Malignant Pleural Mesotheliomas (Mpm)Phase 1NCT05375825
Phase I Evaluation of Immunotoxin LMB-100 Administered by Normothermic, Intrapleural Perfusion Following Cytoreductive Surgery in Participants With Pleural Mesotheliomas, or Pleural Effusions From Cancers Expressing Mesothelin
A Phase 1 study testing Cytoreductive surgery, LMB-100 and Immunohistochemical Assay for Mesothelin in people with Malignant Pleural Mesotheliomas (Mpm) and Malignant Pleural Effusions (Mpe), run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Cancers that spread into the thin tissue lining your lungs (pleura) cause serious illness. They often recur when removed. These tumors include malignant pleural mesothelioma (MPM), caused by exposure to asbestos and related fibers. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Malignant Pleural Mesotheliomas (Mpm), Malignant Pleural Effusions (Mpe), Epithelial Tumors, Malignant
- What is being tested?
- Cytoreductive surgery, LMB-100 and Immunohistochemical Assay for Mesothelin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2024to 31 Jan 2024
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Active smokers.
- Participants receiving systemic steroids other than physiologic replacement doses or inhaled corticosteroids (<= 20 mg of dexamethasone a day [or equivalent]) for <= 7 consecutive days prior to treatment initiation).
- Treatment with chemotherapy, targeted therapy, immunotherapy, radiation, or surgery to an index lesion within three weeks prior to commencing protocol therapy, excluding minor surgical procedures (i.e. VATS/thoracentesis/PleurX catheter placement to palliate
- MPE).
- Treatment with another investigational agent within four weeks prior to commencing protocol therapy.
- History of allergic reactions attributed to compounds of chemical or biologic composition similar to LMB-100 or SS1P including pseudomonas endotoxin.
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- Clinically significant cardiovascular/cerebrovascular disease as follows: cerebral vascular accident/stroke (within 6 months prior to treatment initiation) or myocardial infarction (within 6 months prior to treatment initiation) unless revascularized, unstable angina, congestive heart failure (New York Heart Association Classification Class >= II), serious cardiac arrhythmia, abnormal ejection fraction (echocardiogram [ECHO]) <= 40%, clinically significant bleeding or clinically significant pulmonary embolism.
- History of pneumonitis (idiopathic or drug-induced) unless cleared by pulmonary consultants.
- Receipt of any organ transplantation, including allogeneic stem-cell transplantation, except transplants that do not require immunosuppression (e.g., corneal transplant, hair transplant).
- HIV-infected participants. Participants on stable doses of antiretroviral therapy whose HIV RNA is below level of quantification are eligible.
- Active COVID-19 infection.
- Active infections requiring systemic therapy.
- An additional malignancy that is progressing or requires active treatment.
- Pregnancy
- Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Background:
Cancers that spread into the thin tissue lining your lungs (pleura) cause serious illness. They often recur when removed. These tumors include malignant pleural mesothelioma (MPM), caused by exposure to asbestos and related fibers. Malignant pleural effusions (MPEs) are caused when cancers in other parts of the body spread to the lungs and pleura. Many people diagnosed with pleural tumors survive less than a year.
Read more
Objective:
To test the safety of a study drug (LMB-100) in people. LMB-100 may help stop pleural tumors from recurring after surgery.
Eligibility:
People aged 18 years or older diagnosed with MPM or related cancer that has spread into the pleura.
Design:
Participants will undergo screening. They will have a physical exam with blood and urine tests. They will have CT scans. They will have tests that measure the how their heart and lungs function. They will provide a sample of tumor tissue to determine if their tumor expresses a protein called mesothelin.
Participants will undergo standard surgery to maximally remove the plural tumors. Then they will have LMB-100 pumped into their chest. The liquid will rinse the chest wall, diaphragm, heart sac, and surface of the lungs for 90 minutes. Then the liquid will be drained and the surgical incisions closed. The participants will be under anesthesia during this procedure.
