Locally Advanced Unresectable CarcinomaPhase 1/2NCT05105464
A Study to Investigate the Safety of SYHA1815 in Subjects With Unresectable Locally Advanced or Metastatic Solid Tumors
A Phase 1/2 study testing SYHA1815 in people with Locally Advanced Unresectable Carcinoma, run by Shanghai Runshi Pharmaceutical Technology Co., Ltd at 1 site in China.
Trial summary
This is a multi-center, open-label, dose escalation and expansion, phase I study to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) characteristics, preliminary efficacy of SYHA1815 in subjects with unresectable locally advanced or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Unresectable Carcinoma
- What is being tested?
- SYHA1815
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteChina
- Study dates
- 25 Jun 2021to Sep 2023
- Phase
- Phase 1/2
- 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
- Male or female subjects aged 18 to 75 years (inclusive)；
- Histologically or cytologically confirmed diagnosis of unresectable locally advanced or metastatic solid tumors (thyroid cancer, non-small cell lung cancer, gastric cancer [including gastroesophageal junction cancer], colorectal cancer, pancreatic cancer, soft tissue sarcoma, etc.), failure of standard treatment (disease progression or intolerance), or no alternative standard treatment or refusal of standard treatment;
- The subjects included in the dose expansion study should provide written biomarker test reports or tumor tissue samples to the central laboratory;
- The time interval between the last dose of anti-tumor drug and the first administration of SHYA1815 must meet the following conditions: ≥ 4 weeks for cytotoxic drugs, PD-1 / PD-L1, cellular immunotherapy; ≥2 weeks for oral molecular targeted drug therapy; ≥4 weeks for radiotherapy (≥ 2 weeks for palliative local radiotherapy for pain relief), and had recovered from the toxicities of radiotherapy; ≥2 weeks for anticancer Traditional Chinese medicine or Chinese patent medicine;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- Life expectancy ≥ 12 weeks;
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- At least one measurable lesion according to RECIST 1.1 at the screening phase;
- The organ function level and related laboratory values of the subjects must meet the following requirements within 7 days before the first dose of study drug (not receiving blood transfusion within 14 days before the first administration):
- Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; Platelet count ≥ 75 × 10^9/L /L; Hemoglobin ≥ 90 g / L; the values of blood phosphorus and calcium are in normal range;
- Blood biochemistry: serum total bilirubin ≤ 1.5× upper limit of normal value (ULN); AST / ALT ≤ 3 ×ULN (≤ 5 ×ULN for liver metastasis); Serum creatinine ≤ 1.5 × ULN;
- Coagulation: Internationally standardized ratio (INR) or prothrombin time (PT) ≤ 1.5×ULN, activated partial thrombin time (APTT) ≤ 1.5×ULN;
- For women of childbearing potential: the serum pregnancy test within 7 days before the first administration must be negative, and female subjects are willing to take adequate contraceptive measures during the treatment period and for at least 3 months after the last dose of the study drug. Male subjects must agree to take contraceptive measures (non-drug or instrumental contraception) from the beginning of the study to at least 3 months after the last dose of study drug;
- Voluntarily participate in the study and sign the informed consent form.
Who cannot join
- The previous anti-tumor or surgical treatment history with any of the following conditions:
- Received the treatment of other intervention clinical studies with 4 weeks before the first dose of study drug;
- Had undergone major surgery within 4 weeks before the first dose of study drug or had not fully recovered from any previous invasive operation;
- Prior treatment of RET/FGFR inhibitors or small molecular kinase inhibitors with RET/FGFR as the main targets;
- Any unresolved toxicities from prior anti-tumor therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1, except for alopecia, pigmentation, previous chemotherapy-related neurotoxicity (≤ grade 2) and other adverse reactions judged no safety risk by the investigators;
- Subjects with symptomatic brain metastasis or meningeal metastasis, spinal cord compression or mental disorder, and asymptomatic brain metastasis can be enrolled (there is no disease progress within at least 4 weeks after radiotherapy and/or no neurological symptoms after surgical resection, and glucocorticoids, anticonvulsant drugs and mannitol are not required);
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- Impaired cardiac function or clinically significant cardiovascular and cerebrovascular diseases, including any of the following:
- History of myocardial infarction, congestive heart failure (NYHA grade ≥ grade III), and unstable angina pectoris within 6 months prior to screening;
- Cerebrovascular disease occurred within 6 months before screening (except for transient ischemic attack (TIA), lacunar infarction with no clinical significance);
- Severe uncontrollable arrhythmia requiring medical treatment;
- Electrocardiogram (ECG) examination, female QTc interval>470 milliseconds (ms), male QTc interval>450 milliseconds (ms) according to Fridericia formula;
- The left ventricular ejection fraction is less than 50% according to cardiac ultrasound examination;
- History of active bleeding within 6 months before screening;
- Any serious or uncontrollable disease, and not suitable for this study as determined by the investigator;
- Any uncontrollable active infection that will prevent the subjects from receiving the study drug within 2 weeks prior to the first dose of study drug;
- HIV positive, HCV positive with HCV RNA quantity higher than the upper limit of normal value in the research center;
- Active hepatitis B infection, with the HBV DNA quantity higher than the upper limit of normal value of the research center;
- A history of any other malignant tumors within 5 years (except for effectively controlled non-melanoma skin basal cell carcinoma, cervical carcinoma in situ, and other malignant tumors that have been effectively controlled without treatment in the past 5 years;
- Subjects who have taken potent inhibitors and inducers of CYP3A4 liver metabolic enzymes within 2 weeks before the first administration and still need to continue to use such drugs;
- Women who are breastfeeding;
- Concomitant disease or condition that may interfere with the conduct of the trial, or that would pose an unacceptable risk to the subject in this trial in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jilin Cancer Hospital
Changchun, Jilin, 130012
Cheng Ying, doctor, 0431-85873390, jl.cheng@163.com
About this study
Official title: A Multi-center, Open-label, Dose Escalation and Expansion, Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) Characteristic of SYHA1815 in Subjects With Unresectable Locally Advanced or Metastatic Solid Tumors
This is a multi-center, open-label, dose escalation and expansion, phase I study to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) characteristics, preliminary efficacy of SYHA1815 in subjects with unresectable locally advanced or metastatic solid tumors. Once the expected effective dose is identified, the dose expansion study will be started to further evaluate the safety, clinical activity and PK profile of SYHA1815 in subjects with unresectable locally advanced or metastatic solid tumors.
Read the detailed description
This is a multi-center, open-label, dose escalation and expansion, phase I study to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) characteristics, preliminary efficacy of SYHA1815 in subjects with unresectable locally advanced or metastatic solid tumors. The dose escalation study will include six dose cohorts starting at 2 mg/day. Once the expected effective dose is identified, the dose expansion study will be started to further evaluate the safety, clinical activity and PK profile of SYHA1815 in subjects with unresectable locally advanced or metastatic solid tumors.
- Conditions
- Locally Advanced Unresectable Carcinoma
- Being tested
- SYHA1815
- Keywords
- Locally advanced unresectable or metastatic solid tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYHA1815Drug
Also called SYHA1815 tablet
Subjects will receive SYHA1815 orally.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Cohort | Experimental | Six dose levels will be tested. The dose-limiting toxicity (DLT) will be assessed from the first administration of SYHA1815 to the end of the first cycle (28 days). Receives: Drug: SYHA1815 |
| cohort Expansion Cohort | Experimental | Once the expected effective dose is determined, four expansion cohorts will be started to further evaluate the safety, clinical activity and PK profile of SYHA1815. Receives: Drug: SYHA1815 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Dose-limiting Toxicities
Number of participants with Dose-limiting Toxicities
Measured: Baseline through 28 days after the first dose of study drug
Incidence of adverse events and SAEs
Incidence of adverse events and SAEs defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0).
Measured: Up to 3 years
Clinically significant changes from baseline in routine blood test
Clinically significant changes from baseline in routine blood test
Measured: Up to 3 years
Clinically significant changes from baseline in blood biochemistry test
Clinically significant changes from baseline in blood biochemistry test
Measured: Up to 3 years
Clinically significant changes from baseline in routine urine test
Clinically significant changes from baseline in routine urine test
Measured: Up to 3 years
Clinically significant changes from baseline in coagulation function test
Clinically significant changes from baseline in coagulation function test
Measured: Up to 3 years
