ClinicaliQ Trial Snapshot
- A Study of Tulmimetostat DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas — Recruiting • Phase I • Oncology • NCT04104776.
- Treatment being tested: Tulmimetostat (DZR123/CPI-0209), a novel investigational agent evaluated as monotherapy and combined with enzalutamide, in a first-in-human trial assessing safety, tolerability, pharmacokinetics, and antitumor activity.
- Patient eligibility overview: Adults with advanced (metastatic or unresectable) solid tumors and lymphomas; this is an early-phase study establishing initial safety and dosing before broader patient populations are considered.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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 Snapshot
- Key Inclusion Criteria: All Patients: * 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 * Willingness to provide tumor tissue and blood samples for biomarker analyses * Agreement to protocol-specified contraception requirements * Signed informed consent prior to study procedures Disease-Specific Inclusion Criteria: Phase 1 (Dose Escalation): * Histologically or cytologically confirmed locally advanced or metastatic solid tumors or lymphoma * Disease refractory to standard therapy or with no available effective standard treatment * For prostate cancer: castrate testosterone levels maintained throughout the study Phase 2 (Disease-Specific Cohorts): * M1: ARID1A mutant urothelial carcinoma or other ARID1A mutant solid tumors (with cohort specific prior therapy and RECIST 1.1 measurable disease requirements) * M2: ARID1A mutant ovarian clear cell carcinoma after prior platinum-based therapy (and bevacizumab unless contraindicated) * M3: ARID1A mutant recurrent/metastatic endometrial carcinoma after platinum therapy and appropriate immunotherapy * M4: Relapsed/refractory peripheral T cell lymphoma or diffuse large B cell lymphoma, transplant-ineligible, with measurable disease * M5: Relapsed/refractory pleural or peritoneal mesothelioma with documented BAP1 loss * M6: Metastatic castration-resistant…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.