Locally Advanced Solid TumorPhase 2NCT06534190
CD8 PET Imaging in Metastatic Solid Tumours
A Phase 2 study testing 89Zr-Df-crefmirlimab PET scan, Nivolumab and Cetrelimab in people with Locally Advanced Solid Tumor, run by University Medical Center Groningen at 4 sites in 3 countries.
Trial summary
This is a multi-center, single-arm trial designed to evaluate the safety and imaging characteristics of 89Zr-Df-crefmirlimab in patients with locally advanced or metastatic solid tumours prior to and during PD-1 antibody therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Solid Tumor
- What is being tested?
- 89Zr-Df-crefmirlimab PET scan, Nivolumab and Cetrelimab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 11 Mar 2025to Nov 2028
- Phase
- Phase 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
- Age ≥ 18 years at the time of signing informed consent.
- Patients with histologically confirmed diagnosis of locally advanced or metastatic solid cancer types who, according to the opinion of the principal investigator, based on available clinical data, may benefit from anti-PD1 antibody therapy.
- Disease progression following first-line therapy or any subsequent treatment line or no superior standard line of therapy available.
- At least 1 lesion that is accessible per investigator's assessment and eligible for biopsy according to standard clinical care procedures.
- Measurable disease, as defined by standard RECIST v1.1. Previously irradiated lesions should not be counted as target lesions except for lesions that have progressed after radiotherapy administered at least 3 months earlier.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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- Life expectancy ≥ 12 weeks.
- Adequate organ and bone marrow function as defined below:
- Hemoglobin ≥9.0 g/dL
- Absolute neutrophil count ≥1.0 x 109/L
- Absolute lymphocyte count ≥0.75 x 109/L
- Platelet count ≥75 x 109/L
- Serum creatinine ≤1.5 x upper limit of normal (ULN) or estimated glomerular filtration rate > 30 mL/min/1.73 m2. A 24-hour urine creatinine collection may substitute for the calculated creatinine clearance to meet eligibility criteria.
- Adequate hepatic function:
- Total bilirubin ≤1.5 x ULN (≤3 x ULN if liver tumour involvement); Patients with Gilbert's syndrome do not need to meet total bilirubin requirements, provided their total bilirubin is unchanged from their baseline. Gilbert's syndrome must be documented appropriately as past medical history.
- Aspartate aminotransferase (AST) ≤2.5 x ULN (≤5 x ULN if liver tumour involvement) iii. Alanine aminotransferase (ALT) ≤2.5 x ULN (≤5 x ULN if liver tumour involvement) iv. Alkaline phosphatase (ALP) ≤2.5 x ULN (≤5 x ULN if liver or bone tumour involvement)
- Signed informed consent.
- Willingness and ability to comply with all protocol required procedures.
- For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception (i.e., one that results in a low failure rate (< 1% per year) when used consistently and correctly)).
Who cannot join
- Treatment with any approved anti-cancer therapy, investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to 89Zr-Df-crefmirlimab infusion and nivolumab or cetrelimab treatment.
- Symptomatic, untreated brain metastasis, leptomeningeal disease, or spinal cord compression. Patients are eligible if central nervous system (CNS) metastases are adequately treated and neurologically stable for at least 2 weeks prior to enrollment.
- Prior ICI treatment, including but not limited to anti-PD1, anti-PD-L1 and anti-CTLA4 therapeutic antibodies.
- Major surgical procedure other than for diagnosis within 28 days prior to 89Zr-Df-crefmirlimab infusion or anticipation of need for a major surgical procedure during the course of the study.
- History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematous, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis or glomerulonephritis.
- Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for his study.
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- Patients with controlled type I diabetes mellitus on a stable dose of insulin regimen may be eligible for this study.
- Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumour necrosis factor agents) within 4 weeks prior to 89Zr-Df-crefmirlimab infusion.
- Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g. a one-time of dexamethasone for nausea) may be enrolled in the study after discussion with and approval by the sponsor.
- The use of inhaled corticosteroids for chronic obstructive pulmonary disease, mineralocorticoids (e.g. fludrocortisone) for patients with orthostatic hypotension, and low-dose supplemental corticosteroids for adrenocortical insufficiency are allowed.
- Prior allogeneic bone marrow transplantation or solid organ transplant.
- Active infection with human immunodeficiency virus (HIV), hepatitis B, hepatitis C or tuberculosis infection; or diagnosis of immunodeficiency.
- Patients will be tested for hepatitis C virus (HCV) and hepatitis B virus (HBV) at screening.
