Locally Advanced or Metastatic Solid TumorsPhase 1ASOTIAPWSTNCT06246071
A Study of TYK-00540 in Adult Patients With Solid Tumors
A Phase 1 study testing TYK-00540 in people with Locally Advanced or Metastatic Solid Tumors, run by TYK Medicines, Inc at 1 site in China.
Trial summary
The primary objective of this study is to evaluate the safety and tolerability of TYK-00540, with dose-escalation stage and dose-expansion stage. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Locally Advanced or Metastatic Solid Tumors
- What is being tested?
- TYK-00540
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- 2 Jan 2024to 5 Dec 2026
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- In the Single-agent escalation phase, subjects should fulfill the following criterion at Screening: Histologically or cytologically confirmed locally advanced/metastatic solid tumors that do not have, failed or intolerated standard of care (SOC).In the single-agent expansion phase, subjects should fulfill the following criteria at Screening: Cohort 1: Histologically or cytologically confirmed platinum-resistant HGSOC (Platinum-resistant: responds at first to treatment with drugs that contain platinum, but then comes back within 6 months period; only female subjects will be enrolled). Cohort 2: Histologically or cytologically confirmed locally advanced/metastatic TNBC who have received two lines of standard of care (SOC) regimens, including:
- Any prior treatment can be considered as one of the SOC regimens if executed on patients with the receptor status of triple-negative no matter the previous pathological type;
- For patients whose treatment have been changed due to intolerability to toxicity, the intolerable regimens can be included as one of the prior standards of care regimens;
- For neoadjuvant and/or adjuvant chemotherapy, if relapse or disease progression to locally advanced or metastatic disease occurs during treatment or within 12 months after discontinuation of treatment (at least 2 cycles have been completed), it will be considered as one of the SOC regimens;
- For patients with documented germline BRCA1/BRCA2 mutations, if they have been treated with an approved PARP inhibitor, then the PARP inhibitor can be considered as one of the 2 lines of prior SOC regimens required.
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- In the combination-agent escalation and combination expansion phase (Cohort 3), subjects should fulfill the following criteria at Screening: ER+/HER2-breast cancer with who have relapsed or progressed after treatment with CDK4/6 inhibitors (no prior treatment of fulvestrant or other SERDs, SERCA; no contraindications to the use of fulvestrant; for locally advanced or metastatic disease stages, the number of chemotherapy lines≤ 1). Note: Histologically-confirmed breast carcinoma expressing positive ER (≥1% tumor cells expressing ER as positive on IHC staining, recommended by ASCO/CAP Guideline Update 2020. For the purposes of the expansion study, only ER+ IHC staining ≥10% will be considered ER+ in this cohort. Negative HER2 is defined as IHC 0 or 1+, or IHC 2+ but confirmed by the negative ISH, recommended by ASCO/CAP Guideline 2018.
- Subjects in the escalation phase should have measurable or evaluable lesions at baseline; Measurable lesions required in the expansion phase (RECIST 1.1).
- ECOG performance status is 0 to 1 and there is no deterioration in the 2 weeks prior to the first dose.
- Life expectancy of at least 3 months.
- Adequate organ functions, defined as: ALT or AST ≤ 2.5×the upper limit of normal (ULN) or ≤ 5 ×ULN with documented liver involvement (such as liver metastasis or a primary biliary tumor) and Total bilirubin ≤ 1.5 ×ULN (subjects with Gilbert's Disease may be enrolled with Sponsor approval); Absolute neutrophil count (ANC) ≥ 1.5×109/L, Platelet count ≥ 80 ×109/L and Hemoglobin (Hb) ≥ 9 mg/dL, not requiring growth factor and transfusion support for at least 14 days prior to screening; Adequate renal function, creatinine clearance ≥ 60 mL/min (According to the Cockcroft and Gault formula). Coagulation function: International normalized ratio (INR) ≤ 1.5 ×ULN and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN. Left ventricular ejection fraction (LVEF) ≥50%.
- Willing and able to provide written informed consent approved by institutional review board (IRB) or independent ethics committee (IEC).
- Willingness of men and women of reproductive potential to observe conventional and effective birth control for the duration of treatment and 6 months following the last dose of study treatment; this may include barrier methods such as condom or diaphragm with spermicidal gel.
Who cannot join
- Known allergy to any excipients of TYK-00540 tablets (for combination-agent escalation phase and combination expansion phase, known contraindications to fulvestrant should also be considered).
- Subjects with prior therapy of: Systemic anti-tumor treatment such as standard chemotherapy, macromolecular targeted drugs and immunological drug therapy within 28 days prior to the first dose; reception of endocrine therapy, small molecule targeted drugs and oral fluorouracil within 14 days before the first dose; reception of nitrosoureas and mitomycin within 6 weeks prior to the first dose Major surgery (except minor surgeries such as appendicitis and tumor biopsy) within 4 weeks prior to the planned start of TYK-00540. Subjects who have taken proton pump inhibitors (PPIs) within 7 days prior to the first dose of TYK-00540, or require continuation of therapy during the study. Subjects who were receiving and need to continue treatment with medications known to prolong the QTc interval or potentially cause Torsade de pointe ventricular tachycardia during the treatment. Participation in other clinical trials (excluding non-interventional drug clinical trials) within 28 days prior to the first dose; Prior allogeneic bone marrow transplantation.
- Subjects with other malignancies or a history of other malignant tumors, except for cured basal cell carcinoma of the skin or squamous cell carcinoma, carcinoma in situ of the cervix, papillary thyroid cancer, carcinoma in situ of the breast duct, or other malignant tumors that have survived for more than 5 years.
- Any unresolved toxicities from prior therapy greater than NCI CTCAE Grade 1 at the time of starting study treatment with the exception of Grade 2 alopecia and prior platinum-therapy related neuropathy.
- Patients with primary central nervous system (CNS) tumors or CNS metastases that have failed local therapy. Patients who are asymptomatic or clinically stable and do not require steroids and other treatments for CNS metastases ≥ 28 days and are radiographically stable during the screening period may be enrolled.
- The subject has symptoms of spinal cord compression due to the tumor.
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- Uncontrollable or poorly controlled effusion of chest, abdomen, pelvis, or pericardium.
- Any baseline 12-lead ECG abnormalities which may impair the safety of subjects (such as baseline QTc interval ≥ 470 msec, complete left bundle branch block (LBBB), acute or unspecified myocardial infarction, active myocardial ischemic ST-T segment changes with clinical significance, second- or third-degree atrioventricular (AV) block, or severe bradycardia or tachycardia).
- Have had any of the following in the past 6 months: myocardial infarction, long QT syndrome, torsades de pointes, arrhythmias (double-bundle branch block, such as right bundle branch block (RBBB) with left anterior or posterior branch block, third-degree atrioventricular block) , unstable angina, coronary/peripheral artery bypass grafting, symptomatic chronic heart failure (CHF), Grade III or IV cardiac function as defined by the New York Heart Association, cerebrovascular accident, transient cerebral ischemia, symptomatic pulmonary embolism, and/or other clinically significant thromboembolic disease episodes. NCI CTCAE ≥ Grade 2 persistent arrhythmia, any grade of atrial fibrillation (asymptomatic uncomplicated atrial fibrillation was required to be of ≥Grade 2). Enrollment of patients who have an implanted cardiac rhythm device/pacemaker with QTcF > 470 msec needs to be discussed by the investigators and sponsor.
- Subjects with any other disease or medical condition that is unstable or could affect their safety or study compliance, any serious or uncontrolled systemic disease, including uncontrolled hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg). Uncontrolled diabetes, active bleeding, ocular lesions, and other serious mental, neurological, cardiovascular or respiratory system diseases.
