Urinary Bladder NeoplasmsPhase 2/3HOPE-07-MIBCNCT07608224
HOPE-07-MIBC: Disitamab Vedotin Plus Immunotherapy vs Chemoimmunotherapy in Resectable HER2-Expressing MIBC
A Phase 2/3 study testing Disitamab Vedotin (RC48), Gemcitabine + Cisplatin（GC）+Toripalimab and Toripalimab (JS001 ) in people with Urinary Bladder Neoplasms, run by West China Hospital.
Trial summary
This is a multicenter, randomized controlled clinical trial (HOPE-07) designed to evaluate the efficacy and safety of perioperative treatment with disitamab vedotin (RC48) combined with toripalimab compared with toripalimab combined with chemotherapy in patients with resectable HER2-expressing (HER2 1+, 2+, or 3+)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder Neoplasms
- What is being tested?
- Disitamab Vedotin (RC48), Gemcitabine + Cisplatin（GC）+Toripalimab and Toripalimab (JS001 )
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2026to 31 Dec 2030
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent and comply with study requirements and scheduled assessments.
- Male or female patients aged ≥18 years at the time of signing informed consent.
- Histologically or radiologically confirmed muscle-invasive bladder cancer (MIBC) staged as cT2-T4aN0/1M0 according to AJCC 8th edition, with residual disease after transurethral resection of bladder tumor (TURBT) as assessed by the investigator. All patients must have histological evidence of muscularis propria invasion. For mixed histology tumors, urothelial carcinoma must be the predominant component (≥50%).
- HER2 expression ≥1+ confirmed by immunohistochemistry (IHC) testing of pretreatment tumor tissue in a local laboratory.
- Deemed suitable for radical cystectomy as assessed by the investigator.
- No prior systemic chemotherapy or immunotherapy for muscle-invasive bladder cancer.
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Adequate organ function as defined by the following laboratory criteria obtained within 14 days prior to enrollment (unless otherwise specified):
- Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L Platelet count ≥100 × 10⁹/L Hemoglobin ≥90 g/L International normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤1.5 × upper limit of normal (ULN) Total bilirubin ≤1.5 × ULN AST, ALT, and alkaline phosphatase ≤2.5 × ULN Creatinine clearance (CrCl) >40 mL/min Left ventricular ejection fraction (LVEF) ≥50% For borderline renal function: CrCl ≥40 to <60 mL/min (defined subgroup); adequate renal function: CrCl ≥60 mL/min
- Women of childbearing potential must agree to use highly effective contraception during the study and for at least 180 days after the last dose of disitamab vedotin or toripalimab (whichever occurs later). A negative urine or serum pregnancy test is required within 7 days prior to enrollment.
- Non-sterilized male patients must agree to use highly effective contraception during the study and for at least 180 days after the last dose of disitamab vedotin or toripalimab (whichever occurs later).
- Life expectancy of more than 12 months.
- Willing and able to comply with study procedures and follow-up visits.
Who cannot join
- Prior treatment with therapies targeting PD-1, PD-L1, PD-L2, CTLA-4, HER2, or any other immune checkpoint or T-cell co-stimulatory pathways.
- Receipt of any systemic anticancer therapy or systemic immunomodulatory agents (e.g., interferon, interleukin-2, tumor necrosis factor) within 28 days prior to enrollment.
- Prior radiotherapy for bladder cancer.
- Prior systemic antitumor therapy for bladder cancer (e.g., chemotherapy), except for intravesical chemotherapy or immunotherapy completed at least 2 weeks prior to initiation of study treatment.
- Major surgery or significant traumatic injury within 28 days prior to enrollment. Placement of vascular access devices and transurethral resection of bladder tumor (TURBT) are not considered major surgery.
- Severe infections requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days prior to enrollment (hepatitis B virus infection is addressed in exclusion criterion 12).
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- Receipt of live vaccines within 28 days prior to enrollment (inactivated influenza vaccines are allowed; intranasal vaccines are considered live vaccines and are not allowed).