Participants will remain in the intensive care unit for a least 48 hours. They will remain in the hospital for up to a week or more until recovered enough to be safely discharged.
Participants will return for regular follow-up visits for 2 years.
Read the detailed description
Background
- Malignant pleural mesotheliomas (MPM) are aggressive cancers with a high predilection for intrapleural recurrences despite potentially curative resections.
- Pleural metastases and associated malignant pleural effusions (MPE) cause considerable morbidity and mortality in patients with lung and esophageal cancers, gastrointestinal, pancreatic, and ovarian carcinomas, as well as sarcomas.
- Mesothelin (MSLN), a tumor differentiatio antigen, is expressed in over 95% of epithelioid MPM, as well as 80% of thymic carcinomas, 50% of lung and gastroesophageal cancers, 75% of pancreatic carcinomas, and 30% of ovarian carcinomas and synovial sarcomas.
- Mesothelin is an attractive target for cancer therapy due to its limited expression in normal human tissues and effects on invasion and metastasis of cancer cells.
- LMB-100 is a novel recombinant anti-mesothelin immunotoxin containing a humanized fragment of an anti-mesothelin Fab conjugated to a de-immunized Pseudomonas exotoxin A (PEA) which exhibits broad activity against cancer lines and tumor xenografts expressing mesothelin.
- Despite de-immunizing modifications, LMB-100 still induces neutralizing antibodies that prevent repeated systemic administration of this immunotoxin.
- Local (intraperitoneal) administration of LMB-100 can eradicate low-volume carcinomatosis in a murine model of minimal residual disease.
- Conceivably, intracavitary administration of LMB-100 following cytoreductive surgery may enhance local control of pleural-based malignancies that express mesothelin while minimizing systemic exposure of the immunotoxin.
Primary Objective
-To identify maximum tolerated dose (MTD) and evaluate the toxicities of LMB-100 administered by 90-minute normothermic, intrapleural perfusion in participants with mesothelin-positive MPM, or MPE from cancers that express mesothelin.
Eligibility
- Age >= 18 years
- Histologically confirmed mesothelioma, or other mesothelin-positive malignancy metastatic to the pleura, potentially amenable to cytoreductive surgery and subsequent intrapleural perfusion.
- No systemic or local therapy for their malignancy within 3 weeks prior to protocol treatment.
- Adequate organ function and cardiopulmonary reserve to tolerate intended resection.
- No active infections.
- No active central nervous system (CNS) metastases.
Design
- Participant s will undergo maximal cytoreductive surgery for their malignancies by open or minimally invasive procedures as dictated by histologic, anatomic, and physiologic parameters.
- Thereafter, LMB-100 will be administered by 90-minute normothermic intrathoracic perfusion using a closed circuit and roller pump with a heat exchanger.
- LMB-100 levels will be measured in pulmonary lavage and plasma.
- The dose of LMB-100 will be increased using a 3 plus 3 design to define MTD.
- Once the MTD has been defined, the enrollment will be expanded to more fully define toxicities and evaluate time to disease progression and overall survival (OS) using 2 separate cohorts of participants with MPM and pleural effusions from other malignances (MPE).
- The accrual ceiling will be set at 42.
- Conditions
- Malignant Pleural Mesotheliomas (Mpm), Malignant Pleural Effusions (Mpe), Epithelial Tumors, Malignant, Pleural Effusions, Malignant, Mesothelin (Msln)
- Being tested
- Cytoreductive surgery, LMB-100, Immunohistochemical Assay for Mesothelin
- Keywords
- Pleural Metastases, Malignant Pleural Mesotheliomas (Mpm), Malignant Pleural Effusions (Mpe), Anti-Mesothelin, Mesothelin-Positive Malignancy, Progression Free Survival (Pfs), Overall Survival (Os)
- Medical subject headings
- Mesothelioma, Malignant, Pleural Effusion, Malignant, Myeloproliferative Disorder, Chronic, with Eosinophilia, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytoreductive surgeryProcedure or surgery
Cytoreductive surgery: minimally invasive (VATS/robotic) or open (thoracotomy)
LMB-100Drug
1000 mcg/mL (DL1) post-operative dose as a single 90-minute normothermic intrathoracic perfusion using a closed circuit and roller pump with a heat exchanger following maximal cytoreductive surgery
Immunohistochemical Assay for MesothelinDiagnostic test
Performed at screening to determine mesothelin expression; separate testing of tumor mesothelin expression will be assessed retrospectively in resected tumor tissues. The device is not diagnostic; protocol assessment of mesothelin expression status will only be used to help to increase the possibility that all persons enrolling on the study might derive benefit from therapy.
