Advanced EGFR Positive Solid TumorPhase 1NCT04412616
ZZ06 in Adult Patients With Advanced Solid Tumor Malignancies
A Phase 1 study testing ZZ06 in people with Advanced EGFR Positive Solid Tumor, run by Changchun Intellicrown Pharmaceutical Co. LTD at 5 sites in 2 countries.
Trial summary
This is a Phase 1, Multicenter, Open-label study to assess the safety, tolerability and preliminary efficacy of ZZ06 in participants with all Adult Patients with Advanced EGFR-positive Solid Tumor Malignancies who are not able to have current standard anti-tumor therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced EGFR Positive Solid Tumor
- What is being tested?
- ZZ06
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 1 Sep 2020to 6 Jul 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically or cytologically confirmed advanced solid tumor that is positive for EGFR and has progressed despite standard therapy or for whom no standard therapy exists.
- Patients are required to have archival tumor tissue available for assessment of EGFR status via FDA-approved EGFR assay .
- Age ≥ 18 years.
- Patients must have at least 1 measurable lesion as defined by RECIST v1.1.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Life expectancy ≥ 12 weeks.
Show all 12Show fewer
- Baseline organ function and laboratory data meet the following criteria:
- Bone marrow： ANC ≥ 1500 cells/mm3； Platelet count ≥ 75 000 cells/mm3； Hemoglobin ≥ 8.0 g/dL.
- Coagulation： Prothrombin time ≤ 1.5× ULN； Activated partial thromboplastin time ≤ 1.5× ULN；
- Renal function： Serum creatinine ≤ 1.5× ULN ； estimated glomerular filtration rate≥ 60 mL/min (Cockcroft-Gault formula).
- Hepatic function： Serum total bilirubin ≤ 1.5 mg/dL； AST and ALT ≤ 3.0× ULN (if metastases are present, ≤ 5.0× ULN).
- Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.Patients must provide written informed consent prior to any study procedures.
Who cannot join
- History of another primary cancer ≤ 3 years, with the exception of completely resected nonmelanoma skin cancer or carcinoma in situ of uterine cervix.
- Active or symptomatic CNS metastases. Patients with treated CNS metastases that have been stable for ≥ 4 weeks and do not require treatment with steroids or anticonvulsants may be enrolled at the discretion of the Investigator.
- Tests positive for hepatitis C virus, hepatitis B virus, or human immunodeficiency virus infection.
- Active, clinically significant infections.
- Clinically significant cardiovascular disease, including any of the following:
- Congestive heart failure (New York Heart Association Class > 2).
Show all 15Show fewer
- Serious cardiac arrhythmia.
- Myocardial infarction ≤ 6 months.
- Unstable angina.
- Prior clinically significant allergic reaction to chimerized or murine monoclonal antibody therapy.
- Prior treatment ≤ 6 months with cetuximab, panitumomab, gefitinb, erlotinib, or other therapy that specifically and directly targets the EGF pathway.
- Anticancer therapy or investigational agents for nonmalignant disease ≤ 4 weeks or 5 half-lives, whichever is shorter, prior to Cycle 1 Day 1, with the exception of tamoxifen for patients with a history of operated breast cancer > 3 years and no evidence of disease after surgery.
- Major surgery ≤ 4 weeks.
- Clinically significant psychiatric illness, other comorbidity, or laboratory abnormality that, in the opinion of the Investigator, makes it unsafe for the patient to participate in the study or may interfere with study compliance or study results.
- Other unspecified reasons that, in the opinion of the Investigator, make the patient unsuitable for enrollment.
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
United States3 sites, 3 recruiting
- Recruiting
Kansas University Cancer Center
Fairway, Kansas, 66205-2528
Joaquina Baranda, MD
- Recruiting
Cedars Sinai Medical Center
Los Angeles, California, 90048-1804
Monica Mita, MD
- Recruiting
Montefiore Medical Center
The Bronx, New York, 90048-1804
Sanjay Goel, MD
China2 sites, 2 recruiting
- Not yet recruiting
Jilin Cancer Hospital
Changchun, Jilin, 130000
Ying Cheng, BMed
- Recruiting
The first Bethune hospital of Jilin University
Changchun, Jilin, 130021
Yanhua Ding, Ph.D
Songling Zhang, Ph.D
About this study
Official title: A Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Evidence of Antitumor Activity of ZZ06 in Adult Patients With Advanced Solid Tumor Malignancies
This is a Phase 1, Multicenter, Open-label study to assess the safety, tolerability and preliminary efficacy of ZZ06 in participants with all Adult Patients with Advanced EGFR-positive Solid Tumor Malignancies who are not able to have current standard anti-tumor therapies. The purpose of this study is to determine the maximum tolerated dose (MTD) , to characterise the safety, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of ZZ06 as a single agent in adult participants with advanced solid tumors.