- Use of traditional Chinese medicine or proprietary Chinese medicine with anti-cancer intent within 14 days prior to enrollment.
- Active autoimmune disease requiring systemic treatment that may interfere with study therapy as judged by the investigator.
- Requirement for long-term systemic corticosteroids or other immunosuppressive therapy that may interfere with study treatment.
- Any uncontrolled comorbid conditions that may affect study participation, including but not limited to significant electrolyte abnormalities, hypoalbuminemia, interstitial lung disease, non-infectious pneumonitis, uncontrolled tuberculosis, neurological disorders, psychiatric disorders, or uncontrolled systemic diseases. This includes uncontrolled cardiovascular disease such as active cardiac disease within 6 months prior to enrollment, including severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, or clinically significant arrhythmias requiring treatment.
- Chronic hepatitis B infection with HBV DNA ≥500 IU/mL (2500 copies/mL) without adequate antiviral therapy. Patients with inactive HBsAg carrier status or well-controlled HBV infection (HBV DNA <500 IU/mL under antiviral therapy) may be eligible. HBV DNA testing is required only in HBsAg-positive patients.
- Active hepatitis C infection. Patients who are HCV antibody negative, or HCV antibody positive with negative HCV RNA, are eligible. HCV RNA testing is required for HCV antibody-positive patients.
- History of immunodeficiency, including HIV infection, other acquired or congenital immunodeficiency disorders, or prior allogeneic stem cell transplantation or solid organ transplantation.
- Known hypersensitivity to any study drug, its excipients, or other monoclonal antibodies.
- Pregnant or breastfeeding women.
- Concurrent participation in another interventional clinical trial.
- Presence of another active malignancy, except for adequately treated non-melanoma skin cancer or other malignancies considered cured.
- Any condition that, in the investigator's judgment, makes the patient unsuitable for participation in the study
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
Official title: A Prospective, Randomized Controlled Study of Perioperative Disitamab Vedotin Plus Immunotherapy Versus Chemotherapy Plus Immunotherapy in Patients With Resectable HER2-Expressing Muscle-Invasive Bladder Cancer (HOPE-07-MIBC Study)
This is a multicenter, randomized controlled clinical trial (HOPE-07) designed to evaluate the efficacy and safety of perioperative treatment with disitamab vedotin (RC48) combined with toripalimab compared with toripalimab combined with chemotherapy in patients with resectable HER2-expressing (HER2 1+, 2+, or 3+) muscle-invasive bladder cancer (MIBC, cT2-4aN0/1M0).A total of 240 patients will be enrolled and randomized in a 1:1 ratio to receive either RC48 plus toripalimab or chemotherapy plus toripalimab, with 120 patients in each arm.
The primary objective is to compare 2-year event-free survival (2-year EFS) between the two treatment groups.
Read more
Secondary endpoints include pathological complete response (pCR), event-free survival (EFS), disease-free survival (DFS), 1-year event-free survival (1-year EFS), metastasis-free survival (MFS), overall survival (OS), R0 resection rate, and safety outcomes including adverse events (AEs), serious adverse events (SAEs), vital signs, physical examination, ECOG performance status, laboratory tests, and electrocardiography, assessed according to CTCAE v5.0.
Exploratory objectives include assessment of quality of life using EQ-5D-5L and EORTC QLQ-C30, evaluation of associations between biomarkers (HER2 expression, PD-L1 expression, circulating tumor DNA) and treatment efficacy, and multi-omics analyses using tumor tissue, ctDNA, and urinary tumor DNA to identify potential predictive biomarkers.
- Conditions
- Urinary Bladder Neoplasms
- Being tested
- Disitamab Vedotin (RC48), Gemcitabine + Cisplatin（GC）+Toripalimab, Toripalimab (JS001 )
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disitamab Vedotin (RC48)Drug
Disitamab vedotin (RC48) will be administered in combination with toripalimab in the experimental arm. Treatment consists of 6 cycles in the neoadjuvant setting prior to radical cystectomy, followed by 6 cycles in the adjuvant setting after surgery. Toripalimab maintenance therapy will continue for up to 1 year in patients without disease progression or unacceptable toxicity.
