HER2-Positive Solid TumorsPhase 1NCT04501770
A Study of M802 (HER2 and CD3) in HER2-Positive Advanced Solid Tumors
A Phase 1 study testing Chort 1 of M802, Chort 2 of M802 and Cohort 3 of M802 in people with HER2-Positive Solid Tumors, run by Wuhan YZY Biopharma Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of different doses of M802 in patients with HER2-positive advanced solid tumors, and to determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) so as to provide basis for the recommended phase 2 dose (RP2D). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-Positive Solid Tumors
- What is being tested?
- Chort 1 of M802, Chort 2 of M802 and Cohort 3 of M802
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 27 Sep 2018to 14 Sep 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females, aged ≥18 years old.
- Patients must have a diagnosis of histologically or cytologically confirmed metastatic advanced solid tumor with failure to standard treatment and who have no available therapy that may confer clinical benefit. Patients with HER2-positive metastatic breast cancer should have received standard anti-HER2 therapies.
- HER2 expression status report should be provided during the screening period with fluorescence in-situ hybridization (FISH) or Chromogenic in situ hybridization (CISH) test positive, or immunohistochemistry IHC 3+, or immunohistochemistry IHC 2+ and confirmed by amplification of FISH or CISH.
- Patients must have stopped anti-tumor treatment for at least 4 weeks prior to the first dose of M802. The anti-tumor treatment includes chemotherapy, immunotherapy, targeted therapy, endocrine therapy, and radiotherapy (except for local radiation therapy for alleviating pain, at least 14 days after end of treatment).
- Patients must have measurable lesions at baseline according to the RECIST Version 1.1.
- Patients must have an ECOG performance status (PS) Score of 0-1.
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- Patients must have an expected survival > 12 weeks.
- Patients must have a baseline left ventricular ejection fraction (LVEF) ≥ 50%.
- Patients must have adequate haematological and organ functions as indicated by the following laboratory values:
- Haematological: Absolute Neutrophil Count (ANC) ≥ 1.5 ×10^9/L; Blood Platelet Count (BPC) ≥ 80 ×10^9/L; Hemoglobin ≥ 9.0 g/dL (No blood transfusions within 14 days).
- Hepatic: Bilirubin ≤ 1.5 × upper limit of normal (ULN); AST and ALT ≤ 2.5 × ULN (AST, ALT ≤ 5 × ULN is allowed when there is liver metastasis).
- Renal: Serum creatinine ≤ 1.5 × ULN.
- Patients must understand and voluntarily agree to participate by signing written informed consent.
Who cannot join
- Patients who had prior treatment with trastuzumab or similar monoclonal drugs within 4 weeks before first dosing of M802.
- Patients with brain metastasis.
- Patients who have uncontrollable active infections (Grade ≥ 2 according to CTCAE Version 5.0).
- Patients with severe respiratory disease who are not suitable for the study at the judgment of investigator.
- Patients with severe immunosuppression (long-term use of immunosuppressant or glucocorticoid with daily dosage of dexamethasone ≥10 mg).
- Patients who have other malignant tumors in the past 5 years, except the complete cured cervical carcinoma in situ or basal cell or squamous cell carcinoma.
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- Patients with a history of serious cardiovascular disease, including receiving coronary artery bypass grafts or coronary stenting, occurrence of myocardial infarction, congestive heart failure within 6 months, or a history of unstable angina, uncontrolled severe hypertension or arrhythmia requiring medication.
- Patients with a history of autoimmune diseases (e.g. inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis).
- Patients with severe hyperthyroidism or hypothyroidism.
- Patients with metabolic diseases such as uncontrolled diabetes, severe gastrointestinal bleeding, severe diarrhea (Grade ≥ 2 according to CTCAE Version 5.0), or severe gastrointestinal obstruction requiring intervention.
- Patients with a history of immunodeficiency, including HIV positive.
- Patients with Hepatitis b surface antigen test positive or hepatitis c antibody test positive.
- Patients who have received inoculation of (attenuated) live virus vaccine within 4 weeks before first dosing of M802.
