Advanced Renal Cell CarcinomaPhase 1NCT04522323
A Study to Evaluate MEDI5752 and Axitinib in Subjects With Advanced Renal Cell Carcinoma
A Phase 1 study testing MEDI5752, Axitinib and Lenvatinib in people with Advanced Renal Cell Carcinoma, run by MedImmune LLC at 20 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate MEDI5752 in combination with Lenvatinib (or Axitinib), in subjects with advanced renal cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 101 years
- Conditions the study is for
- Advanced Renal Cell Carcinoma
- What is being tested?
- MEDI5752, Axitinib and Lenvatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 20 sitesin 4 countries
- Study dates
- 5 Aug 2020to 26 Sep 2025
- 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 101 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 at the time of screening
- Body weight > 35 kg
- Written informed consent
- Histologically or cytologically proven advanced RCC with clear cell component
- Advanced RCC not previously treated in that setting
- Provision of tumor material (≥ 5 unstained slides or tissue block) from an archival or fresh tissue sample
Show all 12Show fewer
- ECOG performance status of 0 or 1
- Subjects must have at least 1 measurable lesion according to RECIST v1.1
- Life expectancy ≥ 12 weeks
- Adequate organ and marrow function
- Female subjects of childbearing potential must have negative pregnancy test at screening and prior to each administration of investigational product, and must use at least one highly effective method of contraception.
- Strongly recommend nonsterilized male partners of female subjects of childbearing potential use a male condom plus spermicide from screening to 7.6 months after the last dose of MEDI5752 and 30 days after the last dose of lenvatinib.
Who cannot join
- Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
- Concurrent enrollment in another clinical study, unless it is an observational study.
- Previous treatment with mTOR inhibitors, PD-1, PD-L1, or CTLA-4 inhibitors for RCC or any other immune checkpoint inhibitor
- Previous treatment with VEGF inhibitors
- Evidence of the following infections: active infection including tuberculosis, human immunodeficiency virus, chronic or active hepatitis B or chronic or active hepatitis C
- History of organ transplant
Show all 24Show fewer
- Active or prior documented autoimmune or inflammatory disorders
- Current or prior use of immunosuppressive medication within 14 days prior to the first dose of investigational product.
- Poorly controlled blood pressure (BP) defined as systolic BP ≥ 140/90 mmHg at screening and not able to be controlled prior to Cycle 1 Day 1 and any change in antihypertensive medications within 1 week prior to Cycle 1 Day 1.
- Thromboembolic (arterial or venous) events within previous 6 months
- Any concurrent therapy for cancer
- Receipt of live attenuated vaccine within 30 days prior to the first dose of investigational product
- Known allergy or hypersensitivity to investigational product(s) or any of the excipients of the investigational product(s)
- Untreated or progressive CNS metastatic disease, any leptomeningeal disease, or cord compression
- History of another primary malignancy
- Unresolved toxicities from previous anticancer therapy
- Major surgery within 4 weeks prior to enrollment or radiation therapy within 2 weeks prior to enrollment or has not recovered from AEs due to prior treatment
- Female subjects must not breastfeed and must not donate, or retrieve for their own use, ova from screening to 3 months after the last dose of MEDI5752 and 30 days after the last dose of lenvatinib.
- History of arrhythmia which is symptomatic or requires treatment, symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia
- Uncontrolled intercurrent illness within the last 6 months prior to enrollment
- Clinically significant gastrointestinal abnormality
- Serious nonhealing wound, ulcer, or bone fracture
- Has clinically significant hemoptysis (at least 0.5 teaspoon of bright red blood) or tumor bleeding within 2 weeks before the first dose of investigational product
- Radiographic evidence of major blood vessel invasion/infiltration/encasement
Trial locations and contacts
20 sites in 4 countries.
20 sites in 4 countries
Spain10 sites
Research Site
Barcelona, 08003
Research Site
Barcelona, 08025
Research Site
Barcelona, 08035
Research Site
Barcelona, 08908
Research Site
Córdoba, 14004
Research Site
Madrid, 28040
Research Site
Madrid, 28041
Research Site
Sabadell, 08208
Research Site
Seville, 41013
Research Site
Valencia, 46009
United States7 sites
Research Site
Cleveland, Ohio, 44195
Research Site
Fort Myers, Florida, 33908
Research Site
Hershey, Pennsylvania, 17033
Research Site
Nashville, Tennessee, 37232
Research Site
New York, New York, 10065
Research Site
St Louis, Missouri, 63156
Research Site
Washington D.C., District of Columbia, 20007
About this study
Official title: A Phase 1b, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI5752 in Combination With Axitinib in Subjects With Advanced Renal Cell Carcinoma
The purpose of this study is to evaluate MEDI5752 in combination with Lenvatinib (or Axitinib), in subjects with advanced renal cell carcinoma.
