancy surveillance every 3 months for the first 3 years, then every 6 months thereafter. The trial aims to gather detailed data on treatment effects and tolerability over extended periods, with participant involvement lasting until study completion or discontinuation.

A Study of Tulmimetostat DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas