Advanced Solid TumorsPhase 1NCT05879627
To Evaluate the Safety, Tolerance and Pharmacokinetics of BAT8007 for Injection in Patients With Advanced Solid Tumors
A Phase 1 study testing BAT8007 for injection in people with Advanced Solid Tumors, run by Bio-Thera Solutions at 1 site in China.
Trial summary
A multicenter, open phase I clinical study to evaluate the safety, tolerance and pharmacokinetics of BAT8007 for injection in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- BAT8007 for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteChina
- Study dates
- 17 Jan 2023to 31 Mar 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 75 years old (including the boundary value), regardless of gender;
- Sign the informed consent form voluntarily;
- Dose-climbing studies: cytologically or histologically confirmed patients with advanced solid tumors who failed standard therapy, had no standard therapy, were intolerant to standard therapy, or refused to receive standard therapy; Dose-expansion studies: Patients with cytologically or histologically confirmed locally advanced/metastatic urothelial carcinoma or other advanced or metastatic solid tumors with cytologically or histologically confirmed failure of standard therapy or intolerance to standard therapy (at least first-line systemic antitumor therapy).
- Patients in the dose increasing study must have an evaluable tumor focus, and patients in the dose expanding study must have at least one measurable tumor focus (according to RECIST 1.1 standard);
- The physical status score of the East American Cooperative Oncology Group (ECOG) is required to be 0 or 1;
- The investigator assessed that the expected survival period was ≥ 12 weeks;
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- Prepare sufficient organ and bone marrow reserve function, and the definition is as follows: blood routine test (no blood component, cell growth factor support treatment and no drug to correct the number of blood cells within 14 days before the first administration), absolute neutrophil count (ANC) ≥ 1.5 × 109/L platelet count ≥ 90 × 109/L hemoglobin ≥ 90g/L coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (those not receiving anticoagulation therapy) can be included in patients receiving oral anticoagulation therapy with INR of 2-3; Subjects currently receiving intravenous or subcutaneous anticoagulation therapy must be excluded. Liver function: total bilirubin (TBIL) generally ≤ 1.5 × ULN； Hepatocellular carcinoma, liver metastasis ≤ 2 × ULN alanine aminotransferase (ALT), aspartate aminotransferase (AST) generally ≤ 2.5 × ULN； Hepatocellular carcinoma, liver metastasis ≤ 5 × ULN Renal function: serum creatinine ≤ 1.5 × ULN or serum creatinine clearance>60ml/min (Cockcroft Gault formula is adopted, see appendix)
- Female patients with fertility must have negative serum pregnancy test within 7 days before the first administration and be willing to take effective birth control/contraception methods to prevent pregnancy during the study period until 6 months after the last administration. Male patients must agree to take effective contraceptive methods during the study period until 6 months after the last administration of the drug; Postmenopausal women must be amenorrhoea for at least 12 months before they are considered infertile;
- We must agree to abide by the epidemic prevention regulations of the host country and region against COVID-19 novel coronavirus, and minimize the exposure to COVID-19 from the screening period to the end of the study (28 days of safety follow-up);
- Able to understand the test requirements, willing and able to follow the test and follow-up procedures.
Who cannot join
- Within 4 weeks before the first administration of the study drug, he received experimental drug treatment;
- Subjects who have received previous treatment with Nectin-4 or related target research drugs (not limited to antibody, ADC, etc.);
- Have received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks before the first use of the study drug, except for the following: ① Nitrosourea or mitomycin C within 6 weeks before the first use of the study drug; ② Oral fluorouracil and small molecule targeted drugs were taken 2 weeks before the first use of the study drug or within 5 half lives of the drug (whichever is longer); ③ Within 2 weeks before the first use of the investigational drug, the systematic treatment of traditional Chinese medicine/Chinese patent medicine with clear anti-tumor effect and drugs with immunomodulatory effect (including but not limited to thymosin, interferon, interleukin, etc.); ④ Palliative radiotherapy was performed within 2 weeks before the first use of the study drug;
- After receiving any topoisomerase I inhibitor (such as irinotecan) in the past, there has been a drug related or unknown AE ≥ 3 levels (using CTCAE version 5.0 for grading);
- Before the first administration of the study drug, AE (CTCAE version 5.0) caused by previous anti-tumor treatment was still greater than grade 1, except for the following circumstances: a. alopecia; B pigmentation; c. The distal neurotoxicity caused by chemotherapy and radiotherapy can not be further recovered after judgment; d. Stable hypothyroidism after hormone replacement therapy;
- Patients who have undergone major surgery or have not recovered from surgery within 4 weeks before the first administration of the study drug, or have experienced significant trauma, or need to undergo elective surgery during the trial. Note: Those who have undergone minor surgery ≥ 28 days before screening must have fully recovered from the surgery before the first administration, except for the indwelling operation at the intravenous infusion port;
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- Have a history of allograft cell or solid organ transplantation;
- Primary central nervous system tumor or symptomatic central nervous system metastasis (meningeal metastasis with or without symptoms must be excluded). Patients with asymptomatic or symptomatic central nervous system metastasis who have reached clinical control but are judged by the researcher to be stable can be included, but the following conditions must be met simultaneously: a The clinical symptoms were stable ≥ 4 weeks before the first administration; b. No evidence of progression of central nervous system disease was found in brain MRI enhancement within 4 weeks before the first administration; c. The antiepileptic drugs have been stopped at least 2 weeks before the first medication;
- In the dose expansion study, there were other active malignant tumors within 3 years before the first administration. Except for locally cured tumors (such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer or breast cancer in situ);
- The following cardiovascular diseases occurred within 6 months before the first drug use: symptomatic heart failure with NYHA grade of 2 or above, left ventricular ejection fraction (LVEF)<50%, unstable arrhythmia or unstable angina pectoris, myocardial infarction requiring treatment, pulmonary embolism Uncontrolled hypertension (this protocol is defined as systolic blood pressure > 160mmHg and/or diastolic blood pressure > 100mmHg after treatment, although the optimal antihypertensive treatment is used, and it is evaluated by the researcher as clinically significant). Note: 3 times of 12 lead ECG suggested that QTc interval extension>450 ms (male) or>470 ms (female) should be excluded; The patients with atrial fibrillation or paroxysmal supraventricular tachycardia that must be treated can be considered to be included after the investigator has assessed that the condition is stable;
- Suffering from any other disease, physical examination or laboratory examination results, which are not suitable for the use of the study drug according to the judgment of the investigator;
- Subjects who had previously suffered from non infectious pneumonia/pulmonary inflammation requiring glucocorticoid treatment, or currently suffered from interstitial lung disease (ILD), or failed to rule out ILD/pulmonary inflammation through imaging examination during the screening period;
- Untreated or under treatment tuberculosis subjects, including but not limited to tuberculosis; Those who have been treated with standardized anti tuberculosis treatment and confirmed to be cured by researchers can be included;
- Serious infection occurred within 4 weeks or active infection occurred within 2 weeks before the first medication;
- People infected with the following diseases: human immunodeficiency virus (HIV) infection; Active hepatitis B virus infected persons [hepatitis B surface antigen (HBsAg) is positive, and the detection of hepatitis B virus deoxyribonucleic acid (HBV-DNA) is>200 IU/ml or 103 copies/ml]; HCV infected persons [HCV antibody and viral ribonucleic acid (HCV RNA) detection results are positive]; Treponema pallidum antibody positive and RPR positive;