Read the detailed description
The purpose of this Phase 1b study is to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of MEDI5752 in combination with Lenvatinib (or Axitinib) in subjects with advanced renal cell carcinoma.
- Conditions
- Advanced Renal Cell Carcinoma
- Being tested
- MEDI5752, Axitinib, Lenvatinib
- Keywords
- renal cell carcinoma, MEDI5752, PD-1/CTLA-4 bispecific, PD-1, CTLA-4, bispecific, axitinib, lenvatinib
- Medical subject headings
- Carcinoma, Renal Cell, Diabetes Mellitus, Insulin-Dependent, 12
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI5752Biological
MEDI5752
AxitinibDrug
INLYTA
LenvatinibDrug
LENVIMA
| Study group | Role | What they receive |
|---|---|---|
| Dose Exploration | Experimental | The Dose exploration Phase is made up of Part A, B and Part C. Part A will evaluate the safety and tolerability of MEDI5752 in combination with Axitinib (2 patients), and Part B and C will evaluate the safety and tolerability of MEDI5752 in combination with Lenvatinib (~72 patients) Receives: Biological: MEDI5752; Drug: Axitinib; Drug: Lenvatinib |
| Dose Expansion | Experimental | Evaluate safety and anti-tumor activity of MEDI5752 in combination with Lenvatinib (~105 patients ) Receives: Biological: MEDI5752; Drug: Axitinib; Drug: Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects experiencing adverse events (AEs)/serious adverse events (SAEs)
The primary safety endpoint is as assessed by the number of subjects with adverse events and serious adverse events (SAEs) graded per NCI CTCAE v5.0.
Measured: Informed consent through 90-Day Post Last Dose.
Number of Participants With Dose Limiting Toxicities (DLT) of MEDI5752 and Lenvatinib (or Axitinib) during the Dose Exploration period.
Determine the MTD and recommended Phase 2 dose (RP2D) of the combination of MEDI5752 and Lenvatinib.
A dose limiting toxicity (DLT) is defined as MEDI5752 treatment-related AE of any Grade 3 or higher toxicity (as defined in the protocol) CTCAE v5.0.
Measured: Informed consent through the first 21 days of treatment with MEDI5752 and Lenvatinib (or Axitinib) in the Dose Exploration Period.
Number of subjects experiencing adverse events (AEs) leading to discontinuation.
The primary safety endpoint is as assessed by the number of subjects with serious adverse events (SAEs) graded per NCI CTCAE v5.0.
Measured: Informed consent through 90-Day Post Last Dose.
Number of subjects experiencing abnormal laboratory evaluations.
The primary safety endpoint is as assessed by the number of subjects experiencing changes in laboratory evaluations from baseline.
Measured: Informed Consent through 90 post treatment date.
Number of subjects experiencing changes in vital signs reported as Adverse Events.
The primary safety endpoint is assessed by the change in vital signs from baseline.
Measured: Informed consent through 90-Day Post Last Dose
Number of subjects experiencing abnormal electrocardiograms (ECG) reported as Adverse Events.
The primary safety endpoint is as assessed by the change in ECG parameters from baseline.
Measured: Informed consent through 90-Day Post Last Dose
Preliminary antitumor activity of MEDI5752 combined with Lenvatinib (or Axitinib) by Objective response rate per RECIST version (v) 1.1.
The primary efficacy endpoint is assessed by the antitumor activity of MEDI5752 combined with Lenvatinib.
Measured: First subject enrolled through 18 months from last subject enrolled, an average of 30 months.
Secondary outcomes (11)
Antitumor activity of MEDI5752 combined with Lenvatinib by measuring the progression free survival (PFS) according to RECIST v1.1.
The endpoint for assessment of PFS is defined as the time from the first dose of treatment until the documentation of PD or death due to any cause, whichever occurs first.
Measured: Last Subject Enrolled through study completion, an average of 48 months.
Antitumor activity of MEDI5752 combined with Lenvatinib by measuring the Best Overall Response (BOR) according to RECIST v1.1.
The endpoint for assessment of BOR will be based on all post-baseline disease assessments that occur prior to the initiation of subsequent anticancer treatment
Measured: First subject enrolled through 18 months from last subject enrolled, an average of 30 months.
Antitumor activity of MEDI5752 combined with Lenvatinib by measuring the Disease Control Rate (DCR).
The endpoint for assessment of DCR is measured by the proportion of subjects with a BOR of confirmed CR, PR, or SD.
Measured: Informed Consent through the date of first documented progression, end of study, date of death, or two years after last subject starts treatment whichever should occur first
Antitumor activity of MEDI5752 combined with Lenvatinib by measuring the Duration of Response (DOR) according to RECIST v1.1.
The endpoint for assessment of DOR is measured by the duration from the first documented OR to the first documented PD or death due to any cause, whichever occurs first.
