A Study of Tulmimetostat DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas
Condition(s) studied
Investigational drug(s) / intervention(s)
Tulmimetostat: Tulmimetostat dosed once per day orally in 28 day cycles
Enzalutamide: Enzalutamide dosed once per day orally in 28 day cycles
Study 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.
Eligibility
Primary outcome measure(s)
- Tulmimetostat Monotherapy Phase 1: Frequency of Dose-limiting toxicities (DLTs) — DLTs assessed during Cycle 1 (cycle = 28 days)
The maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of Tulmimetostat as monotherapy in patients with advanced tumors. - Tulmimetostat Monotherapy Phase 2: Overall response rate (ORR) — Up to 30 months
ORR is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) based on RECIST 1.1 or applicable response criteria - Cohort M8 Part 1: Frequency of Dose-limiting toxicities (DLTs) — DLTs assessed during Cycle 1 (cycle = 28 days)
The maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of Tulmimetostat in combination with enzalutamide in patients with castration-resistant prostate cancer (mCRPC) with measurable soft tissue disease. - Cohort M8 Part 2: Prostate-Specific Antigen 50 (PSA50) Response — Up to 30 months
Prostate-Specific Antigen 50 (PSA50) is defined as a ≥ 50% decrease in PSA levels from baseline at any timepoint, confirmed by a second PSA measurement ≥ 3 weeks without any PSA progression in between
Trial sites (80)
| Facility | City | Region | Status |
|---|---|---|---|
| H. Lee Moffitt Cancer Center & Research Institute | Tampa | Florida | Withdrawn |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | Recruiting |
| University of Chicago Medical Center | Chicago | Illinois | Recruiting |
| Loyola University Medical Center | Maywood | Illinois | Withdrawn |
| University of Maryland Greenebaum Cancer Center | Baltimore | Maryland | Withdrawn |
| Massachusetts General Hospital | Boston | Massachusetts | Recruiting |
| Dana Farber Cancer Institute | Boston | Massachusetts | Completed |
| University of Michigan Hospitals | Ann Arbor | Michigan | Withdrawn |
| South Texas Accelerated Research Therapeutics (START) - Midwest Location | Grand Rapids | Michigan | Active Not Recruiting |
| Hackensack University Medical Center | Hackensack | New Jersey | Completed |
| Roswell Park Cancer Institute | Buffalo | New York | Withdrawn |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York | Completed |
| Memorial Sloan Kettering Cancer Center - NYC | New York | New York | Withdrawn |
| Weill Medical College of Cornell University | New York | New York | Withdrawn |
| University of Rochester Medical Center, James P. Wilmot Cancer Center | Rochester | New York | Withdrawn |
| Montefiore Medical Center, Montefiore Medical Center Laboratories | The Bronx | New York | Withdrawn |
| University of Cincinnati Medical Center | Cincinnati | Ohio | Withdrawn |
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | Recruiting |
| South Texas Accelerated Research Therapeutics | San Antonio | Texas | Completed |
| University of Virginia Health System | Charlottesville | Virginia | Recruiting |
| Swedish Cancer Institute | Seattle | Washington | Recruiting |
| Fred Hutchinson Cancer Center | Seattle | Washington | Recruiting |
| CHU Bordeaux Hopital Saint Andre | Bordeaux | France | Withdrawn |
| CLCC Institut Bergonie | Bordeaux | France | Recruiting |
| Centre Oscar Lambret | Lille | France | Recruiting |
| Centre Leon Berard | Lyon | France | Recruiting |
| CHU Nantes Hopital Hotel Dieu | Nantes | France | Recruiting |
| CHU Nantes Hopital Nord Laennec | Saint-Herblain | France | Recruiting |
| Hopital Hautepierre | Strasbourg | France | Recruiting |
| Gustave Roussy | Villejuif | France | Recruiting |
| Irccs University Hospital of Bologna | Bologna | Italy | Completed |
| National Cancer Institute, IRCCS | Milan | Italy | Recruiting |
| National Cancer Institute, IRCCS | Milan | Italy | Withdrawn |
| European Institute of Oncology (IEO), IRCCS | Milan | Italy | Completed |
| European Institute of Oncology (IEO), IRCCS | Milan | Italy | Recruiting |
| Humanitas San Pio X | Milan | Italy | Recruiting |
| University Polyclinic Foundation "Agostino Gemelli" - IRCCS | Roma | Italy | Recruiting |
| Gruppo Humanitas - Humanitas Research Hospital - Cancer Center | Rozzano | Italy | Recruiting |
| University Teaching Centre, Early Clinical Trials Unit | Gdansk | Poland | Recruiting |
| Pratia MCM Krakow | Krakow | Poland | Withdrawn |
+ 40 more sites — see the full list on the official registry below.
On this site
📄 Xtandi (enzalutamide) drug profile →More Novartis Pharmaceuticals trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04104776 on ClinicalTrials.gov ↗ ← All trials in France