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, and preliminary clinical activity of Tulmimetostat as a monotherapy in patients with advanced solid tumors and lymphomas.
Description
The study is divided into Phase 1 and Phase 2. In Phase 1 and the Phase 2 expansion (M1 to M7), patients are non-randomized. In Phase 2 optimization, patients in Cohort M2 and M3 (Stage 2a and 2b) and Cohort M8 (Part 2) are randomized. Phase 1 of the study is composed of a Tulmimetostat Dose Escalation period in patients with advanced tumors and aims to determine maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of Tulmimetostat as monotherapy in patients with advanced tumors. Phase 2 of the study is planned to evaluate safety and tolerability and antitumor activity of Tulm…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * Eligible Phase 1 patients are adults who have a confirmed locally advanced or metastatic tumors (solid tumors or lymphoma) that have relapsed following standard therapy or progressed through standard therapy or who have a disease for which no standard effective therapy exists. * Eligible Phase 2 patients in cohorts M1 to M3 are adults who are known to have the ARID1A mutation by next-generation sequencing (NGS) testing; have measurable disease per Response Evaluation Criteria in Solid Tumors 1.1 and who have confirmed relapsed urothelial or other advanced/metastatic…
Interventions
- DrugTulmimetostat
Tulmimetostat dosed once per day orally in 28 day cycles
- DrugEnzalutamide
Enzalutamide dosed once per day orally in 28 day cycles
Locations (60)
- Winship Cancer Institute of Emory UniversityAtlanta, Georgia
- University of Chicago Medical CenterChicago, Illinois
- University of Maryland - Marlene and Stewart Greenebaum Cancer CenterBaltimore, Maryland
- Massachusetts General HospitalBoston, Massachusetts
- Dana Farber Cancer InstituteBoston, Massachusetts
- University of Michigan HospitalAnn Arbor, Michigan