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Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML)Phase 1/2NCT06563804

A Study to Evaluate S227928 as a Single Agent and in Combination With Venetoclax in Patients With R/R AML, MDS/AML, or CMML

A Phase 1/2 study testing S227928 and Venetoclax in people with Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)/AML, run by Servier Bio-Innovation LLC at 16 sites in 6 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The objective of this study is to determine the safety, tolerability, and anti-leukemic activity of S227928 as single agent and in combination with venetoclax, and to determine the recommended Phase 2 dose (RP2D) of this combination. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
S227928 and Venetoclax
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
16 sitesin 6 countries
Study dates
25 Feb 2025to 9 Oct 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

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

  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Women of childbearing potential (WOCBP) must use a highly effective method of birth control during study treatment and at least 6 months after the last dose of Investigational Medicinal Product (IMP). In case of the use of oral contraception, women should have been on a stable dose of the same contraceptive drug (i.e., same active principle) for at least 3 months prior to the first IMP administration.
  • Male participants with WOCBP partners must use a condom during the study and for at least 3 months after the last dose of IMP. In addition, contraception should be considered for their female partners. Contraceptive measures do not apply if the participant is sterile, vasectomised or sexually abstinent. Sperm donation will not be allowed during the study and for at least 3 months after the last dose of IMP.
  • Patients with pathologically confirmed AML, MDS/AML, or CMML as defined by the World Health Organization (WHO) 2022 classification or ICC, who have been previously treated with at least one prior standard treatment and have relapsed and/or refractory disease.
  • Patients must not be candidates for further standard therapy,
  • Treatment with agents for lower risk MDS such as erythropoietin or luspatercept are not considered anticancer therapies.
Show all 12Show fewer
  • Circulating leukocytes < 10 x 109/L (use of hydroxycarbamide before study drug initiation is allowed to achieve this inclusion criterion).
  • Adequate renal function within 7 days before study enrollment defined as:
  • Calculated creatinine clearance (determined by the modification of diet in renal disease [MDRD] equation) ≥ 60 mL/min
  • Adequate hepatic function within 7 days before study enrollment defined as:
  • Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 3 x upper limit of normal (ULN),
  • Total bilirubin level ≤ 1.5 x ULN, except for patients with known Gilbert's syndrome, who may be included if their total bilirubin is ≤ 3.0 x ULN and their direct bilirubin is ≤ 1.5 x ULN.