| Study group | Role | What they receive |
|---|---|---|
| 1/ Dose Escalation | Experimental | LMB-100 at escalating/de-escalating doses + MSLN testing Receives: Procedure: Cytoreductive surgery; Drug: LMB-100; Diagnostic Test: Immunohistochemical Assay for Mesothelin |
| 2/ Dose Expansion | Experimental | LMB-100 at the MTD + MSLN testing Receives: Procedure: Cytoreductive surgery; Drug: LMB-100; Diagnostic Test: Immunohistochemical Assay for Mesothelin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify maximum tolerated dose (MTD) and evaluate the toxicities of LMB-100 administered by 90-minute normothermic, intrapleural perfusion in participants with mesothelin-positive MPM, or MPE from cancers that express mesothelin
List of adverse event frequency, type, and grade Safety data based on toxicity grades and types of toxicity will be reported by dose level during dose escalation.
Measured: 21 days
Secondary outcomes (2)
Determine 2 year progression free survival (PFS), and 3 year overall survival of participants following intrapleural LMB-100 perfusion
Cytoreductive surgery until time of documented clinical recurrence (radiographically or pathologically) Progression free survival (PFS): 2 year PFS probability will be calculated from the on-study date through 2 years after initiation of study therapy using the Kaplan-Meier method. Overall Survival (OS): 3 year OS probability from the on-study date through 3 years after initiation of study therapy
Measured: at initial perfusion, every 3 months (+/- 2 weeks), to time of documented clinical recurrence and/or death
Identify pharmacokinetics of LMB-100 administered by 90-minute normothermic, intrapleural perfusion
Pharmacokinetic accumulation of free and total plasma concentrations of LMB-100 will be measured using validated ligand-binding assays analyzed in the blood (plasma)and pulmonary lavage at protocol time points. Analyses will be performed retrospectively in batched samples or at the end of the trial.
Measured: Pre-dose, completion of perfusion, and 1, 3, 24 hours after start of perfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start31 Jan 2024
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Why it stopped: No participants enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pleural Mesotheliomas (Mpm)Studies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- David S Schrump, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05375825
- Sponsor's protocol ID
- 10000062
- Other IDs
- 000062-C
- Status last verified
- Jan 2024
- First submitted
- 14 May 2022
- Last updated
- 2 Feb 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: .All IPD recorded in the medical record will be shared with intramural investigators upon request.@@@@@@@@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Evaluation of Immunotoxin LMB-100 Administered by Normothermic, Intrapleural Perfusion Following Cytoreductive Surgery in Participants With Pleural Mesotheliomas, or Pleural Effusions From Cancers Expressing Mesothelin
- ClinicalTrials.gov ID
- NCT05375825
- Acronym / sponsor ID
- 10000062
- Conditions
- Malignant Pleural Mesotheliomas (Mpm), Malignant Pleural Effusions (Mpe), Epithelial Tumors, Malignant, Pleural Effusions, Malignant, Mesothelin (Msln)
- Keywords
- Pleural Metastases, Malignant Pleural Mesotheliomas (Mpm), Malignant Pleural Effusions (Mpe), Anti-Mesothelin, Mesothelin-Positive Malignancy, Progression Free Survival (Pfs), Overall Survival (Os)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 17 May 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.
