Advanced Solid TumorPhase 1/2NCT05417321
A Study Evaluating the Safety and Efficacy of HB0036 in Subjects With Advanced Solid Tumors
A Phase 1/2 study testing HB0036 in people with Advanced Solid Tumor and NSCLC, run by Shanghai Huaota Biopharmaceutical Co., Ltd. at 4 sites in 2 countries.
Trial summary
It is a Phase I/II, Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of HB0036 in Subjects with Advanced Solid Tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, NSCLC
- What is being tested?
- HB0036
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 25 Aug 2022to 1 Aug 2025
- Phase
- Phase 1/2
- 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
- Patients must meet all the following criteria to be eligible for participation in this study:
- Male or female. Age ≥ 18 years;
- Phase I: Patients with histologically or cytologically confirmed locally advanced, recurrent, or metastatic solid tumors (or clinically diagnosed hepatocellular carcinoma) that failed all standard therapies known to provide clinical benefit; [These solid tumors include but not limit to: non-small cell lung cancer, esophageal squamous cell carcinoma, melanoma, head and neck squamous cell carcinomas, hepatocellular carcinoma, gastric or gastroesophageal junction adenocarcinoma, renal cell carcinoma, etc.];
- Phase II: Histologically or cytologically documented locally advanced, recurrent or metastatic cancer. There will be several tumor-specific cohorts Advanced non-small cell lung cancer cohort Histologically or cytologically documented locally advanced, recurrent or metastatic NSCLC; Confirmed availability of representative tumor specimens in formalin-fixed paraffin-embedded (FFPE）blocks or at least 5 stained serial slides or fresh biopsied specimens (preferred),samples obtained before adjuvant / neoadjuvant chemotherapy are allowed only if biopsy cannot be performed; Tumor PD-L1 expression with a TPS≥1 %; Negative for actionable molecular markers [including but not limited to: epidermal growth factor receptor (EGFR) mutations, anaplastic lymphoma kinase (ALK) gene fusion mutation, etc.]； Assessed by the investigator as likely to benefit from the study drug therapy; and should have progressed at least one prior systemic therapy regimen.
- Advanced other cancer cohort Histologically or cytologically documented locally advanced, recurrent or metastatic cancer (esophageal squamous cell carcinoma, melanoma) Other tumor histologies will be evaluated pending data from the dose escalation phase that may inform on possible efficacy in select tumors
- At least one measurable lesion( assessable lesion only accepted during accelerated titration stage) as per RECIST v. 1.1 defined as non-nodal lesions having at least one dimension with a minimum size of 10 mm in the longest diameter by CT or MRI scan or ≥15 mm in short axis for nodal lesions. Radiographic disease assessment at baseline can be performed up to 21 days prior to the first dose.
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- Note: Tumour lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, are not considered measurable unless there has been demonstrated progression in the lesion.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
- Life expectancy ≥12 weeks
- Adequate organ function within 14 days of the first dose as defined by the following criteria:
- Hematology
- absolute neutrophil count (ANC) ≥ 1.5×109/L;
- ② platelets (PLT) ≥ 75×109/L;
- ③ hemoglobin (HGB) ≥ 90 g/L; Note: The above three items require that patients should not have received any blood component or cell growth factor supportive therapy within two weeks prior to blood sampling.
- Renal function: Calculated creatinine clearance (CrCL) > 50 mL/min (Cockroft-Gault Equation); c) Liver function:
- AST and ALT ≤ 2.5×ULN; AST or ALT ≤5×ULN if liver metastases are present;
- ② Total bilirubin (TBIL) ≤ 1.5×ULN; ≤3 X ULN for patients with Gilbert's disease; d) Coagulation function:
- International normalized ratio (INR)or prothrombin time (PT)≤ 1.5×ULN (unless patient on oral anticoagulant with stable dose); ② Activated partial thromboplastin time (APTT)≤ 1.5×ULN;
- Women of childbearing potential must confirm a negative serum or urine pregnancy test within 3 days prior to the initiation of study treatment; Fertile patients and their partners must agree to use effective contraceptives for the duration of study drug use and for 90 days after the last administration of study treatment
- Recovery to Grade 0-1 from adverse events (AEs) related to prior anticancer therapy except alopecia, < Grade 2 sensory neuropathy, and endocrinopathies controlled with hormone replacement therapy
- The subject is able to understand and willing to sign the ICF; willing and able to comply with all study procedures.
Who cannot join
- Patients are excluded from the study if any of the following criteria apply:
- Concurrent malignancy < 5 years prior to entry other than adequately treated cervical carcinoma-in-situ, localized squamous cell cancer of the skin, basal cell carcinoma, localized prostate cancer, ductal carcinoma in situ of the breast, or < T1 urothelial carcinoma. Patients with prostate cancer that is under active surveillance are eligible.