- Known active infections, including human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) infection, except for asymptomatic chronic HBV or HCV carriers. Active HBV, HCV, or HIV infections are defined as:
- Hepatitis B surface antigen (HBsAg) positive and HBV-DNA ≥ 2000 cps/mL or 500 IU/mL; HBsAg-negative, anti-HBc-positive patients are at high risk of HBV reactivation who require suppressive antiviral therapy prior to initiation of cancer therapy;
- Anti-HCV antibody positive and HCV-RNA > upper normal limit defined by sites;
- Anti-HIV antibody positive with uncontrolled opportunistic infections; anti-HIV antibody positive with CD4+ count< 350 cells/uL that requires HIV therapy prior to the cancer treatment; other conditions allowing concurrent ART but the therapy not tolerated and that the toxicities confused with investigational drug toxicities.
- History of positively diagnosed interstitial lung disease or interstitial pneumonia (ILD), drug-induced ILD, or radiation pneumonitis requiring hormone therapy, or any evidence of active ILD (e.g., acute onset or progressive pneumonitis/pulmonary fibrosis at baseline), or the pulmonary symptoms which are not suitable for enrollment in the investigator's judgment or the high-risk factors which may cause interstitial lung disease and are not suitable for enrollment.
- Clinically significant gastrointestinal abnormalities at screening that may affect the intake, transport or absorption of drugs (such as dysphagia, uncontrollable nausea and vomiting, active gastric ulcer, ulcerative colitis, Crohn's disease, chronic diarrhea, intestinal obstruction, gastric diseases requiring long-term administration of PPIs without a cure, etc.).
- Clinically significant hypercoagulability.
- Pregnant and lactating women.
- Subjects who, in the opinion of the investigator, would not be suitable for participation in this study (e.g., not in line with the treatment of the subject's best benefit, subject compliance, etc.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase Ia/Ib, Multicenter, Open-label Study of TYK-00540, Administered Orally in Adult Patients With Locally Advanced/Metastatic Solid Tumors
The primary objective of this study is to evaluate the safety and tolerability of TYK-00540, with dose-escalation stage and dose-expansion stage.
Read the detailed description
To evaluate dose limiting toxicities (DLT) and determine the maximum tolerated dose (MTD) in subjects with locally advanced or metastatic solid tumors.
To investigate the pharmacokinetic profile of TYK-00540 and its metabolites after single then multiple doses of TYK-00540 administered orally once daily. To assess preliminary effectiveness.
- Being tested
- TYK-00540
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TYK-00540Drug
TYK-00540 PO, BID
| Study group | Role | What they receive |
|---|---|---|
| TYK-00540 | Experimental | Escalation stage: Multiple doses of TYK-00540 tablets as monotherapy for oral administration to find the maximum tolerated dose. The administration frequency will be twice daily (BID), every 28 days as a cycle.
Expansion stage: an optimal dose of TYK-00540 tablets for cohort expansion. The administration frequency will be twice daily (BID), every 28 days as a cycle. Receives: Drug: TYK-00540 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity (DLT)
Numbers of participants experiencing AEs which are defined as DLTs classfied by CTCAE
Measured: Within 31 days of the first dose
Recommended dose for combination-agent escalation and single-agent expansion (RDE)
To determine the recommended dose for combination-agent escalation and single-agent expansion agent expansion.
Measured: 1 year
Adverse events (AEs)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Measured: From Baseline up to 28 days after the end of the treatment
Objective response rate (ORR)
ORR is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) assessment in accordance to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Measured: At least 24 weeks
Secondary outcomes (5)
The time to the peak concentration (Tmax)
Tmax is defined as the time of maximum concentration of the drug in blood observed after a drug dose administration.
Measured: 0 hours (h) (within 30 min before dosing), 0.25 h, 0.5 h , 1 h , 2 h , 3 h, 4 h, 8 h , 12 h, 24 h after dosing
Maximum plasma concentration (Cmax)
Cmax is the maximum (or peak) plasma concentration that the drug achieves in blood after the drug has been administered.
Measured: 0 hours (h) (within 30 min before dosing), 0.25 h, 0.5 h , 1 h , 2 h , 3 h, 4 h, 8 h , 12 h, 24 h after dosing
Minimum plasma concentration (Cmin)
Cmin is the minimum plasma concentration that the drug achieves in blood after the drug has been administered.
