Breast NeoplasmsPhase 1NCT06530082
A Single Arm Clinical Study of Dendritic Cell Vaccine Loaded With Circular RNA Encoding Cryptic Peptide for Patients With HER2-negative Advanced Breast Cancer
A Phase 1 study testing CircFam53B-219aa DC vaccine and camrelizumab in people with Breast Neoplasms, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Trial summary
The purpose of this clinical trial is to understand the safety and tolerability of CircFAM53B-219aa DC vaccine monotherapy and its combination with camrelizumab in the treatment of HER2-negative advanced breast cancer, as well as to evaluate its efficacy. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- CircFam53B-219aa DC vaccine and camrelizumab
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 1 Jan 2027
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following inclusion criteria to be enrolled:
- In order to be eligible for participation in this trial, the participant must:
- Have voluntarily joined the study, signed the informed consent form, and be willing and able to comply with the study protocol.
- Be a female aged 18 to 70 years (calculated on the day of signing the informed consent).
- Have been diagnosed with unresectable locally advanced or recurrent, metastatic breast cancer (stage IIIB/C or IV), HER2-negative (diagnosed according to the latest ASCO CAP guidelines), with the disease in a stable or progressive state.
- Have triple-negative breast cancer with disease progression or intolerance to prior first-line chemotherapy, or ER and/or PgR-positive breast cancer with failure in at least one line of endocrine or CDK4/6 inhibitor therapy.
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- Have HLA-A*02:01 genotype (detected by peripheral blood extraction using PCR-SBT and Sanger sequencing, and typed with reference to the IMGT/HLA database).
- Have a positive FAM53B-219aa IHC test result in tumor biopsy specimens.
- Have not received any previous cell infusion therapy or tumor vaccine treatment.
- Have had adequate washout from previous antitumor treatments: no anti-angiogenesis drugs within 4 weeks, no chemotherapy or targeted therapy within 3 weeks, no radiotherapy within 2 weeks, and no endocrine therapy within 1 week. For the sample size expansion phase, if the immune checkpoint inhibitors to be used in this study were used in prior (neo)adjuvant treatment, at least 12 months must have elapsed before enrollment in this study.
- Have at least one measurable lesion as defined by RECIST v1.1. If the lesion has received prior radiotherapy, it must have shown definite disease progression post-radiotherapy to be considered measurable.
- Have accessible recent tumor tissue from the breast cancer lesion (unresectable locally advanced or recurrent, metastatic breast cancer lesion) to determine breast cancer molecular typing and PD-L1 expression levels, unless inaccessible or unsafe to obtain.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Have an expected survival time of ≥12 weeks.
- Have adequate function of major organs meeting the following requirements (use of any blood components and cell growth factors is not allowed within 14 days before surgery):
- Complete Blood Count test:
- Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L;
- Lymphocyte count (LC) > 0.5×10⁹/L;
- Platelet count (PLT) ≥ 100×10⁹/L;
- Hemoglobin (Hb) ≥ 90 g/L; b) Liver function test: AST, ALT, and alkaline phosphatase ≤ 2.5×ULN (upper limit of normal), total bilirubin (TBIL) ≤ 1.5×ULN, except for the following:
- Patients with confirmed liver metastases: AST and/or ALT ≤ 5×ULN;
- Patients with confirmed liver or bone metastases: alkaline phosphatase ≤ 5×ULN;
- Patients with confirmed Gilbert's syndrome: total bilirubin ≤ 3.0 mg/dL; c) Kidney function test: serum creatinine ≤ 1.5×ULN; d) Coagulation function test: APTT ≤ 1.5×ULN, and INR or PT ≤ 1.5×ULN; e) Cardiac ultrasound: left ventricular ejection fraction (LVEF) ≥ 50%; e) Pulmonary function test: FEV1 ≥ 60%.
Who cannot join
- The participant must be excluded from participating in this trial if the participant:
- Has rapidly progressing breast cancer as determined by the investigator.
- Has active central nervous system metastases or carcinomatous meningitis (except stable brain metastases, those deemed not requiring medication within 2 weeks by clinical judgment, or those not dependent on hormones). Stable brain metastases that have been treated must provide at least two brain imaging assessments: (i) after completion of brain metastasis treatment, and (ii) at the screening period of this study (with a minimum of 4 weeks from (i)).
- Has spinal cord compression that has not been relieved by surgery and/or radiotherapy (patients whose symptoms have improved for ≥1 week before surgical sampling can be included).
- Has uncontrolled pleural effusion, pericardial effusion, or ascites (patients with indwelling catheters are allowed to participate).
- Has uncontrollable tumor-related pain as determined by the investigator. Participants requiring analgesic treatment must have a stable pain management plan before enrollment, and symptomatic lesions suitable for palliative radiotherapy should be treated before enrollment.
