A Study of Tulmimetostat DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas (NCT04104776) | Clinical Trial Compass
RecruitingPhase 1/2
A Study of Tulmimetostat DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas
United States, France, Italy275 participantsStarted 2019-09-18
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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: Meta…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Tulmimetostat Monotherapy Phase 1: Frequency of Dose-limiting toxicities (DLTs)
Timeframe: DLTs assessed during Cycle 1 (cycle = 28 days)