Background:
Cancers that spread into the thin tissue lining your lungs (pleura) cause serious illness. They often recur when removed. These tumors include malignant pleural mesothelioma (MPM), caused by exposure to asbestos and related fibers. Malignant pleural effusions (MPEs) are caused when cancers in other parts of the body spread to the lungs and pleura. Many people diagnosed with pleural tumors survive less than a year.
Objective:
To test the safety of a study drug (LMB-100) in people. LMB-100 may help stop pleural tumors from recurring after surgery.
Eligibility:
People aged 18 years or older diagnosed with MPM or related cancer that has spread into the pleura.
Design:
Participants will undergo screening. They will have a physical exam with blood and urine tests. They will have CT scans. They will have tests that measure the how their heart and lungs function. They will provide a sample of tumor tissue to determine if their tumor expresses a protein called mesothelin.
Participants will undergo standard surgery to maximally remove the plural tumors. Then they will have LMB-100 pumped into their chest. The liquid will rinse the chest wall, diaphragm, heart sac, and surface of the lungs for 90 minutes. Then the liquid will be drained and the surgical incisions closed. The participants will be under anesthesia during this procedure.
Participants will remain in the intensive care unit for a least 48 hours. They will remain in the hospital for up to a week or more until recovered enough to be safely discharged.
Participants will return for regular follow-up visits for 2 years.
Detailed description
Background
- Malignant pleural mesotheliomas (MPM) are aggressive cancers with a high predilection for intrapleural recurrences despite potentially curative resections.
- Pleural metastases and associated malignant pleural effusions (MPE) cause considerable morbidity and mortality in patients with lung and esophageal cancers, gastrointestinal, pancreatic, and ovarian carcinomas, as well as sarcomas.
- Mesothelin (MSLN), a tumor differentiatio antigen, is expressed in over 95% of epithelioid MPM, as well as 80% of thymic carcinomas, 50% of lung and gastroesophageal cancers, 75% of pancreatic carcinomas, and 30% of ovarian carcinomas and synovial sarcomas.
- Mesothelin is an attractive target for cancer therapy due to its limited expression in normal human tissues and effects on invasion and metastasis of cancer cells.
- LMB-100 is a novel recombinant anti-mesothelin immunotoxin containing a humanized fragment of an anti-mesothelin Fab conjugated to a de-immunized Pseudomonas exotoxin A (PEA) which exhibits broad activity against cancer lines and tumor xenografts expressing mesothelin.
- Despite de-immunizing modifications, LMB-100 still induces neutralizing antibodies that prevent repeated systemic administration of this immunotoxin.
- Local (intraperitoneal) administration of LMB-100 can eradicate low-volume carcinomatosis in a murine model of minimal residual disease.
- Conceivably, intracavitary administration of LMB-100 following cytoreductive surgery may enhance local control of pleural-based malignancies that express mesothelin while minimizing systemic exposure of the immunotoxin.
Primary Objective
-To identify maximum tolerated dose (MTD) and evaluate the toxicities of LMB-100 administered by 90-minute normothermic, intrapleural perfusion in participants with mesothelin-positive MPM, or MPE from cancers that express mesothelin.
Eligibility
- Age >= 18 years
- Histologically confirmed mesothelioma, or other mesothelin-positive malignancy metastatic to the pleura, potentially amenable to cytoreductive surgery and subsequent intrapleural perfusion.
- No systemic or local therapy for their malignancy within 3 weeks prior to protocol treatment.
- Adequate organ function and cardiopulmonary reserve to tolerate intended resection.
- No active infections.
- No active central nervous system (CNS) metastases.
Design
- Participant s will undergo maximal cytoreductive surgery for their malignancies by open or minimally invasive procedures as dictated by histologic, anatomic, and physiologic parameters.
- Thereafter, LMB-100 will be administered by 90-minute normothermic intrathoracic perfusion using a closed circuit and roller pump with a heat exchanger.
- LMB-100 levels will be measured in pulmonary lavage and plasma.
- The dose of LMB-100 will be increased using a 3 plus 3 design to define MTD.