Measured: Informed Consent through the date of first documented progression, end of study, date of death, or two years after last subject starts treatment whichever should occur first
Antitumor activity of MEDI5752 combined with Lenvatinib by measuring the Time to Response (TTR) according to RECIST v1.1.
The endpoint for assessment of TTR is defined as the time from the first dose of treatment until the first documentation of an OR.
Measured: Informed Consent through the date of first documented progression, end of study, date of death, or two years after last subject starts treatment whichever should occur first
Pharmacokinetics of MEDI5752: Cmax
The endpoints for the assessment of PK of MEDI5752 include individual MEDI5752 concentrations at different time points after administration.
Measured: Day 1, 8, 15, 22, 64 and then Day 1 of every other cycle
Pharmacokinetics of MEDI5752: AUC
The endpoints for the assessment of PK of MEDI5752 include individual MEDI5752 concentrations at different time points after administration.
Measured: Day 1, 8, 15, 22, 64 and then Day 1 of every other cycle
Pharmacokinetics of MEDI5752: Cmin
The endpoints for the assessment of PK of MEDI5752 include individual MEDI5752 concentrations at different time points after administration.
Measured: Day 1, 8, 15, 22, 64 and then Day 1 of every other cycle
Pharmacokinetics of MEDI5752: t 1/2
The endpoints for the assessment of PK of MEDI5752 include individual MEDI5752 concentrations at different time points after administration.
Measured: Day 1, 8, 15, 22, 64 and then Day 1 of every other cycle
Pharmacokinetics of MEDI5752: Clearance
The endpoints for the assessment of PK of MEDI5752 include individual MEDI5752 concentrations at different time points after administration.
Measured: Day 1, 8, 15, 22, 64 and then Day 1 of every other cycle
Immunogencity of MEDI572: Incidence of ADAs against MEDI5752
The endpoints for the immunogenicity of MEDI5752 include the number of subjects who develop detectable anti-drug antibodies (ADAs) to MEDI5752.
Measured: Day 1, 8, 15, 22, 30, 64 and then Day 1 of every other cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start5 Aug 2020
- Primary completion26 Sep 2025 (estimated)
- Study completion26 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Renal Cell CarcinomaStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AstraZeneca Early Oncology, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522323
- Sponsor's protocol ID
- D7980C00003
- Other IDs
- 2023-509604-15-00, 2019-004338-41, 2019, 2023
- Status last verified
- Jul 2025
- First submitted
- 22 Jul 2020
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI5752 in Combination With Axitinib in Subjects With Advanced Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04522323
- Acronym / sponsor ID
- D7980C00003
- Conditions
- Advanced Renal Cell Carcinoma
- Keywords
- renal cell carcinoma, MEDI5752, PD-1/CTLA-4 bispecific, PD-1, CTLA-4, bispecific, axitinib, lenvatinib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 67 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2020 (actual)
- Primary completion
- 26 Sep 2025 (estimated)
- Study completion
- 26 Sep 2025 (estimated)
- First posted
- 21 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate MEDI5752 in combination with Lenvatinib (or Axitinib), in subjects with advanced renal cell carcinoma.
Detailed description
The purpose of this Phase 1b study is to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of MEDI5752 in combination with Lenvatinib (or Axitinib) in subjects with advanced renal cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Exploration | Experimental | Biological: MEDI5752, Drug: Axitinib, Drug: LenvatinibThe Dose exploration Phase is made up of Part A, B and Part C. Part A will evaluate the safety and tolerability of MEDI5752 in combination with Axitinib (2 patients), and Part B and C will evaluate the safety and tolerability of MEDI5752 in combination with Lenvatinib (~72 patients) |
| Dose Expansion | Experimental | Biological: MEDI5752, Drug: Axitinib, Drug: LenvatinibEvaluate safety and anti-tumor activity of MEDI5752 in combination with Lenvatinib (~105 patients ) |
Who may qualify
- Ages
- 18 to 101 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 18 at the time of screening
- Body weight > 35 kg
- Written informed consent
- Histologically or cytologically proven advanced RCC with clear cell component
- Advanced RCC not previously treated in that setting
Key exclusion criteria (24 listed)
- Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
- Concurrent enrollment in another clinical study, unless it is an observational study.
- Previous treatment with mTOR inhibitors, PD-1, PD-L1, or CTLA-4 inhibitors for RCC or any other immune checkpoint inhibitor
- Previous treatment with VEGF inhibitors
- Evidence of the following infections: active infection including tuberculosis, human immunodeficiency virus, chronic or active hepatitis B or chronic or active hepatitis C
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 |
|---|---|---|
| MEDI5752MEDI5752 | Biological | Dose Expansion, Dose Exploration |
| AxitinibINLYTA | Drug | Dose Expansion, Dose Exploration |
| LenvatinibLENVIMA | Drug | Dose Expansion, Dose Exploration |
Primary outcome
Number of subjects experiencing adverse events (AEs)/serious adverse events (SAEs)
Time frame: Informed consent through 90-Day Post Last Dose.
