Multiple MyelomaPhase 1NCT05641324

A Study of ANV419 Alone or in Combination With Approved Treatments in Patients With Multiple Myeloma (OMNIA-2)

A Phase 1 study testing ANV419, Lenalidomide with low-dose dexamethasone and Daratumumab in people with Multiple Myeloma and Relapsed Cancer, run by Anaveon AG at 11 sites in 5 countries.

Terminated

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

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate the safety and tolerability of ANV419 monotherapy followed by ANV419 in combination with lenalidomide plus low-dose dexamethasone or ANV419 in combination with daratumumab. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Multiple Myeloma, Relapsed Cancer, Refractory Multiple Myeloma
What is being tested?: ANV419, Lenalidomide with low-dose dexamethasone and Daratumumab
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 11 sitesin 5 countries
Study dates: 10 Feb 2023to 12 Jul 2023
Phase: Phase 1
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

Must provide written informed consent for the study;
Must be able to comply with the Protocol as judged by the Investigator;
Are ≥18 years of age on the day of signing informed consent
Have been diagnosed with symptomatic MM per CRAB (calcium elevation, renal dysfunction, anemia, bone disease) criteria;
Have had evidence of a response (defined as partial response [PR] or better according to IMWG response criteria [Appendix C]) during previous treatment;
Have undergone treatment with ASCT or have progressed from at least 2 other prior treatment lines (including an immunomodulatory imide drug and/or daratumumab);

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Have relapsed on, or been refractory or intolerant to, the last treatment line, and have measurable disease evaluated by monoclonal proteins (M-proteins) and/or free light chains according to IMWG response criteria (Appendix C). Non-secretory MM must have measurable, active lesions by positron emission tomography;
Have a performance status of 0 to 2 on the ECOG Performance Status;
Have adequate organ functions;
Willing to undergo bone marrow biopsies if determined clinically feasible based on the Investigator's assessment;
Are eligible for treatment with daratumumab;
Are eligible for treatment or re-treatment with lenalidomide (as per the European Medicines Agency labeling criteria);
Are eligible for prophylaxis for thromboembolism per IMWG response criteria;
Female patients of childbearing potential must have a negative serum pregnancy test at screening and a negative (urine or serum) pregnancy test within 72 hours prior to receiving the first dose of study drug. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required and must be negative for the patient to be eligible;
Female patients who are not postmenopausal, and who have not undergone surgical sterilization, must agree to use highly effective methods of contraception during the treatment period and for 6 months after the last dose of study drug. They must also agree not to donate eggs (ova, oocytes) during the same timeframe; and
Male patients with partners of childbearing potential must agree to use highly effective methods of contraception and barrier contraception (condom) during the treatment period and for 6 months after the last dose of study drug. They must also agree not to donate sperm during the same timeframe.

Who cannot join

Have received an investigational agent (including investigational device) <4 weeks or 5 half-lives prior to study Cycle 1 Day 1, whichever is longer;
Have hypersensitivity to any components of ANV419 (IL-2, anti-IL-2 mAb) or its formulation (L-histidine, L-histidine HCl, sucrose, polysorbate 80, water; see Appendix D);
Have hypersensitivity to lenalidomide, dexamethasone, daratumumab, or any of their excipients;
Have received daratumumab <3 months prior to the signing of informed consent;
Have received any drugs that may be active for MM <3 weeks prior to the signing of informed consent;
Have received high-dose corticosteroids (≥1 mg/kg) ≤3 weeks prior to the signing of informed consent;