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- Has a history of malignancy other than the target indications within the last 5 years (exceptions include: adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, and ductal carcinoma in situ of the breast after radical surgery).
- General Medical Exclusion Criteria:
- Has a significant history of cardiovascular disease, including but not limited to: (1) congestive heart failure (NYHA classification >2); (2) unstable angina; (3) myocardial infarction within the past 3 months; (4) any supraventricular or ventricular arrhythmia requiring treatment or intervention.
- Has interstitial pneumonia or clinically significant active pneumonia at screening, or other respiratory diseases that seriously affect pulmonary function.
- Has an active infection requiring systemic antibiotic therapy (local use of antibiotics excluded) or has unexplained fever >38.5℃ at screening, excluding fever due to cancer.
- Has had arterial and/or venous thrombotic events within the past 5 months, such as cerebrovascular accident, deep vein thrombosis, or pulmonary embolism.
- Is currently participating in or has participated in another clinical trial within the last 4 weeks and received other investigational drug treatments. If the participant is in the follow-up phase of a previous clinical trial and has had at least 4 weeks since the last investigational drug or removal of investigational devices, they may be eligible for this study.
- Has known psychiatric disorders, alcoholism, substance abuse, or drug abuse.
- Is pregnant or breastfeeding.
- Study Drug-Related Exclusion Criteria:
- Has any active autoimmune disease, history of autoimmune disease, or disease requiring systemic corticosteroids or immunosuppressive therapy (e.g., >10 mg/day prednisone or equivalent). Hormone replacement therapy (e.g., thyroid hormone, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency) is allowed.
- Has a history of congenital or acquired immunodeficiency (e.g., positive serology test for HIV).
- Has had active tuberculosis within the past year or has a history of active tuberculosis more than one year ago but did not receive regular treatment.
- Has active hepatitis B or hepatitis C. Participants who are hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive may participate provided that the HBV DNA level is below the lower limit of normal for the study center. Participants who are hepatitis C antibody positive may participate provided that the HCV RNA level is below the lower limit of normal for the study center. Carriers of HBV or HCV must receive antiviral therapy and undergo regular DNA copy number tests during the trial.
- Has active syphilis.
- Has received a live attenuated vaccine within 4 weeks prior to enrollment or plans to receive a live attenuated vaccine during the trial.
- Has previously received allogeneic bone marrow or organ transplants.
- Has a history of allergy to any of the study drugs (including but not limited to DC cell vaccine, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40, antibiotics (β-lactam antibiotics, gentamicin), or SHR-1210) or their components.
- Has participated in a clinical trial using immune experimental therapies (such as monoclonal antibodies, cytokines, or active cellular immunotherapies) within the last 6 months.
- Has a history of Grade ≥2 neuropathy.
- Is taking any medication prohibited in combination with study treatments, unless the medication was stopped within 7 days prior to enrollment.
- Has any condition, therapy, or laboratory abnormality that might interfere with study results, affect participation for the full duration of the study, or render participation not in the participant's best interest, as determined by the investigator.
- Other conditions that the investigator believes may affect the participant's safety and compliance.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of this clinical trial is to understand the safety and tolerability of CircFAM53B-219aa DC vaccine monotherapy and its combination with camrelizumab in the treatment of HER2-negative advanced breast cancer, as well as to evaluate its efficacy.
Read the detailed description
Breast cancer is one of the most common malignant tumors. Patients with HER2-negative advanced breast cancer who fail first-line treatment receive existing second-line standard treatments (mainly including endocrine therapy and chemotherapy), but the survival benefits are limited, and the recurrence and metastasis rates are high.
Nowadays, immunotherapy has become an emerging treatment method following traditional treatments. Autologous antigen-presenting cells (APCs) such as dendritic cells can be pulsed with tumor antigens in vitro to become antigen-presenting APCs, which can exert antitumor effects after being injected into the body. Clinical trials using dendritic cell vaccines for cancer treatment have confirmed the successful induction of immune responses and potential clinical benefits.
Previous founding in this project discovered that CircFAM53B, which is specifically highly expressed in breast cancer tissues, encodes HLA-A*02:01-restricted peptide CircFAM53B-219aa. In vitro studies have shown that CircFAM53B-219aa has the ability to activate antigen-specific T cell immune responses, and animal models have demonstrated that using CircFAM53B-219aa-loaded DC cells to activate antigen-specific T cells can significantly inhibit the growth of tumors with high CircFAM53B expression.The purpose of this clinical trial is to understand the safety and tolerability of CircFAM53B-219aa DC vaccine monotherapy and its combination with camrelizumab in the treatment of HER2-negative advanced breast cancer, as well as to evaluate its efficacy.
