Actively Recruiting
A Study of Tulmimetostat DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas
Led by Novartis Pharmaceuticals · Updated on 2025-05-15
275
Participants Needed
60
Research Sites
545 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Tulmimetostat DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with confirmed locally advanced or metastatic solid tumors or lymphoma that have relapsed or progressed after standard therapy or have no effective standard therapy.
- Adults with ARID1A mutation and measurable disease for specific solid tumors in Cohorts M1 to M3.
- Adults with relapsed or refractory peripheral T-cell lymphoma or diffuse large B-cell lymphoma in Cohort M4.
- Adults with BAP1 loss and malignant pleural or peritoneal mesothelioma in Cohort M5.
- Adults with metastatic castration-resistant prostate cancer with measurable soft tissue disease, low baseline testosterone, and prior therapies in Cohort M6.
- Adults with recurrent advanced ARID1A wild-type endometrial carcinoma with measurable disease and prior systemic therapies in Cohort M7.
- Adults with metastatic castration-resistant prostate cancer receiving androgen deprivation therapy and prior specified treatments in Cohort M8 Part 1 and Part 2.
- All patients must have ECOG performance status of 0 or 1 and adequate organ function.
You will not qualify if you...
- Prior solid organ or allogeneic hematopoietic cell transplantation.
- Untreated symptomatic brain metastases or CNS lymphoma involvement in Cohort M4.
- Significant cardiovascular disease including recent myocardial infarction, stroke, unstable angina, severe heart failure, ventricular arrhythmias, uncontrolled hypertension, or prolonged QT interval.
- Major surgery within 4 weeks before study drug or not recovered from prior surgery effects.
- Gastrointestinal disorders affecting drug absorption.
- Active uncontrolled infections requiring IV medications within 14 days before study drug.
- History or presence of pneumonitis or interstitial lung disease.
- Concurrent or second malignancies except certain treated cancers in remission.
- Active or chronic infections like HIV, hepatitis B or C.
- Unstable or severe uncontrolled medical or psychiatric conditions.
- Pregnancy, breastfeeding, or planning to conceive during and up to 183 days after treatment.
- Prior anticancer therapies within specified washout periods.
- Use of strong CYP3A4/5 inducers or inhibitors (except enzalutamide in Cohort M8).
- Specific exclusions for Cohort M6 including bone-only disease, unstable bone lesions, certain prostate cancer treatments, and herbal product use affecting PSA.
- Specific exclusions for Cohort M8 including prior enzalutamide or similar treatments, certain gastrointestinal conditions, seizure history, prior investigational agents, and bone marrow irradiation over 25%.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 60 locations
1
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322-1013
Actively Recruiting
2
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
3
University of Maryland - Marlene and Stewart Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Withdrawn
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
5
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215-5450
Actively Recruiting
6
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Withdrawn
7
South Texas Accelerated Research Therapeutics (Start) - Midwest Location
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
8
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
9
NYU Langone Medical Center - Laura and Isaac Perlmutter Cancer Center
New York, New York, United States, 10016
Actively Recruiting
10
Weill Medical College of Cornell University
New York, New York, United States, 10065
Withdrawn
11
Montefiore Einstein Center for Cancer Care
The Bronx, New York, United States, 10467-2490
Withdrawn
12
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219
Withdrawn
13
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
14
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229
Actively Recruiting
15
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Actively Recruiting
16
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Actively Recruiting
17
Fred Hutchinson Cancer
Seattle, Washington, United States, 98109-1023
Actively Recruiting
18
Bergonie Institute
Bordeaux, France, 33000
Actively Recruiting
19
Oscar Lambret Center
Lille, France, 59020
Actively Recruiting
20
Leon Berard Center
Lyon, France, 69373
Actively Recruiting
21
Nantes University Hospital Center - Hotel Dieu Hospital (Satellite)
Nantes, France, 44093
Actively Recruiting
22
Nantes University Hospital Center - Hotel Dieu Hospital
Nantes, France, 44093
Actively Recruiting
23
Nord Laennec Hospital
Saint-Herblain, France, 44800
Actively Recruiting
24
Strasbourg Europe Institut of Cancerology
Strasbourg, France, 67200
Actively Recruiting
25
Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
26
Irccs University Hospital of Bologna
Bologna, Italy, 40138
Actively Recruiting
27
National Cancer Institute, IRCCS
Milan, Italy, 20133
Actively Recruiting
28
European Institute of Oncology (IEO), IRCCS
Milan, Italy, 20141
Actively Recruiting
29
University Polyclinic Foundation "Agostino Gemelli" - IRCCS
Rome, Italy, 00168
Actively Recruiting
30
Gruppo Humanitas - Humanitas Research Hospital - Cancer Center
Rozzano, Italy, 20089
Actively Recruiting
31
University Teaching Centre, Early Clinical Trials Unit
Gdansk, Poland, 80-214
Actively Recruiting
32
Polish Mother's Memorial Hospital-Research Institute
Lodz, Poland, 93-338
Actively Recruiting
33
University Teaching Hospital in Poznan, Department of Gynecologic Oncology
Poznan, Poland, 60-569
Actively Recruiting
34
Medical Center Pratia Poznan
Skorzewo, Poland, 60-185
Actively Recruiting
35
Maria Sklodowska-Curie - National Research Institute of Oncology
Warsaw, Poland, 02-781
Actively Recruiting
36
Keimyung University - Dongsan Medical Center
Daegu, South Korea, 42601
Actively Recruiting
37
National Cancer Center
Goyang-si, South Korea, 10408
Actively Recruiting
38
Gachon University Gil Medical Center
Incheon, South Korea, 21565
Actively Recruiting
39
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
40
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
41
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
42
Gangnam Severance Hospital
Seoul, South Korea, 06273
Actively Recruiting
43
University Hospital Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
44
University Hospital of Girona Dr. Josep Trueta
Girona, Spain, 17007
Actively Recruiting
45
University Clinic of Navarra - Madrid
Madrid, Spain, 28027
Actively Recruiting
46
University Hospital 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
47
University Hospital Quiron Madrid
Madrid, Spain, 28223
Actively Recruiting
48
University Hospital Son Espases
Palma de Mallorca, Spain, 07120
Actively Recruiting
49
University Clinic of Navarra - Pamplona
Pamplona, Spain, 31008
Actively Recruiting
50
University Clinical Hospital of Salamanca
Salamanca, Spain, 37007
Actively Recruiting
51
University Hospital Complex of Santiago (CHUS)
Santiago de Compostela, Spain, 15706
Actively Recruiting
52
University Hospital Virgen del Rocio (HUVR)
Seville, Spain, 41013
Actively Recruiting
53
Valencia Oncology Institute (IVO)
Valencia, Spain, 46009
Actively Recruiting
54
Royal United Hospital
Bath, United Kingdom, BA1 3NG
Actively Recruiting
55
University Hospitals of Leicester NHS Trust
Leicester, United Kingdom, LE5 4PW
Actively Recruiting
56
Royal Marsden Hospital - London
London, United Kingdom, SW3 6JJ
Actively Recruiting
57
Imperial College Healthcare NHS Trust
London, United Kingdom, SW7 2AZ
Actively Recruiting
58
The Christie NHS Foundation Trust, Department of Medical Oncology
Manchester, United Kingdom, M20 4BX
Actively Recruiting
59
Royal Marsden Hospital - Sutton
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
60
Musgrove Park Hospital
Taunton, United Kingdom, TA1 5DA
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
10
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