- Patients with known HIV infection who have controlled infection (undetectable viral load (HIV ribonucleic acid (RNA) polymerase chain reaction (PCR)) and CD4 count above 350 either spontaneously or on a stable antiviral regimen are permitted. For patients with controlled HIV infection, monitoring will be performed per local standards.
- Patients with hepatitis B who have a controlled infection (serum HBV deoxyribonucleic acid (DNA) 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 HBV DNA. Patients must remain on anti-viral therapy for at least 6 months beyond the last dose of investigational study drug.
- Patients who are HCV antibody positive who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted.
- Patients positive for HCV antibody are eligible only if PCR is negative for HCV RNA.
- Receipt of a live vaccine (including attenuated) within 30 days of planned start of study medication.
- Evidence of an active infection that requires systemic antibiotics within 2 weeks prior to 89Zr-Df-crefmirlimab infusion.
- At least 2 weeks recovered from COVID 19 infection, where this infection has to be documented in the case record form.
- Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of 89Zr-Df-crefmirlimab, or that may affect the interpretation of the results or render the patient at high risk from complications.
- Altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
- Sponsor employee/member of the clinical site study team and/or his or her immediate family
- Women with a positive serum chorionic gonadotropin HCG pregnancy test at the screening/baseline visit. Breastfeeding women are also excluded.
- Women of childbearing potential* and sexually active men who are unwilling to practice highly effective contraception prior to the first dose of study therapy, during the study, and for at least 6 months after the last dose. Highly effective contraceptive measures include:
- stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening
- intrauterine device (IUD); intrauterine hormone-releasing system (IUS)
- bilateral tubal ligation
- vasectomized partner (provided that the male vasectomized partner is the sole sexual partner of the women of childbearing potential (WOCBP) study participant and that the vasectomized partner has obtained medical assessment of surgical success for the procedure)
- and/or sexual abstinence.
- Contraindications for MRI scan
- Patients who have any splenic disorders, or had splenectomy, that could compromise protocol objectives
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
Netherlands2 sites, 2 recruiting
- Recruiting
VUMC
Amsterdam, 1081 HV
C. W. Menke-van der Houven van Oordt, MD, PhD
C. W. Menke-van der Houven van Oordt, MD, PhD
- Recruiting
University Medical Center Groningen
Groningen, 9713 GZ
Elisabeth G.E. de Vries, MD, PhD, +31 50 361 2934, e.g.e.de.vries@umcg.nl
Daan G. Knapen, MD, +31 50 361 6161, d.g.knapen@umcg.nl
Spain1 site, 1 recruiting
- Not yet recruiting
Vall d'Hebron Institute of Oncology (VHIO) / Vall d'Hebron Institute Research (VHIR)
Barcelona, 08035
E. G. Garralda, MD, PhD
E. G. Garralda, MD, PhD
United Kingdom1 site, 1 recruiting
- Not yet recruiting
University of Cambridge
Cambridge, CB2 1TN
B. Basu, MD, PhD
B. Basu, MD, PhD
About this study
Official title: A Phase II, Open Label, Multi-center Study of 89Zr-DF-Crefmirlimab for CD8 Positron Emission Tomography in Patients With Locally Advanced or Metastatic Solid Tumours
This is a multi-center, single-arm trial designed to evaluate the safety and imaging characteristics of 89Zr-Df-crefmirlimab in patients with locally advanced or metastatic solid tumours prior to and during PD-1 antibody therapy.
- Conditions
- Locally Advanced Solid Tumor
- Being tested
- 89Zr-Df-crefmirlimab PET scan, Nivolumab, Cetrelimab, zirconium Zr 89 crefmirlimab berdoxam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
89Zr-Df-crefmirlimab PET scanRadiation
89Zr-Df-crefmirlimab will be administered followed by a PET scan 24 hours later. All patients will undergo a 89Zr-Df-crefmirlimab PET scan at baseline and after treatment with the PD-1 antibody. All patients participating in this imaging trial will undergo preferably 2 but at least one tumour biopsy. The biopsy procedure(s) will be performed after the 89Zr-Df-crefmirlimab PET scan at baseline and/or after the 89Zr-Df-crefmirlimab PET on-treatment.
After the first PET scan and tumour biopsy the patients will start treatment with PD-1 antibody nivolumab or cetrelimab.
