Tulmimetostat treatment for advanced solid tumors and lymphomas

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label trial evaluates the safety, tolerability, and preliminary clinical activity of Tulmimetostat as a monotherapy in patients with advanced solid tumors and lymphomas. The study consists of two phases: Phase 1 focuses on determining the maximum tolerated dose of Tulmimetostat, while Phase 2 assesses its antitumor activity across six disease-specific cohorts. Patients will be enrolled based on specific eligibility criteria, including the presence of certain mutations and prior treatment history. The trial aims to provide insights into the effectiveness of Tulmimetostat in treating these challenging cancers.

Why it matters

Who can join: the full rules

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 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 it's running

• Winship Cancer Institute of Emory University
  Atlanta, Georgia, United States Recruiting
• University of Chicago Medical Center
  Chicago, Illinois, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Abramson Cancer Center of the University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting
• University of Virginia Health System
  Charlottesville, Virginia, United States Recruiting
• Swedish Cancer Institute
  Seattle, Washington, United States Recruiting

+30 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.