Myeloid DiseasesPhase 1NCT05552469
Dose Optimization and Expansion Study of DFV890 in Adult Patients With Myeloid Diseases
A Phase 1 study testing DFV890 in people with Myeloid Diseases, run by Novartis Pharmaceuticals at 25 sites in 8 countries.
Trial summary
Study CDFV890G12101 is an open-label, phase 1b, multicenter study with a randomized two-dose optimization part, and a dose expansion part consisting of three groups evaluating DFV890 in patients with myeloid diseases. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Myeloid Diseases
- What is being tested?
- DFV890
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 25 sitesin 8 countries
- Study dates
- 8 May 2023to 1 Feb 2027
- Phase
- Phase 1
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients must be ≥ 18 years of age at the time of signing the informed consent form (ICF) 2. The Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2 3. Patient must be a candidate for serial bone marrow aspirate and/or biopsy according to the institutions guidelines and must be willing to undergo a bone marrow aspirate.
- 4. Patients must have one of the following for eligibility into the study:
- In dose optimization: IPSS-R defined very low, low or intermediate risk Myelodysplastic Syndrome (LR MDS) who failed to respond to or did not tolerate ESAs or luspatercept or HMAs and patients with del 5q who failed to respond to or did not tolerate lenalidomide; or
- In dose optimization and expansion: IPSS-R defined very low, low or intermediate risk Chronic Myelomonocytic Leukemia (LR CMML) who failed to respond to or did not tolerate hydroxyurea or HMAs.
- changes for dose expansion (applicable as of amendment 3):
- LR MDS with ≤ 10% bone marrow blasts, IPSS-R score of ≤ 3.5, transfusion independent (TID) status as per IWG 2006 criteria (requiring <4U pRBC in 8 weeks), clinically meaningful cytopenia(s) and no or limited (<4 months) prior therapy for MDS.
- LR CMML patients with symptomatic cytopenias and/or constitutional symptoms refractory, intolerant or unsuitable for standard first-line therapy.
- HR-CCUS: Diagnosis of high-risk CCUS by clonal hematopoiesis risk score (CHRS) with clinically meaningful cytopenias and no prior therapy for a myeloid neoplasm.
Who cannot join
- 1. Systemic antineoplastic therapy (including cytotoxic chemotherapy, alpha-interferon, kinase inhibitors or other targeted small molecules, and toxin-immunoconjugates) or any experimental therapy within 28 days or 5 half-lives, whichever is longer, and recovered from the toxicities before the first dose of study treatment. For patients that received antibodies the washout period is 4 weeks prior to study treatment.
- For TID LR MDS in Dose Expansion Phase only (applicable as of amendment 03):
- Prior therapy for MDS administered for >4 months (ESA and luspatercept administered for ≤4 months will be allowed if washout period followed)
- Concurrent malignancy requiring active systemic therapy
- Prior or concurrent cytotoxic chemotherapy for MDS at any time
- 2. History of hypersensitivity to the study treatment or its excipients or to drugs of similar chemical classes.
Show all 12Show fewer
- 3. Patients who have previously been treated with agents that have the same mechanism of action as DFV890 as defined in Table 6-7, list of prohibited medications (e.g., drugs targeting the NLRP3 inflammasome pathway and the IL-1 pathway (canakinumab and anakinra)).
- 4. Use of hematopoietic colony-stimulating growth factors (e.g., G-CSF, GM-CSF, M-CSF), thrombopoietin mimetics or erythroid stimulating agents anytime ≤ 1 week (or 5 half lives, whichever is longer) prior to start of study treatment.
- 5. Patients receiving:
- concomitant medications that are known to be modulators of cytochrome P450 enzymes CYP2C9 and/or CYP3A (specifically strong or moderate inducers of CYP2C9, strong inducers of CYP3A enzymes, strong inhibitors of CYP2C9 and/or strong or moderate dual inhibitors of CYP2C9/CYP3A); and b. patients, who are poor CYP2C9 metabolizers receiving concomitant medications known to be strong or moderate inhibitors of CYP3A, whose concomitant medications cannot be discontinued or switched to a different medication within 5 half-lives or 1 week (whichever is longer) prior to start of study treatment and for duration of the study. See Section 6.8 and list of prohibited drugs in Appendix 8 for more details.
