Advanced Solid TumorPhase 1/2NCT04104776
A Study of Tulmimetostat DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas
A Phase 1/2 study testing Tulmimetostat and Enzalutamide in people with Advanced Solid Tumor and Diffuse Large B Cell Lymphoma, run by Novartis Pharmaceuticals at 80 sites in 7 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Diffuse Large B Cell Lymphoma, Lymphoma, T-Cell
- What is being tested?
- Tulmimetostat and Enzalutamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 80 sitesin 7 countries
- Study dates
- 18 Sep 2019to 27 Feb 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All Patients:
- Adults aged ≥18 years with life expectancy ≥12 weeks
- ECOG performance status 0-1
- Adequate recovery from prior therapy-related toxicities (Grade ≤1, with exceptions)
- Adequate bone marrow, renal, and hepatic function per protocol-defined thresholds
- Willingness to provide tumor tissue and blood samples for biomarker analyses
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- Agreement to protocol-specified contraception requirements
- Signed informed consent prior to study procedures
- Disease-Specific Inclusion Criteria:
- Phase 1 (Dose Escalation):
- Histologically or cytologically confirmed locally advanced or metastatic solid tumors or lymphoma
- Disease refractory to standard therapy or with no available effective standard treatment
- For prostate cancer: castrate testosterone levels maintained throughout the study
- Phase 2 (Disease-Specific Cohorts):
- M1: ARID1A mutant urothelial carcinoma or other ARID1A mutant solid tumors (with cohort specific prior therapy and RECIST 1.1 measurable disease requirements)
- M2: ARID1A mutant ovarian clear cell carcinoma after prior platinum-based therapy (and bevacizumab unless contraindicated)
- M3: ARID1A mutant recurrent/metastatic endometrial carcinoma after platinum therapy and appropriate immunotherapy
- M4: Relapsed/refractory peripheral T cell lymphoma or diffuse large B cell lymphoma, transplant-ineligible, with measurable disease
- M5: Relapsed/refractory pleural or peritoneal mesothelioma with documented BAP1 loss
- M6: Metastatic castration-resistant prostate cancer (mCRPC) with documented progression after AR targeted therapy and taxane chemotherapy
- M7: ARID1A wild type endometrial carcinoma (exploratory food-effect cohort)
- M8: mCRPC treated with DZR123 in combination with enzalutamide, with cohort specific requirements for prior androgen receptor pathway inhibitor and chemotherapy exposure
Who cannot join
- All Patients:
- Medical Conditions:
- Prior solid organ or allogeneic hematopoietic cell transplant
- Active or untreated symptomatic CNS metastases (with limited exceptions)
- Clinically significant cardiovascular disease, including uncontrolled arrhythmias or prolonged QTc
- Active interstitial lung disease or pneumonitis
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- Uncontrolled infections or significant gastrointestinal disorders affecting absorption
- Active HIV or hepatitis B/C infection
- Concurrent malignancy requiring active treatment (with protocol-defined exceptions)
- Pregnancy, breastfeeding, or inability to comply with protocol requirements
- Prior or Concomitant Therapy:
- Recent anticancer therapy within protocol-defined washout periods
- Prior EZH2 inhibitor treatment
- Recent radiation or liver-directed therapies outside allowed windows
- Use of strong CYP3A4/5 inhibitors or inducers
- Additional Cohort-Specific Exclusions:
- M6 (mCRPC): Bone-only disease, unstable bone lesions, PSA-lowering herbal products, recent prohibited prostate cancer therapies
- M8 (Combination): PSA-only disease, prior investigational androgen receptor pathway inhibitors, significant seizure risk, extensive prior bone marrow irradiation, active inflammatory gastrointestinal disease
Trial locations and contacts
80 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
80 sites in 7 countries
United States22 sites, 7 recruiting
- Withdrawn
University of Michigan Hospitals
Ann Arbor, Michigan, 48109
- Recruiting
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322-1013
Beryl Manning-Geist, MD
- Withdrawn
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, 21201
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Ryan Sullivan, MD
- Completed
Dana Farber Cancer Institute
Boston, Massachusetts, 02215-5450
- Withdrawn
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
- Recruiting
University of Virginia Health System
Charlottesville, Virginia, 22908
Linda Duska, MD
- Recruiting
University of Chicago Medical Center
Chicago, Illinois, 60637
Hedy Lee Kindler, MD
- Withdrawn