- Phase I: Patients may have received single agent treatments targeting the TIGIT pathway.
- Phase II: Have received previous simultaneous therapy with a PD-1 pathway inhibitor and a TIGIT inhibitor; previous monotherapy with TIGIT/PD-1/PD-L1 inhibitor is allowed.
- Have received antibiotics lasting over 1 week within 28 days prior to first dose;
- Have clinically active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously-treated brain or meningeal metastases may participate and be eligible for treatment provided they are stable and asymptomatic. Patients with asymptomatic brain metastasis or subjects who are symptomatically stable after treatment and are on < 10 mg/d prednisone or equivalent are eligible.
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- Have history of interstitial lung disease or non-infectious pneumonitis (except from radiotherapy);
- Active autoimmune disease or history of autoimmune disease requiring systemic therapy < 2 years prior to screening except hypothyroidism, vitiligo, Grave's disease, Hashimoto's disease, or Type I diabetes. Patients with childhood asthma or atopy that has not been active in the 2 years prior to study screening are eligible.
- History of Grade 3-4 immune-related adverse events (irAEs) or irAEs requiring discontinuation of prior therapies, (except for grade 3 endocrinopathy that is managed with hormone replacement therapy).
- Use of systemic corticosteroids in a dose equivalent to >10 mg/day of prednisone or other immunosuppressive agent < 2 weeks prior to screening; the use of topical, intraocular, intraarticular, intranasal, or inhaled corticosteroids and systemic steroids to prevent (e.g., allergy to contrast agents) or treat non-autoimmune condition (e.g., delayed hypersensitivity caused by exposure to allergens) or short course (< 5 days) will be allowed
- Anticancer therapy or radiation < 5 half-lives or 4 weeks (whichever is shorter) prior to study entry; palliative radiotherapy to a single area < 2 weeks prior to study screening is permitted. Measurable lesions cannot be previously irradiated unless they have demonstrated growth after radiation therapy (RT).
- Major surgery (except for diagnostic needle biopsy or intravenous catheterization) or chemotherapy/ interventional therapy/radiation therapy/ablation therapy < 4 weeks prior to the first dose;
- Cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction (MI), unstable angina, or New York Heart Association (NYHA) class III or IV heart failure < 6 months of study entry; mean ECG QT-interval corrected according to Fridericia's formula (QTcF) > 470 milliseconds (ms) obtained from three ECGs; uncontrolled arrhythmia < 3 months of study entry. Patients with rate-controlled arrhythmias may be eligible for study entry at discretion of the Investigator.
- Patients who have previously received allogeneic stem cell or solid organ transplantation.
- Have received or will receive a live vaccine within 4 weeks prior to the first dose, except COVID-19 vaccine.
- Patients whose existing significant clinical abnormalities or laboratory abnormalities may affect the evaluation of the study drug by the Investigator's judgement, e.g. uncontrolled active infection (>Grade 2, CTCAE v5.0), uncontrolled diabetes, poorly controlled hypertension with the combination of the two drugs (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg), congestive heart failure, myocardial infarction within 24 weeks, etc.;.
- Positive results for HIV test.
- Active hepatitis B or C. Patients with asymptomatic hepatitis B virus carriers (HBV DNA titer < 1000 CPS /mL or 200 IU/mL) or cured hepatitis C (negative HCV RNA test) may be enrolled;
- Positive COVID-19 qRT-PCR or rapid screening test during screening; can be eligible after quarantine (14 days) if COVID-19 test becomes negative.
- Patients with active tuberculosis (TB) who are receiving anti-TB treatment or who received anti-TB treatment within 1 year prior to screening;
- Women who are pregnant or lactating, or women of childbearing potential who do not wish to use effective contraception method during the trial.
- Men with a partner of childbearing potential who do not consent to use acceptable methods of birth control during treatment and for an additional 90 days after the last administration of study drug.
- History of severe allergic reactions, grade 3-4 allergic reactions to treatment with another monoclonal antibody, or known to be allergic to protein drugs or recombinant proteins or excipients in HB0036 drug formulation;
- Patients who have participated in any clinical trial of a drug or medical device within 4 weeks prior to the first dose.
- Abuse of alcohol, cannabis- derived products or other drugs; can be eligible with remote history of abuse more than 2 years.
- Any other serious underlying medical condition (e.g., active gastric ulcer, uncontrolled seizures, cerebrovascular incidents, gastrointestinal bleeding, severe signs and symptoms of coagulation and clotting disorders, cardiac conditions), or psychiatric, psychological, familial condition or geographical location that, in the judgment of the Investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment.
- Other conditions which would make it inappropriate for the patient to participate as judged by the investigator.
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
United States3 sites, 3 recruiting
- Recruiting
Horizon Oncology
Lafayette, Indiana, 47905
Albany Constantine, MD/PHD, 765-466-5111, calbany@horizonbioadvance.com
- Recruiting
Next Oncology
San Antonio, Texas, 78229
Anthony Tolcher, MD, 210-580-9500, atolcher@nextoncology.com
- Recruiting
Summit Cancer Centers
Spokane, Washington, 99216
Chaudhry Arvind, MD/PHD, 509-462-2273, Arvind.chaudhry@aoncology.com
China1 site, 1 recruiting
- Recruiting
Shandong Hospital
Jinan, Shandong, 250117
Jinming Yu, MD/PHD, 0531-67626995, sdyujinming@126.com
Yuping Sun, MD/PHD, 0531-67626995, 13370582181@163.com
About this study
Official title: A Phase I/II, Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of HB0036 in Subjects With Advanced Solid Tumors
It is a Phase I/II, Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of HB0036 in Subjects with Advanced Solid Tumors
Read the detailed description
This is a phase Ⅰ/Ⅱ, multicenter, open-label, first-in-human study in patients with advanced solid tumors. During the phase Ⅰ study, the safety and tolerability of HB0036 will be evaluated in patients with advanced solid tumors. In the phase Ⅱ study, the safety and efficacy of HB0036 at the RP2D will be evaluated in cohorts of patients with NSCLC and/or other solid tumors.
A Safety Review Committee (SRC) will be established throughout the study period, consisting of the principal investigator, representatives of the contract research organization (CRO) (medical inspectors and other relevant personnel), and the Sponsor's medical monitor. The SRC will evaluate safety data based on the study process. The SRC may recommend extended doses, possible changes in the frequency of administration, and extended tumor types for safety reasons based on existing studies prior to starting the phase II study.
- Conditions
- Advanced Solid Tumor, NSCLC
- Being tested
- HB0036
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HB0036Drug
Also called Anti-PD-L1 and anti-TIGIT bifunctional molecule
Patients will be assigned to dose regimens in the order of enrollment, and they will receive their assigned fixed dose of HB0036 via intravenous infusion. HB0036 IV every 3 weeks (q3w).
| Study group | Role | What they receive |
|---|---|---|
| HB0036 | Experimental | HB0036 IV every 3 weeks (q3w) Receives: Drug: HB0036 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Number of participants with a Dose Limiting Toxicity (DLT) [ Time Frame: During the first 21 days ]DLTs will be assessed during the first 21 days of treatment for dose-escalation phase and are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected or definite relationship to study drug.
Measured: Up to 12 Months
MTD
MTD or OBD and/or RP2D.
Measured: Up to 24 Months
Secondary outcomes (3)
AUC
Area Under concentration-time Curve (AUC)
Measured: Up to 24 Months
Cmax
Maximum serum concentration (Cmax)
Measured: Up to 24 Months
Tmax
half-life time of maximum concentration
Measured: Up to 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start25 Aug 2022
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by Shanghai Huaota Biopharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- A single-subject cohort will be enrolled at the protocol starting dose of HB0036 every 3 weeks (Q3W). Dose escalation will proceed to the next main dose level according to the 3+3 dose-escalation procedure until the MTD/OBD is reached. Phase II of the study will be initiated at the Sponsor's discretion at the dose level and treatment schedule which was established as the recommended Phase 2 dose (RP2D) in the dose-escalation phase.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Huaota Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yang Yang, MD/PHD, Study director, Shanghai Huaota Biopharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417321
- Sponsor's protocol ID
- HB0036-01
- Status last verified
- Jan 2025
- First submitted
- 30 May 2022
- Last updated
- 3 Jan 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 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of HB0036 in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05417321
- Acronym / sponsor ID
- HB0036-01
- Conditions
- Advanced Solid Tumor, NSCLC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shanghai Huaota Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Aug 2022 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 14 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is a Phase I/II, Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of HB0036 in Subjects with Advanced Solid Tumors
Detailed description
This is a phase Ⅰ/Ⅱ, multicenter, open-label, first-in-human study in patients with advanced solid tumors. During the phase Ⅰ study, the safety and tolerability of HB0036 will be evaluated in patients with advanced solid tumors. In the phase Ⅱ study, the safety and efficacy of HB0036 at the RP2D will be evaluated in cohorts of patients with NSCLC and/or other solid tumors.
A Safety Review Committee (SRC) will be established throughout the study period, consisting of the principal investigator, representatives of the contract research organization (CRO) (medical inspectors and other relevant personnel), and the Sponsor's medical monitor. The SRC will evaluate safety data based on the study process. The SRC may recommend extended doses, possible changes in the frequency of administration, and extended tumor types for safety reasons based on existing studies prior to starting the phase II study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-subject cohort will be enrolled at the protocol starting dose of HB0036 every 3 weeks (Q3W). Dose escalation will proceed to the next main dose level according to the 3+3 dose-escalation procedure until the MTD/OBD is reached. Phase II of the study will be initiated at the Sponsor's discretion at the dose level and treatment schedule which was established as the recommended Phase 2 dose (RP2D) in the dose-escalation phase.
| Arm | Type | Receives |
|---|---|---|
| HB0036 | Experimental | Drug: HB0036HB0036 IV every 3 weeks (q3w) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Patients must meet all the following criteria to be eligible for participation in this study:
- Male or female. Age ≥ 18 years;
- Phase I: Patients with histologically or cytologically confirmed locally advanced, recurrent, or metastatic solid tumors (or clinically diagnosed hepatocellular carcinoma) that failed all standard therapies known to provide clinical benefit; [These solid tumors include but not limit to: non-small cell lung cancer, esophageal squamous cell carcinoma, melanoma, head and neck squamous cell carcinomas, hepatocellular carcinoma, gastric or gastroesophageal junction adenocarcinoma, renal cell carcinoma, etc.];
- Phase II: Histologically or cytologically documented locally advanced, recurrent or metastatic cancer. There will be several tumor-specific cohorts Advanced non-small cell lung cancer cohort Histologically or cytologically documented locally advanced, recurrent or metastatic NSCLC; Confirmed availability of representative tumor specimens in formalin-fixed paraffin-embedded (FFPE）blocks or at least 5 stained serial slides or fresh biopsied specimens (preferred),samples obtained before adjuvant / neoadjuvant chemotherapy are allowed only if biopsy cannot be performed; Tumor PD-L1 expression with a TPS≥1 %; Negative for actionable molecular markers [including but not limited to: epidermal growth factor receptor (EGFR) mutations, anaplastic lymphoma kinase (ALK) gene fusion mutation, etc.]； Assessed by the investigator as likely to benefit from the study drug therapy; and should have progressed at least one prior systemic therapy regimen.
- Advanced other cancer cohort Histologically or cytologically documented locally advanced, recurrent or metastatic cancer (esophageal squamous cell carcinoma, melanoma) Other tumor histologies will be evaluated pending data from the dose escalation phase that may inform on possible efficacy in select tumors
Key exclusion criteria (27 listed)
- Concurrent malignancy < 5 years prior to entry other than adequately treated cervical carcinoma-in-situ, localized squamous cell cancer of the skin, basal cell carcinoma, localized prostate cancer, ductal carcinoma in situ of the breast, or < T1 urothelial carcinoma. Patients with prostate cancer that is under active surveillance are eligible.
- Phase I: Patients may have received single agent treatments targeting the TIGIT pathway.
- Phase II: Have received previous simultaneous therapy with a PD-1 pathway inhibitor and a TIGIT inhibitor; previous monotherapy with TIGIT/PD-1/PD-L1 inhibitor is allowed.
- Have received antibiotics lasting over 1 week within 28 days prior to first dose;
- Have clinically active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously-treated brain or meningeal metastases may participate and be eligible for treatment provided they are stable and asymptomatic. Patients with asymptomatic brain metastasis or subjects who are symptomatically stable after treatment and are on < 10 mg/d prednisone or equivalent are eligible.
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 |
|---|---|---|
| HB0036Also: Anti-PD-L1 and anti-TIGIT bifunctional moleculePatients will be assigned to dose regimens in the order of enrollment, and they will receive their assigned fixed dose of HB0036 via intravenous infusion. HB0036 IV every 3 weeks (q3w). | Drug | HB0036 |
Primary outcome
Safety and tolerability
Time frame: Up to 12 Months
Number of participants with a Dose Limiting Toxicity (DLT) [ Time Frame: During the first 21 days ]DLTs will be assessed during the first 21 days of treatment for dose-escalation phase and are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected or definite relationship to study drug.
MTD
Time frame: Up to 24 Months
MTD or OBD and/or RP2D.
3 secondary outcomes
AUC
Time frame: Up to 24 Months
Cmax
Time frame: Up to 24 Months
Tmax
Time frame: Up to 24 Months
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 3 Jan 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.
Yang Yang, MD/PHD study director
Shanghai Huaota Biopharmaceutical Co., Ltd.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HB0036 in people with Advanced Solid Tumor and NSCLC, run by Shanghai Huaota Biopharmaceutical Co., Ltd. at 4 sites in 2 countries.
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 21 inclusion and 27 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: looking for participants now, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Jingjing Wang, Master (021-51320053 ext. 6029, jingjing.wang@huaota.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability (time frame: Up to 12 Months). 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 3 Jan 2025.