Clinically significant changes from baseline in 12-lead electrocardiogram (ECG)
Clinically significant changes from baseline in 12-lead electrocardiogram (ECG)
Measured: Up to 3 years
Clinically significant changes from baseline in vital signs examination
Clinically significant changes from baseline in vital signs examination
Measured: Up to 3 years
Clinically significant changes from baseline in physical examination
Clinically significant changes from baseline in physical examination
Measured: Up to 3 years
Secondary outcomes (19)
Objective Response Rate (ORR)
Assessed by Blinded Independent Review Committee (IRC) per RECIST Version 1.1
Measured: Up to 3 years
Disease control rate (DCR)
Disease control rate (DCR)
Measured: Up to 3 years
Duration of response (DOR)
Duration of response (DOR)
Measured: Up to 3 years
Progression free survival (PFS)
Progression free survival (PFS)
Measured: Up to 3 years
Time to maximum plasma concentration (Tmax)
Time to maximum plasma concentration (Tmax)
Measured: Up to 3 years
Maximum Plasma Concentration (Cmax)
Maximum Plasma Concentration (Cmax)
Measured: Up to 3 years
Plasma half-life (T1/2)
Plasma half-life (T1/2)
Measured: Up to 3 years
Area under the plasma concentration-time curve from time 0 to time t (AUC0-t)
Area under the plasma concentration-time curve from time 0 to time t (AUC0-t)
Measured: Up to 3 years
Area under the plasma concentration-time curve from time 0 to infinity (AUCinf)
Area under the plasma concentration-time curve from time 0 to infinity (AUCinf)
Measured: Up to 3 years
Terminal disposition rate constant (λz)
Terminal disposition rate constant (λz)
Measured: Up to 3 years
Apparent total clearance of the drug from plasma after oral administration (CL/F)
Apparent total clearance of the drug from plasma after oral administration (CL/F)
Measured: Up to 3 years
Apparent volume of distribution during terminal phase after non-intravenous administration (Vz/F)
Apparent volume of distribution during terminal phase after non-intravenous administration (Vz/F)
Measured: Up to 3 years
Change from baseline in serum phosphate
Change from baseline in serum phosphate
Measured: Up to 3 years
Serum carcinoembryonic antigen (CEA)
Serum carcinoembryonic antigen (CEA)
Measured: Up to 3 years
Calcitonin (thyroid cancer detection only)
Calcitonin (thyroid cancer detection only)
Measured: Up to 3 years
Fibroblast growth factor 23 (FGF23)
Fibroblast growth factor 23 (FGF23)
Measured: Up to 3 years
Vascular endothelial growth factor receptor 2 (sVEGFR2)
Vascular endothelial growth factor receptor 2 (sVEGFR2)
Measured: Up to 3 years
Potential population who benefit from the study drug
To evaluate the efficacy of the study drug in patients with different indications according to the results of anti-tumor response rate in the corresponding indications.
Measured: Up to 3 years
Correlation between the changes of RET/FGFR gene and efficacy
The percentage of patients with RET/FGFR gene in patients who benefit from the study drug will be assessed.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start25 Jun 2021
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Unresectable CarcinomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 97 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Runshi Pharmaceutical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jilin Provincial Tumor Hospital
- Responsible party
- Sponsor
- Investigators
- Huang Yanli, PD, Study director, CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105464
- Sponsor's protocol ID
- SYHA1815-202001/PRO
- Status last verified
- Oct 2021
- First submitted
- 13 Sep 2021
- Last updated
- 3 Nov 2021
- Results posted
- 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 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label, Dose Escalation and Expansion, Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) Characteristic of SYHA1815 in Subjects With Unresectable Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05105464
- Acronym / sponsor ID
- SYHA1815-202001/PRO
- Conditions
- Locally Advanced Unresectable Carcinoma
- Keywords
- Locally advanced unresectable or metastatic solid tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 97 participants (estimated)
- Lead sponsor
- Shanghai Runshi Pharmaceutical Technology Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Jilin Provincial Tumor Hospital
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 3 Nov 2021 (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 multi-center, open-label, dose escalation and expansion, phase I study to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) characteristics, preliminary efficacy of SYHA1815 in subjects with unresectable locally advanced or metastatic solid tumors. Once the expected effective dose is identified, the dose expansion study will be started to further evaluate the safety, clinical activity and PK profile of SYHA1815 in subjects with unresectable locally advanced or metastatic solid tumors.
