Locally Advanced Unresectable or Metastatic Solid TumorsPhase 1CSG-1906-101NCT05857332
SG1906 for CLDN18.2-Positive Solid Tumors
A Phase 1 study testing SG1906 in people with Locally Advanced Unresectable or Metastatic Solid Tumors, run by Hangzhou Sumgen Biotech Co., Ltd. at 9 sites in China.
Trial summary
This is a Phase Ia/Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SG1906 in Patients with CLDN18.2-Positive Locally Advanced Unresectable or Metastatic Solid Tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Unresectable or Metastatic Solid Tumors
- What is being tested?
- SG1906
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 9 sitesChina
- Study dates
- 30 May 2023to 30 Aug 2027
- 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 must meet all the following criteria to be eligible for participation in this study:
- Understand and voluntarily sign the informed consent form (ICF).
- Age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
- Expected survival time of ≥3 months.
- Able to provide tumor tissue samples for CLDN18.2 detection.
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- Specific requirements for patients enrolled in Phase Ia and Phase Ib are as follows:
- Phase Ia Dose Escalation Phase
- Patients with CLDN18.2-positive histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor who have relapsed after standard therapy, have failed standard therapy, are intolerant to standard therapy, are not eligible for standard therapy, or refuse standard therapy.
- CLDN18.2 positivity is defined as H score ≥1 by central laboratory immunohistochemistry.
- Phase Ib Dose Expansion Stage
- Patients with histologically or cytologically confirmed CLDN18.2-positive locally advanced unresectable or metastatic G/GEJ adenocarcinoma or pancreatic cancer who have failed to respond to standard therapy, have relapsed after standard therapy, or are intolerant to standard therapy.
- CLDN18.2 positivity is defined as H score ≥40 by central laboratory immunohistochemistry.
- At least one evaluable lesion (refer to Response Evaluation Criteria in Solid Tumors, version 1.1 [RECIST 1.1]).
- Adequate function of vital organs, defined as follows:
- Bone marrow function (no transfusion, erythropoietin, granulocyte colony-stimulating factor, or other medically supportive therapy within 7 days prior to the first dose): neutrophil count ≥1.5 × 109/L, platelet count ≥100 × 109/L, and hemoglobin level ≥10.0 g/dL.
- Adequate liver function, which must meet all of the following criteria:
- Serum total bilirubin ≤1.5 × upper limit of normal (ULN).
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN (AST and ALT ≤5 × ULN in patients with liver metastases).
- Albumin ≥3.0 g/L.
- Renal function: serum creatinine ≤1.5 × ULN or endogenous creatinine clearance ≥50 mL/min (Cockcroft-Gault formula).
- Coagulation: international normalized ratio ≤1.5 × ULN or prothrombin time ≤1.5 × ULN, activated partial thromboplastin time ≤1.5 × ULN without receiving anticoagulation therapy.
- Toxicity caused by prior anti-tumor therapy recovered to Grade 0 to 1 (CTCAE 5.0), except for alopecia, Grade ≤2 sensory neuropathy, lymphocytopenia, and endocrine disorders controlled with hormone replacement therapy.
- Female patients of childbearing potential and male patients whose female partners are of childbearing potential need to use at least one approved contraceptive (e.g., intrauterine device, pill, or condom) during study treatment and for at least 6 months (180 days) after the last dose; female patients of childbearing potential must have a negative blood human chorionic gonadotropin (HCG) test within 7 days prior to dosing and must not be lactating.
- Male patients must refrain from donating sperm from the time the ICF is signed until at least 6 months after the last dose.
Who cannot join
- Patients who meet any of the following criteria cannot be enrolled:
- Presence of active central nervous system metastatic lesions; presence of metastases to the brainstem or meninges, spinal cord metastases or compression. Exception: patients with previously treated brain metastases (e.g., surgery, radiation therapy) who are clinically stable for at least 4 weeks after treatment (calculated from the first dose of investigational drug) and have discontinued corticosteroids for ≥14 days prior to the administration of investigational drug; patients with untreated, asymptomatic brain metastases (i.e., no neurological symptoms, no need for corticosteroids, brain metastases ≤1.5 cm in length, no significant edema around the brain metastases).
- Active autoimmune disease requiring systemic therapy within the past 2 years (e.g., use of immunomodulatory drugs, corticosteroids, or immunosuppressive medications); related replacement therapy is allowed (e.g., thyroid hormone, insulin, or physiologic corticosteroid replacement for renal or pituitary insufficiency).
- Pyloric obstruction or any other condition that can cause long-term chronic nausea, persistent recurrent vomiting (≥3 vomit episodes in 24 hours) or diarrhea.