Who cannot join

  • Pregnant or lactating women.
  • WOCBP tested positive in a serum pregnancy test within 7 days prior to the first day of IMP administration.
  • Legally incapacitated person under guardianship or trusteeship.
  • Failure to recover to ≤ Grade 1 (Common Terminology Criteria for Adverse Events version 5.0 [CTCAE v5.0]) from acute non-hematologic toxicities (to ≤ Grade 2 for neuropathy) due to previous therapy, prior to screening.
  • Diagnosis of myeloproliferative neoplasms (MPNs) or other non-CMML MDS/MPNs as defined by the WHO 2022 classification
  • Diagnosis of acute promyelocytic leukemia (French-American-British [FAB] M3 classification).
Show all 41Show fewer
  • Diagnosis of acute leukemia of mixed or ambiguous lineage or histiocytic/dendritic cell neoplasms defined by the WHO 2022 classification
  • Uncontrolled infections requiring systemic antibiotics and/or antifungal agents as per investigator's judgment. Patients receiving prophylactic antibiotics and/or antifungal agents are eligible for this study.
  • Serologic evidence of chronic hepatitis B virus (HBV) infection and unable or unwilling to receive standard prophylactic antiviral therapy, or with detectable HBV viral load.
  • Serologic evidence of hepatitis C virus (HCV) infection without completion of curative treatment or with detectable HCV viral load.
  • Human immunodeficiency virus (HIV) seropositive with any of the following:
  • CD4+ T-cell (CD4+) counts < 350 cells/µL
  • Acquired immunodeficiency syndrome-defining opportunistic infection within 12 months prior to screening
  • Not on antiretroviral therapy, or on antiretroviral therapy for < 6 weeks at the time of Day 1 in Cycle 1
  • HIV viral load ≥ 400 copies/mL
  • Participants with a known clinically significant cardiovascular disease or condition, including
  • Uncontrolled arterial hypertension per the investigator's judgment
  • New York Heart Association class III or IV congestive heart failure
  • Congenital or substance-induced long QT defined as heart rate-corrected QT (QTc) interval >450 ms for males and >470 ms for females according to Fridericia's formula
  • Uncontrolled cardiac arrhythmia (e.g., participants with rate-controlled atrial fibrillation are eligible)
  • Severe uncorrected conduction disturbances (e.g., 3rd degree heart block). Patients with severe conduction disturbances corrected by a pacemaker are eligible
  • Acute coronary syndrome (including unstable angina pectoris, acute myocardial infarction), coronary angioplasty or bypass grafting within 6 months prior to the first IMP administration
  • Troponin I > ULN or troponin T > ULN if troponin I cannot be assessed
  • Any factors that could increase the risk of QTc interval prolongation or risk of arrhythmic events such as heart failure, family history of QT syndrome, or family history of unexplained sudden death under 40 years of age
  • Known active central nervous system involvement by AML, MDS/AML, or CMML.
  • Coagulation disorders or abnormalities that may increase the risk of bleeding complications according to investigator's judgment (e.g., disseminated intravascular coagulation).
  • Any clinically significant medical condition (e.g., organ dysfunction, gastric ulcer) or laboratory abnormality likely to jeopardize the patient's safety or to interfere with the conduct of the study.
  • Major surgery within 4 weeks before the first IMP administration, or patients who have not recovered from the acute effects of surgery.
  • Allogeneic stem cell transplantation (SCT) within 3 months before the first dose of IMP
  • Patients cannot be receiving any immunosuppressive treatment, except for corticosteroids used as physiologic replacement doses up to the equivalent of 10 mg of oral prednisone
  • Malignant disease, other than that being treated in this study. Exceptions to this exclusion include the following: 1) malignancies that were treated curatively, which have not recurred within 3 years prior to study entry and do not require further treatment; 2) completely resected basal and squamous cell skin cancers; 3) any malignancy considered to be indolent and that has never required anticancer therapy; and 4) completely resected carcinoma in situ of any type.
  • History of severe allergic or anaphylactic reactions to BH3 mimetics (including venetoclax) or to any excipients of S227928.
  • Any previous anticancer treatment for the studied disease within 2 weeks or at least 5 half-lives (whichever is longer) prior to first dose of IMPs (except for hydroxycarbamide). In case of investigational biologic agents with a long half-life, such as immune checkpoint or bispecific antibodies, a flat wash-out period of 28 days will be acceptable. Participation in non-interventional registries or epidemiological studies is allowed. Hormonal therapies are not considered anticancer treatments for eligibility purposes.
  • Any cellular therapies (e.g., NK or CAR T cells) within 100 days prior to first dose of IMP.
  • Any radiotherapy within 2 weeks before the first dose of IMPs (except for palliative radiotherapy to localized lesions, i.e., chloromas).
  • Any drugs known to prolong the QT interval and induce Torsade de pointes (TdP) within 7 days prior to the first administration of IMP.
  • Dose Escalation Arm A ONLY: Although participants may be treated with strong inhibitors of CYP3A4 or of CYP2C8, they may not be treated with medications that are strong inhibitors of both CYP3A4 and CYP2C8, or with separate medications that when combined would cause strong inhibition of these two enzymes. In addition, participants may not be treated with a strong inhibitor of CYP3A4 and a moderate inhibitor of CYP2C8 and/or a moderate inhibitor of P-gp. These prohibitions begin 7 days prior to the start of IMP and continue for the entire duration of treatment. Triazole antifungal agents may be used, but only if they are in agreement with the criteria described above (i.e., they must not be dual strong inhibitors of both CYP3A4 and CYP2C8 or strong inhibitors of CYP3A4 and moderate inhibitors of either CYP2C8 or P-gp).
  • Dose Escalation Arm B and Dose Expansion ONLY: a malabsorption syndrome or other condition that precludes enteral route of administration.
  • Dose Escalation Arm B and Dose Expansion ONLY: Both moderate and strong inhibitors of CYP3A4 are prohibited, beginning 7 days prior to the start of IMP and continuing for the entire duration of treatment.
  • Dose Escalation Arm B and Dose Expansion ONLY: Both moderate and strong CYP3A4 inducers are prohibited, beginning 14 days before the start of IMP and continuing for the entire duration of treatment.
  • Dose Escalation Arm B and Dose Expansion ONLY: treatment with P-gp and BCRP inhibitors; or with medications with a narrow therapeutic index (NTIs) which are substrates of P-gp or BCRP; or with OATP1B1 substrates that cannot be discontinued 7 days before and during study treatment

Trial locations and contacts

16 sites in 6 countries.