The primary safety endpoint is as assessed by the number of subjects with adverse events and serious adverse events (SAEs) graded per NCI CTCAE v5.0.
Number of Participants With Dose Limiting Toxicities (DLT) of MEDI5752 and Lenvatinib (or Axitinib) during the Dose Exploration period.
Time frame: Informed consent through the first 21 days of treatment with MEDI5752 and Lenvatinib (or Axitinib) in the Dose Exploration Period.
Determine the MTD and recommended Phase 2 dose (RP2D) of the combination of MEDI5752 and Lenvatinib. A dose limiting toxicity (DLT) is defined as MEDI5752 treatment-related AE of any Grade 3 or higher toxicity (as defined in the protocol) CTCAE v5.0.
Number of subjects experiencing adverse events (AEs) leading to discontinuation.
Time frame: Informed consent through 90-Day Post Last Dose.
The primary safety endpoint is as assessed by the number of subjects with serious adverse events (SAEs) graded per NCI CTCAE v5.0.
Number of subjects experiencing abnormal laboratory evaluations.
Time frame: Informed Consent through 90 post treatment date.
The primary safety endpoint is as assessed by the number of subjects experiencing changes in laboratory evaluations from baseline.
Number of subjects experiencing changes in vital signs reported as Adverse Events.
Time frame: Informed consent through 90-Day Post Last Dose
The primary safety endpoint is assessed by the change in vital signs from baseline.
Number of subjects experiencing abnormal electrocardiograms (ECG) reported as Adverse Events.
Time frame: Informed consent through 90-Day Post Last Dose
The primary safety endpoint is as assessed by the change in ECG parameters from baseline.
Preliminary antitumor activity of MEDI5752 combined with Lenvatinib (or Axitinib) by Objective response rate per RECIST version (v) 1.1.
Time frame: First subject enrolled through 18 months from last subject enrolled, an average of 30 months.
The primary efficacy endpoint is assessed by the antitumor activity of MEDI5752 combined with Lenvatinib.
11 secondary outcomes
Antitumor activity of MEDI5752 combined with Lenvatinib by measuring the progression free survival (PFS) according to RECIST v1.1.
Time frame: Last Subject Enrolled through study completion, an average of 48 months.
Antitumor activity of MEDI5752 combined with Lenvatinib by measuring the Best Overall Response (BOR) according to RECIST v1.1.
Time frame: First subject enrolled through 18 months from last subject enrolled, an average of 30 months.
Antitumor activity of MEDI5752 combined with Lenvatinib by measuring the Disease Control Rate (DCR).
Time frame: Informed Consent through the date of first documented progression, end of study, date of death, or two years after last subject starts treatment whichever should occur first
Antitumor activity of MEDI5752 combined with Lenvatinib by measuring the Duration of Response (DOR) according to RECIST v1.1.
Time frame: Informed Consent through the date of first documented progression, end of study, date of death, or two years after last subject starts treatment whichever should occur first
Antitumor activity of MEDI5752 combined with Lenvatinib by measuring the Time to Response (TTR) according to RECIST v1.1.
Time frame: Informed Consent through the date of first documented progression, end of study, date of death, or two years after last subject starts treatment whichever should occur first
Pharmacokinetics of MEDI5752: Cmax
Time frame: Day 1, 8, 15, 22, 64 and then Day 1 of every other cycle
Pharmacokinetics of MEDI5752: AUC
Time frame: Day 1, 8, 15, 22, 64 and then Day 1 of every other cycle
Pharmacokinetics of MEDI5752: Cmin
Time frame: Day 1, 8, 15, 22, 64 and then Day 1 of every other cycle
Pharmacokinetics of MEDI5752: t 1/2
Time frame: Day 1, 8, 15, 22, 64 and then Day 1 of every other cycle
Pharmacokinetics of MEDI5752: Clearance
Time frame: Day 1, 8, 15, 22, 64 and then Day 1 of every other cycle
Immunogencity of MEDI572: Incidence of ADAs against MEDI5752
Time frame: Day 1, 8, 15, 22, 30, 64 and then Day 1 of every other cycle
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 25 Jul 2025.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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.
AstraZeneca Early Oncology study director
AstraZeneca
20 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MEDI5752, Axitinib and Lenvatinib in people with Advanced Renal Cell Carcinoma, run by MedImmune LLC at 20 sites in 4 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 24 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 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Spain, United States, Australia, France. 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?
Number of subjects experiencing adverse events (AEs)/serious adverse events (SAEs) (time frame: Informed consent through 90-Day Post Last Dose.). The study lists 7 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 25 Jul 2025.