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
- Active, not recruiting
South Texas Accelerated Research Therapeutics (START) - Midwest Location
Grand Rapids, Michigan, 49546
- Completed
Hackensack University Medical Center
Hackensack, New Jersey, 07601
- Withdrawn
Loyola University Medical Center
Maywood, Illinois, 60153
- Completed
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016
- Withdrawn
Memorial Sloan Kettering Cancer Center - NYC
New York, New York, 10065
- Withdrawn
Weill Medical College of Cornell University
New York, New York, 10065
- Recruiting
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Lainie Martin, MD
- Withdrawn
University of Rochester Medical Center, James P. Wilmot Cancer Center
Rochester, New York, 14642
- Completed
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
- Recruiting
Swedish Cancer Institute
Seattle, Washington, 98104
Charles Drescher, MD
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109-1023
Kalyan Banda, MD
- Withdrawn
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
- Withdrawn
Montefiore Medical Center, Montefiore Medical Center Laboratories
The Bronx, New York, 10467-2490
Spain19 sites, 16 recruiting
- Recruiting
University Hospital Vall d'Hebron
Barcelona, 08035
Ana Oaknin
- Recruiting
Hospital Clinic of Barcelona
Barcelona, 08036
Begona Mellado Gonzalez
- Recruiting
University Hospital of Girona Dr. Josep Trueta
Girona, 17007
Maria Pilar Barretina Ginesta
- Withdrawn
Catalan Institute of Oncology, Hospital Duran i Reynals
L'Hospitalet de Llobregat, 08908
- Recruiting
University Clinic of Navarra - Madrid
Madrid, 28027
Antonio Gonzalez Martin
- Recruiting
University Hospital Ramon y Cajal
Madrid, 28034
Teresa Alonso Gordoa
- Recruiting
University Hospital Clinical San Carlos, Department of Medical Oncology
Madrid, 28040
Jorge Bartolome Arcilla
- Recruiting
University Hospital Foundation Jimenez Diaz
Madrid, 28040
Bernard Gaston Doger De Speville
- Completed
University Hospital 12 de Octubre
Madrid, 28041
- Recruiting
University Hospital Quiron Madrid
Madrid, 28223
Jesus Fuentes Antras
- Recruiting
University Hospital Puerta de Hierro Majadahonda
Majadahonda, 28222
Aranzazu Gonzalez-Del-Alba
- Recruiting
University Hospital Son Espases
Palma, 07120
Marina Justo de la Pena
- Recruiting
University Clinic of Navarra - Pamplona
Pamplona, 31008
Antonio Gonzalez Martin
- Recruiting
Parc Tauli Health Corporation
Sabadell, 08208
Enrique Gallardo Diaz
- Completed
University Clinical Hospital of Salamanca
Salamanca, 37007
- Recruiting
University Hospital Complex of Santiago (CHUS)
Santiago de Compostela, 15706
Maria Teresa Curiel Garcia
- Recruiting
University Hospital Virgen del Rocio (HUVR)
Seville, 41013
Alejandro Falcon Gonzalez
- Recruiting
Valencia Oncology Institute (IVO)
Valencia, 46009
Ignacio Romero Noguera
- Recruiting
University and Polytechnic Hospital La Fe
Valencia, 46026
Regina Girones Sarrio
United Kingdom9 sites, 1 recruiting
- Withdrawn
Royal United Hospital, Department of Oncology/Hematology
Bath, BA1 3NG
- Recruiting
Leicester Royal Infirmary
Leicester, LE1 5WW
Harriet Walter
- Withdrawn
Royal Marsden Hospital - London
London, SW3 6JJ
- Withdrawn
Imperial College Healthcare NHS Trust
London, SW7 2AZ
- Completed
The Christie NHS Foundation Trust, Department of Medical Oncology
Manchester, M20 4BX
- Withdrawn
Churchill Hospital
Oxford, OX3 7LE
- Withdrawn
University Hospital Southampton NHS Foundation Trust
Southampton, SO16 6YD
- Completed
Royal Marsden Hospital - Sutton
Sutton, SM2 5PT
- Completed
Musgrove Park Hospital
Taunton, TA1 5DA
France8 sites, 7 recruiting
- Withdrawn
CHU Bordeaux Hopital Saint Andre
Bordeaux, 33000
- Recruiting
CLCC Institut Bergonie
Bordeaux, 33000
Antoine Italiano
- Recruiting
Centre Oscar Lambret
Lille, 59000
Cyril Abdeddaim
- Recruiting
Centre Leon Berard
Lyon, 69008
Medhi Brahmi
- Recruiting
CHU Nantes Hopital Hotel Dieu
Nantes, 44093 Cedex 1
Caroline Viala
- Recruiting
CHU Nantes Hopital Nord Laennec
Saint-Herblain, 44800
Caroline Viala
- Recruiting
Hopital Hautepierre
Strasbourg, 67098
Lauriane Eberst
- Recruiting
Gustave Roussy
Villejuif, 94805 Cedex
Vincent Ribrag
Italy8 sites, 5 recruiting
- Completed
Irccs University Hospital of Bologna
Bologna, 40138
- Recruiting
National Cancer Institute, IRCCS
Milan, 20133
Mara Mantiero
- Withdrawn
National Cancer Institute, IRCCS
Milan, 20133
- Completed
European Institute of Oncology (IEO), IRCCS
Milan, 20141
- Recruiting
European Institute of Oncology (IEO), IRCCS
Milan, 20141
Franco Nole
- Recruiting
Humanitas San Pio X
Milan, 20159
Domenica Lorusso
- Recruiting
University Polyclinic Foundation "Agostino Gemelli" - IRCCS