16 sites in 6 countries

United States5 sites

  • City of Hope

    Duarte, California, 91010

  • The University of Kansas

    Fairway, Kansas, 66205

  • START Midwest

    Grand Rapids, Michigan, 49546

  • Memorial Sloan Kettering

    New York, New York, 10065

  • Fred Hutch Cancer Center

    Seattle, Washington, 98109

Other trials in United States

France4 sites

  • Institut Paoli Calmette

    Marseille, 13009

  • Chu de Nice - Hôpital L'archet 1

    Nice, 062000

  • CHU de Bordeaux - Hopital du Haut Levêque

    Pessac, 33604

  • Institut Gustave Roussy

    Villejuif, 94800

Other trials in France

Australia2 sites

  • Peter MacCallum Cancer Centre

    Melbourne, 3000

  • Prince of Wales Hospital

    Randwick, 2031

Other trials in Australia

Germany2 sites

  • Klinikum rechts der Isar der TU München

    München, 81675

  • Universitätsklinikum Ulm

    Ulm, 89081

Other trials in Germany

Japan2 sites

  • Sapporo Hokuyu Hospital

    Hokkaido, 003-0006

  • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

    Tokyo, 113-8677

Other trials in Japan

Finland1 site

  • Helsinki University Hospital - Comprehensive Cancer Center

    Helsinki, 00029

Other trials in Finland

About this study

Official title: Phase 1/2 Clinical Trial of S227928, an Anti-CD74 Antibody-Drug Conjugate Targeting MCL-1, as a Single Agent and in Combination With Venetoclax in Patients With Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)/AML, or Chronic Myelomonocytic Leukemia (CMML)

The objective of this study is to determine the safety, tolerability, and anti-leukemic activity of S227928 as single agent and in combination with venetoclax, and to determine the recommended Phase 2 dose (RP2D) of this combination. The study will begin as a Phase 1 Dose Escalation study to determine the RP2D and then will transition to a Phase 2 Dose Expansion study to assess the efficacy of the selected RP2D. During the treatment period participants will have study visits every two weeks, with additional visits occurring during the first and second cycle. Approximately 30 days after treatment has ended, an end-of-treatment visit will occur and then participants will be followed for survival every 12 weeks for the next 6 months. Study visits may include a bone marrow aspirate and/or biopsy, blood and urine tests, ECG, vital signs, physical examination, and administration of study treatment.

Being tested
S227928, Venetoclax
Medical subject headings
Recurrence, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • S227928Drug

    For administration via intravenous (IV) infusion

  • VenetoclaxDrug

    For oral administration

Study groups in NCT06563804
Study groupRoleWhat they receive
Dose Escalation - Arm AExperimentalS227928 as a single agent
Receives: Drug: S227928
Dose Escalation - Arm BExperimentalS227928 in combination with venetoclax
Receives: Drug: S227928; Drug: Venetoclax
Dose Expansion - Cohort 1ExperimentalFor participants with R/R AML and MDS/AML. S227928 in combination with venetoclax at RP2D
Receives: Drug: S227928; Drug: Venetoclax
Dose Expansion - Cohort 2ExperimentalFor participants with CMML. S227928 in combination with venetoclax at RP2D
Receives: Drug: S227928; Drug: Venetoclax

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Escalation: Number and severity of Dose Limiting Toxicities (DLTs)

    Measured: Through Cycle 1 (each cycle is 28 days)

  2. Dose Escalation: Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Measured: Through 30 days after the end of treatment (Approximately 3.5 years)

  3. Dose Escalation: Number of dose reductions, interruptions, delays, or study withdrawal due to AEs

    Measured: Through 30 days after the end of treatment (Approximately 3.5 years)

  4. Dose Expansion: Complete remission (CR)

    Measured: Through 6 months after the end of treatment (Approximately 4 years)

Secondary outcomes (48)

