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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT04104776
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

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, and preliminary clinical activity of Tulmimetostat as a monotherapy in patients with advanced solid tumors and lymphomas.

Key Dates

Start date
Sep 18, 2019
Status verified
May 2025
Primary completion
Feb 27, 2030
Completion
Feb 27, 2030

Study Design

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

Arms

  • Experimental: Phase 1
    Tulmimetostat will be dosed once per day orally in patients with advanced tumors.
  • Experimental: Phase 2 Cohort M1
    Tulmimetostat will be dosed once per day orally in 28 day cycles. • Cohort M1: patients with urothelial carcinoma or other advanced/metastatic solid tumors (with known ARID1A mutation)
  • Experimental: Phase 2 Cohort M2
    Tulmimetostat will be dosed once per day orally in 28 day cycles. • Cohort M2 patients with ovarian clear cell carcinoma (with known ARID1A mutation)
  • Experimental: Phase 2 Cohort M3
    Tulmimetostat will be dosed once per day orally in 28 day cycles. • Cohort M3 patients with endometrial carcinoma (with known ARID1A mutation)
  • Experimental: Phase 2 Cohort M4
    Tulmimetostat will be dosed once per day orally in 28 day cycles. • Cohort M4 patients with peripheral T-cell lymphoma (PTCL) and patients with diffuse large B-cell lymphoma (DLBCL), including patients with documented germinal center B cell like diffuse large B-cell lymphoma (GCB-DLBCL) with at least 1 Enhancer of Zeste Homolog 2 (EZH2) hotspot mutation
  • Experimental: Phase 2 Cohort M5
    Tulmimetostat will be dosed once per day orally in 28 day cycles. • Cohort M5 patients with relapsed or refractory malignant pleural or peritoneal mesothelioma with known BAP1 loss
  • Experimental: Phase 2 Cohort M6
    Tulmimetostat will be dosed once per day orally in 28 day cycles. • Cohort M6 patients with castration-resistant prostate cancer (mCRPC) with measurable soft tissue disease
  • Experimental: Phase 2 Cohort M7
    Tulmimetostat will be dosed once per day orally in 28 day cycles. • Cohort M7 food effect in patients with ARID1A wildtype (ARID1A WT) endometrial carcinoma
  • Experimental: Phase 1 Cohort M8
    Tulmimetostat will be dosed once per day orally in combination with enzalutamide Cohort M8 patients with castration-resistant prostate cancer (mCRPC).
  • Experimental: Phase 2 Cohort M8
    Tulmimetostat will be dosed once per day orally in 28-day cycles in combination with enzalutamide. • Cohort M8 patients with castration-resistant prostate cancer (mCRPC).

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 (17)

FacilityCityStateZIPSite coordinators
Winship Cancer Institute of Emory UniversityAtlantaGeorgia30322-1013
Adam Burgess
[email protected]
404-712-9858
R. Donald Harvey, MD (PRINCIPAL_INVESTIGATOR)
University of Chicago Medical CenterChicagoIllinois60637
Iryna Kobrynets
[email protected]
773-834-6421
Hedy Lee Kindler, MD (PRINCIPAL_INVESTIGATOR)
University of Maryland - Marlene and Stewart Greenebaum Cancer CenterBaltimoreMaryland21201-
Dana Farber Cancer InstituteBostonMassachusetts02215-5450
Brian Rasp
[email protected]
857-215-2265
Alok Tewari, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Terry Liu
[email protected]
617-632-9250
Ryan Sullivan, MD (PRINCIPAL_INVESTIGATOR)
University of Michigan HospitalAnn ArborMichigan48109-
South Texas Accelerated Research Therapeutics (Start) - Midwest LocationGrand RapidsMichigan49546
Oliva Sweeney
[email protected]
616-954-5554
Yvette Cole
[email protected]
616-954-5554
Nehal Lakhani, MD (PRINCIPAL_INVESTIGATOR)
Hackensack University Medical CenterHackensackNew Jersey07601
Celina Joco
[email protected]
551-996-8170
Martin Gutierrez, MD (PRINCIPAL_INVESTIGATOR)
NYU Langone Medical Center - Laura and Isaac Perlmutter Cancer CenterNew YorkNew York10016
Stephen Cumberbatch
[email protected]
407-517-8471
Salman Punekar, MD (PRINCIPAL_INVESTIGATOR)
Weill Medical College of Cornell UniversityNew YorkNew York10065-
Montefiore Einstein Center for Cancer CareThe 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
Karen Mcgee
[email protected]
210-593-5270
Carrie Choi, RN
[email protected]
210-593-2547
Drew Rasco, MD (PRINCIPAL_INVESTIGATOR)
University of Virginia Health SystemCharlottesvilleVirginia22908
Chrystal Axford
[email protected]
804-683-2880
Linda Duska, MD (PRINCIPAL_INVESTIGATOR)
Fred Hutchinson CancerSeattleWashington98109-1023
Elizabeth Liu
[email protected]
206-606-7494
Kalyan Banda, MD (PRINCIPAL_INVESTIGATOR)
Swedish Cancer InstituteSeattleWashington98104
Chun-Fang Qiu
[email protected]
206-215-6430
Charles Drescher, MD (PRINCIPAL_INVESTIGATOR)

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Winship Cancer Institute of Emory University· Atlanta, GAUniversity of Chicago Medical Center· Chicago, ILUniversity of Maryland - Marlene and Stewart Greenebaum Cancer Center· Baltimore, MDDana Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MAUniversity of Michigan Hospital· Ann Arbor, MI

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