- Known hypersensitivity or delayed anaphylaxis to any component of the study drug;
- It is known that there has been ≥ grade 3 allergic reaction to macromolecular protein preparation/monoclonal antibody;
- Patients with uncontrollable pleural effusion, pericardial effusion or peritoneal effusion within 2 weeks before the first administration or who need drainage;
- Those with the following risk of thrombosis or bleeding:
- Cerebrovascular accident or transient ischemic attack occurred within 6 months before the first administration;
- There is a history of deep vein thrombosis, pulmonary embolism or any other serious thromboembolism within 3 months before the first administration (implanted venous infusion port or catheter derived thrombosis, or superficial venous thrombosis is not considered as "serious" thromboembolism);
- Any life threatening bleeding event or grade 3 or 4 gastrointestinal/variceal bleeding event requiring blood transfusion, endoscopy or surgery within 3 months before the first administration;
- Other diseases that the researchers believe have a high risk of bleeding or thrombosis in the future;
- Existence of any other serious underlying disease (such as Gilbert syndrome, unstably controlled diabetes, active gastric ulcer, unstably controlled convulsion, coagulation dysfunction with serious symptoms or signs);
- Known psychiatric diseases, drug abuse history, alcohol abuse history or drug abuse history, which affect the test results;
- Pregnant or lactating women or women or men preparing for childbirth;
- Those who have received any live attenuated vaccine within 4 weeks before the first administration of the study drug. About COVID-19 vaccination: the interval between COVID-19 vaccination and the first administration must be at least 14 days, and COVID-19 vaccination is not allowed during DLT observation. Some special cases can be included in the study with the consent of the medical supervisor;
- It is estimated that the patient's compliance to participate in this clinical study is insufficient or the investigator believes that there are other factors that are not suitable for participating in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Open Phase I Clinical Study to Evaluate the Safety, Tolerance and Pharmacokinetics of BAT8007 for Injection in Patients With Advanced Solid Tumors
A multicenter, open phase I clinical study to evaluate the safety, tolerance and pharmacokinetics of BAT8007 for injection in patients with advanced solid tumors.
Read the detailed description
This is a multicenter, open, dose increasing and dose expanding Phase I clinical study. About 169~292 patients will be enrolled from research centers in China, the United States, Australia, etc. In the dose increasing stage, accelerated titration and "3+3" dose increasing design were used to explore the safety, tolerance and PK characteristics of BAT8007 for injection in patients with advanced solid tumors. During the dose increasing test, select the appropriate dose according to the previous study data for the extended study.
- Conditions
- Advanced Solid Tumors
- Being tested
- BAT8007 for injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAT8007 for injectionDrug
Also called Recombinant all human anti Nectin-4 monoclonal antibody for injection Exatecan conjugate
Intravenous infusion: once every three weeks.The infusion time in the first cycle is recommended to be ≥ 90 minutes. If no infusion reaction occurs, the subsequent cycle can be completed within 30~120 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | BAT8007 for Injection does according to protocol (frequency: Q3W) Receives: Drug: BAT8007 for injection |
| Cohort 2 | Experimental | BAT8007 for Injection does according to protocol (frequency: Q3W) Receives: Drug: BAT8007 for injection |
| Cohort 3 | Experimental | BAT8007 for Injection does according to protocol (frequency: Q3W) Receives: Drug: BAT8007 for injection |
| Cohort 4 | Experimental | BAT8007 for Injection does according to protocol (frequency: Q3W) Receives: Drug: BAT8007 for injection |
| Cohort 5 | Experimental | BAT8007 for Injection does according to protocol (frequency: Q3W) Receives: Drug: BAT8007 for injection |
| Cohort 6 | Experimental | BAT8007 for Injection does according to protocol (frequency: Q3W) Receives: Drug: BAT8007 for injection |
| Cohort 7 | Experimental | BAT8007 for Injection does according to protocol (frequency: Q3W) Receives: Drug: BAT8007 for injection |
| Cohort 8 | Experimental | BAT8007 for Injection does according to protocol (frequency: Q3W) Receives: Drug: BAT8007 for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT)
number of subjects who experience DLT events during 21 days. Toxicity will be graded according to NCI CTCAE, Version 5.0.
Measured: A minimum of 21 days after first dose of BAT8007
Adverse Events (AEs)
Incidence of treatment -related AEs as assessed by NCI CTCAE, Version 5.0.
Measured: AE needs continuous monitoring and evaluation from the first administration to 28 days after the last administration or before receiving new anti-tumor treatment.
Secondary outcomes (6)
Anti-drug antibodies (ADA)
Level of ADA
Measured: up to Cycle 3, each cycle is 14 days
neutralizing antibodies (NAb)
Level of NAb
Measured: up to Cycle 3, each cycle is 14 days
Cmax
Level of Cmax
Measured: up to Cycle 3, each cycle is 14 days
Tmax (Time to reach maximum serum concentration)
Level of Cmax
Measured: up to Cycle 3, each cycle is 14 days
T1/2 (terminal half-life)
Level of T1/2
Measured: up to Cycle 3, each cycle is 14 days
Systemic Clearance (CL)
Level of CL
Measured: up to Cycle 3, each cycle is 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start17 Jan 2023
- Primary completion18 Aug 2025
- Study completion31 Mar 2026
Why it stopped: Due to the adjustment of our company's research and development strategy, we are now prematurely terminating this project.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio-Thera Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zhejiang Tumor Hospital
- Responsible party
- Sponsor
- Investigators
- Xiangdong Cheng, PI, Principal investigator, Medical Ethics Committee of Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05879627
- Sponsor's protocol ID
- BAT-8007-001-CR
- Status last verified
- Jul 2025
- First submitted
- 7 Feb 2023
- Last updated
- 13 Apr 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 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open Phase I Clinical Study to Evaluate the Safety, Tolerance and Pharmacokinetics of BAT8007 for Injection in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05879627
- Acronym / sponsor ID
- BAT-8007-001-CR
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the adjustment of our company's research and development strategy, we are now prematurely terminating this project.
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Bio-Thera SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- Zhejiang Tumor Hospital
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 18 Aug 2025 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 30 May 2023 (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.
A multicenter, open phase I clinical study to evaluate the safety, tolerance and pharmacokinetics of BAT8007 for injection in patients with advanced solid tumors.
Detailed description
This is a multicenter, open, dose increasing and dose expanding Phase I clinical study. About 169~292 patients will be enrolled from research centers in China, the United States, Australia, etc. In the dose increasing stage, accelerated titration and "3+3" dose increasing design were used to explore the safety, tolerance and PK characteristics of BAT8007 for injection in patients with advanced solid tumors. During the dose increasing test, select the appropriate dose according to the previous study data for the extended study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: BAT8007 for injectionBAT8007 for Injection does according to protocol (frequency: Q3W) |
| Cohort 2 | Experimental | Drug: BAT8007 for injectionBAT8007 for Injection does according to protocol (frequency: Q3W) |
| Cohort 3 | Experimental | Drug: BAT8007 for injectionBAT8007 for Injection does according to protocol (frequency: Q3W) |
| Cohort 4 | Experimental | Drug: BAT8007 for injectionBAT8007 for Injection does according to protocol (frequency: Q3W) |
| Cohort 5 | Experimental | Drug: BAT8007 for injectionBAT8007 for Injection does according to protocol (frequency: Q3W) |
| Cohort 6 | Experimental | Drug: BAT8007 for injectionBAT8007 for Injection does according to protocol (frequency: Q3W) |
| Cohort 7 | Experimental | Drug: BAT8007 for injectionBAT8007 for Injection does according to protocol (frequency: Q3W) |
| Cohort 8 | Experimental | Drug: BAT8007 for injectionBAT8007 for Injection does according to protocol (frequency: Q3W) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 to 75 years old (including the boundary value), regardless of gender;
- Sign the informed consent form voluntarily;
- Dose-climbing studies: cytologically or histologically confirmed patients with advanced solid tumors who failed standard therapy, had no standard therapy, were intolerant to standard therapy, or refused to receive standard therapy; Dose-expansion studies: Patients with cytologically or histologically confirmed locally advanced/metastatic urothelial carcinoma or other advanced or metastatic solid tumors with cytologically or histologically confirmed failure of standard therapy or intolerance to standard therapy (at least first-line systemic antitumor therapy).
- Patients in the dose increasing study must have an evaluable tumor focus, and patients in the dose expanding study must have at least one measurable tumor focus (according to RECIST 1.1 standard);
- The physical status score of the East American Cooperative Oncology Group (ECOG) is required to be 0 or 1;
Key exclusion criteria (28 listed)
- Within 4 weeks before the first administration of the study drug, he received experimental drug treatment;
- Subjects who have received previous treatment with Nectin-4 or related target research drugs (not limited to antibody, ADC, etc.);
- Have received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks before the first use of the study drug, except for the following: ① Nitrosourea or mitomycin C within 6 weeks before the first use of the study drug; ② Oral fluorouracil and small molecule targeted drugs were taken 2 weeks before the first use of the study drug or within 5 half lives of the drug (whichever is longer); ③ Within 2 weeks before the first use of the investigational drug, the systematic treatment of traditional Chinese medicine/Chinese patent medicine with clear anti-tumor effect and drugs with immunomodulatory effect (including but not limited to thymosin, interferon, interleukin, etc.); ④ Palliative radiotherapy was performed within 2 weeks before the first use of the study drug;
- After receiving any topoisomerase I inhibitor (such as irinotecan) in the past, there has been a drug related or unknown AE ≥ 3 levels (using CTCAE version 5.0 for grading);
- Before the first administration of the study drug, AE (CTCAE version 5.0) caused by previous anti-tumor treatment was still greater than grade 1, except for the following circumstances: a. alopecia; B pigmentation; c. The distal neurotoxicity caused by chemotherapy and radiotherapy can not be further recovered after judgment; d. Stable hypothyroidism after hormone replacement 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 |
|---|---|---|
| BAT8007 for injectionAlso: Recombinant all human anti Nectin-4 monoclonal antibody for injection Exatecan conjugateIntravenous infusion: once every three weeks.The infusion time in the first cycle is recommended to be ≥ 90 minutes. If no infusion reaction occurs, the subsequent cycle can be completed within 30~120 minutes. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Cohort 8 |
Primary outcome
Dose limiting toxicity (DLT)
Time frame: A minimum of 21 days after first dose of BAT8007
number of subjects who experience DLT events during 21 days. Toxicity will be graded according to NCI CTCAE, Version 5.0.
Adverse Events (AEs)
Time frame: AE needs continuous monitoring and evaluation from the first administration to 28 days after the last administration or before receiving new anti-tumor treatment.
Incidence of treatment -related AEs as assessed by NCI CTCAE, Version 5.0.
6 secondary outcomes
Anti-drug antibodies (ADA)
Time frame: up to Cycle 3, each cycle is 14 days
neutralizing antibodies (NAb)
Time frame: up to Cycle 3, each cycle is 14 days
Cmax
Time frame: up to Cycle 3, each cycle is 14 days
Tmax (Time to reach maximum serum concentration)
Time frame: up to Cycle 3, each cycle is 14 days
T1/2 (terminal half-life)
Time frame: up to Cycle 3, each cycle is 14 days
Systemic Clearance (CL)
Time frame: up to Cycle 3, each cycle is 14 days
Results and safety
The study was stopped early (reason given: Due to the adjustment of our company's research and development strategy, we are now prematurely terminating this project.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 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. This study is not recruiting at the moment.
Xiangdong Cheng, PI principal investigator
Medical Ethics Committee of Zhejiang Cancer Hospital
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 BAT8007 for injection in people with Advanced Solid Tumors, run by Bio-Thera Solutions 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 10 inclusion and 28 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: stopped early, as of the sponsor's last update on 13 Apr 2026. 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 was stopped early (reason given: Due to the adjustment of our company's research and development strategy, we are now prematurely terminating this project.). Results are not available in the source record.
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?
Dose limiting toxicity (DLT) (time frame: A minimum of 21 days after first dose of BAT8007). 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 13 Apr 2026.