- Once the MTD has been defined, the enrollment will be expanded to more fully define toxicities and evaluate time to disease progression and overall survival (OS) using 2 separate cohorts of participants with MPM and pleural effusions from other malignances (MPE).
- The accrual ceiling will be set at 42.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1/ Dose Escalation | Experimental | Procedure: Cytoreductive surgery, Drug: LMB-100, Diagnostic Test: Immunohistochemical Assay for MesothelinLMB-100 at escalating/de-escalating doses + MSLN testing |
| 2/ Dose Expansion | Experimental | Procedure: Cytoreductive surgery, Drug: LMB-100, Diagnostic Test: Immunohistochemical Assay for MesothelinLMB-100 at the MTD + MSLN testing |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (15 listed)
- Active smokers.
- Participants receiving systemic steroids other than physiologic replacement doses or inhaled corticosteroids (<= 20 mg of dexamethasone a day [or equivalent]) for <= 7 consecutive days prior to treatment initiation).
- Treatment with chemotherapy, targeted therapy, immunotherapy, radiation, or surgery to an index lesion within three weeks prior to commencing protocol therapy, excluding minor surgical procedures (i.e. VATS/thoracentesis/PleurX catheter placement to palliate
- MPE).
- Treatment with another investigational agent within four weeks prior to commencing protocol therapy.
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 |
|---|---|---|
| Cytoreductive surgeryCytoreductive surgery: minimally invasive (VATS/robotic) or open (thoracotomy) | Procedure or surgery | 1/ Dose Escalation, 2/ Dose Expansion |
| LMB-1001000 mcg/mL (DL1) post-operative dose as a single 90-minute normothermic intrathoracic perfusion using a closed circuit and roller pump with a heat exchanger following maximal cytoreductive surgery | Drug | 1/ Dose Escalation, 2/ Dose Expansion |
| Immunohistochemical Assay for MesothelinPerformed at screening to determine mesothelin expression; separate testing of tumor mesothelin expression will be assessed retrospectively in resected tumor tissues. The device is not diagnostic; protocol assessment of mesothelin expression status will only be used to help to increase the possibility that all persons enrolling on the study might derive benefit from therapy. | Diagnostic test | 1/ Dose Escalation, 2/ Dose Expansion |
Primary outcome
Identify maximum tolerated dose (MTD) and evaluate the toxicities of LMB-100 administered by 90-minute normothermic, intrapleural perfusion in participants with mesothelin-positive MPM, or MPE from cancers that express mesothelin
Time frame: 21 days
List of adverse event frequency, type, and grade Safety data based on toxicity grades and types of toxicity will be reported by dose level during dose escalation.
2 secondary outcomes
Determine 2 year progression free survival (PFS), and 3 year overall survival of participants following intrapleural LMB-100 perfusion
Time frame: at initial perfusion, every 3 months (+/- 2 weeks), to time of documented clinical recurrence and/or death
Identify pharmacokinetics of LMB-100 administered by 90-minute normothermic, intrapleural perfusion
Time frame: Pre-dose, completion of perfusion, and 1, 3, 24 hours after start of perfusion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. .All IPD recorded in the medical record will be shared with intramural investigators upon request.@@@@@@@@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
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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.
David S Schrump, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cytoreductive surgery, LMB-100 and Immunohistochemical Assay for Mesothelin in people with Malignant Pleural Mesotheliomas (Mpm) and Malignant Pleural Effusions (Mpe), run by National Cancer Institute (NCI) at 1 site in United States.
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 0 inclusion and 15 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: withdrawn, as of the sponsor's last update on 2 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 1 site in United States. 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 withdrawn before enrolling participants, so there are no results.
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?
Identify maximum tolerated dose (MTD) and evaluate the toxicities of LMB-100 administered by 90-minute normothermic, intrapleural perfusion in participants with mesothelin-positive MPM, or MPE from cancers that express mesothelin (time frame: 21 days). 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 2 Feb 2024.