Gemcitabine + Cisplatin（GC）+ToripalimabDrug
Gemcitabine and cisplatin (GC) chemotherapy will be administered in combination with toripalimab in the control arm. Treatment consists of 4 cycles in the neoadjuvant setting prior to radical cystectomy.
Toripalimab (JS001 )Drug
Toripalimab will be administered in combination with disitamab vedotin in the experimental arm during both neoadjuvant and adjuvant phases, and will be continued as maintenance therapy for up to 1 year after surgery in patients without disease progression or unacceptable toxicity.
Toripalimab (JS001 )Drug
Toripalimab will be administered in combination with GC chemotherapy in the neoadjuvant setting for 4 cycles prior to radical cystectomy and will be continued as maintenance therapy for up to 1 year after surgery in patients without disease progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Disitamab Vedotin + Anti-PD-1 Therapy | Experimental | Patients in the experimental arm will receive perioperative treatment with disitamab vedotin (RC48) in combination with toripalimab.
The treatment includes a neoadjuvant phase of 6 cycles of RC48 plus toripalimab, followed by radical cystectomy. After surgery, patients will receive 6 cycles of adjuvant therapy with RC48 plus toripalimab. Toripalimab maintenance therapy will be continued for up to 1 year in patients without disease progression or unacceptable toxicity. Receives: Drug: Disitamab Vedotin (RC48); Drug: Toripalimab (JS001 ) |
| Gemcitabine and Cisplatin plus Toripalimab | Active comparator | Patients in the control arm will receive perioperative treatment with gemcitabine and cisplatin (GC) chemotherapy in combination with toripalimab.
The treatment includes a neoadjuvant phase of 4 cycles of GC chemotherapy plus toripalimab, followed by radical cystectomy. After surgery, patients will receive toripalimab maintenance therapy for up to 1 year in patients without disease progression or unacceptable toxicity. Receives: Drug: Gemcitabine + Cisplatin（GC）+Toripalimab; Drug: Toripalimab (JS001 ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year Event-Free Survival
Event-free survival is defined as the time from randomization to disease progression, recurrence, metastasis, or death from any cause, whichever occurs firsth
Measured: From randomization to 2 years after treatment initiation
Secondary outcomes (7)
Pathological Complete Response (pCR)
Pathological complete response is defined as the absence of residual viable tumor cells in the surgical specimen (ypT0N0) at radical cystectomy.
Measured: At the time of radical cystectomy
Disease-Free Survival (DFS)
Disease-free survival is defined as the time from radical cystectomy to tumor recurrence or death from any cause, whichever occurs first.
Measured: Up to 5 years after radical cystectomy
Event-Free Survival (EFS)
Event-free survival is defined as the time from randomization to disease progression, recurrence, metastasis, or death from any cause, whichever occurs first.
Measured: Up to 5 years after randomization
Metastasis-Free Survival (MFS)
Metastasis-free survival is defined as the time from randomization to distant metastasis or death from any cause.
Measured: Up to 5 years after randomization
Overall Survival (OS)
From the date of randomization until death from any cause, assessed up to 5 years
Measured: Up to 5 years after randomization
R0 Resection Rate
R0 resection rate is defined as the proportion of patients achieving microscopically margin-negative resection at radical cystectomy.
Measured: At the time of radical cystectomy
Incidence of Adverse Events
Safety will be assessed by incidence and severity of adverse events and serious adverse events, graded according to CTCAE version 5.0. Assessments include vital signs, physical examination, ECOG performance status, laboratory tests, and electrocardiography.
Measured: From first dose until 30 days after last dose (or up to 1 year follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start20 Jun 2026 (estimated)
- Primary completion30 Jun 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder NeoplasmsStudies of the same condition, open and under way.