Roma, 00168
Vanda Salutari
- Recruiting
Gruppo Humanitas - Humanitas Research Hospital - Cancer Center
Rozzano, 20089
Carmelo Carlo-Stella
South Korea8 sites, 5 recruiting
- Withdrawn
Keimyung University - Dongsan Medical Center
Daegu, 42601
- Completed
National Cancer Center
Goyang-si, 10408
- Recruiting
Gachon University Gil Medical Center
Incheon, 21565
Kwang-Beom Lee
- Recruiting
Seoul National University Hospital
Seoul, 03080
Jae Weon Kim
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
Jung-Yun Lee
- Recruiting
Asan Medical Center
Seoul, 05505
Shin Wha Lee
- Recruiting
Gangnam Severance Hospital
Seoul, 06273
Jae-Hoon Kim
- Withdrawn
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
Poland6 sites, 2 recruiting
- Recruiting
University Teaching Centre, Early Clinical Trials Unit
Gdansk, 80-214
Rafal Dziadziuszko
- Withdrawn
Pratia MCM Krakow
Krakow, 30-510
- Withdrawn
Polish Mother's Memorial Hospital-Research Institute
Lodz, 93-338
- Completed
Pratia - Poznan
Poznan, 60-192
- Recruiting
University Teaching Hospital in Poznan, Department of Gynecologic Oncology
Poznan, 60-569
Radoslaw Madry
- Completed
Maria Sklodowska-Curie - National Research Institute of Oncology
Warsaw, 02-781
About this study
Official title: A Phase 1/2 Study of DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas
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.
Read the detailed description
This study consists of Phase 1 dose-escalation and Phase 2 dose-expansion cohorts designed to characterize DZR123 across multiple tumor-specific populations and to identify dose levels for further clinical development. Phase 2 includes disease-specific monotherapy cohorts, dose-optimization cohorts, a food-effect cohort, and a combination cohort evaluating DZR123 with enzalutamide in metastatic castration-resistant prostate cancer. The study also includes long-term follow-up to monitor survival and the occurrence of second primary malignancies, with assessments conducted approximately every 3 months for the first 3 years and every 6 months thereafter.
Phase 1: Dose Escalation (Monotherapy) The initial phase of the study consists of a dose-escalation period using a traditional 3+3 design. Adult patients with advanced, relapsed, or refractory solid tumors or lymphomas receive escalating doses of DZR123 as monotherapy. The primary objective of this phase is to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of DZR123. Dose-escalation decisions are based on safety, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary antitumor activity data. Patients are not randomized during this phase.
Phase 2: Dose Expansion and Optimization Phase 2 further evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of DZR123 in disease-specific cohorts and explores dose optimization and combination therapy approaches.
Cohorts M1-M6: Disease-Specific Monotherapy Patients are enrolled into disease-specific cohorts defined by tumor type and/or molecular characteristics, including adenine-thymine-rich interactive domain-containing protein 1A (ARID1A) mutations, BRCA1-associated protein 1 (BAP1) loss, lymphoma subtypes, and metastatic castration-resistant prostate cancer (mCRPC).
Cohorts M1, M5, and M6 use a Simon's two-stage design in which 10 patients are enrolled in Stage 1; if at least 1 response is observed, up to 19 additional patients are enrolled in Stage 2. Cohorts M2 and M3 also begin with a Simon's two-stage design and subsequently transition into dose-optimization stages. Cohort M4 enrolls approximately 20 patients with lymphoma in a single stage without further expansion. Patients are not randomized except during dose-optimization stages in Cohorts M2 and M3.
Dose Optimization in Cohorts M2 and M3 For ovarian clear cell carcinoma (Cohort M2) and endometrial carcinoma (Cohort M3), dose optimization is conducted after initial cohort expansion. In Stage 2a, participants are randomized 1:1 to receive DZR123 200 mg or 300 mg once daily. Depending on predefined efficacy and safety criteria, Stage 2b may enroll additional participants in one or both dose groups to further evaluate the optimal dose for future clinical development.
Cohort M7: Food-Effect Evaluation Cohort M7 evaluates the effect of a high-fat, high-calorie meal on the pharmacokinetics of DZR123 in patients with ARID1A wild-type endometrial carcinoma. Approximately 20 participants receive a single dose of DZR123 with a standardized meal on Cycle 1 Day 1, followed by continued DZR123 administration. Results from this cohort may inform future administration instructions regarding food intake in subsequent DZR123 studies and cohorts.