- Conditions
- Breast Neoplasms
- Being tested
- CircFam53B-219aa DC vaccine, camrelizumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CircFam53B-219aa DC vaccineBiological
Dendritic cell vaccine loaded with circular RNA-encoded cryptic peptide. Administer intradermally once every 3 weeks according to a dose-escalation gradient of 0.5-1×10⁷, 1.5-2×10⁷, and 4-5×10⁷ cells.
camrelizumabDrug
Camrelizumab for Injection, 200 mg IV infusion, administered once every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| CircFam53B-219aa DC vaccine | Experimental | Subjects enrolled in the dose-escalation phase will receive CircFam53B-219aa DC vaccine once every 3 weeks according to the study protocol. Evaluations will be conducted every 6 weeks. If the investigator deems that the subject is deriving clinical benefit and with the subject's consent, additional vaccinations may be administered until unacceptable toxicity occurs, consent is withdrawn, or disease progression is observed. Receives: Biological: CircFam53B-219aa DC vaccine |
| CircFam53B-219aa DC vaccine+camrelizumab | Experimental | Subjects enrolled in the sample size expansion phase will receive CircFam53B-219aa DC vaccine combined with camrelizumab once every 3 weeks. Evaluations will be conducted every 6 weeks. If the investigator deems that the subject is deriving clinical benefit and with the subject's consent, additional vaccinations may be administered until unacceptable toxicity occurs, consent is withdrawn, or disease progression is observed. Receives: Biological: CircFam53B-219aa DC vaccine; Drug: camrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicity (DLT)
DLT (Dose-Limiting Toxicity) is defined as the following adverse events occurring during the first cycle (21 days) of treatment with the CircFAM53B-219aa DC vaccine, and deemed related to the study vaccine by the investigator.
Any adverse event resulting in death, for which it is unclear if it is due to the study disease, pre-existing conditions, new complications, or unrelated to treatment, is also considered a DLT.
Measured: From the vaccine up to 21 days post-injection
Incidence of Grade≥3 Treatment-Emergent Adverse Event (TEAE)
Adverse events are reported based upon CTCAE version 5.0 criteria. The incidence of Grade≥3 TEAE occurring within the 21 days immediately after DC vaccine will be summarized with descriptive statistics.
Measured: From the vaccine up to 21 days post-injection
Secondary outcomes (3)
Objective Response Rate (ORR)
Objective response rate is defined as the percentage of participants in the analysis population who have achieved complete response (CR) or partial response (PR) assessed by modified RECIST criteria by breast MRI during the study. The percentage of participants who experienced a CR or PR is presented.
Measured: Up to approximately two years
Overall Survival (OS)
Overall survival is defined as the time from enrollment to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up.
Measured: Up to approximately two years
Progression Free Survival (PFS)
Progression Free Survival is defined as the time from enrollment to disease progression or death due to any cause.
Measured: Up to approximately two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erwei Song, M.D., Ph.D., Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigators
- Erwei Song, M.D.. Ph.D., Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530082
- Sponsor's protocol ID
- 202402
- Status last verified
- Jul 2024
- First submitted
- 28 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Clinical Study of Dendritic Cell Vaccine Loaded With Circular RNA Encoding Cryptic Peptide for Patients With HER2-negative Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT06530082
- Acronym / sponsor ID
- 202402
- Conditions
- Breast Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 31 Jul 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.
The purpose of this clinical trial is to understand the safety and tolerability of CircFAM53B-219aa DC vaccine monotherapy and its combination with camrelizumab in the treatment of HER2-negative advanced breast cancer, as well as to evaluate its efficacy.
Detailed description
Breast cancer is one of the most common malignant tumors. Patients with HER2-negative advanced breast cancer who fail first-line treatment receive existing second-line standard treatments (mainly including endocrine therapy and chemotherapy), but the survival benefits are limited, and the recurrence and metastasis rates are high.
Nowadays, immunotherapy has become an emerging treatment method following traditional treatments. Autologous antigen-presenting cells (APCs) such as dendritic cells can be pulsed with tumor antigens in vitro to become antigen-presenting APCs, which can exert antitumor effects after being injected into the body. Clinical trials using dendritic cell vaccines for cancer treatment have confirmed the successful induction of immune responses and potential clinical benefits.