- More trials run by West China HospitalThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- RenJi Hospital, Tongji Hospital, The Second Affiliated Hospital of Kunming Medical University, Peking University First Hospital, The First Affiliated Hospital of Air Force Medical University, The First Affiliated Hospital with Nanjing Medical University, First Affiliated Hospital Xi'an Jiaotong University, Tianjin Medical University Second Hospital
- Responsible party
- Principal investigator, PING TAN, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07608224
- Sponsor's protocol ID
- WCH-ZP-MIBC-RCT-01
- Acronym
- HOPE-07-MIBC
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Controlled Study of Perioperative Disitamab Vedotin Plus Immunotherapy Versus Chemotherapy Plus Immunotherapy in Patients With Resectable HER2-Expressing Muscle-Invasive Bladder Cancer (HOPE-07-MIBC Study)
- ClinicalTrials.gov ID
- NCT07608224
- Acronym / sponsor ID
- HOPE-07-MIBC / WCH-ZP-MIBC-RCT-01
- Conditions
- Urinary Bladder Neoplasms
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Collaborators
- RenJi Hospital, Tongji Hospital, The Second Affiliated Hospital of Kunming Medical University, Peking University First Hospital, The First Affiliated Hospital of Air Force Medical University, The First Affiliated Hospital with Nanjing Medical University, First Affiliated Hospital Xi'an Jiaotong University, Tianjin Medical University Second Hospital
- Study start
- 20 Jun 2026 (estimated)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized controlled clinical trial (HOPE-07) designed to evaluate the efficacy and safety of perioperative treatment with disitamab vedotin (RC48) combined with toripalimab compared with toripalimab combined with chemotherapy in patients with resectable HER2-expressing (HER2 1+, 2+, or 3+) muscle-invasive bladder cancer (MIBC, cT2-4aN0/1M0).A total of 240 patients will be enrolled and randomized in a 1:1 ratio to receive either RC48 plus toripalimab or chemotherapy plus toripalimab, with 120 patients in each arm.
The primary objective is to compare 2-year event-free survival (2-year EFS) between the two treatment groups.
Secondary endpoints include pathological complete response (pCR), event-free survival (EFS), disease-free survival (DFS), 1-year event-free survival (1-year EFS), metastasis-free survival (MFS), overall survival (OS), R0 resection rate, and safety outcomes including adverse events (AEs), serious adverse events (SAEs), vital signs, physical examination, ECOG performance status, laboratory tests, and electrocardiography, assessed according to CTCAE v5.0.
Exploratory objectives include assessment of quality of life using EQ-5D-5L and EORTC QLQ-C30, evaluation of associations between biomarkers (HER2 expression, PD-L1 expression, circulating tumor DNA) and treatment efficacy, and multi-omics analyses using tumor tissue, ctDNA, and urinary tumor DNA to identify potential predictive biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Disitamab Vedotin + Anti-PD-1 Therapy | Experimental | Drug: Disitamab Vedotin (RC48), Drug: Toripalimab (JS001 )Patients in the experimental arm will receive perioperative treatment with disitamab vedotin (RC48) in combination with toripalimab. The treatment includes a neoadjuvant phase of 6 cycles of RC48 plus toripalimab, followed by radical cystectomy. After surgery, patients will receive 6 cycles of adjuvant therapy with RC48 plus toripalimab. Toripalimab maintenance therapy will be continued for up to 1 year in patients without disease progression or unacceptable toxicity. |
| Gemcitabine and Cisplatin plus Toripalimab | Active comparator | Drug: Gemcitabine + Cisplatin（GC）+Toripalimab, Drug: Toripalimab (JS001 )Patients in the control arm will receive perioperative treatment with gemcitabine and cisplatin (GC) chemotherapy in combination with toripalimab. The treatment includes a neoadjuvant phase of 4 cycles of GC chemotherapy plus toripalimab, followed by radical cystectomy. After surgery, patients will receive toripalimab maintenance therapy for up to 1 year in patients without disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Willing and able to provide written informed consent and comply with study requirements and scheduled assessments.
- Male or female patients aged ≥18 years at the time of signing informed consent.