- 6. Dose expansion only: Poor CYP2C9 metabolizers defined as genotype of the CYP2C9 3/3 or CYP2C9 2/3 allele combinations are excluded.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
25 sites in 8 countries.
25 sites in 8 countries
United States11 sites
Sidney Kimmel CCC At JH
Baltimore, Maryland, 21231
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Northwestern University
Chicago, Illinois, 60611
Univ of TX MD Anderson Cancer Cntr
Houston, Texas, 77030
Vanderbilt University Medical Ctr
Nashville, Tennessee, 37232
Weill Cornell Medicine NY-Presb
New York, New York, 10021
Memorial Sloan Kettering Cancer Ctr
New York, New York, 10065
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Stanford Cancer Center
Stanford, California, 94305
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
France3 sites
Novartis Investigative Site
Grenoble, 38043
Novartis Investigative Site
Nantes, 44093
Novartis Investigative Site
Paris, 75475
Germany3 sites
Novartis Investigative Site
Dresden, Saxony, 01307
Novartis Investigative Site
Leipzig, Saxony, 04103
Novartis Investigative Site
Lübeck, 23538
United Kingdom3 sites
Novartis Investigative Site
Cardiff, CF14 4XW
Novartis Investigative Site
London, SE5 9RS
Novartis Investigative Site
Manchester, M20 2BX
Italy2 sites
Novartis Investigative Site
Brescia, BS, 25123
Novartis Investigative Site
Rozzano, MI, 20089
About this study
Official title: A Phase 1b, Open Label, Multi-center, Dose Optimization and Dose Expansion Study to Assess the Safety and Efficacy of DFV890 in Adult Patients With Myeloid Diseases
Study CDFV890G12101 is an open-label, phase 1b, multicenter study with a randomized two-dose optimization part, and a dose expansion part consisting of three groups evaluating DFV890 in patients with myeloid diseases. The purpose of this study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, efficacy and recommended dose for single agent DFV890 in patients with lower risk (LR: very low, low or intermediate risk) myelodysplastic syndromes (LR MDS), lower risk chronic myelomonocytic leukemia (LR CMML) and High-Risk Clonal Cytopenia of Undetermined Significance (HR CCUS).
Read the detailed description
This research study is to find out if study treatment DFV890 is safe and tolerable, and can help patients who were diagnosed with a myeloid disease such as: very low, low or intermediate risk myelodysplastic syndromes (MDS), very low, low or intermediate risk chronic myelomonocytic leukemia (CMML) and High-Risk Clonal Cytopenia of Undetermined Significance (HR CCUS). The study seeks to determine the optimal dose of DFV890 that is safe and efficacious in patients with myeloid disease. The effectiveness and safety/tolerability of the study treatment is not yet confirmed in this disease setting.
Eligible patients meeting all study entry requirements will be required to provide a sample from their bone marrow at screening and at select study timepoints. All enrolled patients will be dosed for a minimum of twenty-four weeks (6 cycles of treatment) unless they experience side effects related to the study treatment requiring dose interruption/discontinuation, worsening of the disease, and/or if treatment is discontinued at the discretion of the investigator or the patient.
- Conditions
- Myeloid Diseases
- Being tested
- DFV890
- Keywords
- MDS, CMML, CCUS, CHRS, NLRP3, Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, inflammasome, CYP2C9
- Medical subject headings
- Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DFV890Drug
DFV890 Single Agent
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation: DFV890 low dose | Experimental | DFV890 given as single agent at a low dose Receives: Drug: DFV890 |
| Dose escalation: DFV890 high dose | Experimental | DFV890 given as single agent at a high dose Receives: Drug: DFV890 |
| Dose expansion: DFV890 low dose | Experimental | DFV890 given as single agent at a low dose Receives: Drug: DFV890 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-limiting Toxicities (DLTs)
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value assessed as clinically relevant, occurring during the DLT monitoring period following the first administration of study treatment.