- Pregnant, lactating women, or females or males who have fertility plan within 12 months.
- Patients with a previous history of definite neurological or psychiatric disorders, including epilepsy or dementia.
- Patients who participated in clinical studies of other drugs within 4 weeks prior to first dosing of M802 (using last dosing of other drug's clinical studies as end).
- Patients with adverse reactions from previous treatment haven't recovered to grade 1 according to CTCAE Version 5.0 (except for residual effect on hair loss).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity Profiles of the Recombinant Anti-HER2 and Anti-CD3 Humanized Bispecific Antibody (M802) in HER2-Positive Advanced Solid Tumors
The purpose of this study is to evaluate the safety and tolerability of different doses of M802 in patients with HER2-positive advanced solid tumors, and to determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) so as to provide basis for the recommended phase 2 dose (RP2D).
- Conditions
- HER2-Positive Solid Tumors
- Being tested
- Chort 1 of M802, Chort 2 of M802, Cohort 3 of M802, Cohort 4 of M802, Cohort 5 of M802
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chort 1 of M802Drug
Cohort 1, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 2 μg, and the maintenance dose during core treatment period and extended treatment period is 5 μg.
Chort 2 of M802Drug
Cohort 2, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 5 μg, and the maintenance dose during core treatment period and extended treatment period is 10 μg.
Cohort 3 of M802Drug
Cohort 3, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 10 μg, and the maintenance dose during core treatment period and extended treatment period is 20 μg.
Cohort 4 of M802Drug
Cohort 4, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 20 μg, and the maintenance dose during core treatment period and extended treatment period is 50 μg.
Cohort 5 of M802Drug
Cohort 5, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 50 μg, and the maintenance dose during core treatment period and extended treatment period is 100 μg.
Cohort 6 of M802Drug
Cohort 6, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 100 μg, and the maintenance dose during core treatment period and extended treatment period is 150 μg.
Cohort 7 of M802Drug
Cohort 7, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. Dose on D1 is 150 μg, and on D8, D15, D22 is 225 μg.
Cohort 8 of M802Drug
Cohort 8, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 225 μg, and the maintenance dose during core treatment period and extended treatment period is 300 μg.
| Study group | Role | What they receive |
|---|---|---|
| M802 | Experimental | Subjects who meet the enrollment criteria will enter the core treatment period and receive a cycle of treatment with M802 (once weekly for 4 weeks) via intravenous infusion. And eligible subjects who complete the core treatment period will receive a cycle of extended treatment (once weekly for 4 weeks) until disease progression or toxicity intolerance. Receives: Drug: Chort 1 of M802; Drug: Chort 2 of M802; Drug: Cohort 3 of M802; Drug: Cohort 4 of M802; Drug: Cohort 5 of M802; Drug: Cohort 6 of M802; Drug: Cohort 7 of M802; Drug: Cohort 8 of M802 |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD
Number of DLTs (dose limiting toxicities) during the first 28 days after the first administrations of study drug in each cohort.
Measured: From the time of first dosing (Day 1) until the forth dosing (Day 28)
RP2D
Incidence and severity of AEs, and SAEs, including but not limited to laboratory values, PK and biomarkers. All AEs will be classified as Grades 1 through 5 as defined by NCI CTCAE v5.0.
Measured: From the start of administration to the end of the study or 28 days after the administration is stopped (up to 1 years and 28 days)
Secondary outcomes (13)
Area under the curve (AUC) of M802
The endpoints for assessment of PK of M802 include serum concentrations of M802 at different timepoints after M802 administration.
Measured: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 1 years).
Maximum observed concentration (Cmax) of M802
The endpoints for assessment of PK of M802 include serum concentrations of M802 at different timepoints after M802 administration.
Measured: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 1 years).
Minimum observed concentration (Cmin) of M802
The endpoints for assessment of PK of M802 include serum concentrations of M802 at different timepoints after M802 administration.
Measured: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 1 years).
Expression levels of CEA
As tumor marker, expression levels of CEA will be tested in hospitals.