Cohort M8: DZR123 in Combination With Enzalutamide Cohort M8 evaluates DZR123 in combination with enzalutamide in participants with metastatic castration-resistant prostate cancer and consists of two parts.
- Part 1 (Dose Escalation): Participants receive escalating doses of DZR123 in combination with enzalutamide 160 mg once daily. Dose escalation is guided by a Bayesian logistic regression model (BLRM) using the Escalation With Overdose Control (EWOC) principle to determine the RP2D for the combination. Approximately 30 participants are enrolled. A 7-day enzalutamide run-in period may be used prior to combination treatment.
- Part 2 (Dose Expansion): Following selection of the RP2D, approximately 40 additional participants receive DZR123 at the selected dose in combination with enzalutamide to further evaluate safety, tolerability, PK, PD, and antitumor activity. Amendment 15 increased the planned enrollment in Part 2 from approximately 15 to approximately 40 participants and revised the primary efficacy assessment to focus on prostate-specific antigen response.
The study includes safety monitoring throughout treatment and follow-up, including collection of adverse events, laboratory assessments, tumor evaluations, and dedicated surveillance for second primary malignancies associated with EZH1/2 inhibition.
- Conditions
- Advanced Solid Tumor, Diffuse Large B Cell Lymphoma, Lymphoma, T-Cell, Mesothelioma, Malignant, Prostatic Neoplasms, Castration-Resistant, Endometrial Cancer
- Being tested
- Tulmimetostat, Enzalutamide
- Keywords
- Tulmimetostat, DZR123, Lymphoma, Large B-Cell, Diffuse, Lymphoma, B-cell, Lymphoma, T-cell, Lymphoma, Non-Hodgkin, Lymphoma, Neoplasms by Site, Neoplasms by Histologic Type, Neoplasms, Lymphoproliferative Disorders, Lymphatic Diseases, Immunoproliferative Disorders, Immune System Diseases, Topoisomerase Inhibitors, Molecular Mechanisms of Pharmacological Action, Antineoplastic Agents, Endometrial Cancer, Ovarian Clear Cell Carcinoma, Food effect
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, T-Cell, Mesothelioma, Malignant, Prostatic Neoplasms, Castration-Resistant, Endometrial Neoplasms, Lymphoma, B-Cell, Lymphoma, Non-Hodgkin, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TulmimetostatDrug
Also called DZR123
Tulmimetostat dosed once per day orally in 28 day cycles
EnzalutamideDrug
Enzalutamide dosed once per day orally in 28 day cycles
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 | Experimental | Eligible participants with advanced tumors will receive escalating doses of Tulmimetostat once per day orally. Receives: Drug: Tulmimetostat |
| Phase 2 - Cohort M1 (Advanced/metastatic solid tumors or urothelial carcinoma with ARID1A mutation) | Experimental | 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. Receives: Drug: Tulmimetostat |
| Phase 2 - Cohort M2 (Ovarian clear cell carcinoma with ARID1A mutation) | Experimental | 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. Receives: Drug: Tulmimetostat |
| Phase 2 - Cohort M3 (Endometrial carcinoma with ARID1A mutation) | Experimental | 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. Receives: Drug: Tulmimetostat |
| Phase 2 - Cohort M4 (Relapsed/refractory lymphoma (PTCL or DLBCL)) | Experimental | 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. Receives: Drug: Tulmimetostat |
| Phase 2 - Cohort M5 (Malignant mesothelioma with BAP1 loss) | Experimental | 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. Receives: Drug: Tulmimetostat |
| Phase 2 - Cohort M6 (Metastatic castration-resistant prostate cancer (mCRPC)) | Experimental | 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. Receives: Drug: Tulmimetostat |
| Phase 2 - Cohort M7 (Food effect in ARID1A wildtype endometrial carcinoma) | Experimental | 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. Receives: Drug: Tulmimetostat |
| Cohort M8 - Part 1 (Tulmimetostat + enzalutamide in mCRPC) | Experimental | Eligible participants with mCRPC receive DZR123 in combination with enzalutamide. Part 1 is dose escalation to determine the recommended dose. Receives: Drug: Tulmimetostat |
| Cohort M8 - Part 2 (Tulmimetostat + enzalutamide in mCRPC) | Experimental | 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. Receives: Drug: Tulmimetostat; Drug: Enzalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tulmimetostat Monotherapy Phase 1: Frequency of Dose-limiting toxicities (DLTs)
The maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of Tulmimetostat as monotherapy in patients with advanced tumors.
Measured: DLTs assessed during Cycle 1 (cycle = 28 days)
Tulmimetostat Monotherapy Phase 2: Overall response rate (ORR)
ORR is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) based on RECIST 1.1 or applicable response criteria
Measured: Up to 30 months
Cohort M8 Part 1: Frequency of Dose-limiting toxicities (DLTs)
The maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of Tulmimetostat in combination with enzalutamide in patients with castration-resistant prostate cancer (mCRPC) with measurable soft tissue disease.