Measured: 28 days
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Incidence and severity of AEs and SAEs by treatment group, including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs.
Measured: 36 months
Incidence of dose interruptions, discontinuations and reductions
Number of patients with dose adjustments (interruptions, discontinuations and reductions) summarized by treatment group.
Measured: 36 months
Secondary outcomes (18)
Reduction in red blood cell (RBC) / platelet transfusions from baseline for transfusion-dependent (TD) patients
The number of red cell or platelet transfusions a patient receives over the course of study treatment will be compared to the patient's baseline transfusion requirements based on the transfusions received during the 16-weeks period prior to the start of study treatment.
Measured: Baseline, 36 months
Percentage of patients developing transfusion independence (TI) for ≥8 weeks, ≥12 weeks, ≥16 weeks or ≥24 weeks for TD patients
Percentage of patients who develop red cell or platelet transfusion independence (defined as no red cell or platelet transfusions with a duration lasting for 8, 12, 16, or 24 weeks)
Measured: Baseline, 8 weeks, 12 weeks, 16 weeks and 24 weeks
Best overall response (BOR) per 2006 IWG criteria for MDS and CMML
BOR is defined as the proportion of patients with best response recorded from the start of the treatment until disease progression/recurrence as per local investigator review and according to 2006 International Working Group (IWG) criteria
Measured: Baseline, 36 months
Hematological improvement per 2006 IWG criteria for MDS and CMML.
Number of participants with hematologic response will be based on erythroid response (HI-E), platelet response (HI-P), or neutrophil response (HI-N) as per local investigator review and according to 2006 IWG criteria
Measured: 36 months
Rate of hematological improvement per 2006 IWG criteria for CCUS
Rate of hematologic improvement is the proportion of patients with hematologic response based on erythroid response (HI-E), platelet response (HI-P), or neutrophil response (HI-N) as per local investigator review and according to 2006 IWG criteria
Measured: 36 months
Time to onset of transfusion independence
Time to onset of either red cell transfusion independence or platelet transfusion independence
Measured: 36 months
Duration of response (DOR)
DOR is defined as the duration from the first documented onset of any response to the date of progressive disease/relapse or death due to MDS/CMML
Measured: 36 months
Change from baseline in hemoglobin (Hb)
Hemoglobin levels over the course of the study will be compared to the patient's baseline to monitor for improvements in anemia
Measured: Baseline, 36 months
Change from baseline in platelet count
Platelet count over the course of the study will be compared to the patient's baseline to monitor for improvements in thrombocytopenia
Measured: Baseline, 36 months
Change from baseline in Absolute Neutrophil Count/White Blood Cells (ANC/WBC)
Ratio ANC/WBC over the course of the study will be compared to the patient's baseline to monitor for improvements in neutropenia
Measured: Baseline, 36 months
Overall response rate (ORR) for MDS and CMML
ORR is the proportion of patients with a BOR of Complete Remission (CR) or Partial Remission (PR). Response is based on 2006 IWG criteria per local investigator review.
Measured: 36 months
Time to progression to any type of myeloid malignancy (TTPM) for CCUS
TTPM is a time-to-event endpoint that measures the duration from the start of the study to the first documented progression from CCUS to a myeloid neoplasm
Measured: 36 months
Progression free survival (PFS)
PFS is defined as the time from the date of start of treatment to the date of the first documented progression, or death due to any cause. Response is based on 2006 IWG criteria per local investigator review.
Measured: 36 months
Time to progression (TTP)
TTP is defined as the time between date of first documented CR or PR to the date of first documented progression/relapse or death due to any cause, whichever occurs first. Response is based on 2006 IWG criteria per local investigator review.