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Have received radiotherapy ≤1 month prior to the signing of informed consent;
Have had an autologous hematopoietic cell transplant (HCT) within the last 6 months;
Have had a previous allogeneic HCT;
Have had major surgery <4 weeks prior to the signing of informed consent or anticipate the need for major surgery during treatment; Note: Major surgery is defined as any surgery requiring entrance into a body cavity (eg, chest, abdomen, or brain), organ removal, normal anatomy alteration, or joint replacement. Minor surgery is defined as any surgery in which skin, mucosa, or connective tissue sections are altered (eg, biopsy, cataract, endoscopic procedures, etc).
Have clinical signs of meningeal involvement of MM;
Have a history of a past or current malignancy prior to screening, except for:
Cervical carcinoma of Stage 1B or less;
Non-invasive basal cell or squamous cell skin carcinoma requiring treatment; or
Current or past malignancy with a complete response for <3 years at screening.
Have plasma cell leukemia defined as a plasma cell count >2000/mm3;
Have known amyloidosis;
Have sensory and/or motor neuropathy ≥Grade 3 per NCI CTCAE version 5.0 at screening;
Have active (measurable) and/or uncontrolled (unresponsive to current therapy) infectious disease (bacterial, fungal, viral, or protozoic);
Have evidence of uncontrolled (unresponsive to current therapy), concomitant disease including, but not limited to, uncontrolled diabetes mellitus (pre-existing diabetes mellitus type 1 is acceptable), chronic obstructive pulmonary diseases Grade 3 (per NCI CTCAE version 5.0) or higher, asthma, bronchospasm, obstructive pulmonary disease, hematological diseases except MM, renal impairment (except when related to MM), hyperthyroidism due to thyroiditis, known autoimmune disease, or disease with ongoing fibrosis;
Have clinically significant (defined as a disease that requires intervention) cardiovascular disease including, but not limited to, acute myocardial infarction and/or transient ischemic attack <6 months prior to screening, unstable angina, congestive heart failure (New York Heart Association Class II or higher), or arrhythmia requiring therapy;
Have an average QTcF interval >480 msec at screening;
Have active, untreated, immune-related endocrinopathy untreatable with hormone replacement or prior immune-related toxicities (eg, colitis, neuropathy) >Grade 3 (per NCI CTCAE version 5.0) after treatment with immunostimulatory drugs that have not been resolved;
Have evidence of severe hepatic impairment (equivalent to Child-Pugh Class C [for liver cirrhosis] or a MELD [Model for End-Stage Liver Disease] score of 10 or higher for hepatic impairment not limited to cirrhosis]);
Have a history or current evidence of any condition, therapy, or laboratory abnormality that might significantly confound the results of the study, interfere with the patient's participation for the full duration of the study, or it is not in the best interest of the patient to participate in the study, in the opinion of the treating Investigator;
Have a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study;
Are pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, from screening through 6 months after the last dose of study drug;
Are known to be human immunodeficiency virus (HIV) positive (or tests positive for HIV 1 or 2 at screening), unless the following criteria are met:
CD4+ lymphocyte count >350 µL;
Had no history of AIDS (acquired immunodeficiency syndrome)-defining opportunistic infections within the past 12 months;
Have been on established anti-retroviral therapy for at least 4 weeks; and
Have an HIV viral load of <400 copies/mL prior to study Day 1. Note: Patients on strong cytochrome P450 (CYP)3A4 inhibitors or strong CYP3A4 inducers must be switched to an alternate effective anti-retroviral therapy regimen prior to study treatment or are excluded if regimen prior to study Day 1 cannot be altered.
Have uncontrolled hepatitis B infection or hepatitis C infection; Note: Patients with hepatitis B (positive hepatitis B surface antigen) who have controlled infection (serum hepatitis B virus DNA by PCR that is below the limit of detection and receiving anti-viral therapy for hepatitis B) are permitted. Patients with controlled infections must undergo periodic monitoring of hepatitis B virus DNA. Note: Patients with hepatitis C (positive hepatitis C virus antibody) who have controlled infection (undetectable hepatitis C virus RNA by PCR either spontaneously or in response to a successful prior course of anti-hepatitis C virus therapy) are permitted.
Have received a live vaccine within 30 days of study Day 1. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however, intranasal influenza vaccines (eg, Flu-Mist®) are live attenuated vaccines, and are not allowed

Trial locations and contacts

11 sites in 5 countries.

Country

City, postcode or hospital

11 sites in 5 countries

Spain4 sites

Hospital Clinic Barcelona
Barcelona
Hospital Universitario La Princesa
Madrid, 28006
Hospital General Universitario Morales Meseguer
Murcia
Hospital Clinico Universitario de Salamanca
Salamanca

Other trials in Spain

France3 sites

Institut Paoli-Calmettes
Marseille
CHU de Nantes - Hôtel-Dieu
Nantes
Institut de cancérologie Strasbourg Europe (ICANS)
Strasbourg

Other trials in France

Switzerland2 sites

Inselspital, Universitätsspital Bern
Bern
Kantonsspital St. Gallen
Sankt Gallen

Other trials in Switzerland

Denmark1 site

Vejle Hospital
Vejle

Other trials in Denmark

Germany1 site

Universitätsklinikum Jena
Jena, 07747

Other trials in Germany

About this study

Official title: A Phase 1 Study of ANV419 as Monotherapy, and ANV419 in Combination With Daratumumab or With Lenalidomide Plus Low-Dose Dexamethasone, in Patients With Relapsed or Refractory Multiple Myeloma (OMNIA-2)

Read the detailed description

The purpose of this multi-site, open-label, Phase 1 adaptive design study is to evaluate the safety, tolerability and preliminary efficacy of ANV419 as a monotherapy followed by ANV419 in combination with lenalidomide plus low-dose dexamethasone or ANV419 in combination with daratumumab in patients aged 18 years or older with with relapsed or refractory Multiple Myeloma.

