Advanced Solid TumoursPhase 1NCT03852823
Study of Recombinant Human Anti-PD-1 Monoclonal Antibody in Patients With Advanced Tumours
A Phase 1 study testing SG001 in people with Advanced Solid Tumours and Cervical Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
This study is an open, multi-dose, dose escalation and cohort expansion, phase Ⅰ study to investigate the safety, tolerability, efficiency, pharmacokinetics, immunogenicity of SG001 in subjects with advanced tumours. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumours, Cervical Cancer, Malignant Mesothelioma
- What is being tested?
- SG001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- 23 May 2019to Mar 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 on the day of signing informed consent.
- Phase Ⅰa: Histologically/cytologically confirmed diagnosis of advanced solid tumor, and failure of standard anti-tumor treatment (disease progression or intolerance), or no standard treatment or rejection of standard treatment.
- Phase Ⅰb:
- Cohort A: Histologically or cytologically documented locally-advanced, relapsed or metastatic solid malignancy with PD-L1 positive and/or deficiency in mismatch repair (dMMR) / Microsatellites instability-High (MSI-H) and/or EBV positive, and has failed at least first line standard therapy or for which standard therapy is not tolerated.
- Cohort B: Histologically documented relapsed or metastatic uterine cervical cancer and has failed at least first line standard therapy or for which standard therapy is not tolerated.
- Cohort C: Histologically documented malignant mesothelioma, and has failed to pemetrexed-based chemotherapy or chemotherapy is not tolerated.
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- Cohort D: Histologically documented relapsed or refractory lymphoma, and has failed at least 2 lines standard therapy, including radiotherapy or autologous hematopoietic stem cell transplantation.
- Cohort E: Histologically or cytologically documented non-small cell lung cancer without EGFR or ALK gene mutation, and has failed at least first line standard therapy or for which standard therapy is not tolerated.
- Solid tumor except malignant pleural mesothelioma will be assessed by RECIST 1.1, malignant pleural mesothelioma will be evaluated by Modified RECIST for malignant pleural mesothelioma, and lymphoma will be assessed by Lugano criteria (2014). All the subjects should have at least one measurable lesion in CT or MRI test.
- If subjects have received anti-tumor therapies before, the toxicity severity must decrease to ≤ Grade1 evaluated by CTCAE 5.0, except for residual alopecia.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Has a predicted survival period ≥ 3 months.
- Demonstrate adequate organ function as defined below(No anticoagulants or other drugs affecting clotting function were used within 14 days prior to the first administration. No blood transfusions were performed, no hematopoietic stimulators were used, and no drugs were used to correct blood cell counts). a) Hemoglobin (HGB)≥9 g/dL;b)Absolute neutrophil count (ANC) ≥1.5×109/L;c)Platelets ≥75×109/L;d) Serum total bilirubin (TBIL) ≤ 1.5 X upper limit of normal ULN (Subjects with Gilbert's syndrome can be up to 3 x ULN);e) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 X ULN or ≤5 X ULN for subjects with hepatocellular carcinoma and liver metastases;f)Serum creatinine ≤1.5 X ULN or Creatinine clearance (CCr) ≥ 50mL/min;g)International Normalized Ratio (INR) and activated partial thromboplastin time (APPT) ≤1.5 X ULN.
- From signing the informed consent form to 6 months after last dose of investigational drug, subjects of childbearing potential should be willing to use reliable contraceptive methods.
Who cannot join
- History of allergic reactions attributed to any monoclonal antibody, and uncontrolled history of allergic asthma.
- Subjects with primary central nervous system tumor, or symptomatic/untreated central nervous system metastases (except for residual signs or symptoms related to CNS treatment, those with stable or improved neurological symptoms at least 2 weeks before inclusion can be included)
- Patients with any autoimmune disease, i.e., but not limited to, subjects with well-controlled type I diabetes, well-controlled hypothyroidism with hormone replacement therapy, skin diseases (such as vitiligo, psoriasis, or hair loss) without systemic treatment, or who are not expected to relapse without external triggers.