- Patients who have recently developed gastrointestinal bleeding (i.e., a history of hematemesis, hematochezia, or melena within the past 3 months) without evidence of recovery confirmed by endoscopy or colonoscopy; or patients with evidence of risk of gastric bleeding.
- Patients with active gastrointestinal disease including, but not limited to, gastric or duodenal ulcers, acute gastric or intestinal perforation, acute necrotizing pancreatitis, ulcerative enteritis, congenital megacolon or Crohn's disease.
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- Patients requiring long-term treatment with non-steroidal anti-inflammatory drugs (NSAIDs); patients who are using anticoagulants such as heparin at therapeutic doses or vitamin K antagonists (except for prophylaxis).
- Presence of body fluid (hydrothorax, ascites, pericardial effusion, etc.) requiring local treatment or repeated drainage.
- Unintentional weight loss ≥5% within 1 month prior to initial dose, even with peripheral or central intravenous nutritional support.
- History of hemolytic anemia from any cause (including Evans syndrome).
- History of defects in red blood cell production, hemoglobin production, or metabolism, such as glucose-6-phosphate dehydrogenase deficiency, thalassemia, sickle cell disease, and hereditary spherocytosis.
- History of hemophagocytic lymphohistiocytosis.
- Presence of active infection requiring antibiotic therapy within 2 weeks prior to the first dose, except for prophylaxis.
- Presence of cardiovascular system disease within 6 months prior to screening that meets any of the following:
- Cardiac function: congestive heart failure of New York Heart Association (NYHA) class III or IV; left ventricular ejection fraction <50%.
- Clinically significant cardiac disease or surgery within 6 months prior to the first dose of the investigational drug, including myocardial infarction, unstable angina pectoris, cerebrovascular accident, coronary/peripheral artery bypass, etc.
- QTcF (corrected QT interval with Fridericia formula) >450 ms in men and >470 ms in women; history of clinically significant ventricular arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, tip-twist ventricular tachycardia); history or family history of congenital long QT syndrome; arrhythmias requiring antiarrhythmic drug therapy (patients with atrial fibrillation with controllable heart rate 1 month prior to the first dose of the investigational drug may be enrolled).
- History of arterial thrombosis, deep venous thrombosis and pulmonary embolism within 6 months prior to the first dose.
- Hypertension (systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥90 mmHg) that has not been effectively controlled after treatment with standardized antihypertensive medication.
- Patients with active hepatitis B or C. In case of positive hepatitis B surface antigen (HBsAg) or positive hepatitis B core antibody (HBcAb) during the screening period, further hepatitis B virus (HBV) DNA titer testing must be performed (HBV DNA≤200 IU/mL is required). Patients who are positive for hepatitis C virus (HCV) must receive further HCV RNA testing (no higher than the upper limit of the detection value at their study site); patients may be enrolled in the study only after active hepatitis B or C requiring treatment has been excluded.
- Known history of human immunodeficiency virus (HIV) infection (i.e., HIV antibody positive);
- Known history of Grade 3 to 4 hypersensitivity reactions to any biological product, history of life threatening hypersensitivity reactions, or known hypersensitivity to components of SG1906 drug product (Grade ≥3 hypersensitivity reactions).
- Have received any of the following treatments or procedures:
- Prior treatment with any antitumor therapy targeting CLDN18.2 or CD47
- Patients who have undergone open surgery ≤3 months prior to the first dose (except for surgeries for the purpose of biopsy).
- Prior allogeneic organ grafting.
- Systemic anticancer therapy (including chemotherapy, targeted therapy, hormonal therapy and immunotherapy) within 28 days or 5 drug half-lives (whichever is shorter) prior to the first dose of the investigational drug, and all AEs have not returned to grade ≤1 (CTCAE 5.0), except for alopecia.
- Radiotherapy ≤14 days prior to the first dose of the investigational drug; palliative radiotherapy is allowed if it is completed within 2 weeks prior to the enrollment in the study and radiotherapy-related toxicity has recovered to grade ≤1 (CTCAE 5.0), except for alopecia
- Any live vaccine within 4 weeks prior to the first dose of the investigational drug
- Have received treatment with various growth factors, blood transfusions or other blood products for anemia or decreased platelet count within 14 days prior to the first dose of the investigational drug.
- Have received systemic corticosteroids (at a dose equivalent to >10 mg/day prednisone) or other immunosuppressive drugs within 14 days prior to the first dose. The following are permitted:
- Topical or inhaled glucocorticoids in physiologic replacement doses are allowed
- The use of short-course (≤7 days) corticosteroids at physiologic replacement doses for the prevention or treatment of non-autoimmune diseases is allowed.