Measured: 0 hours (h) (within 30 min before dosing), 0.25 h, 0.5 h , 1 h , 2 h , 3 h, 4 h, 8 h , 12 h, 24 h after dosing
Area under the plasma concentration time
AUC0-inf defined as the area under the plasma concentration-time curve from time 0 extrapolated to Infinite time.
Measured: 0 hours (h) (within 30 min before dosing), 0.25 h, 0.5 h , 1 h , 2 h , 3 h, 4 h, 8 h , 12 h, 24 h after dosing
Disease Control Rate (DCR)
DCR is defined as the proportion of patients with a best overall response of complete response (CR) , partial response (PR) or Stable disease (SD) ≥6 weeks during the study treatment
Measured: At least 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start2 Jan 2024
- Primary completion5 Dec 2026 (estimated)
- Study completion5 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TYK Medicines, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246071
- Sponsor's protocol ID
- TYKM5807102
- Acronym
- ASOTIAPWST
- Status last verified
- Dec 2023
- First submitted
- 18 Jan 2024
- Last updated
- 7 Feb 2024
- 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 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia/Ib, Multicenter, Open-label Study of TYK-00540, Administered Orally in Adult Patients With Locally Advanced/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06246071
- Acronym / sponsor ID
- ASOTIAPWST / TYKM5807102
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- TYK Medicines, IncIndustry (pharma, biotech, devices)
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 5 Dec 2026 (estimated)
- Study completion
- 5 Dec 2026 (estimated)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the safety and tolerability of TYK-00540, with dose-escalation stage and dose-expansion stage.
Detailed description
To evaluate dose limiting toxicities (DLT) and determine the maximum tolerated dose (MTD) in subjects with locally advanced or metastatic solid tumors.
To investigate the pharmacokinetic profile of TYK-00540 and its metabolites after single then multiple doses of TYK-00540 administered orally once daily. To assess preliminary effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TYK-00540 | Experimental | Drug: TYK-00540Escalation stage: Multiple doses of TYK-00540 tablets as monotherapy for oral administration to find the maximum tolerated dose. The administration frequency will be twice daily (BID), every 28 days as a cycle. Expansion stage: an optimal dose of TYK-00540 tablets for cohort expansion. The administration frequency will be twice daily (BID), every 28 days as a cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age ≥18 years.
- In the Single-agent escalation phase, subjects should fulfill the following criterion at Screening: Histologically or cytologically confirmed locally advanced/metastatic solid tumors that do not have, failed or intolerated standard of care (SOC).In the single-agent expansion phase, subjects should fulfill the following criteria at Screening: Cohort 1: Histologically or cytologically confirmed platinum-resistant HGSOC (Platinum-resistant: responds at first to treatment with drugs that contain platinum, but then comes back within 6 months period; only female subjects will be enrolled). Cohort 2: Histologically or cytologically confirmed locally advanced/metastatic TNBC who have received two lines of standard of care (SOC) regimens, including:
- In the combination-agent escalation and combination expansion phase (Cohort 3), subjects should fulfill the following criteria at Screening: ER+/HER2-breast cancer with who have relapsed or progressed after treatment with CDK4/6 inhibitors (no prior treatment of fulvestrant or other SERDs, SERCA; no contraindications to the use of fulvestrant; for locally advanced or metastatic disease stages, the number of chemotherapy lines≤ 1). Note: Histologically-confirmed breast carcinoma expressing positive ER (≥1% tumor cells expressing ER as positive on IHC staining, recommended by ASCO/CAP Guideline Update 2020. For the purposes of the expansion study, only ER+ IHC staining ≥10% will be considered ER+ in this cohort. Negative HER2 is defined as IHC 0 or 1+, or IHC 2+ but confirmed by the negative ISH, recommended by ASCO/CAP Guideline 2018.
- Subjects in the escalation phase should have measurable or evaluable lesions at baseline; Measurable lesions required in the expansion phase (RECIST 1.1).