Measured: DLTs assessed during Cycle 1 (cycle = 28 days)
Cohort M8 Part 2: Prostate-Specific Antigen 50 (PSA50) Response
Prostate-Specific Antigen 50 (PSA50) is defined as a ≥ 50% decrease in PSA levels from baseline at any timepoint, confirmed by a second PSA measurement ≥ 3 weeks without any PSA progression in between
Measured: Up to 30 months
Secondary outcomes (19)
Tulmimetostat Monotherapy (Phase 1 & 2) and Cohort M8 (Parts 1 & 2): Incidence Rate of Adverse Events (AEs)
Number of Participants With Adverse Events (AEs)
Measured: Up to 18 months
Tulmimetostat Monotherapy (Phase 1 & 2), Cohort M7 and Cohort M8 (Parts 1 & 2): Maximum observed plasma concentration (Cmax)
Venous whole blood samples will be collected for pharmacokinetics characterization. Cmax of Tulmimetostat will be listed and summarized using descriptive statistics.
Measured: Up to 18 months
Tulmimetostat Monotherapy (Phase 1 & 2), Cohort M7 and Cohort M8 (Parts 1 & 2): Time of maximum observed plasma concentration (Tmax)
Venous whole blood samples will be collected for pharmacokinetics characterization. Tmax of Tulmimetostat will be listed and summarized using descriptive statistics.
Measured: Up to 18 months
Tulmimetostat Monotherapy (Phase 1 & 2), Cohort M7 and Cohort M8 (Parts 1 & 2): Area under the plasma concentration-time curve from time zero to the last quantifiable time point (AUC0-last)
Venous whole blood samples will be collected for pharmacokinetics characterization. AUC0-last of Tulmimetostat will be listed and summarized using descriptive statistics.
Measured: Up to 18 months
Tulmimetostat Monotherapy (Phase 1 & 2), Cohort M7 and Cohort M8 (Parts 1 & 2): Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-Inf)
Venous whole blood samples will be collected for pharmacokinetics characterization. AUC0-Inf of Tulmimetostat will be listed and summarized using descriptive statistics.
Measured: Up to 18 months
Tulmimetostat Monotherapy (Phase 1 & 2) and Cohort M7: Terminal elimination half-life (T1/2)
Venous whole blood samples will be collected for pharmacokinetics characterization. T 1/2 of Tulmimetostat will be listed and summarized using descriptive statistics.
Measured: Up to 18 months
Tulmimetostat Monotherapy (Phase 1 & 2), Cohort M7 and Cohort M8 (Parts 1 & 2): Plasma concentrations prior to the next dose-trough (Cmin)
Venous whole blood samples will be collected for pharmacokinetics characterization. Cmin of Tulmimetostat will be listed and summarized using descriptive statistics.
Measured: Up to 18 months
Tulmimetostat Monotherapy (Phase 1) and Cohort M8 (Part 1): Objective Response Rate (ORR)
ORR defined as proportion of patients with a best overall response of complete response (CR) or partial response (PR), per Investigator assessment based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1 or applicable response criteria)
Measured: Up to 30 months
Tulmimetostat Monotherapy (Phase 1 & 2): ORR per Gynecologic Cancer Intergroup (GCIG)
ORR per Gynecologic Cancer Intergroup (GCIG)-defined CA-125 response criteria (ovarian cancer patients)
Measured: Up to 30 months
Tulmimetostat Monotherapy (Phase 1): ORR per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
ORR per Prostate Cancer Clinical Trials Working Group 3 (PCWG3) (in Phase 1 prostate cancer patients only)
Measured: Up to 30 months
Tulmimetostat Monotherapy (Phase 1 & 2) and Cohort M8 (Part 2): Progression-free survival (PFS)
PFS defined as the time from first dose to confirmed disease progression or death
Measured: Up to 30 months
Tulmimetostat Monotherapy (Phase 1 & 2) and Cohort M8 (Parts 1 & 2): Duration of response (DOR)
DOR defined as the time from the date of first response to the date of confirmed disease progression
Measured: Up to 30 months
Tulmimetostat Monotherapy (Phase 1 & 2): Time to response (TTR)
TTR defined as the time from first dose to date of first response
Measured: Up to 30 months
Tulmimetostat Monotherapy (Phase 1 & 2) and Cohort M8 (Part 1): Disease Control Rate (DCR)
DCR defined as the proportion of patients with a best overall response of CR, PR, or stable disease (SD)
Measured: Up to 30 months
Tulmimetostat Monotherapy Phase 2: Time-to-progression (TTP)
TTP defined as duration from the start of treatment until the disease progression
Measured: Up to 30 months
Tulmimetostat Monotherapy (Phase 2) and Cohort M8 (Part 2): Overall survival (OS)
OS defined as the time from first dose to death
Measured: Up to 30 months
Cohort M8 Part 1: Prostate-Specific Antigen 50 (PSA50) Response
PSA50 response defined as PSA decline by >=50% from baseline
Measured: Up to 18 months