  1. Dose Escalation: Cmax of S227928, total Monoclonal Antibody (mAb), and unconjugated S64315

    Measured: Through the end of treatment (Approximately 3.5 years)

  2. Dose Expansion: Cmax of S227928, total mAb, and unconjugated S64315

    Measured: Through the end of treatment (Approximately 3.5 years)

  3. Dose Escalation: Tmax of S227928, total mAb, and unconjugated S64315

    Measured: Through the end of treatment (Approximately 3.5 years)

  4. Dose Expansion: Tmax of S227928, total mAb, and unconjugated S64315

    Measured: Through the end of treatment (Approximately 3.5 years)

  5. Dose Escalation: Area Under the Curve (AUC) of S227928, total mAb, and unconjugated S64315

    Measured: Through the end of treatment (Approximately 3.5 years)

  6. Dose Expansion: AUC of S227928, total mAb, and unconjugated S64315

    Measured: Through the end of treatment (Approximately 3.5 years)

  7. Dose Escalation: Plasma concentration vs. time profile of S227928

    Measured: Through the end of treatment (Approximately 3.5 years)

  8. Dose Expansion: Plasma concentration vs. time profile of S227928

    Measured: Through the end of treatment (Approximately 3.5 years)

  9. Dose Escalation: Plasma concentration vs. time profile of unconjugated S64315

    Measured: Through the end of treatment (Approximately 3.5 years)

  10. Dose Expansion: Plasma concentration vs. time profile of unconjugated S64315

    Measured: Through the end of treatment (Approximately 3.5 years)

  11. Dose Escalation: Plasma concentration vs. time profile of total mAb

    Measured: Through the end of treatment (Approximately 3.5 years)

  12. Dose Expansion: Plasma concentration vs. time profile of total mAb

    Measured: Through the end of treatment (Approximately 3.5 years)

  13. Dose Escalation (Arm B ONLY): Plasma concentration vs. time profile of venetoclax

    Measured: Through the end of treatment (Approximately 3.5 years)

  14. Dose Expansion: Plasma concentration vs. time profile of venetoclax

    Measured: Through the end of treatment (Approximately 3.5 years)

  15. Dose Escalation: Detection of Anti-Drug Antibodies (ADAs) against S227928

    Measured: Through the end of treatment (Approximately 3.5 years)

  16. Dose Expansion: Detection of ADAs against S227928

    Measured: Through the end of treatment (Approximately 3.5 years)

  17. Dose Escalation: Complete remission (CR)

    For patients with R/R AML or MDS/AML, or R/R CMML

    Measured: Through 6 months after the end of treatment (Approximately 4 years)

  18. Dose Escalation: Complete remission with incomplete hematologic recovery (CRi)

    For patients with R/R AML or MDS/AML

    Measured: Through 6 months after the end of treatment (Approximately 4 years)

  19. Dose Expansion: CRi

    Cohort 1 only

    Measured: Through 6 months after the end of treatment (Approximately 4 years)

  20. Dose Escalation: Morphologic leukemia-free state (MLFS)

    For patients with R/R AML or MDS/AML

    Measured: Through 6 months after the end of treatment (Approximately 4 years)

  21. Dose Expansion: MLFS

    Cohort 1 only

    Measured: Through 6 months after the end of treatment (Approximately 4 years)

  22. Dose Escalation: CR with partial hematologic recovery (CRh)

    For patients with R/R AML or MDS/AML, or R/R CMML

    Measured: Through 6 months after the end of treatment (Approximately 4 years)

  23. Dose Expansion: CRh

    Measured: Through 6 months after the end of treatment (Approximately 4 years)

  24. Dose Escalation: Partial remission (PR)

    For patients with R/R AML or MDS/AML, or R/R CMML

    Measured: Through 6 months after the end of treatment (Approximately 4 years)

  25. Dose Expansion: PR

    Measured: Through 6 months after the end of treatment (Approximately 4 years)

  26. Dose Escalation: Overall survival (OS)

    For patients with R/R AML or MDS/AML, or R/R CMML

    Measured: Through 6 months after the end of treatment (Approximately 4 years)

  27. Dose Expansion: OS

    Measured: Through 6 months after the end of treatment (Approximately 4 years)

  28. Dose Escalation: Duration of response (DOR)

    For patients with R/R AML or MDS/AML

    Measured: Through 6 months after the end of treatment (Approximately 4 years)