Conditions: Multiple Myeloma, Relapsed Cancer, Refractory Multiple Myeloma, Adult Disease, Hematologic Diseases
Being tested: ANV419, Lenalidomide with low-dose dexamethasone, Daratumumab
Keywords: IL-2, ANV419, Cancer, Multiple Myeloma, OMNIA
Medical subject headings: Multiple Myeloma, Recurrence, Disease, Hematologic Diseases, Neoplasms

What participants receive

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

ANV419Drug
ANV419 administered by intravenous (IV) infusion
Lenalidomide with low-dose dexamethasoneDrug
Lenalidomide and dexamethasone administered orally
DaratumumabDrug
Daratumumab administered by subcutaneous injection

Study groups in NCT05641324
Study group	Role	What they receive
ANV419 single agent, dose 1, Q2W	Experimental	Not described Receives: Drug: ANV419
ANV419 single agent, dose 2, Q2W	Experimental	Not described Receives: Drug: ANV419
ANV419 Q2W + Lenalidomide plus low-dose dexamethasone	Experimental	Not described Receives: Drug: ANV419; Drug: Lenalidomide with low-dose dexamethasone
ANV419 Q2W + Daratumumab	Experimental	Not described Receives: Drug: ANV419; Drug: Daratumumab

What is being measured

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

Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) with ANV419 monotherapy
Measured: Day 1 up to 12 months
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) with ANV419 in combination with lenalidomide plus low-dose dexamethasone
Measured: Day 1 up to 12 months
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) with ANV419 in combination with daratumumab
Measured: Day 1 up to 12 months

Secondary outcomes (11)

Serum concentration of ANV419 in blood
Measured: Day 1 up to 12 months
Impact of ANV419 on the expression of markers of PBMC lineage in blood
Measured: Day 1 up to 12 months
Levels of specific anti-ANV419 antibodies in blood
Measured: Day 1 up to 12 months
Objective Response Rate (ORR) as defined by IMWG response criteria, with ANV419 monotherapy
Measured: Day 1 up to 12 months
Objective Response Rate (ORR) as defined by IMWG response criteria, with ANV419 in combination with lenalidomide plus low-dose dexamethasone
Measured: Day 1 up to 12 months
Objective Response Rate (ORR) as defined by IMWG response criteria, with ANV419 in combination with daratumumab
Measured: Day 1 up to 12 months
Quality of life assessed with European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L)
Measured: Day 1 up to 12 months
Quality of life assessed with European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Measured: Day 1 up to 12 months
Progression-free survival (PFS) according to IMWG response criteria
Measured: Day 1 up to 12 months
Duration of Response (DOR) according to IMWG response criteria
Measured: Day 1 up to 12 months
Clinical Benefit Rate (CBR) according to IMWG response criteria
Measured: Day 1 up to 12 months

Timeline

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

10 Feb 202312 Jul 2023

First posted7 Dec 2022
Study start10 Feb 2023
Primary completion12 Jul 2023
Study completion12 Jul 2023

Why it stopped: The study was ended due to a lack of recruitment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Multiple MyelomaStudies of the same condition, open and under way.
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: Sequential
Masking: None (open label)
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05641324
Sponsor's protocol ID: ANV419-102
Status last verified: Feb 2024
First submitted: 29 Nov 2022
Last updated: 12 Feb 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
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Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

All Multiple Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Study of ANV419 as Monotherapy, and ANV419 in Combination With Daratumumab or With Lenalidomide Plus Low-Dose Dexamethasone, in Patients With Relapsed or Refractory Multiple Myeloma (OMNIA-2)
ClinicalTrials.gov ID: NCT05641324
Acronym / sponsor ID: ANV419-102
Conditions: Multiple Myeloma, Relapsed Cancer, Refractory Multiple Myeloma, Adult Disease, Hematologic Diseases
Keywords: IL-2, ANV419, Cancer, Multiple Myeloma, OMNIA
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was ended due to a lack of recruitment
Enrolment: 4 participants (actual)
Lead sponsor: Anaveon AGIndustry (pharma, biotech, devices)
Study start: 10 Feb 2023 (actual)
Primary completion: 12 Jul 2023 (actual)
Study completion: 12 Jul 2023 (actual)
First posted: 7 Dec 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
ANV419 single agent, dose 1, Q2W	Experimental	Drug: ANV419
ANV419 single agent, dose 2, Q2W	Experimental	Drug: ANV419
ANV419 Q2W + Lenalidomide plus low-dose dexamethasone	Experimental	Drug: ANV419, Drug: Lenalidomide with low-dose dexamethasone
ANV419 Q2W + Daratumumab	Experimental	Drug: ANV419, Drug: Daratumumab