- History of primary immunodeficiency
- Patients with serious cardiovascular diseases, such as grade 2 or above heart failure, previous myocardial infarction within 3 months, poorly controlled arrhythmias or unstable angina pectoris, as rated by New York Heart Association;.
- Has history of Interstitial Lung Disease or non-infectious pneumonitis. (Patients caused by radiotherapy are eligible).
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- Prior therapy with an anti-PD-1, anti-PD-L1,or anti CTLA-4 antibody ( any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
- Immune-related adverse events of grade 3 or higher（CTCAE 5.0）after immune therapy.
- Have received allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Any active infection requiring systemic treatment by intravenous infusion within 14 days prior to screening.
- Have received major surgery or radical radiotherapy within 28 days, or palliative radiotherapy within 14 days, or radiological agents (strontium, samarium, etc.) within 56 days prior to screening.
- Have received systemic anti-tumour therapy 28 days before the first dose, including but not limited to chemotherapy, immunotherapy, macromolecular targeted therapy, and biological therapy (tumour vaccine, cytokines or growth factors controlling cancer); Patients who received small-molecule targeted and oral fluorouracil therapy within 14 days before the first dose (or 5 half-life, whichever is longer); Patients who received mitomycin C and urea nitrite within 6 weeks before the first dose.
- Live attenuated vaccine should be given within 14 days before screening or during the study period
- Have received Chinese herbal medicine or Chinese patent medicine with anti-tumor activity within14 days prior to the screening.
- Have received whole blood transfusion or blood component transfusion within 14 days prior to screening.
- Have a history of active tuberculosis or tuberculosis.
- Active hepatitis B virus infection or syphilis, or hepatitis C virus antibody or human immunodeficiency virus (HIV) antibody positive.
- Have participated other clinical trials and received related investigated drugs within 28 days prior to the first dose of study drug.
- Pregnant or lactating women; Or the blood pregnancy test of women at child-bearing age is positive during screening.
- Have received systemic corticosteroids (at doses equivalent to or greater than 10 mg/day of prednisone) or other immunosuppressive drugs within 14 days prior to the first dose of study drug.
- Other conditions that may increase the risk of drug use in the study, or interfere with the interpretation of the study results, or affect the compliance of the study, etc.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200223
Jin Li, PhD
About this study
Official title: An Open, Multi-dose, Dose Escalation and Cohort Expansion, Phase Ⅰ Study of the Recombinant Human Anti-PD-1 Monoclonal Antibody in Patients With Advanced Tumours.
This study is an open, multi-dose, dose escalation and cohort expansion, phase Ⅰ study to investigate the safety, tolerability, efficiency, pharmacokinetics, immunogenicity of SG001 in subjects with advanced tumours.
Read the detailed description
Phase Ⅰa: open, multi-dose, dose escalation. Phase Ⅰb: open, fixed-dose, cohort expansion.
- Conditions
- Advanced Solid Tumours, Cervical Cancer, Malignant Mesothelioma, Lymphoma, Non-Small-Cell Lung Cancer
- Being tested
- SG001
- Medical subject headings
- Uterine Cervical Neoplasms, Mesothelioma, Malignant, Lymphoma, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SG001Drug
Also called Recombinant Human Anti-PD-1 Monoclonal Antibody
Phase Ia: Subjects will receive intravenous infusion of SG001 following a sequential dose escalation design (1mg/kg, 3mg/kg and 10mg/kg). Dose limited toxicity (DLT) will be observed within 21 days after the first administration, then subjects can continuously receive SG001 every 2 weeks until confirmed progression, unacceptable toxicity, or withdrawal from the trial. Phase Ib: Subjects will receive intravenous infusion of SG001 at the dose of 240 mg every 2 weeks until confirmed progression, unacceptable toxicity, or withdrawal from the trial.
| Study group | Role | What they receive |
|---|---|---|
| SG001 | Experimental | Recombinant Human Anti-PD-1 Monoclonal Antibody Receives: Drug: SG001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of SG001 by assessing the percentage of participants who experience a dose-limiting toxicity (DLT)
To investigate the safety and tolerance profile tolerance profile of SG001 in subjects with advanced solid tumors
Measured: Phase Ⅰa: 21 days
Objective response rate (ORR) in solid tumor（The ORR of cohort B, C, and E will be evaluated by Independent Review Committee）.