Read the detailed description
The study will start with an accelerated-titration dose escalation scheme, enrolling 1 patient per cohort for the first 2 cohorts with expansion to 3 patients in the event of Grade ≥ 2 treatment-emergent adverse event (TEAE) or dose limiting toxicity (DLT) possibly, probably, or definitely related to the study drug. After the first 2 cohorts, the study will then proceed to a 3+3 design, with enrollment of 3 patients per cohort and expansion to 6 patients in the event of a DLT.
- Conditions
- Advanced EGFR Positive Solid Tumor
- Being tested
- ZZ06
- Keywords
- treatment-emergent adverse event (TEAE), dose limiting toxicity (DLT), pharmacokinetic (PK), antidrug antibodies (ADA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZZ06Biological
The phase I "3 + 3" study design was used in dose escalation from low dose to high dose to determine the MTD.Sequential assignment of Patient cohorts to one of five dose levels of ZZ06 : 0.03mg/kg,0.06mg/kg,0.12mg/kg,0.22mg/kg,0.39mg/kg,0.70mg/kg,1 mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| ZZ06 0.03 mg/kg dose group | Experimental | ZZ06 0.03 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor. Receives: Biological: ZZ06 |
| ZZ06 0.06 mg/kg dose group | Experimental | ZZ06 0.06 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor. Receives: Biological: ZZ06 |
| ZZ06 0.12 mg/kg dose group | Experimental | ZZ06 0.12 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor. Receives: Biological: ZZ06 |
| ZZ06 0.22 mg/kg dose group | Experimental | ZZ06 0.22 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor. Receives: Biological: ZZ06 |
| ZZ06 0.39 mg/kg dose group | Experimental | ZZ06 0.39 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor. Receives: Biological: ZZ06 |
| ZZ06 0.70 mg/kg dose group | Experimental | ZZ06 0.70 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor. Receives: Biological: ZZ06 |
| ZZ06 1.00 mg/kg dose group | Experimental | ZZ06 1.00 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor. Receives: Biological: ZZ06 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ZZ06 AEs
Adverse events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0
Measured: up to 36 weeks
Incidence of abnormal laboratory test results
The data of the clinical laboratory evaluation is collected and analyzed according to the time point of the test flow chart
Measured: up to 36 weeks
Incidence of abnormal physical exam findings
The data of the physical examinations is collected and analyzed according to the time point of the test flow chart
Measured: up to 36 weeks
Secondary outcomes (5)
PK parameters: Area under curve (AUC)
According to the test schedule, the blood volume of each subject's PK was analyzed and PK analysis was performed.
Measured: up to 28 weeks
PK parameters: Cmax
According to the test schedule, the blood volume of each subject's PK was analyzed and PK analysis was performed.
Measured: up to 28 weeks
PK parameters: Clearance rate (CL)
According to the test schedule, the blood volume of each subject's PK was analyzed and PK analysis was performed.
Measured: up to 28 weeks
PK parameters: t1/2
According to the test schedule, the blood volume of each subject's PK was analyzed and PK analysis was performed.
Measured: up to 28 weeks
PK parameters: Vz
According to the test schedule, the blood volume of each subject's PK was analyzed and PK analysis was performed.
Measured: up to 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start1 Sep 2020
- Primary completion1 Dec 2025 (estimated)
- Study completion6 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced EGFR Positive Solid TumorStudies 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun Intellicrown Pharmaceutical Co. LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Responsible party
- Sponsor
- Investigators
- Sanjay Goel, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04412616
- Sponsor's protocol ID
- ZZ06-2020A
- Status last verified
- Jun 2025
- First submitted
- 14 May 2020
- Last updated
- 10 Jun 2025
- Results posted
- 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 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Evidence of Antitumor Activity of ZZ06 in Adult Patients With Advanced Solid Tumor Malignancies
- ClinicalTrials.gov ID
- NCT04412616
- Acronym / sponsor ID
- ZZ06-2020A
- Conditions
- Advanced EGFR Positive Solid Tumor
- Keywords
- treatment-emergent adverse event (TEAE), dose limiting toxicity (DLT), pharmacokinetic (PK), antidrug antibodies (ADA)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Changchun Intellicrown Pharmaceutical Co. LTDIndustry (pharma, biotech, devices)
- Collaborators
- Covance
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 6 Jul 2026 (estimated)
- First posted
- 2 Jun 2020 (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 Phase 1, Multicenter, Open-label study to assess the safety, tolerability and preliminary efficacy of ZZ06 in participants with all Adult Patients with Advanced EGFR-positive Solid Tumor Malignancies who are not able to have current standard anti-tumor therapies. The purpose of this study is to determine the maximum tolerated dose (MTD) , to characterise the safety, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of ZZ06 as a single agent in adult participants with advanced solid tumors.