- Any other condition that, in the opinion of the Investigator, may lead to inappropriate participation in this study.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100039
Jianming XU
- Recruiting
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
Yanhong Deng
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Jian Ruan
- Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Ying Yuan
- Recruiting
The First Hospital of China Medical University
Shenyang, Liaoning, 110002
Zhenning WANG
Funan LIU
- Recruiting
Liaoning Cancer Hospital
Shenyang, Liaoning, 110801
Jingdong ZHANG
- Recruiting
Shanxi Cancer Hospital
Taiyuan, Shanxi, 030013
Yusheng WANG
- Recruiting
The First Affiliated Hospital Of Xiamen University
Xiamen, Fujian
Xin Zhao, 361003
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450003
Jufeng Wang
About this study
Official title: A Phase Ia/Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SG1906 in Patients With CLDN18.2-Positive Locally Advanced Unresectable or Metastatic Solid Tumors.
This is a Phase Ia/Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SG1906 in Patients with CLDN18.2-Positive Locally Advanced Unresectable or Metastatic Solid Tumors.
Read the detailed description
After a screening period of up to 28 days for each study phase, qualified patients will be enrolled to receive their assigned dose of SG1906, administered every 2 weeks (Q2W), until disease progression or intolerable toxicity, starting of a new anticancer treatment, withdrawal of consent, lost to follow up, death, or end of the study, whichever occurs first.
Phase Ia: Dose-escalation Stage The study population in Phase Ia includes patients with CLDN18.2-positive histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor who have relapsed after standard therapy, have failed standard therapy, are intolerant to standard therapy, are not eligible for standard therapy, or refuse standard therapy. Phase Ib: Dose-expansion Stage The study population in this phase will include patients with histologically or cytologically confirmed CLDN18.2-positive locally advanced unresectable or metastatic G/GEJ cancer or PC who have failed to respond to standard therapy, have relapsed after standard therapy, or are intolerant to standard therapy; and who have disease progression as confirmed by the Investigator or documented by medical history.
- Being tested
- SG1906
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SG1906Drug
Phase 1a will use an accelerated titration-Bayesian optimal interval (AT-BOIN) design with 7 dose cohorts: 0.1 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg, 6 mg/kg, 9 mg/kg, and 12 mg/kg by IV infusion. Accelerated titration (i.e., 1 patient each) will be applied to the first 2 cohorts.
| Study group | Role | What they receive |
|---|---|---|
| SG1906 | Experimental | SG1906 monotherapy intravenous (IV) infusion - Biweekly doses Receives: Drug: SG1906 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Number and percentage of AE which is calculated by worst CTCAE grade by CTCAE 5.0
Measured: Through study completion, an average of one year
MTD/MAD/ RP2D
To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) for intravenous (IV) administration of SG1906 in patients with CLDN18.2-positive locally advanced unresectable or metastatic solid tumors.; To preliminarily determine the recommended Phase 2 dose (RP2D) of SG1906 given intravenously in patients with CLDN18.2-positive locally advanced unresectable or metastatic solid tumors.
Measured: Through study completion, an average of one year
Secondary outcomes (6)
Pharmacokinetics (PK): AUC
The area under the curve (AUC) of serum concentration of the drug after the administration.
Measured: Through study completion, an average of one year
Pharmacokinetics (PK): Cmax
Cmax to maximum drug concentration.
Measured: Through study completion, an average of one year
Pharmacokinetics (PK):limination half-life (T1/2)
limination half-life (T1/2) of the drug after administration.
Measured: Through study completion, an average of one year
receptor occupancy (RO)
receptor occupancy (RO) of CD47 on the surface of peripheral blood cells;
Measured: Through study completion, an average of one year
Immunogenicity endpoints:
levels of anti-drug antibodies (ADAs) and neutralizing antibodies (tested in ADA-positive samples only).
Measured: Through study completion, an average of one year
Efficacy endpoints:
objective response rate (ORR).
Measured: Through study completion, an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start30 May 2023
- Primary completion28 Feb 2027 (estimated)
- Study completion30 Aug 2027 (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 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
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Sumgen Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857332
- Sponsor's protocol ID
- CSG-1906-101
- Acronym
- CSG-1906-101
- Status last verified
- Aug 2026
- First submitted
- 23 Apr 2023
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia/Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SG1906 in Patients With CLDN18.2-Positive Locally Advanced Unresectable or Metastatic Solid Tumors.
- ClinicalTrials.gov ID
- NCT05857332
- Acronym / sponsor ID
- CSG-1906-101 / CSG-1906-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hangzhou Sumgen Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 May 2023 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 12 May 2023 (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 Ia/Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SG1906 in Patients with CLDN18.2-Positive Locally Advanced Unresectable or Metastatic Solid Tumors.