Measured: 36 months
For CMML: reduction in spleen volume
Spleen volume over the course of the study will be compared to the patient's baseline
Measured: Baseline, 36 months
For CMML: MPN-SAF total symptom score (TSS)
The Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) Total Symptom Score (TTS) will be used for the assessment of symptom burden at baseline and monitoring symptom status during the course of treatment. MPN-SAF TSS includes the assessment of 10 symptoms (fatigue, concentration, early satiety, inactivity, night sweats, itching, bone pain, abdominal discomfort, weight loss, and fevers). Severity of each symptom is rated on a 0 (absent/as good as it can be) to 10 (worst-imaginable/as bad as it can be) scale. MPN-SAF TSS has a possible range of scores of 0 to 100 with 100 representing the highest level of symptom severity.
Measured: Baseline, 12 months
Maximum plasma concentration (Cmax) of DFV890
Pharmacokinetic parameters will be calculated based on DFV890 plasma concentrations by using non-compartmental method(s). Cmax is defined as the maximum (peak) observed concentration following a dose.
Measured: 15 days
Area under the plasma concentration-time curve from time zero to the last measurable concentration sampling time (AUClast) of DFV890
Pharmacokinetic parameters will be calculated based on DFV890 plasma concentrations by using non-compartmental method(s). AUClast is defined as the area under the plasma concentration-time curve from time zero to the last measurable concentration sampling time.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start8 May 2023
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloid DiseasesStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05552469
- Sponsor's protocol ID
- CDFV890G12101
- Other IDs
- 2022-501406-36-00
- Status last verified
- Sep 2026
- First submitted
- 20 Sep 2022
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Open Label, Multi-center, Dose Optimization and Dose Expansion Study to Assess the Safety and Efficacy of DFV890 in Adult Patients With Myeloid Diseases
- ClinicalTrials.gov ID
- NCT05552469
- Acronym / sponsor ID
- CDFV890G12101
- Conditions
- Myeloid Diseases
- Keywords
- MDS, CMML, CCUS, CHRS, NLRP3, Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, inflammasome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 8 May 2023 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 23 Sep 2022 (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.
Study CDFV890G12101 is an open-label, phase 1b, multicenter study with a randomized two-dose optimization part, and a dose expansion part consisting of three groups evaluating DFV890 in patients with myeloid diseases. The purpose of this study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, efficacy and recommended dose for single agent DFV890 in patients with lower risk (LR: very low, low or intermediate risk) myelodysplastic syndromes (LR MDS), lower risk chronic myelomonocytic leukemia (LR CMML) and High-Risk Clonal Cytopenia of Undetermined Significance (HR CCUS).
Detailed description
This research study is to find out if study treatment DFV890 is safe and tolerable, and can help patients who were diagnosed with a myeloid disease such as: very low, low or intermediate risk myelodysplastic syndromes (MDS), very low, low or intermediate risk chronic myelomonocytic leukemia (CMML) and High-Risk Clonal Cytopenia of Undetermined Significance (HR CCUS). The study seeks to determine the optimal dose of DFV890 that is safe and efficacious in patients with myeloid disease. The effectiveness and safety/tolerability of the study treatment is not yet confirmed in this disease setting.
Eligible patients meeting all study entry requirements will be required to provide a sample from their bone marrow at screening and at select study timepoints. All enrolled patients will be dosed for a minimum of twenty-four weeks (6 cycles of treatment) unless they experience side effects related to the study treatment requiring dose interruption/discontinuation, worsening of the disease, and/or if treatment is discontinued at the discretion of the investigator or the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose escalation: DFV890 low dose | Experimental | Drug: DFV890DFV890 given as single agent at a low dose |
| Dose escalation: DFV890 high dose | Experimental | Drug: DFV890DFV890 given as single agent at a high dose |
| Dose expansion: DFV890 low dose | Experimental | Drug: DFV890DFV890 given as single agent at a low dose |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. Patients must be ≥ 18 years of age at the time of signing the informed consent form (ICF) 2. The Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2 3. Patient must be a candidate for serial bone marrow aspirate and/or biopsy according to the institutions guidelines and must be willing to undergo a bone marrow aspirate.