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Must provide written informed consent for the study;
Must be able to comply with the Protocol as judged by the Investigator;
Are ≥18 years of age on the day of signing informed consent
Have been diagnosed with symptomatic MM per CRAB (calcium elevation, renal dysfunction, anemia, bone disease) criteria;
Have had evidence of a response (defined as partial response [PR] or better according to IMWG response criteria [Appendix C]) during previous treatment;

Key exclusion criteria (34 listed)

Have received an investigational agent (including investigational device) <4 weeks or 5 half-lives prior to study Cycle 1 Day 1, whichever is longer;
Have hypersensitivity to any components of ANV419 (IL-2, anti-IL-2 mAb) or its formulation (L-histidine, L-histidine HCl, sucrose, polysorbate 80, water; see Appendix D);
Have hypersensitivity to lenalidomide, dexamethasone, daratumumab, or any of their excipients;
Have received daratumumab <3 months prior to the signing of informed consent;
Have received any drugs that may be active for MM <3 weeks prior to the signing of informed consent;

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
ANV419ANV419 administered by intravenous (IV) infusion	Drug	ANV419 Q2W + Daratumumab, ANV419 Q2W + Lenalidomide plus low-dose dexamethasone, ANV419 single agent, dose 1, Q2W, ANV419 single agent, dose 2, Q2W
Lenalidomide with low-dose dexamethasoneLenalidomide and dexamethasone administered orally	Drug	ANV419 Q2W + Lenalidomide plus low-dose dexamethasone
DaratumumabDaratumumab administered by subcutaneous injection	Drug	ANV419 Q2W + Daratumumab

Primary outcome

Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) with ANV419 monotherapy
Time frame: Day 1 up to 12 months
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) with ANV419 in combination with lenalidomide plus low-dose dexamethasone
Time frame: Day 1 up to 12 months
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) with ANV419 in combination with daratumumab
Time frame: Day 1 up to 12 months

11 secondary outcomes

Serum concentration of ANV419 in blood
Time frame: Day 1 up to 12 months
Impact of ANV419 on the expression of markers of PBMC lineage in blood
Time frame: Day 1 up to 12 months
Levels of specific anti-ANV419 antibodies in blood
Time frame: Day 1 up to 12 months
Objective Response Rate (ORR) as defined by IMWG response criteria, with ANV419 monotherapy
Time frame: Day 1 up to 12 months
Objective Response Rate (ORR) as defined by IMWG response criteria, with ANV419 in combination with lenalidomide plus low-dose dexamethasone
Time frame: Day 1 up to 12 months
Objective Response Rate (ORR) as defined by IMWG response criteria, with ANV419 in combination with daratumumab
Time frame: Day 1 up to 12 months
Quality of life assessed with European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L)
Time frame: Day 1 up to 12 months
Quality of life assessed with European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Time frame: Day 1 up to 12 months
Progression-free survival (PFS) according to IMWG response criteria
Time frame: Day 1 up to 12 months
Duration of Response (DOR) according to IMWG response criteria
Time frame: Day 1 up to 12 months
Clinical Benefit Rate (CBR) according to IMWG response criteria
Time frame: Day 1 up to 12 months

Results and safety

The study was stopped early (reason given: The study was ended due to a lack of recruitment). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
Individual participant dataSharing planned: No

Related trials for Multiple Myeloma

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
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Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
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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.

Eduard Gasal, MD study director

Anaveon AG

11 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ANV419, Lenalidomide with low-dose dexamethasone and Daratumumab in people with Multiple Myeloma and Relapsed Cancer, run by Anaveon AG at 11 sites in 5 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 16 inclusion and 34 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 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Spain, France, Switzerland, Denmark, Germany. 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?

The study was stopped early (reason given: The study was ended due to a lack of recruitment). 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?

Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) with ANV419 monotherapy (time frame: Day 1 up to 12 months). 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?

On the ClinicalTrials.gov record for NCT05641324.

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 12 Feb 2024.