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

Part of paid clinical trials in Tampa, Florida.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT04104776
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tulmimetostat — DRUG
    Tulmimetostat dosed once per day orally in 28 day cycles
  • Enzalutamide — DRUG
    Enzalutamide dosed once per day orally in 28 day cycles

Study Details

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.

Key Dates

First listed
Sep 26, 2019
Start date
Sep 18, 2019
Status verified
Aug 2026
Primary completion
Feb 27, 2030
Completion
Feb 27, 2030

Study Design

Enrollment
300 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1
    Eligible participants with advanced tumors will receive escalating doses of Tulmimetostat once per day orally.
  • Experimental: Phase 2 - Cohort M1 (Advanced/metastatic solid tumors or urothelial carcinoma with ARID1A mutation)
    Eligible participants with advanced/metastatic solid tumors (excluding ovarian clear cell and endometrial carcinoma) or urothelial carcinoma, confirmed to have ARID1A mutations will receive oral Tulmimetostat once daily in 28-day treatment cycles.
  • Experimental: Phase 2 - Cohort M2 (Ovarian clear cell carcinoma with ARID1A mutation)
    Eligible participants with advanced ovarian clear cell carcinoma, confirmed to have ARID1A mutations, who have received prior platinum-based chemotherapy will receive oral Tulmimetostat once daily in 28-day treatment cycles.
  • Experimental: Phase 2 - Cohort M3 (Endometrial carcinoma with ARID1A mutation)
    Eligible participants with recurrent, metastatic, or unresectable endometrial carcinoma, confirmed to have ARID1A mutations, and prior platinum-based therapy will receive oral Tulmimetostat once daily in 28-day treatment cycles.
  • Experimental: Phase 2 - Cohort M4 (Relapsed/refractory lymphoma (PTCL or DLBCL))
    Eligible participants with relapsed or refractory peripheral T-cell lymphoma (PTCL) or diffuse large B-cell lymphoma (DLBCL), including those with EZH2 hotspot mutations will receive oral Tulmimetostat once daily in 28-day treatment cycles.
  • Experimental: Phase 2 - Cohort M5 (Malignant mesothelioma with BAP1 loss)
    Eligible participants with relapsed or refractory malignant pleural or peritoneal mesothelioma, confirmed to have BAP1 loss will receive oral Tulmimetostat once daily in 28-day treatment cycles.
  • Experimental: Phase 2 - Cohort M6 (Metastatic castration-resistant prostate cancer (mCRPC))
    Eligible participants with mCRPC, measurable soft tissue disease, and prior treatment with at least one androgen receptor signaling inhibitor and one taxane-based chemotherapy will receive oral Tulmimetostat once daily in 28-day treatment cycles.
  • Experimental: Phase 2 - Cohort M7 (Food effect in ARID1A wildtype endometrial carcinoma)
    Eligible participants with recurrent, advanced endometrial carcinoma that is ARID1A wildtype (no ARID1A mutation), to evaluate the effect of food on DZR123 pharmacokinetics will receive oral Tulmimetostat once daily in 28-day treatment cycles.
  • Experimental: Cohort M8 - Part 1 (Tulmimetostat + enzalutamide in mCRPC)
    Eligible participants with mCRPC receive DZR123 in combination with enzalutamide. Part 1 is dose escalation to determine the recommended dose.
  • Experimental: Cohort M8 - Part 2 (Tulmimetostat + enzalutamide in mCRPC)
    Eligible participants with mCRPC receive DZR123 in combination with enzalutamide. Part 2 is expansion at the selected dose to further assess safety and antitumor activity.

Primary Outcome Measure

Tulmimetostat Monotherapy Phase 1: Frequency of Dose-limiting toxicities (DLTs) [ Time Frame: DLTs assessed during Cycle 1 (cycle = 28 days) ]

Central Contacts

Locations (22)

FacilityCityStateZIPSite coordinators
H. Lee Moffitt Cancer Center & Research InstituteTampaFlorida33612-
Winship Cancer Institute of Emory UniversityAtlantaGeorgia30322-1013
Beryl Manning-Geist, MD (PRINCIPAL_INVESTIGATOR)
University of Chicago Medical CenterChicagoIllinois60637
Hedy Lee Kindler, MD (PRINCIPAL_INVESTIGATOR)
Loyola University Medical CenterMaywoodIllinois60153-
University of Maryland Greenebaum Cancer CenterBaltimoreMaryland21201-
Dana Farber Cancer InstituteBostonMassachusetts02215-5450-
Massachusetts General HospitalBostonMassachusetts02114
Ryan Sullivan, MD (PRINCIPAL_INVESTIGATOR)
University of Michigan HospitalsAnn ArborMichigan48109-
South Texas Accelerated Research Therapeutics (START) - Midwest LocationGrand RapidsMichigan49546-
Hackensack University Medical CenterHackensackNew Jersey07601-
Roswell Park Cancer InstituteBuffaloNew York14263-0001-
Laura and Isaac Perlmutter Cancer Center at NYU LangoneNew YorkNew York10016-
Memorial Sloan Kettering Cancer Center - NYCNew YorkNew York10065-
Weill Medical College of Cornell UniversityNew YorkNew York10065-
University of Rochester Medical Center, James P. Wilmot Cancer CenterRochesterNew York14642-
Montefiore Medical Center, Montefiore Medical Center LaboratoriesThe BronxNew York10467-2490-
University of Cincinnati Medical CenterCincinnatiOhio45219-
Abramson Cancer Center of the University of PennsylvaniaPhiladelphiaPennsylvania19104
Lainie Martin, MD (PRINCIPAL_INVESTIGATOR)
South Texas Accelerated Research TherapeuticsSan AntonioTexas78229-
University of Virginia Health SystemCharlottesvilleVirginia22908
Linda Duska, MD (PRINCIPAL_INVESTIGATOR)
Fred Hutchinson Cancer CenterSeattleWashington98109-1023
Kalyan Banda, MD (PRINCIPAL_INVESTIGATOR)
Swedish Cancer InstituteSeattleWashington98104
Charles Drescher, MD (PRINCIPAL_INVESTIGATOR)

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H. Lee Moffitt Cancer Center & Research Institute· Tampa, FLWinship Cancer Institute of Emory University· Atlanta, GAUniversity of Chicago Medical Center· Chicago, ILLoyola University Medical Center· Maywood, ILUniversity of Maryland Greenebaum Cancer Center· Baltimore, MDDana Farber Cancer Institute· Boston, MA

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