Detailed description
This is a multi-center, open-label, dose escalation and expansion, phase I study to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) characteristics, preliminary efficacy of SYHA1815 in subjects with unresectable locally advanced or metastatic solid tumors. The dose escalation study will include six dose cohorts starting at 2 mg/day. Once the expected effective dose is identified, the dose expansion study will be started to further evaluate the safety, clinical activity and PK profile of SYHA1815 in subjects with unresectable locally advanced or metastatic solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Cohort | Experimental | Drug: SYHA1815Six dose levels will be tested. The dose-limiting toxicity (DLT) will be assessed from the first administration of SYHA1815 to the end of the first cycle (28 days). |
| cohort Expansion Cohort | Experimental | Drug: SYHA1815Once the expected effective dose is determined, four expansion cohorts will be started to further evaluate the safety, clinical activity and PK profile of SYHA1815. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female subjects aged 18 to 75 years (inclusive)；
- Histologically or cytologically confirmed diagnosis of unresectable locally advanced or metastatic solid tumors (thyroid cancer, non-small cell lung cancer, gastric cancer [including gastroesophageal junction cancer], colorectal cancer, pancreatic cancer, soft tissue sarcoma, etc.), failure of standard treatment (disease progression or intolerance), or no alternative standard treatment or refusal of standard treatment;
- The subjects included in the dose expansion study should provide written biomarker test reports or tumor tissue samples to the central laboratory;
- The time interval between the last dose of anti-tumor drug and the first administration of SHYA1815 must meet the following conditions: ≥ 4 weeks for cytotoxic drugs, PD-1 / PD-L1, cellular immunotherapy; ≥2 weeks for oral molecular targeted drug therapy; ≥4 weeks for radiotherapy (≥ 2 weeks for palliative local radiotherapy for pain relief), and had recovered from the toxicities of radiotherapy; ≥2 weeks for anticancer Traditional Chinese medicine or Chinese patent medicine;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
Key exclusion criteria (21 listed)
- The previous anti-tumor or surgical treatment history with any of the following conditions:
- Any unresolved toxicities from prior anti-tumor therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1, except for alopecia, pigmentation, previous chemotherapy-related neurotoxicity (≤ grade 2) and other adverse reactions judged no safety risk by the investigators;
- Subjects with symptomatic brain metastasis or meningeal metastasis, spinal cord compression or mental disorder, and asymptomatic brain metastasis can be enrolled (there is no disease progress within at least 4 weeks after radiotherapy and/or no neurological symptoms after surgical resection, and glucocorticoids, anticonvulsant drugs and mannitol are not required);
- Impaired cardiac function or clinically significant cardiovascular and cerebrovascular diseases, including any of the following:
- History of active bleeding within 6 months before screening;
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 |
|---|---|---|
| SYHA1815Also: SYHA1815 tabletSubjects will receive SYHA1815 orally. | Drug | Dose Escalation Cohort, cohort Expansion Cohort |
Primary outcome
Number of participants with Dose-limiting Toxicities
Time frame: Baseline through 28 days after the first dose of study drug
Number of participants with Dose-limiting Toxicities
Incidence of adverse events and SAEs
Time frame: Up to 3 years
Incidence of adverse events and SAEs defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0).
Clinically significant changes from baseline in routine blood test
Time frame: Up to 3 years
Clinically significant changes from baseline in routine blood test
Clinically significant changes from baseline in blood biochemistry test
Time frame: Up to 3 years
Clinically significant changes from baseline in blood biochemistry test
Clinically significant changes from baseline in routine urine test
Time frame: Up to 3 years
Clinically significant changes from baseline in routine urine test
Clinically significant changes from baseline in coagulation function test
Time frame: Up to 3 years
Clinically significant changes from baseline in coagulation function test
Clinically significant changes from baseline in 12-lead electrocardiogram (ECG)
Time frame: Up to 3 years
Clinically significant changes from baseline in 12-lead electrocardiogram (ECG)
Clinically significant changes from baseline in vital signs examination
Time frame: Up to 3 years
Clinically significant changes from baseline in vital signs examination
Clinically significant changes from baseline in physical examination
Time frame: Up to 3 years
Clinically significant changes from baseline in physical examination
19 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to 3 years
Disease control rate (DCR)
Time frame: Up to 3 years
Duration of response (DOR)
Time frame: Up to 3 years
Progression free survival (PFS)
Time frame: Up to 3 years
Time to maximum plasma concentration (Tmax)
Time frame: Up to 3 years
Maximum Plasma Concentration (Cmax)
Time frame: Up to 3 years
Plasma half-life (T1/2)
Time frame: Up to 3 years
Area under the plasma concentration-time curve from time 0 to time t (AUC0-t)
Time frame: Up to 3 years
Area under the plasma concentration-time curve from time 0 to infinity (AUCinf)
Time frame: Up to 3 years
Terminal disposition rate constant (λz)
Time frame: Up to 3 years
Apparent total clearance of the drug from plasma after oral administration (CL/F)
Time frame: Up to 3 years
Apparent volume of distribution during terminal phase after non-intravenous administration (Vz/F)
Time frame: Up to 3 years
Change from baseline in serum phosphate
Time frame: Up to 3 years
Serum carcinoembryonic antigen (CEA)
Time frame: Up to 3 years
Calcitonin (thyroid cancer detection only)
Time frame: Up to 3 years
Fibroblast growth factor 23 (FGF23)
Time frame: Up to 3 years
Vascular endothelial growth factor receptor 2 (sVEGFR2)
Time frame: Up to 3 years
Potential population who benefit from the study drug
Time frame: Up to 3 years
Correlation between the changes of RET/FGFR gene and efficacy
Time frame: Up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
- 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.
Huang Yanli, PD study director
CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SYHA1815 in people with Locally Advanced Unresectable Carcinoma, run by Shanghai Runshi Pharmaceutical Technology 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 21 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: status not confirmed, as of the sponsor's last update on 3 Nov 2021. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Li, AM (13321898532, lcliyang@mail.ecspc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Dose-limiting Toxicities (time frame: Baseline through 28 days after the first dose of study drug). The study lists 9 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 Nov 2021.