A Phase 1/2 Study of DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas

Who is this study for? Adult patients with diffuse large B-cell lymphoma and advanced solid tumors
What treatments are being studied? CPI-0209
Status: Recruiting
Location: See all (60) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Eligible Phase 1 patients are adults who have a confirmed locally advanced or metastatic tumors (solid tumors or lymphoma) that have relapsed following standard therapy or progressed through standard therapy or who have a disease for which no standard effective therapy exists.

• Eligible Phase 2 patients in cohorts M1 to M3 are adults who are known to have the ARID1A mutation by next-generation sequencing (NGS) testing; have measurable disease per Response Evaluation Criteria in Solid Tumors 1.1 and who have confirmed relapsed urothelial or other advanced/metastatic solid tumors (M1), ovarian clear cell carcinoma (M2), or endometrial carcinoma (M3).

• Eligible Phase 2 patients in Cohort M4 are adults who have either relapsed or refractory PTCL (at least 10 patients) or DLBCL (up to 10 patients), including patients with documented GCB DLBCL with EZH2 hotspot mutation. 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; and are not considered candidates to receive CAR-T or ASCT therapy.

• Eligible Phase 2 patients in Cohort M5 are adults who are known to the have the BAP1 loss, have malignant pleural or peritoneal mesothelioma, and have progressed on at least 1 prior line of active therapy.

• Eligible Phase 2 patients in Cohort M6 are adults who have mCRPC with measurable soft tissue disease with CT scan as defined by PCWG3 criteria, have baseline testosterone levels ≤ 50 ng/dL (≤ 2.0 nM) and have surgical or ongoing medical castration and who have progressed on at least 1 androgen-receptor signaling inhibitor and at least 1 taxane-based chemotherapy (cabazitaxel, France only).

• Eligible Phase 2 patients in Cohort M7 are adults with recurrent, advanced ARID1A WT endometrial carcinoma confirmed by NGS testing and have measurable disease per Response Evaluation Criteria in Solid Tumors 1.1 Patients will be enrolled with maximum up to 2 prior lines of systemic therapy for treating endometrial carcinoma that must include at least one treatment line with systemic platinum-based chemotherapy in advanced/ recurrent disease setting, and 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.

• Eligible Part 1 and Part 2 patients in Cohort M8 are adults who have mCRPC with measurable soft tissue disease as per PCWG3 criteria, have baseline testosterone levels ≤ 50 ng/dL (≤ 2.0 nM), have surgical or ongoing medical castration or hormone sensitive prostate cancer (HSPC) disease stage. In addition, Eligible part 1 patients in Cohort M8 may have received abiraterone treatment in mCRPC while eligible part 2 patients in Cohort M8 must have received abiraterone treatment in mCRPC. In addition, only for M8 Part 1: Patients may have received no more than one previous regimen of taxane-based chemotherapy in mCRPC or HSPC setting. For M8 Part 2: Patients may have received no more than one previous regimen of taxane-based chemotherapy in HSPC setting. Patients for both M8 Part 1 and M8 Part 2 must have evidence of prostate cancer progression (per PCWG3) and must have ongoing ADT (androgen deprivation therapy) with a GnRH analogue, antagonist or bilateral orchiectomy (i.e., surgical or medical castration).

• All patients will have Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 and adequate organ function.

