Health Trials

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

ConditionsAdvanced Solid TumorDiffuse Large B Cell LymphomaLymphoma, T-CellMesothelioma, MalignantProstatic Neoplasms, Castration-ResistantEndometrial CancerOvarian Clear Cell CarcinomaMetastatic Castration-resistant Prostate Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNovartis Pharmaceuticals

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Tulmimetostat
  • Enzalutamide

Treatment groups

275 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.

Sponsors and collaborators

Novartis Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov