Actively Recruiting
A Phase 1/2 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating Tulmimetostat, an oral drug, as a monotherapy in adults with advanced solid tumors and lymphomas. This open-label, first-in-human trial aims to assess the safety, tolerability, and early clinical activity of Tulmimetostat. The study includes both Phase 1 and Phase 2 parts, focusing on determining the best dose and exploring the drug's effect in specific tumor types, including conditions such as ovarian clear cell carcinoma, endometrial carcinoma, lymphoma, mesothelioma, and castration-resistant prostate cancer. Tulmimetostat is given once daily by mouth in 28-day treatment cycles. The study has multiple cohorts targeting different tumor types or genetic mutations, including ARID1A mutations and BAP1 loss. Some cohorts explore Tulmimetostat alone, while others combine it with another oral drug called enzalutamide, especially in prostate cancer patients. Phase 1 involves dose escalation to establish safe dosing, while Phase 2 evaluates safety and anti-tumor activity across various tumor-specific groups. Certain parts of Phase 2 include randomized comparisons of two dose levels. Participants will undergo regular assessments including imaging scans to evaluate tumor response, blood tests to monitor drug levels and safety, and evaluations of side effects. Researchers will track outcomes like dose-limiting toxicities, overall response rates, progression-free survival, and duration of response for up to 30 months. Safety monitoring includes laboratory tests and clinical evaluations. The study lasts until disease progression, unacceptable side effects, or other criteria are met, with ongoing follow-up to capture long-term effects and responses.
CONDITIONS
Brief 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 aged 18 years or older
- Confirmed locally advanced or metastatic solid tumors or lymphoma that have relapsed or progressed after standard therapy
- Specific genetic mutations or disease types depending on cohort, including ARID1A mutation, BAP1 loss, or EZH2 mutation
- Measurable disease according to standard criteria (e.g., RECIST 1.1 or PCWG3)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function
- For certain cohorts, prior therapies and disease progression must meet defined criteria
You will not qualify if you...
- Previous solid organ or allogeneic hematopoietic cell transplantation
- Untreated or symptomatic brain metastases or CNS lymphoma involvement
- Significant cardiovascular disease, including recent heart attack, stroke, unstable angina, severe heart failure, or serious arrhythmias
- Uncontrolled hypertension despite medication
- Prolonged QTc interval above specified limits
- Major surgery within 4 weeks prior to treatment start
- Gastrointestinal conditions interfering with drug absorption
- Active uncontrolled infections requiring intravenous treatment
- History or presence of pneumonitis or interstitial lung disease
- Concurrent or recent second malignancies except certain treated cancers
- Active HIV, hepatitis B or C infections
- Pregnancy or breastfeeding
- Use of strong CYP3A4/5 inducers or inhibitors (except enzalutamide in specified cohort)
- Specific exclusions related to prior cancer treatments and herbal product use
- Planned palliative procedures for bone pain
- History of seizures or conditions increasing seizure risk
- Inability or unwillingness to comply with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive Tulmimetostat once per day orally in 28-day cycles. Some participants also receive enzalutamide in combination with Tulmimetostat depending on their cohort. Treatment aims to evaluate safety, tolerability, and antitumor activity of the study drugs.
Monthly visits corresponding to each 28-day treatment cycle
Duration - Up to 30 months after treatment
Participants are monitored after treatment ends for safety and long-term outcomes including disease progression and survival.
Periodic visits for up to 30 months
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
N
Novartis Pharmaceuticals
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
10
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here