Cohort M8 Part 1: Number of participants experiencing Dose-limiting toxicities (DLTs)
To establish dose-toxicity relationship between Tulmimetostat and enzalutamide combination
Measured: DLTs assessed during Cycle 1 (cycle = 28 days)
Cohort M8 Part 2: Time to Prostate-Specific Antigen (PSA) Progression
Time to PSA progression defined as the time from first dose to PSA progression
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start18 Sep 2019
- Primary completion27 Feb 2030 (estimated)
- Study completion27 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04104776
- Sponsor's protocol ID
- CDZR123A02101
- Other IDs
- CPI-0209-01, 2023-508002-20-00, 2023
- Status last verified
- Aug 2026
- First submitted
- 23 Sep 2019
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas
- ClinicalTrials.gov ID
- NCT04104776
- Acronym / sponsor ID
- CDZR123A02101
- Conditions
- Advanced Solid Tumor, Diffuse Large B Cell Lymphoma, Lymphoma, T-Cell, Mesothelioma, Malignant, Prostatic Neoplasms, Castration-Resistant, Endometrial Cancer
- Keywords
- Tulmimetostat, DZR123, Lymphoma, Large B-Cell, Diffuse, Lymphoma, B-cell, Lymphoma, T-cell, Lymphoma, Non-Hodgkin, Lymphoma, Neoplasms by Site
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2019 (actual)
- Primary completion
- 27 Feb 2030 (estimated)
- Study completion
- 27 Feb 2030 (estimated)
- First posted
- 26 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study consists of Phase 1 dose-escalation and Phase 2 dose-expansion cohorts designed to characterize DZR123 across multiple tumor-specific populations and to identify dose levels for further clinical development. Phase 2 includes disease-specific monotherapy cohorts, dose-optimization cohorts, a food-effect cohort, and a combination cohort evaluating DZR123 with enzalutamide in metastatic castration-resistant prostate cancer. The study also includes long-term follow-up to monitor survival and the occurrence of second primary malignancies, with assessments conducted approximately every 3 months for the first 3 years and every 6 months thereafter.
Phase 1: Dose Escalation (Monotherapy) The initial phase of the study consists of a dose-escalation period using a traditional 3+3 design. Adult patients with advanced, relapsed, or refractory solid tumors or lymphomas receive escalating doses of DZR123 as monotherapy. The primary objective of this phase is to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of DZR123. Dose-escalation decisions are based on safety, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary antitumor activity data. Patients are not randomized during this phase.
Phase 2: Dose Expansion and Optimization Phase 2 further evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of DZR123 in disease-specific cohorts and explores dose optimization and combination therapy approaches.
Cohorts M1-M6: Disease-Specific Monotherapy Patients are enrolled into disease-specific cohorts defined by tumor type and/or molecular characteristics, including adenine-thymine-rich interactive domain-containing protein 1A (ARID1A) mutations, BRCA1-associated protein 1 (BAP1) loss, lymphoma subtypes, and metastatic castration-resistant prostate cancer (mCRPC).
Cohorts M1, M5, and M6 use a Simon's two-stage design in which 10 patients are enrolled in Stage 1; if at least 1 response is observed, up to 19 additional patients are enrolled in Stage 2. Cohorts M2 and M3 also begin with a Simon's two-stage design and subsequently transition into dose-optimization stages. Cohort M4 enrolls approximately 20 patients with lymphoma in a single stage without further expansion. Patients are not randomized except during dose-optimization stages in Cohorts M2 and M3.
Dose Optimization in Cohorts M2 and M3 For ovarian clear cell carcinoma (Cohort M2) and endometrial carcinoma (Cohort M3), dose optimization is conducted after initial cohort expansion. In Stage 2a, participants are randomized 1:1 to receive DZR123 200 mg or 300 mg once daily. Depending on predefined efficacy and safety criteria, Stage 2b may enroll additional participants in one or both dose groups to further evaluate the optimal dose for future clinical development.
Cohort M7: Food-Effect Evaluation Cohort M7 evaluates the effect of a high-fat, high-calorie meal on the pharmacokinetics of DZR123 in patients with ARID1A wild-type endometrial carcinoma. Approximately 20 participants receive a single dose of DZR123 with a standardized meal on Cycle 1 Day 1, followed by continued DZR123 administration. Results from this cohort may inform future administration instructions regarding food intake in subsequent DZR123 studies and cohorts.