Measured: From the time of screening period until disease progression or toxicity intolerance (up to 1 years and 28 days).
Expression levels of CA15-3
As tumor marker, expression levels of CA15-3 will be tested in hospitals.
Measured: From the time of screening period until disease progression or toxicity intolerance (up to 1 years and 28 days).
Expression levels of CA125
As tumor marker, expression levels of CA125 will be tested in hospitals.
Measured: From the time of screening period until disease progression or toxicity intolerance (up to 1 years and 28 days).
Expression levels of CA19-9
As tumor marker, expression levels of CA19-9 will be tested in hospitals.
Measured: From the time of screening period until disease progression or toxicity intolerance (up to 1 years and 28 days).
Expression levels of CA72-4
As tumor marker, expression levels of CA72-4 will be tested in hospitals.
Measured: From the time of screening period until disease progression or toxicity intolerance (up to 1 years and 28 days).
Cytokines
The levels of pharmacodynamic cytokines will be determined at the PD central laboratory.
Measured: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 1 years).
Number of subjects who develop detectable anti-drug antibodies (ADAs)
The immunogenicity of M802 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs).
Measured: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 1 years).
The antibody titer of the neutralizing antibody
The immunogenicity of M802 will be collected by testing the antibody titer of the neutralizing antibody.
Measured: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 1 years).
ORR
Objective response rate (ORR) is defined as the proportion of patients with complete response (CR) and partial response (PR), based on RECIST Version 1.1.
Measured: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 1 years).
DCR
Disease Control Rate (DCR) is defined as the proportion of patients with complete response (CR) and partial response (PR), based on RECIST Version 1.1.
Measured: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 1 years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start27 Sep 2018
- Primary completion6 May 2022
- Study completion14 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-Positive Solid TumorsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuhan YZY Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04501770
- Sponsor's protocol ID
- M80201
- Status last verified
- Jul 2025
- First submitted
- 31 Jul 2020
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity Profiles of the Recombinant Anti-HER2 and Anti-CD3 Humanized Bispecific Antibody (M802) in HER2-Positive Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04501770
- Acronym / sponsor ID
- M80201
- Conditions
- HER2-Positive Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Wuhan YZY Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Sep 2018 (actual)
- Primary completion
- 6 May 2022 (actual)
- Study completion
- 14 Sep 2022 (actual)
- First posted
- 6 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 the safety and tolerability of different doses of M802 in patients with HER2-positive advanced solid tumors, and to determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) so as to provide basis for the recommended phase 2 dose (RP2D).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| M802 | Experimental | Drug: Chort 1 of M802, Drug: Chort 2 of M802, Drug: Cohort 3 of M802, Drug: Cohort 4 of M802, Drug: Cohort 5 of M802, Drug: Cohort 6 of M802, Drug: Cohort 7 of M802, Drug: Cohort 8 of M802Subjects who meet the enrollment criteria will enter the core treatment period and receive a cycle of treatment with M802 (once weekly for 4 weeks) via intravenous infusion. And eligible subjects who complete the core treatment period will receive a cycle of extended treatment (once weekly for 4 weeks) until disease progression or toxicity intolerance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Males or females, aged ≥18 years old.
- Patients must have a diagnosis of histologically or cytologically confirmed metastatic advanced solid tumor with failure to standard treatment and who have no available therapy that may confer clinical benefit. Patients with HER2-positive metastatic breast cancer should have received standard anti-HER2 therapies.
- HER2 expression status report should be provided during the screening period with fluorescence in-situ hybridization (FISH) or Chromogenic in situ hybridization (CISH) test positive, or immunohistochemistry IHC 3+, or immunohistochemistry IHC 2+ and confirmed by amplification of FISH or CISH.
- Patients must have stopped anti-tumor treatment for at least 4 weeks prior to the first dose of M802. The anti-tumor treatment includes chemotherapy, immunotherapy, targeted therapy, endocrine therapy, and radiotherapy (except for local radiation therapy for alleviating pain, at least 14 days after end of treatment).
