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OncoMatch/Clinical Trials/NCT04104776

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

Is NCT04104776 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including Tulmimetostat and Enzalutamide for advanced solid tumor.

Phase 1/2RecruitingNovartis PharmaceuticalsNCT04104776Data as of Jun 2026Location: International · 7 countries

Treatment: Tulmimetostat · EnzalutamideThe 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.

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Extracted eligibility criteria

Treatments studied

Endocrine / hormonal

Enzalutamide

Other

Tulmimetostat

Cancer type

Tumor Agnostic

Diffuse Large B-Cell Lymphoma

Non-Hodgkin Lymphoma

Mesothelioma

Prostate Cancer

Endometrial Cancer

Ovarian Cancer

Biomarker criteria

Required: ARID1A mutation

Required: ARID1A wild-type

Required: BAP1 loss

Allowed: EZH2 hotspot mutation

Disease stage

Required: Stage III, IV

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: systemic therapy — relapsed/refractory

relapsed following standard therapy or progressed through standard therapy or who have a disease for which no standard effective therapy exists

Must have received: systemic therapy — PTCL: at least 1 prior line; DLBCL: at least 2 prior lines

patients with PTCL must have at least 1 prior line of therapy and patients with DLBCL must have at least 2 prior lines of standard therapy

Must have received: active therapy — mesothelioma: at least 1 prior line

malignant pleural or peritoneal mesothelioma, and have progressed on at least 1 prior line of active therapy

Must have received: androgen-receptor signaling inhibitor — mCRPC: at least 1 prior

mCRPC...have progressed on at least 1 androgen-receptor signaling inhibitor

Must have received: taxane-based chemotherapy (cabazitaxel) — mCRPC: at least 1 prior (cabazitaxel, France only)

at least 1 taxane-based chemotherapy (cabazitaxel, France only)

Must have received: systemic platinum-based chemotherapy — endometrial carcinoma: at least one treatment line in advanced/recurrent disease

at least one treatment line with systemic platinum-based chemotherapy in advanced/ recurrent disease setting

Must have received: anti-PD-1 therapy — endometrial carcinoma: at least one treatment line

anti-programmed cell death protein 1 (PD-1)/ anti-programmed death-ligand 1 (PD-L1) therapy, either in combination or separately, unless these are contraindicated or are not locally accessible

Cannot have received: EZH2 inhibitor

Previous treatment with an EZH2 inhibitor is not allowed

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Winship Cancer Institute of Emory University · Atlanta, Georgia
  • University of Chicago Medical Center · Chicago, Illinois
  • University of Maryland - Marlene and Stewart Greenebaum Cancer Center · Baltimore, Maryland
  • Massachusetts General Hospital · Boston, Massachusetts
  • Dana Farber Cancer Institute · Boston, Massachusetts

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT04104776 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior EZH2 inhibitor disqualifies patients from enrollment.

Does this trial require ARID1A?

Yes, ARID1A mutation is a required biomarker for enrollment.

Does this trial require ARID1A?

Yes, ARID1A wild-type is a required biomarker for enrollment.

Does this trial require BAP1?

Yes, BAP1 loss is a required biomarker for enrollment.

What disease stage is eligible?

Stage III or IV is required.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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