Cohort M8: DZR123 in Combination With Enzalutamide Cohort M8 evaluates DZR123 in combination with enzalutamide in participants with metastatic castration-resistant prostate cancer and consists of two parts.
- Part 1 (Dose Escalation): Participants receive escalating doses of DZR123 in combination with enzalutamide 160 mg once daily. Dose escalation is guided by a Bayesian logistic regression model (BLRM) using the Escalation With Overdose Control (EWOC) principle to determine the RP2D for the combination. Approximately 30 participants are enrolled. A 7-day enzalutamide run-in period may be used prior to combination treatment.
- Part 2 (Dose Expansion): Following selection of the RP2D, approximately 40 additional participants receive DZR123 at the selected dose in combination with enzalutamide to further evaluate safety, tolerability, PK, PD, and antitumor activity. Amendment 15 increased the planned enrollment in Part 2 from approximately 15 to approximately 40 participants and revised the primary efficacy assessment to focus on prostate-specific antigen response.
The study includes safety monitoring throughout treatment and follow-up, including collection of adverse events, laboratory assessments, tumor evaluations, and dedicated surveillance for second primary malignancies associated with EZH1/2 inhibition.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Phase 1 | Experimental | Drug: TulmimetostatEligible participants with advanced tumors will receive escalating doses of Tulmimetostat once per day orally. |
| Phase 2 - Cohort M1 (Advanced/metastatic solid tumors or urothelial carcinoma with ARID1A mutation) | Experimental | Drug: TulmimetostatEligible 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. |
| Phase 2 - Cohort M2 (Ovarian clear cell carcinoma with ARID1A mutation) | Experimental | Drug: TulmimetostatEligible 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. |
| Phase 2 - Cohort M3 (Endometrial carcinoma with ARID1A mutation) | Experimental | Drug: TulmimetostatEligible 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. |
| Phase 2 - Cohort M4 (Relapsed/refractory lymphoma (PTCL or DLBCL)) | Experimental | Drug: TulmimetostatEligible 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. |
| Phase 2 - Cohort M5 (Malignant mesothelioma with BAP1 loss) | Experimental | Drug: TulmimetostatEligible 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. |
| Phase 2 - Cohort M6 (Metastatic castration-resistant prostate cancer (mCRPC)) | Experimental | Drug: TulmimetostatEligible 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. |
| Phase 2 - Cohort M7 (Food effect in ARID1A wildtype endometrial carcinoma) | Experimental | Drug: TulmimetostatEligible 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. |
| Cohort M8 - Part 1 (Tulmimetostat + enzalutamide in mCRPC) | Experimental | Drug: TulmimetostatEligible participants with mCRPC receive DZR123 in combination with enzalutamide. Part 1 is dose escalation to determine the recommended dose. |
| Cohort M8 - Part 2 (Tulmimetostat + enzalutamide in mCRPC) | Experimental | Drug: Tulmimetostat, Drug: EnzalutamideEligible participants with mCRPC receive DZR123 in combination with enzalutamide. Part 2 is expansion at the selected dose to further assess safety and antitumor activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Adults aged ≥18 years with life expectancy ≥12 weeks
- ECOG performance status 0-1
- Adequate recovery from prior therapy-related toxicities (Grade ≤1, with exceptions)
- Adequate bone marrow, renal, and hepatic function per protocol-defined thresholds
- Willingness to provide tumor tissue and blood samples for biomarker analyses
Key exclusion criteria (18 listed)
- Prior solid organ or allogeneic hematopoietic cell transplant
- Active or untreated symptomatic CNS metastases (with limited exceptions)
- Clinically significant cardiovascular disease, including uncontrolled arrhythmias or prolonged QTc
- Active interstitial lung disease or pneumonitis
- Uncontrolled infections or significant gastrointestinal disorders affecting absorption
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TulmimetostatAlso: DZR123Tulmimetostat dosed once per day orally in 28 day cycles | Drug | Cohort M8 - Part 1 (Tulmimetostat + enzalutamide in mCRPC), Cohort M8 - Part 2 (Tulmimetostat + enzalutamide in mCRPC), Phase 1, Phase 2 - Cohort M1 (Advanced/metastatic solid tumors or urothelial carcinoma with ARID1A mutation), Phase 2 - Cohort M2 (Ovarian clear cell carcinoma with ARID1A mutation), Phase 2 - Cohort M3 (Endometrial carcinoma with ARID1A mutation), Phase 2 - Cohort M4 (Relapsed/refractory lymphoma (PTCL or DLBCL)), Phase 2 - Cohort M5 (Malignant mesothelioma with BAP1 loss), Phase 2 - Cohort M6 (Metastatic castration-resistant prostate cancer (mCRPC)), Phase 2 - Cohort M7 (Food effect in ARID1A wildtype endometrial carcinoma) |
| EnzalutamideEnzalutamide dosed once per day orally in 28 day cycles | Drug | Cohort M8 - Part 2 (Tulmimetostat + enzalutamide in mCRPC) |
Primary outcome
Tulmimetostat Monotherapy Phase 1: Frequency of Dose-limiting toxicities (DLTs)
Time frame: DLTs assessed during Cycle 1 (cycle = 28 days)
The maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of Tulmimetostat as monotherapy in patients with advanced tumors.