- In dose optimization: IPSS-R defined very low, low or intermediate risk Myelodysplastic Syndrome (LR MDS) who failed to respond to or did not tolerate ESAs or luspatercept or HMAs and patients with del 5q who failed to respond to or did not tolerate lenalidomide; or
- In dose optimization and expansion: IPSS-R defined very low, low or intermediate risk Chronic Myelomonocytic Leukemia (LR CMML) who failed to respond to or did not tolerate hydroxyurea or HMAs.
- changes for dose expansion (applicable as of amendment 3):
Key exclusion criteria (12 listed)
- 1. Systemic antineoplastic therapy (including cytotoxic chemotherapy, alpha-interferon, kinase inhibitors or other targeted small molecules, and toxin-immunoconjugates) or any experimental therapy within 28 days or 5 half-lives, whichever is longer, and recovered from the toxicities before the first dose of study treatment. For patients that received antibodies the washout period is 4 weeks prior to study treatment.
- For TID LR MDS in Dose Expansion Phase only (applicable as of amendment 03):
- Prior therapy for MDS administered for >4 months (ESA and luspatercept administered for ≤4 months will be allowed if washout period followed)
- Concurrent malignancy requiring active systemic therapy
- Prior or concurrent cytotoxic chemotherapy for MDS at any time
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 |
|---|---|---|
| DFV890DFV890 Single Agent | Drug | Dose escalation: DFV890 high dose, Dose escalation: DFV890 low dose, Dose expansion: DFV890 low dose |
Primary outcome
Incidence of Dose-limiting Toxicities (DLTs)
Time frame: 28 days
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value assessed as clinically relevant, occurring during the DLT monitoring period following the first administration of study treatment.
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 36 months
Incidence and severity of AEs and SAEs by treatment group, including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs.
Incidence of dose interruptions, discontinuations and reductions
Time frame: 36 months
Number of patients with dose adjustments (interruptions, discontinuations and reductions) summarized by treatment group.
18 secondary outcomes
Reduction in red blood cell (RBC) / platelet transfusions from baseline for transfusion-dependent (TD) patients
Time frame: Baseline, 36 months
Percentage of patients developing transfusion independence (TI) for ≥8 weeks, ≥12 weeks, ≥16 weeks or ≥24 weeks for TD patients
Time frame: Baseline, 8 weeks, 12 weeks, 16 weeks and 24 weeks
Best overall response (BOR) per 2006 IWG criteria for MDS and CMML
Time frame: Baseline, 36 months
Hematological improvement per 2006 IWG criteria for MDS and CMML.
Time frame: 36 months
Rate of hematological improvement per 2006 IWG criteria for CCUS
Time frame: 36 months
Time to onset of transfusion independence
Time frame: 36 months
Duration of response (DOR)
Time frame: 36 months
Change from baseline in hemoglobin (Hb)
Time frame: Baseline, 36 months
Change from baseline in platelet count
Time frame: Baseline, 36 months
Change from baseline in Absolute Neutrophil Count/White Blood Cells (ANC/WBC)
Time frame: Baseline, 36 months
Overall response rate (ORR) for MDS and CMML
Time frame: 36 months
Time to progression to any type of myeloid malignancy (TTPM) for CCUS
Time frame: 36 months
Progression free survival (PFS)
Time frame: 36 months
Time to progression (TTP)
Time frame: 36 months
For CMML: reduction in spleen volume
Time frame: Baseline, 36 months
For CMML: MPN-SAF total symptom score (TSS)
Time frame: Baseline, 12 months
Maximum plasma concentration (Cmax) of DFV890
Time frame: 15 days
Area under the plasma concentration-time curve from time zero to the last measurable concentration sampling time (AUClast) of DFV890
Time frame: 15 days
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 10 Sep 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DFV890 in people with Myeloid Diseases, run by Novartis Pharmaceuticals at 25 sites in 8 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 8 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, France, Germany, United Kingdom, Italy and 3 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 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-limiting Toxicities (DLTs) (time frame: 28 days). The study lists 3 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 10 Sep 2026.