NCT04104776 · Novartis Pharmaceuticals
A Study of Tulmimetostat DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas
What this study is about
The purpose of this where both patients and doctors know the treatment given, first-in-human (FIH) trial is to evaluate the safety, tolerability, and preliminary clinical activity of Tulmimetostat as a treatment given alone in patients with advanced solid tumors and lymphomas.
View original scientific description
The purpose of this open-label, first-in-human (FIH) trial is to evaluate the safety, tolerability, and preliminary clinical activity of Tulmimetostat as a monotherapy in patients with advanced solid tumors and lymphomas.
Interventions
DRUG
Tulmimetostat
Tulmimetostat dosed once per day orally in 28 day cycles
DRUG
Enzalutamide
Enzalutamide dosed once per day orally in 28 day cycles
Primary outcome measures
Tulmimetostat Monotherapy Phase 1: Frequency of Dose-limiting toxicities (DLTs)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 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
Exclusion criteria
- 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
Where
- Tampa, Florida
- Atlanta, Georgia
- Chicago, Illinois
- Maywood, Illinois
- Baltimore, Maryland
- Boston, Massachusetts
- Ann Arbor, Michigan
- Grand Rapids, Michigan
- Hackensack, New Jersey
- Buffalo, New York
- New York, New York
- Rochester, New York
And 6 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 19, 2026 · Source of record for eligibility and locations