To investigate the efficiency of SG001 in subjects with advanced solid tumors
Measured: Phase Ⅰb: From date of first drug administration until the date of first documented progression of disease or the date of death or the date of lose to follow-up, which occurs first, assessed up to 2 years.
Safety of SG001 in patients with advanced tumors.
To investigate the safety of SG001 in advanced tumors.
Measured: Phase Ⅰb: From signing informed consent form (ICF) to 90 days after the last dose of study drug or initiation of a new therapy for cancer, which occurs first.
Secondary outcomes (10)
The pharmacokinetic parameters of SG001, such as Cmax, AUC, t1/2 tmax, Vss, CL (clearance rate) etc.
The pharmacokinetics(PK) profile of SG001.
Measured: Phase Ⅰa: At the end of cycle 7（every cycle is 14 days，except cycle 1 is 21 days）; Phase Ⅰb: At the end of cycle 13 （every cycle is 14 days）.
The ORR of cohort B, C, and E, which will be evaluated by investigators.
The efficiency of SG001.
Measured: From date of first drug administration until the date of first documented progression of disease （PD） or the date of death or the date of lose to follow-up, which occurs first, assessed up to 2 years.
The ORR of cohort D, which will be evaluated by Lugano criteria 2014.
The efficiency of SG001.
Measured: From date of first drug administration until the date of first documented progression of disease （PD） or the date of death or the date of lose to follow-up, which occurs first, assessed up to 2 years.
DOR (duration of response).
The efficiency of SG001.
Measured: From the date of first documentation of confirmed CR（complete response）/PR（partial response） to the date of first documentation of PD or the date of death from any cause or the date of lose to follow-up, which occurs first, assessed up to 2 years.
DCR (disease control rate).
The efficiency of SG001.
Measured: DCR is defined as the percentage of patients with best overall response of CR, PR, or SD（stable disease）, which will be assessed up to 2 years.
TTP (time to progression).
The efficiency of SG001.
Measured: From the date of first drug administration to the date of first documentation of PD, assessed up to 2 years.
PFS (free-progression survival).
The efficiency of SG001.
Measured: From date of first drug administration until the date of first documented progression of disease （PD） or the date of death, which occurs first, assessed up to 2 years.
OS (overall survival).
The efficiency of SG001.
Measured: From date of first drug administration until the date of death, assessed up to 2 years.
Immunogenicity of SG001.
The immune profile of SG001.
Measured: From the first dose of study drug to 28 days after its last dose.
The activated T cell receptor occupancy.
The pharmacodynamics of SG001.
Measured: Phase Ⅰa: At the end of cycle 7（every cycle is 14 days，except cycle 1 is 21 days）; Phase Ⅰb: At the end of cycle 13 （every cycle is 14 days）.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start23 May 2019
- Primary completionSep 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumoursStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jin Li, PhD, Principal investigator, Shanghai East HospitalLingying Wu, PhD, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical SciencesCaicun Zhou, PhD, Principal investigator, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03852823
- Sponsor's protocol ID
- SG001201801
- Status last verified
- Apr 2021
- First submitted
- 20 Feb 2019
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fang J, Jiang O, Li W, Lin J, Fang M, Li Q, Zhao W, Wang K, Shi H, Chen Z, Yu J, Xing X, Zhao M, Liu A, Wang W, Han Z, Xiang S, Zhang X, Li J, Zhou C. Phase 1b Multicenter Study of SG001, a Humanized Anti-PD-1 Antibody, in Patients with Advanced Solid Tumors. Drug Des Devel Ther. 2025 Nov 24;19:10423-10435. doi: 10.2147/DDDT.S546663. eCollection 2025.
