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New treatment option for Advanced Solid Tumor
Official title A Study of Tulmimetostat DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas
ClinicalTrials.gov ID: NCT04104776
What this study is testing
What is Tulmimetostat?
Tulmimetostat is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for advanced solid tumor.
Also referred to as DZR123.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Key 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
You likely can't join if
- All Patients: Medical Conditions:
- 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
- Uncontrolled infections or significant gastrointestinal disorders affecting absorption
See the full eligibility criteria
- Key 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 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 prostate cancer (mCRPC) with documented progression after AR targeted therapy and taxane chemotherapy
- M7: ARID1A wild type endometrial carcinoma (exploratory food-effect cohort)
- M8: mCRPC treated with DZR123 in combination with enzalutamide, with cohort specific requirements for prior androgen receptor pathway inhibitor and chemotherapy exposure Key
- All Patients: Medical Conditions:
- 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
- Uncontrolled infections or significant gastrointestinal disorders affecting absorption
- Active HIV or hepatitis B/C infection
- Concurrent malignancy requiring active treatment (with protocol-defined exceptions)
- Pregnancy, breastfeeding, or inability to comply with protocol requirements Prior or Concomitant Therapy:
- Recent anticancer therapy within protocol-defined washout periods
- Prior EZH2 inhibitor treatment
- Recent radiation or liver-directed therapies outside allowed windows
- Use of strong CYP3A4/5 inhibitors or inducers Additional Cohort-Specific Exclusions:
- M6 (mCRPC): Bone-only disease, unstable bone lesions, PSA-lowering herbal products, recent prohibited prostate cancer therapies
- M8 (Combination): PSA-only disease, prior investigational androgen receptor pathway inhibitors, significant seizure risk, extensive prior bone marrow irradiation, active inflammatory gastrointestinal disease
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Maywood, Illinois, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Hackensack, New Jersey, United States
- Buffalo, New York, United States
- New York, New York, United States
- Rochester, New York, United States
- The Bronx, New York, United States
- Cincinnati, Ohio, United States
- Philadelphia, Pennsylvania, United States
- San Antonio, Texas, United States
- Charlottesville, Virginia, United States
- Seattle, Washington, United States
- Bordeaux, France
- Lille, France
- Lyon, France
+ 37 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States; Maywood, Illinois, United States; Baltimore, Maryland, United States; Boston, Massachusetts, United States and 51 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.