- ECOG performance status is 0 to 1 and there is no deterioration in the 2 weeks prior to the first dose.
Key exclusion criteria (19 listed)
- Known allergy to any excipients of TYK-00540 tablets (for combination-agent escalation phase and combination expansion phase, known contraindications to fulvestrant should also be considered).
- Subjects with prior therapy of: Systemic anti-tumor treatment such as standard chemotherapy, macromolecular targeted drugs and immunological drug therapy within 28 days prior to the first dose; reception of endocrine therapy, small molecule targeted drugs and oral fluorouracil within 14 days before the first dose; reception of nitrosoureas and mitomycin within 6 weeks prior to the first dose Major surgery (except minor surgeries such as appendicitis and tumor biopsy) within 4 weeks prior to the planned start of TYK-00540. Subjects who have taken proton pump inhibitors (PPIs) within 7 days prior to the first dose of TYK-00540, or require continuation of therapy during the study. Subjects who were receiving and need to continue treatment with medications known to prolong the QTc interval or potentially cause Torsade de pointe ventricular tachycardia during the treatment. Participation in other clinical trials (excluding non-interventional drug clinical trials) within 28 days prior to the first dose; Prior allogeneic bone marrow transplantation.
- Subjects with other malignancies or a history of other malignant tumors, except for cured basal cell carcinoma of the skin or squamous cell carcinoma, carcinoma in situ of the cervix, papillary thyroid cancer, carcinoma in situ of the breast duct, or other malignant tumors that have survived for more than 5 years.
- Any unresolved toxicities from prior therapy greater than NCI CTCAE Grade 1 at the time of starting study treatment with the exception of Grade 2 alopecia and prior platinum-therapy related neuropathy.
- Patients with primary central nervous system (CNS) tumors or CNS metastases that have failed local therapy. Patients who are asymptomatic or clinically stable and do not require steroids and other treatments for CNS metastases ≥ 28 days and are radiographically stable during the screening period may be enrolled.
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 |
|---|---|---|
| TYK-00540TYK-00540 PO, BID | Drug | TYK-00540 |
Primary outcome
Dose Limiting Toxicity (DLT)
Time frame: Within 31 days of the first dose
Numbers of participants experiencing AEs which are defined as DLTs classfied by CTCAE
Recommended dose for combination-agent escalation and single-agent expansion (RDE)
Time frame: 1 year
To determine the recommended dose for combination-agent escalation and single-agent expansion agent expansion.
Adverse events (AEs)
Time frame: From Baseline up to 28 days after the end of the treatment
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Objective response rate (ORR)
Time frame: At least 24 weeks
ORR is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) assessment in accordance to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
5 secondary outcomes
The time to the peak concentration (Tmax)
Time frame: 0 hours (h) (within 30 min before dosing), 0.25 h, 0.5 h , 1 h , 2 h , 3 h, 4 h, 8 h , 12 h, 24 h after dosing
Maximum plasma concentration (Cmax)
Time frame: 0 hours (h) (within 30 min before dosing), 0.25 h, 0.5 h , 1 h , 2 h , 3 h, 4 h, 8 h , 12 h, 24 h after dosing
Minimum plasma concentration (Cmin)
Time frame: 0 hours (h) (within 30 min before dosing), 0.25 h, 0.5 h , 1 h , 2 h , 3 h, 4 h, 8 h , 12 h, 24 h after dosing
Area under the plasma concentration time
Time frame: 0 hours (h) (within 30 min before dosing), 0.25 h, 0.5 h , 1 h , 2 h , 3 h, 4 h, 8 h , 12 h, 24 h after dosing
Disease Control Rate (DCR)
Time frame: At least 24 weeks
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 7 Feb 2024.
- 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.
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 TYK-00540 in people with Locally Advanced or Metastatic Solid Tumors, run by TYK Medicines, Inc 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 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: looking for participants now, as of the sponsor's last update on 7 Feb 2024. 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?
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 Jian Zhang, MD (18017312991, syner2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity (DLT) (time frame: Within 31 days of the first dose). The study lists 4 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 7 Feb 2024.