PubMed 41321671
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Multi-dose, Dose Escalation and Cohort Expansion, Phase Ⅰ Study of the Recombinant Human Anti-PD-1 Monoclonal Antibody in Patients With Advanced Tumours.
- ClinicalTrials.gov ID
- NCT03852823
- Acronym / sponsor ID
- SG001201801
- Conditions
- Advanced Solid Tumours, Cervical Cancer, Malignant Mesothelioma, Lymphoma, Non-Small-Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 May 2019 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 25 Feb 2019 (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 study is an open, multi-dose, dose escalation and cohort expansion, phase Ⅰ study to investigate the safety, tolerability, efficiency, pharmacokinetics, immunogenicity of SG001 in subjects with advanced tumours.
Detailed description
Phase Ⅰa: open, multi-dose, dose escalation. Phase Ⅰb: open, fixed-dose, cohort expansion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SG001 | Experimental | Drug: SG001Recombinant Human Anti-PD-1 Monoclonal Antibody |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age ≥ 18 on the day of signing informed consent.
- Phase Ⅰa: Histologically/cytologically confirmed diagnosis of advanced solid tumor, and failure of standard anti-tumor treatment (disease progression or intolerance), or no standard treatment or rejection of standard treatment.
- Cohort A: Histologically or cytologically documented locally-advanced, relapsed or metastatic solid malignancy with PD-L1 positive and/or deficiency in mismatch repair (dMMR) / Microsatellites instability-High (MSI-H) and/or EBV positive, and has failed at least first line standard therapy or for which standard therapy is not tolerated.
- Cohort B: Histologically documented relapsed or metastatic uterine cervical cancer and has failed at least first line standard therapy or for which standard therapy is not tolerated.
- Cohort C: Histologically documented malignant mesothelioma, and has failed to pemetrexed-based chemotherapy or chemotherapy is not tolerated.
Key exclusion criteria (21 listed)
- History of allergic reactions attributed to any monoclonal antibody, and uncontrolled history of allergic asthma.
- Subjects with primary central nervous system tumor, or symptomatic/untreated central nervous system metastases (except for residual signs or symptoms related to CNS treatment, those with stable or improved neurological symptoms at least 2 weeks before inclusion can be included)
- Patients with any autoimmune disease, i.e., but not limited to, subjects with well-controlled type I diabetes, well-controlled hypothyroidism with hormone replacement therapy, skin diseases (such as vitiligo, psoriasis, or hair loss) without systemic treatment, or who are not expected to relapse without external triggers.
- History of primary immunodeficiency
- Patients with serious cardiovascular diseases, such as grade 2 or above heart failure, previous myocardial infarction within 3 months, poorly controlled arrhythmias or unstable angina pectoris, as rated by New York Heart Association;.
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 |
|---|---|---|
| SG001Also: Recombinant Human Anti-PD-1 Monoclonal AntibodyPhase Ia: Subjects will receive intravenous infusion of SG001 following a sequential dose escalation design (1mg/kg, 3mg/kg and 10mg/kg). Dose limited toxicity (DLT) will be observed within 21 days after the first administration, then subjects can continuously receive SG001 every 2 weeks until confirmed progression, unacceptable toxicity, or withdrawal from the trial. Phase Ib: Subjects will receive intravenous infusion of SG001 at the dose of 240 mg every 2 weeks until confirmed progression, unacceptable toxicity, or withdrawal from the trial. | Drug | SG001 |
Primary outcome
Safety and tolerability of SG001 by assessing the percentage of participants who experience a dose-limiting toxicity (DLT)
Time frame: Phase Ⅰa: 21 days
To investigate the safety and tolerance profile tolerance profile of SG001 in subjects with advanced solid tumors
Objective response rate (ORR) in solid tumor（The ORR of cohort B, C, and E will be evaluated by Independent Review Committee）.