Detailed description
The study will start with an accelerated-titration dose escalation scheme, enrolling 1 patient per cohort for the first 2 cohorts with expansion to 3 patients in the event of Grade ≥ 2 treatment-emergent adverse event (TEAE) or dose limiting toxicity (DLT) possibly, probably, or definitely related to the study drug. After the first 2 cohorts, the study will then proceed to a 3+3 design, with enrollment of 3 patients per cohort and expansion to 6 patients in the event of a DLT.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| ZZ06 0.03 mg/kg dose group | Experimental | Biological: ZZ06ZZ06 0.03 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor. |
| ZZ06 0.06 mg/kg dose group | Experimental | Biological: ZZ06ZZ06 0.06 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor. |
| ZZ06 0.12 mg/kg dose group | Experimental | Biological: ZZ06ZZ06 0.12 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor. |
| ZZ06 0.22 mg/kg dose group | Experimental | Biological: ZZ06ZZ06 0.22 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor. |
| ZZ06 0.39 mg/kg dose group | Experimental | Biological: ZZ06ZZ06 0.39 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor. |
| ZZ06 0.70 mg/kg dose group | Experimental | Biological: ZZ06ZZ06 0.70 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor. |
| ZZ06 1.00 mg/kg dose group | Experimental | Biological: ZZ06ZZ06 1.00 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients with histologically or cytologically confirmed advanced solid tumor that is positive for EGFR and has progressed despite standard therapy or for whom no standard therapy exists.
- Patients are required to have archival tumor tissue available for assessment of EGFR status via FDA-approved EGFR assay .
- Age ≥ 18 years.
- Patients must have at least 1 measurable lesion as defined by RECIST v1.1.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
Key exclusion criteria (15 listed)
- History of another primary cancer ≤ 3 years, with the exception of completely resected nonmelanoma skin cancer or carcinoma in situ of uterine cervix.
- Active or symptomatic CNS metastases. Patients with treated CNS metastases that have been stable for ≥ 4 weeks and do not require treatment with steroids or anticonvulsants may be enrolled at the discretion of the Investigator.
- Tests positive for hepatitis C virus, hepatitis B virus, or human immunodeficiency virus infection.
- Active, clinically significant infections.
- Clinically significant cardiovascular disease, including any of the following:
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 |
|---|---|---|
| ZZ06The phase I "3 + 3" study design was used in dose escalation from low dose to high dose to determine the MTD.Sequential assignment of Patient cohorts to one of five dose levels of ZZ06 : 0.03mg/kg,0.06mg/kg,0.12mg/kg,0.22mg/kg,0.39mg/kg,0.70mg/kg,1 mg/kg. | Biological | ZZ06 0.03 mg/kg dose group, ZZ06 0.06 mg/kg dose group, ZZ06 0.12 mg/kg dose group, ZZ06 0.22 mg/kg dose group, ZZ06 0.39 mg/kg dose group, ZZ06 0.70 mg/kg dose group, ZZ06 1.00 mg/kg dose group |
Primary outcome
ZZ06 AEs
Time frame: up to 36 weeks
Adverse events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0
Incidence of abnormal laboratory test results
Time frame: up to 36 weeks
The data of the clinical laboratory evaluation is collected and analyzed according to the time point of the test flow chart
Incidence of abnormal physical exam findings
Time frame: up to 36 weeks
The data of the physical examinations is collected and analyzed according to the time point of the test flow chart
5 secondary outcomes
PK parameters: Area under curve (AUC)
Time frame: up to 28 weeks
PK parameters: Cmax
Time frame: up to 28 weeks
PK parameters: Clearance rate (CL)
Time frame: up to 28 weeks
PK parameters: t1/2
Time frame: up to 28 weeks
PK parameters: Vz
Time frame: up to 28 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 10 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Advanced EGFR Positive Solid Tumor
RecruitingPhase 1/2
Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer
RecruitingPhase 1
Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Solid Tumors and Breast Cancer
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
RecruitingEarly Phase 1
HEAT Trial (HER2 Antibody Therapy With Lutetium-177)
HER2 Gene Mutation, Advanced Solid Tumors
Active, not recruitingPhase 2
A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)
Locally Advanced or Metastatic Malignant Solid Tumors
Active, not recruitingPhase 1/2
A Study to Learn About the Study Medicine (Called PF-07220060 in Combination With PF-07104091) In Participants With Breast Cancer and Solid Tumors
Breast Cancer, Solid Tumors
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.
Sanjay Goel, MD principal investigator
Montefiore Medical Center
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ZZ06 in people with Advanced EGFR Positive Solid Tumor, run by Changchun Intellicrown Pharmaceutical Co. LTD at 5 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 12 inclusion and 15 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 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 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 Shiqi Bai (18943642700, baishiqi@intelli-crown.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ZZ06 AEs (time frame: up to 36 weeks). The study lists 3 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 10 Jun 2025.