  29. Dose Expansion: DOR

    Cohort 1 only

    Measured: Through 6 months after the end of treatment (Approximately 4 years)

  30. Dose Escalation: Time to first remission (CR or CRh or CRi)

    For patients with R/R AML or MDS/AML

    Measured: Through 6 months after the end of treatment (Approximately 4 years)

  31. Dose Expansion: Time to first remission (CR or CRh or CRi)

    Cohort 1 only

    Measured: Through 6 months after the end of treatment (Approximately 4 years)

  32. Dose Escalation: Red-blood cell (RBC) and platelet transfusion independence for at least 8 weeks

    For patients with R/R AML or MDS/AML

    Measured: Through 6 months after the end of treatment (Approximately 4 years)

  33. Dose Expansion: RBC and platelet transfusion independence for at least 8 weeks

    Cohort 1 only

    Measured: Through 6 months after the end of treatment (Approximately 4 years)

  34. Dose Escalation: CR with limited count recovery (CRL)

    For patients with R/R CMML

    Measured: Through 6 months after the end of treatment (Approximately 4 years)

  35. Dose Expansion: CRL

    Cohort 2 only

    Measured: Through 6 months after the end of treatment (Approximately 4 years)

  36. Dose Escalation: CR equivalent

    For patients with R/R CMML

    Measured: Through 6 months after the end of treatment (Approximately 4 years)

  37. Dose Expansion: CR equivalent

    Cohort 2 only

    Measured: Through 6 months after the end of treatment (Approximately 4 years)

  38. Dose Escalation: Hematologic improvement (HI)

    For patients with R/R CMML

    Measured: Through 6 months after the end of treatment (Approximately 4 years)

  39. Dose Expansion: HI

    Cohort 2 only

    Measured: Through 6 months after the end of treatment (Approximately 4 years)

  40. Dose Escalation: Overall response rate (ORR)= CR + CR equivalent + CRh + CRL + PR + HI

    For patients with R/R CMML

    Measured: Through 6 months after the end of treatment (Approximately 4 years)

  41. Dose Expansion: Overall response rate (ORR)= CR + CR equivalent + CRh + CRL + PR + HI

    Cohort 2 only

    Measured: Through 6 months after the end of treatment (Approximately 4 years)

  42. Dose Escalation: Progression-free survival (PFS)

    For patients with R/R CMML

    Measured: Through 6 months after the end of treatment (Approximately 4 years)

  43. Dose Expansion: PFS

    Cohort 2 only

    Measured: Through 6 months after the end of treatment (Approximately 4 years)

  44. Dose Escalation: Event-free survival (EFS)

    For patients with R/R CMML

    Measured: Through 6 months after the end of treatment (Approximately 4 years)

  45. Dose Expansion: EFS

    Measured: Through 6 months after the end of treatment (Approximately 4 years)

  46. Dose Expansion: Number and severity of Dose Limiting Toxicities (DLTs) of S227928 in combination with venetoclax

    Measured: Through Cycle 1 (each cycle is 28 days)

  47. Dose Expansion: AEs and SAEs

    Measured: Through 30 days after the end of treatment (Approximately 3.5 years)

  48. Dose Expansion: Number of dose reductions, interruptions, delays, or study withdrawal due to AEs

    Measured: Through 30 days after the end of treatment (Approximately 3.5 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2024
  2. Study start25 Feb 2025
  3. Primary completion9 Oct 2025
  4. Study completion9 Oct 2025

Why it stopped: Sponsor decision

Resources

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
Sequential
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06563804
Sponsor's protocol ID
S227928-180
Status last verified
Mar 2026
First submitted
14 Aug 2024
Last updated
30 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data. Access can be requested for all interventional clinical studies: * Used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * Where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: * Sponsored by Servier * With a first patient enrolled as of 1 January 2004 onwards * For New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing S227928 and Venetoclax in people with Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)/AML, run by Servier Bio-Innovation LLC at 16 sites in 6 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 12 inclusion and 41 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: stopped early, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States, France, Australia, Germany, Japan and 1 more country. 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?

The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.

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?

Dose Escalation: Number and severity of Dose Limiting Toxicities (DLTs) (time frame: Through Cycle 1 (each cycle is 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?

On the ClinicalTrials.gov record for NCT06563804.

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 30 Mar 2026.

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