Detailed description
After a screening period of up to 28 days for each study phase, qualified patients will be enrolled to receive their assigned dose of SG1906, administered every 2 weeks (Q2W), until disease progression or intolerable toxicity, starting of a new anticancer treatment, withdrawal of consent, lost to follow up, death, or end of the study, whichever occurs first.
Phase Ia: Dose-escalation Stage The study population in Phase Ia includes patients with CLDN18.2-positive histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor who have relapsed after standard therapy, have failed standard therapy, are intolerant to standard therapy, are not eligible for standard therapy, or refuse standard therapy. Phase Ib: Dose-expansion Stage The study population in this phase will include patients with histologically or cytologically confirmed CLDN18.2-positive locally advanced unresectable or metastatic G/GEJ cancer or PC who have failed to respond to standard therapy, have relapsed after standard therapy, or are intolerant to standard therapy; and who have disease progression as confirmed by the Investigator or documented by medical history.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SG1906 | Experimental | Drug: SG1906SG1906 monotherapy intravenous (IV) infusion - Biweekly doses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Patients must meet all the following criteria to be eligible for participation in this study:
- Phase Ia Dose Escalation Phase
- Phase Ib Dose Expansion Stage
Key exclusion criteria (34 listed)
- Presence of active central nervous system metastatic lesions; presence of metastases to the brainstem or meninges, spinal cord metastases or compression. Exception: patients with previously treated brain metastases (e.g., surgery, radiation therapy) who are clinically stable for at least 4 weeks after treatment (calculated from the first dose of investigational drug) and have discontinued corticosteroids for ≥14 days prior to the administration of investigational drug; patients with untreated, asymptomatic brain metastases (i.e., no neurological symptoms, no need for corticosteroids, brain metastases ≤1.5 cm in length, no significant edema around the brain metastases).
- Active autoimmune disease requiring systemic therapy within the past 2 years (e.g., use of immunomodulatory drugs, corticosteroids, or immunosuppressive medications); related replacement therapy is allowed (e.g., thyroid hormone, insulin, or physiologic corticosteroid replacement for renal or pituitary insufficiency).
- Pyloric obstruction or any other condition that can cause long-term chronic nausea, persistent recurrent vomiting (≥3 vomit episodes in 24 hours) or diarrhea.
- Patients who have recently developed gastrointestinal bleeding (i.e., a history of hematemesis, hematochezia, or melena within the past 3 months) without evidence of recovery confirmed by endoscopy or colonoscopy; or patients with evidence of risk of gastric bleeding.
- Patients with active gastrointestinal disease including, but not limited to, gastric or duodenal ulcers, acute gastric or intestinal perforation, acute necrotizing pancreatitis, ulcerative enteritis, congenital megacolon or Crohn's disease.
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 |
|---|---|---|
| SG1906Phase 1a will use an accelerated titration-Bayesian optimal interval (AT-BOIN) design with 7 dose cohorts: 0.1 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg, 6 mg/kg, 9 mg/kg, and 12 mg/kg by IV infusion. Accelerated titration (i.e., 1 patient each) will be applied to the first 2 cohorts. | Drug | SG1906 |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: Through study completion, an average of one year
Number and percentage of AE which is calculated by worst CTCAE grade by CTCAE 5.0
MTD/MAD/ RP2D
Time frame: Through study completion, an average of one year
To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) for intravenous (IV) administration of SG1906 in patients with CLDN18.2-positive locally advanced unresectable or metastatic solid tumors.; To preliminarily determine the recommended Phase 2 dose (RP2D) of SG1906 given intravenously in patients with CLDN18.2-positive locally advanced unresectable or metastatic solid tumors.
6 secondary outcomes
Pharmacokinetics (PK): AUC
Time frame: Through study completion, an average of one year
Pharmacokinetics (PK): Cmax
Time frame: Through study completion, an average of one year
Pharmacokinetics (PK):limination half-life (T1/2)
Time frame: Through study completion, an average of one year
receptor occupancy (RO)
Time frame: Through study completion, an average of one year
Immunogenicity endpoints:
Time frame: Through study completion, an average of one year
Efficacy endpoints:
Time frame: Through study completion, an average of one year
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 11 Aug 2026.
- 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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SG1906 in people with Locally Advanced Unresectable or Metastatic Solid Tumors, run by Hangzhou Sumgen Biotech Co., Ltd. at 9 sites 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 25 inclusion and 34 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 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 Pengyu Shi (+86 010 56315401, shipengyu@sumgenbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: Through study completion, an average of one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.