Previous founding in this project discovered that CircFAM53B, which is specifically highly expressed in breast cancer tissues, encodes HLA-A*02:01-restricted peptide CircFAM53B-219aa. In vitro studies have shown that CircFAM53B-219aa has the ability to activate antigen-specific T cell immune responses, and animal models have demonstrated that using CircFAM53B-219aa-loaded DC cells to activate antigen-specific T cells can significantly inhibit the growth of tumors with high CircFAM53B expression.The purpose of this clinical trial is to understand the safety and tolerability of CircFAM53B-219aa DC vaccine monotherapy and its combination with camrelizumab in the treatment of HER2-negative advanced breast cancer, as well as to evaluate its efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CircFam53B-219aa DC vaccine | Experimental | Biological: CircFam53B-219aa DC vaccineSubjects enrolled in the dose-escalation phase will receive CircFam53B-219aa DC vaccine once every 3 weeks according to the study protocol. Evaluations will be conducted every 6 weeks. If the investigator deems that the subject is deriving clinical benefit and with the subject's consent, additional vaccinations may be administered until unacceptable toxicity occurs, consent is withdrawn, or disease progression is observed. |
| CircFam53B-219aa DC vaccine+camrelizumab | Experimental | Biological: CircFam53B-219aa DC vaccine, Drug: camrelizumabSubjects enrolled in the sample size expansion phase will receive CircFam53B-219aa DC vaccine combined with camrelizumab once every 3 weeks. Evaluations will be conducted every 6 weeks. If the investigator deems that the subject is deriving clinical benefit and with the subject's consent, additional vaccinations may be administered until unacceptable toxicity occurs, consent is withdrawn, or disease progression is observed. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Have voluntarily joined the study, signed the informed consent form, and be willing and able to comply with the study protocol.
- Be a female aged 18 to 70 years (calculated on the day of signing the informed consent).
- Have been diagnosed with unresectable locally advanced or recurrent, metastatic breast cancer (stage IIIB/C or IV), HER2-negative (diagnosed according to the latest ASCO CAP guidelines), with the disease in a stable or progressive state.
- Have triple-negative breast cancer with disease progression or intolerance to prior first-line chemotherapy, or ER and/or PgR-positive breast cancer with failure in at least one line of endocrine or CDK4/6 inhibitor therapy.
- Have HLA-A*02:01 genotype (detected by peripheral blood extraction using PCR-SBT and Sanger sequencing, and typed with reference to the IMGT/HLA database).
Key exclusion criteria (29 listed)
- Has rapidly progressing breast cancer as determined by the investigator.
- Has active central nervous system metastases or carcinomatous meningitis (except stable brain metastases, those deemed not requiring medication within 2 weeks by clinical judgment, or those not dependent on hormones). Stable brain metastases that have been treated must provide at least two brain imaging assessments: (i) after completion of brain metastasis treatment, and (ii) at the screening period of this study (with a minimum of 4 weeks from (i)).
- Has spinal cord compression that has not been relieved by surgery and/or radiotherapy (patients whose symptoms have improved for ≥1 week before surgical sampling can be included).
- Has uncontrolled pleural effusion, pericardial effusion, or ascites (patients with indwelling catheters are allowed to participate).
- Has uncontrollable tumor-related pain as determined by the investigator. Participants requiring analgesic treatment must have a stable pain management plan before enrollment, and symptomatic lesions suitable for palliative radiotherapy should be treated before enrollment.
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 |
|---|---|---|
| CircFam53B-219aa DC vaccineDendritic cell vaccine loaded with circular RNA-encoded cryptic peptide. Administer intradermally once every 3 weeks according to a dose-escalation gradient of 0.5-1×10⁷, 1.5-2×10⁷, and 4-5×10⁷ cells. | Biological | CircFam53B-219aa DC vaccine, CircFam53B-219aa DC vaccine+camrelizumab |
| camrelizumabCamrelizumab for Injection, 200 mg IV infusion, administered once every 3 weeks. | Drug | CircFam53B-219aa DC vaccine+camrelizumab |
Primary outcome
Incidence of Dose-Limiting Toxicity (DLT)
Time frame: From the vaccine up to 21 days post-injection
DLT (Dose-Limiting Toxicity) is defined as the following adverse events occurring during the first cycle (21 days) of treatment with the CircFAM53B-219aa DC vaccine, and deemed related to the study vaccine by the investigator. Any adverse event resulting in death, for which it is unclear if it is due to the study disease, pre-existing conditions, new complications, or unrelated to treatment, is also considered a DLT.
Incidence of Grade≥3 Treatment-Emergent Adverse Event (TEAE)
Time frame: From the vaccine up to 21 days post-injection
Adverse events are reported based upon CTCAE version 5.0 criteria. The incidence of Grade≥3 TEAE occurring within the 21 days immediately after DC vaccine will be summarized with descriptive statistics.
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to approximately two years
Overall Survival (OS)
Time frame: Up to approximately two years
Progression Free Survival (PFS)
Time frame: Up to approximately two 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 31 Jul 2024.
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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.
Erwei Song, M.D.. Ph.D. principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CircFam53B-219aa DC vaccine and camrelizumab in people with Breast Neoplasms, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
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 23 inclusion and 29 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: opening soon, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Shicheng Su, M.D.. Ph.D. (+86 13632394954, DCvaccine@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicity (DLT) (time frame: From the vaccine up to 21 days post-injection). The study lists 2 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 31 Jul 2024.