NivolumabDrug
Immunotherapy treatment with Nivolumab
CetrelimabDrug
Immunotherapy treatment with cetrelimab
zirconium Zr 89 crefmirlimab berdoxamOther
Also called Zr-89 crefmirlimab berdoxam, 89Zr-Df-crefmirlimab, 89Zr-Df-IAB22M2C
89Zr-Df-crefmirlimab will be administered followed by a PET scan 24 hours later
| Study group | Role | What they receive |
|---|---|---|
| CD8 PET imaging | Experimental | 89Zr-Df-crefmirlimab will be administered followed by a PET scan 24 hours later. All patients will undergo a 89Zr-Df-crefmirlimab PET scan at baseline and after treatment with the PD-1 antibody. All patients participating in this imaging trial will undergo preferably 2 but at least one tumour biopsy. The biopsy procedure(s) will be performed after the 89Zr-Df-crefmirlimab PET scan at baseline and/or after the 89Zr-Df-crefmirlimab PET on-treatment.
After the first PET scan and tumour biopsy the patients will start treatment with PD-1 antibody nivolumab or cetrelimab. Receives: Radiation: 89Zr-Df-crefmirlimab PET scan; Drug: Nivolumab; Drug: Cetrelimab; Other: zirconium Zr 89 crefmirlimab berdoxam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole body distribution of 89Zr-Df-crefmirlimab
Evaluate whole body distribution of 89Zr-Df-crefmirlimab in cancer patients prior to and during treatment with an anti-PD-1 antibody by measuring standardized uptake values (SUV) in tumours, healthy tissues and organs.
Measured: 2 years
Pharmacokinetics (PK) of 89Zr-Df-crefmirlimab
Description of pharmacokinetics (PK) of 89Zr-Df-crefmirlimab by measuring standardized uptake value (SUV) on PET scans performed in patients prior to and during treatment with an anti-PD-1 antibody.
Measured: 2 years
Tumour tracer uptake with immune cell CD8 expression
Results of immunohistochemical (IHC) scoring of CD8 expression will be described. These IHC results will be compared with imaging tracer standardized uptake value (SUV) in defined volumes of interest (VOIs) of tumor lesions on the PET scan images.
Measured: 2 years
Changes in tumour volumetry, mpMRI parameters and MRI based texture metrics
DCE-MRI sequences will be evaluated and both semi-quantitative and pharmacokinetic quantitative parameters will be derived using a two-compartmental model.
Measured: 2 years
Secondary outcomes (3)
Incidence, nature, and severity of adverse events (AE) according to NCI-CTCAE v5.0
Adverse events will be assessed using the NCI-CTCAE v5.0 criteria, categorizing the severity from Grade 1 (mild) to Grade 5 (death).
Measured: Up to 100 days after the last study procedure (treatment discontinuation visit)
correlate mpMRI parameters
correlate mpMRI parameters such as Ktrans derived from DCE-MRI; f, D derived from IVIM-DWI and DDKI and K derived from DK-MRI with tumour and immune cell CD8 expression as well as T cell infiltration
Measured: 2 years
Treatment response with nivolumab or cetrelimab
correlate response to treatment with nivolumab or cetrelimab, according to the RECIST v1.1 and iRECIST criteria with 89Zr-Df-crefmirlimab uptake in tumour lesions.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start11 Mar 2025
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Solid TumorStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabeth G.E. de Vries, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06534190
- Sponsor's protocol ID
- 10353
- Status last verified
- Mar 2025
- First submitted
- 13 Jul 2023
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open Label, Multi-center Study of 89Zr-DF-Crefmirlimab for CD8 Positron Emission Tomography in Patients With Locally Advanced or Metastatic Solid Tumours
- ClinicalTrials.gov ID
- NCT06534190
- Acronym / sponsor ID
- 10353
- Conditions
- Locally Advanced Solid Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 2 Aug 2024 (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.
This is a multi-center, single-arm trial designed to evaluate the safety and imaging characteristics of 89Zr-Df-crefmirlimab in patients with locally advanced or metastatic solid tumours prior to and during PD-1 antibody therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD8 PET imaging | Experimental | Radiation: 89Zr-Df-crefmirlimab PET scan, Drug: Nivolumab, Drug: Cetrelimab, Other: zirconium Zr 89 crefmirlimab berdoxam89Zr-Df-crefmirlimab will be administered followed by a PET scan 24 hours later. All patients will undergo a 89Zr-Df-crefmirlimab PET scan at baseline and after treatment with the PD-1 antibody. All patients participating in this imaging trial will undergo preferably 2 but at least one tumour biopsy. The biopsy procedure(s) will be performed after the 89Zr-Df-crefmirlimab PET scan at baseline and/or after the 89Zr-Df-crefmirlimab PET on-treatment. After the first PET scan and tumour biopsy the patients will start treatment with PD-1 antibody nivolumab or cetrelimab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age ≥ 18 years at the time of signing informed consent.