- Histologically or radiologically confirmed muscle-invasive bladder cancer (MIBC) staged as cT2-T4aN0/1M0 according to AJCC 8th edition, with residual disease after transurethral resection of bladder tumor (TURBT) as assessed by the investigator. All patients must have histological evidence of muscularis propria invasion. For mixed histology tumors, urothelial carcinoma must be the predominant component (≥50%).
- HER2 expression ≥1+ confirmed by immunohistochemistry (IHC) testing of pretreatment tumor tissue in a local laboratory.
- Deemed suitable for radical cystectomy as assessed by the investigator.
Key exclusion criteria (19 listed)
- Prior treatment with therapies targeting PD-1, PD-L1, PD-L2, CTLA-4, HER2, or any other immune checkpoint or T-cell co-stimulatory pathways.
- Receipt of any systemic anticancer therapy or systemic immunomodulatory agents (e.g., interferon, interleukin-2, tumor necrosis factor) within 28 days prior to enrollment.
- Prior radiotherapy for bladder cancer.
- Prior systemic antitumor therapy for bladder cancer (e.g., chemotherapy), except for intravesical chemotherapy or immunotherapy completed at least 2 weeks prior to initiation of study treatment.
- Major surgery or significant traumatic injury within 28 days prior to enrollment. Placement of vascular access devices and transurethral resection of bladder tumor (TURBT) are not considered major surgery.
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 |
|---|---|---|
| Disitamab Vedotin (RC48)Disitamab vedotin (RC48) will be administered in combination with toripalimab in the experimental arm. Treatment consists of 6 cycles in the neoadjuvant setting prior to radical cystectomy, followed by 6 cycles in the adjuvant setting after surgery. Toripalimab maintenance therapy will continue for up to 1 year in patients without disease progression or unacceptable toxicity. | Drug | Disitamab Vedotin + Anti-PD-1 Therapy |
| Gemcitabine + Cisplatin（GC）+ToripalimabGemcitabine and cisplatin (GC) chemotherapy will be administered in combination with toripalimab in the control arm. Treatment consists of 4 cycles in the neoadjuvant setting prior to radical cystectomy. | Drug | Gemcitabine and Cisplatin plus Toripalimab |
| Toripalimab (JS001 )Toripalimab will be administered in combination with disitamab vedotin in the experimental arm during both neoadjuvant and adjuvant phases, and will be continued as maintenance therapy for up to 1 year after surgery in patients without disease progression or unacceptable toxicity. | Drug | Disitamab Vedotin + Anti-PD-1 Therapy |
| Toripalimab (JS001 )Toripalimab will be administered in combination with GC chemotherapy in the neoadjuvant setting for 4 cycles prior to radical cystectomy and will be continued as maintenance therapy for up to 1 year after surgery in patients without disease progression or unacceptable toxicity. | Drug | Gemcitabine and Cisplatin plus Toripalimab |
Primary outcome
2-year Event-Free Survival
Time frame: From randomization to 2 years after treatment initiation
Event-free survival is defined as the time from randomization to disease progression, recurrence, metastasis, or death from any cause, whichever occurs firsth
7 secondary outcomes
Pathological Complete Response (pCR)
Time frame: At the time of radical cystectomy
Disease-Free Survival (DFS)
Time frame: Up to 5 years after radical cystectomy
Event-Free Survival (EFS)
Time frame: Up to 5 years after randomization
Metastasis-Free Survival (MFS)
Time frame: Up to 5 years after randomization
Overall Survival (OS)
Time frame: Up to 5 years after randomization
R0 Resection Rate
Time frame: At the time of radical cystectomy
Incidence of Adverse Events
Time frame: From first dose until 30 days after last dose (or up to 1 year follow-up)
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 27 May 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Disitamab Vedotin (RC48), Gemcitabine + Cisplatin（GC）+Toripalimab and Toripalimab (JS001 ) in people with Urinary Bladder Neoplasms, run by West China Hospital.
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 19 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 27 May 2026. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Peng Zhang (186 0284 9307, zpeng2001@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year Event-Free Survival (time frame: From randomization to 2 years after treatment initiation). 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 27 May 2026.