- Patients must have measurable lesions at baseline according to the RECIST Version 1.1.
Key exclusion criteria (17 listed)
- Patients who had prior treatment with trastuzumab or similar monoclonal drugs within 4 weeks before first dosing of M802.
- Patients with brain metastasis.
- Patients who have uncontrollable active infections (Grade ≥ 2 according to CTCAE Version 5.0).
- Patients with severe respiratory disease who are not suitable for the study at the judgment of investigator.
- Patients with severe immunosuppression (long-term use of immunosuppressant or glucocorticoid with daily dosage of dexamethasone ≥10 mg).
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 |
|---|---|---|
| Chort 1 of M802Cohort 1, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 2 μg, and the maintenance dose during core treatment period and extended treatment period is 5 μg. | Drug | M802 |
| Chort 2 of M802Cohort 2, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 5 μg, and the maintenance dose during core treatment period and extended treatment period is 10 μg. | Drug | M802 |
| Cohort 3 of M802Cohort 3, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 10 μg, and the maintenance dose during core treatment period and extended treatment period is 20 μg. | Drug | M802 |
| Cohort 4 of M802Cohort 4, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 20 μg, and the maintenance dose during core treatment period and extended treatment period is 50 μg. | Drug | M802 |
| Cohort 5 of M802Cohort 5, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 50 μg, and the maintenance dose during core treatment period and extended treatment period is 100 μg. | Drug | M802 |
| Cohort 6 of M802Cohort 6, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 100 μg, and the maintenance dose during core treatment period and extended treatment period is 150 μg. | Drug | M802 |
| Cohort 7 of M802Cohort 7, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. Dose on D1 is 150 μg, and on D8, D15, D22 is 225 μg. | Drug | M802 |
| Cohort 8 of M802Cohort 8, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 225 μg, and the maintenance dose during core treatment period and extended treatment period is 300 μg. | Drug | M802 |
Primary outcome
MTD
Time frame: From the time of first dosing (Day 1) until the forth dosing (Day 28)
Number of DLTs (dose limiting toxicities) during the first 28 days after the first administrations of study drug in each cohort.
RP2D
Time frame: From the start of administration to the end of the study or 28 days after the administration is stopped (up to 1 years and 28 days)
Incidence and severity of AEs, and SAEs, including but not limited to laboratory values, PK and biomarkers. All AEs will be classified as Grades 1 through 5 as defined by NCI CTCAE v5.0.
13 secondary outcomes
Area under the curve (AUC) of M802
Time frame: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 1 years).
Maximum observed concentration (Cmax) of M802
Time frame: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 1 years).
Minimum observed concentration (Cmin) of M802
Time frame: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 1 years).
Expression levels of CEA
Time frame: From the time of screening period until disease progression or toxicity intolerance (up to 1 years and 28 days).
Expression levels of CA15-3
Time frame: From the time of screening period until disease progression or toxicity intolerance (up to 1 years and 28 days).
Expression levels of CA125
Time frame: From the time of screening period until disease progression or toxicity intolerance (up to 1 years and 28 days).
Expression levels of CA19-9
Time frame: From the time of screening period until disease progression or toxicity intolerance (up to 1 years and 28 days).
Expression levels of CA72-4
Time frame: From the time of screening period until disease progression or toxicity intolerance (up to 1 years and 28 days).
Cytokines
Time frame: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 1 years).
Number of subjects who develop detectable anti-drug antibodies (ADAs)
Time frame: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 1 years).
The antibody titer of the neutralizing antibody
Time frame: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 1 years).
ORR
Time frame: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 1 years).
DCR
Time frame: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 1 years).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Chort 1 of M802, Chort 2 of M802 and Cohort 3 of M802 in people with HER2-Positive Solid Tumors, run by Wuhan YZY Biopharma Co., Ltd. at 1 site in China.
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 13 inclusion and 17 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: finished, as of the sponsor's last update on 20 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 1 site in China. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
MTD (time frame: From the time of first dosing (Day 1) until the forth dosing (Day 28)). 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 20 Jul 2025.