Locations
United States
Georgia
Winship Cancer Institute of Emory University
RECRUITING
Atlanta
Illinois
University of Chicago Medical Center
RECRUITING
Chicago
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Maryland
University of Maryland - Marlene and Stewart Greenebaum Cancer Center
WITHDRAWN
Baltimore
Michigan
University of Michigan Hospital
WITHDRAWN
Ann Arbor
South Texas Accelerated Research Therapeutics (Start) - Midwest Location
RECRUITING
Grand Rapids
New Jersey
Hackensack University Medical Center
RECRUITING
Hackensack
New York
NYU Langone Medical Center - Laura and Isaac Perlmutter Cancer Center
RECRUITING
New York
Weill Medical College of Cornell University
WITHDRAWN
New York
Montefiore Einstein Center for Cancer Care
WITHDRAWN
The Bronx
Ohio
University of Cincinnati Medical Center
WITHDRAWN
Cincinnati
Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
RECRUITING
Philadelphia
Texas
South Texas Accelerated Research Therapeutics
RECRUITING
San Antonio
Virginia
University of Virginia Health System
RECRUITING
Charlottesville
Washington
Fred Hutchinson Cancer
RECRUITING
Seattle
Swedish Cancer Institute
RECRUITING
Seattle
Other Locations
France
Bergonie Institute
RECRUITING
Bordeaux
Oscar Lambret Center
RECRUITING
Lille
Leon Berard Center
RECRUITING
Lyon
Nantes University Hospital Center - Hotel Dieu Hospital
RECRUITING
Nantes
Nantes University Hospital Center - Hotel Dieu Hospital (Satellite)
RECRUITING
Nantes
Nord Laennec Hospital
RECRUITING
Saint-herblain
Strasbourg Europe Institut of Cancerology
RECRUITING
Strasbourg
Gustave Roussy
RECRUITING
Villejuif
Italy
Irccs University Hospital of Bologna
RECRUITING
Bologna
European Institute of Oncology (IEO), IRCCS
RECRUITING
Milan
National Cancer Institute, IRCCS
RECRUITING
Milan
University Polyclinic Foundation Agostino Gemelli - IRCCS
RECRUITING
Rome
Gruppo Humanitas - Humanitas Research Hospital - Cancer Center
RECRUITING
Rozzano
Poland
University Teaching Centre, Early Clinical Trials Unit
RECRUITING
Gdansk
Polish Mother's Memorial Hospital-Research Institute
RECRUITING
Lodz
University Teaching Hospital in Poznan, Department of Gynecologic Oncology
RECRUITING
Poznan
Medical Center Pratia Poznan
RECRUITING
Skorzewo
Maria Sklodowska-Curie - National Research Institute of Oncology
RECRUITING
Warsaw
Republic of Korea
Keimyung University - Dongsan Medical Center
RECRUITING
Daegu
National Cancer Center
RECRUITING
Goyang-si
Gachon University Gil Medical Center
RECRUITING
Incheon
Asan Medical Center
RECRUITING
Seoul
Gangnam Severance Hospital
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Spain
University Hospital Vall d'Hebron
RECRUITING
Barcelona
University Hospital of Girona Dr. Josep Trueta
RECRUITING
Girona
University Clinic of Navarra - Madrid
RECRUITING
Madrid
University Hospital 12 de Octubre
RECRUITING
Madrid
University Hospital Quiron Madrid
RECRUITING
Madrid
University Hospital Son Espases
RECRUITING
Palma De Mallorca
University Clinic of Navarra - Pamplona
RECRUITING
Pamplona
University Clinical Hospital of Salamanca
RECRUITING
Salamanca
University Hospital Complex of Santiago (CHUS)
RECRUITING
Santiago De Compostela
University Hospital Virgen del Rocio (HUVR)
RECRUITING
Seville
Valencia Oncology Institute (IVO)
RECRUITING
Valencia
United Kingdom
Royal United Hospital
RECRUITING
Bath
University Hospitals of Leicester NHS Trust
RECRUITING
Leicester
Imperial College Healthcare NHS Trust
RECRUITING
London
Royal Marsden Hospital - London
RECRUITING
London
The Christie NHS Foundation Trust, Department of Medical Oncology
RECRUITING
Manchester
Royal Marsden Hospital - Sutton
RECRUITING
Sutton
Musgrove Park Hospital
RECRUITING
Taunton
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
novartis.email@novartis.com
+41613241111
Time Frame
Start Date: 2019-09-18
Estimated Completion Date: 2030-02-27
Participants
Target number of participants: 275
Treatments
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).
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov

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