- Patients with histologically confirmed diagnosis of locally advanced or metastatic solid cancer types who, according to the opinion of the principal investigator, based on available clinical data, may benefit from anti-PD1 antibody therapy.
- Disease progression following first-line therapy or any subsequent treatment line or no superior standard line of therapy available.
- At least 1 lesion that is accessible per investigator's assessment and eligible for biopsy according to standard clinical care procedures.
- Measurable disease, as defined by standard RECIST v1.1. Previously irradiated lesions should not be counted as target lesions except for lesions that have progressed after radiotherapy administered at least 3 months earlier.
Key exclusion criteria (32 listed)
- Treatment with any approved anti-cancer therapy, investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to 89Zr-Df-crefmirlimab infusion and nivolumab or cetrelimab treatment.
- Symptomatic, untreated brain metastasis, leptomeningeal disease, or spinal cord compression. Patients are eligible if central nervous system (CNS) metastases are adequately treated and neurologically stable for at least 2 weeks prior to enrollment.
- Prior ICI treatment, including but not limited to anti-PD1, anti-PD-L1 and anti-CTLA4 therapeutic antibodies.
- Major surgical procedure other than for diagnosis within 28 days prior to 89Zr-Df-crefmirlimab infusion or anticipation of need for a major surgical procedure during the course of the study.
- History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematous, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis or glomerulonephritis.
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 |
|---|---|---|
| 89Zr-Df-crefmirlimab PET scan89Zr-Df-crefmirlimab will be administered followed by a PET scan 24 hours later. All patients will undergo a 89Zr-Df-crefmirlimab PET scan at baseline and after treatment with the PD-1 antibody. All patients participating in this imaging trial will undergo preferably 2 but at least one tumour biopsy. The biopsy procedure(s) will be performed after the 89Zr-Df-crefmirlimab PET scan at baseline and/or after the 89Zr-Df-crefmirlimab PET on-treatment. After the first PET scan and tumour biopsy the patients will start treatment with PD-1 antibody nivolumab or cetrelimab. | Radiation | CD8 PET imaging |
| NivolumabImmunotherapy treatment with Nivolumab | Drug | CD8 PET imaging |
| CetrelimabImmunotherapy treatment with cetrelimab | Drug | CD8 PET imaging |
| zirconium Zr 89 crefmirlimab berdoxamAlso: Zr-89 crefmirlimab berdoxam, 89Zr-Df-crefmirlimab, 89Zr-Df-IAB22M2C89Zr-Df-crefmirlimab will be administered followed by a PET scan 24 hours later | Other | CD8 PET imaging |
Primary outcome
Whole body distribution of 89Zr-Df-crefmirlimab
Time frame: 2 years
Evaluate whole body distribution of 89Zr-Df-crefmirlimab in cancer patients prior to and during treatment with an anti-PD-1 antibody by measuring standardized uptake values (SUV) in tumours, healthy tissues and organs.
Pharmacokinetics (PK) of 89Zr-Df-crefmirlimab
Time frame: 2 years
Description of pharmacokinetics (PK) of 89Zr-Df-crefmirlimab by measuring standardized uptake value (SUV) on PET scans performed in patients prior to and during treatment with an anti-PD-1 antibody.
Tumour tracer uptake with immune cell CD8 expression
Time frame: 2 years
Results of immunohistochemical (IHC) scoring of CD8 expression will be described. These IHC results will be compared with imaging tracer standardized uptake value (SUV) in defined volumes of interest (VOIs) of tumor lesions on the PET scan images.
Changes in tumour volumetry, mpMRI parameters and MRI based texture metrics
Time frame: 2 years
DCE-MRI sequences will be evaluated and both semi-quantitative and pharmacokinetic quantitative parameters will be derived using a two-compartmental model.
3 secondary outcomes
Incidence, nature, and severity of adverse events (AE) according to NCI-CTCAE v5.0
Time frame: Up to 100 days after the last study procedure (treatment discontinuation visit)
correlate mpMRI parameters
Time frame: 2 years
Treatment response with nivolumab or cetrelimab
Time frame: 2 years
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 9 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
Elisabeth G.E. de Vries, MD, PhD principal investigator
University Medical Center Groningen
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 89Zr-Df-crefmirlimab PET scan, Nivolumab and Cetrelimab in people with Locally Advanced Solid Tumor, run by University Medical Center Groningen at 4 sites in 3 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 19 inclusion and 32 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 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands, Spain, United Kingdom. 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 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 Elisabeth GE de Vries, MD, PhD (+31 50 3612934, e.g.e.de.vries@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole body distribution of 89Zr-Df-crefmirlimab (time frame: 2 years). 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 9 Feb 2026.