Time frame: Phase Ⅰb: From date of first drug administration until the date of first documented progression of disease or the date of death or the date of lose to follow-up, which occurs first, assessed up to 2 years.
To investigate the efficiency of SG001 in subjects with advanced solid tumors
Safety of SG001 in patients with advanced tumors.
Time frame: Phase Ⅰb: From signing informed consent form (ICF) to 90 days after the last dose of study drug or initiation of a new therapy for cancer, which occurs first.
To investigate the safety of SG001 in advanced tumors.
10 secondary outcomes
The pharmacokinetic parameters of SG001, such as Cmax, AUC, t1/2 tmax, Vss, CL (clearance rate) etc.
Time frame: Phase Ⅰa: At the end of cycle 7（every cycle is 14 days，except cycle 1 is 21 days）; Phase Ⅰb: At the end of cycle 13 （every cycle is 14 days）.
The ORR of cohort B, C, and E, which will be evaluated by investigators.
Time frame: From date of first drug administration until the date of first documented progression of disease （PD） or the date of death or the date of lose to follow-up, which occurs first, assessed up to 2 years.
The ORR of cohort D, which will be evaluated by Lugano criteria 2014.
Time frame: From date of first drug administration until the date of first documented progression of disease （PD） or the date of death or the date of lose to follow-up, which occurs first, assessed up to 2 years.
DOR (duration of response).
Time frame: From the date of first documentation of confirmed CR（complete response）/PR（partial response） to the date of first documentation of PD or the date of death from any cause or the date of lose to follow-up, which occurs first, assessed up to 2 years.
DCR (disease control rate).
Time frame: DCR is defined as the percentage of patients with best overall response of CR, PR, or SD（stable disease）, which will be assessed up to 2 years.
TTP (time to progression).
Time frame: From the date of first drug administration to the date of first documentation of PD, assessed up to 2 years.
PFS (free-progression survival).
Time frame: From date of first drug administration until the date of first documented progression of disease （PD） or the date of death, which occurs first, assessed up to 2 years.
OS (overall survival).
Time frame: From date of first drug administration until the date of death, assessed up to 2 years.
Immunogenicity of SG001.
Time frame: From the first dose of study drug to 28 days after its last dose.
The activated T cell receptor occupancy.
Time frame: Phase Ⅰa: At the end of cycle 7（every cycle is 14 days，except cycle 1 is 21 days）; Phase Ⅰb: At the end of cycle 13 （every cycle is 14 days）.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Derived from this study: PubMed 41321671Fang J, Jiang O, Li W, Lin J, Fang M, Li Q, Zhao W, Wang K, Shi H, Chen Z, Yu J, Xing X, Zhao M, Liu A, Wang W, Han Z, Xiang S, Zhang X, Li J, Zhou C. Phase 1b Multicenter Study of SG001, a Humanized Anti-PD-1 Antibody, in Patients with Advanced Solid Tumors. Drug Des Devel Ther. 2025 Nov 24;19:10423-10435. doi: 10.2147/DDDT.S546663. eCollection 2025.
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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.
Jin Li, PhD principal investigator
Shanghai East Hospital
Lingying Wu, PhD principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Caicun Zhou, PhD principal investigator
Shanghai Pulmonary Hospital, Shanghai, China
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 SG001 in people with Advanced Solid Tumours and Cervical Cancer, run by CSPC ZhongQi 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 14 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 30 Apr 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiugao Yang (+86-13811660565, yangxiugao@mail.ecspc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of SG001 by assessing the percentage of participants who experience a dose-limiting toxicity (DLT) (time frame: Phase Ⅰa: 21 days). 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?
On the ClinicalTrials.gov record for NCT03852823, which also lists 1 linked publication.
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 30 Apr 2021.