Tulmimetostat Monotherapy Phase 2: Overall response rate (ORR)
Time frame: Up to 30 months
ORR is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) based on RECIST 1.1 or applicable response criteria
Cohort M8 Part 1: Frequency of Dose-limiting toxicities (DLTs)
Time frame: DLTs assessed during Cycle 1 (cycle = 28 days)
The maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of Tulmimetostat in combination with enzalutamide in patients with castration-resistant prostate cancer (mCRPC) with measurable soft tissue disease.
Cohort M8 Part 2: Prostate-Specific Antigen 50 (PSA50) Response
Time frame: Up to 30 months
Prostate-Specific Antigen 50 (PSA50) is defined as a ≥ 50% decrease in PSA levels from baseline at any timepoint, confirmed by a second PSA measurement ≥ 3 weeks without any PSA progression in between
19 secondary outcomes
Tulmimetostat Monotherapy (Phase 1 & 2) and Cohort M8 (Parts 1 & 2): Incidence Rate of Adverse Events (AEs)
Time frame: Up to 18 months
Tulmimetostat Monotherapy (Phase 1 & 2), Cohort M7 and Cohort M8 (Parts 1 & 2): Maximum observed plasma concentration (Cmax)
Time frame: Up to 18 months
Tulmimetostat Monotherapy (Phase 1 & 2), Cohort M7 and Cohort M8 (Parts 1 & 2): Time of maximum observed plasma concentration (Tmax)
Time frame: Up to 18 months
Tulmimetostat Monotherapy (Phase 1 & 2), Cohort M7 and Cohort M8 (Parts 1 & 2): Area under the plasma concentration-time curve from time zero to the last quantifiable time point (AUC0-last)
Time frame: Up to 18 months
Tulmimetostat Monotherapy (Phase 1 & 2), Cohort M7 and Cohort M8 (Parts 1 & 2): Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-Inf)
Time frame: Up to 18 months
Tulmimetostat Monotherapy (Phase 1 & 2) and Cohort M7: Terminal elimination half-life (T1/2)
Time frame: Up to 18 months
Tulmimetostat Monotherapy (Phase 1 & 2), Cohort M7 and Cohort M8 (Parts 1 & 2): Plasma concentrations prior to the next dose-trough (Cmin)
Time frame: Up to 18 months
Tulmimetostat Monotherapy (Phase 1) and Cohort M8 (Part 1): Objective Response Rate (ORR)
Time frame: Up to 30 months
Tulmimetostat Monotherapy (Phase 1 & 2): ORR per Gynecologic Cancer Intergroup (GCIG)
Time frame: Up to 30 months
Tulmimetostat Monotherapy (Phase 1): ORR per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
Time frame: Up to 30 months
Tulmimetostat Monotherapy (Phase 1 & 2) and Cohort M8 (Part 2): Progression-free survival (PFS)
Time frame: Up to 30 months
Tulmimetostat Monotherapy (Phase 1 & 2) and Cohort M8 (Parts 1 & 2): Duration of response (DOR)
Time frame: Up to 30 months
Tulmimetostat Monotherapy (Phase 1 & 2): Time to response (TTR)
Time frame: Up to 30 months
Tulmimetostat Monotherapy (Phase 1 & 2) and Cohort M8 (Part 1): Disease Control Rate (DCR)
Time frame: Up to 30 months
Tulmimetostat Monotherapy Phase 2: Time-to-progression (TTP)
Time frame: Up to 30 months
Tulmimetostat Monotherapy (Phase 2) and Cohort M8 (Part 2): Overall survival (OS)
Time frame: Up to 30 months
Cohort M8 Part 1: Prostate-Specific Antigen 50 (PSA50) Response
Time frame: Up to 18 months
Cohort M8 Part 1: Number of participants experiencing Dose-limiting toxicities (DLTs)
Time frame: DLTs assessed during Cycle 1 (cycle = 28 days)
Cohort M8 Part 2: Time to Prostate-Specific Antigen (PSA) Progression
Time frame: Up to 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
80 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tulmimetostat and Enzalutamide in people with Advanced Solid Tumor and Diffuse Large B Cell Lymphoma, run by Novartis Pharmaceuticals at 80 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 80 sites in United States, Spain, United Kingdom, France, Italy and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tulmimetostat Monotherapy Phase 1: Frequency of Dose-limiting toxicities (DLTs) (time frame: DLTs assessed during Cycle 1 (cycle = 28 days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.