Solid Tumor, AdultPhase 1NCT06027346
A Study of Bio-008 in Subjects With Advanced or Metastatic Solid Tumours
A Phase 1 study testing Bio-008 in people with Solid Tumor, Adult, run by Shijiazhuang Yiling Pharmaceutical Co. Ltd at 1 site in China.
Trial summary
Phase 1: Dose escalation study (Phase Ia) Main purpose: Evaluate the safety and tolerability of BIO-008 in patients with advanced solid tumors, and determine the maximum tolerable dose (MTD) and dose limiting toxicity (DLT) of BIO-008. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- Bio-008
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 17 Jul 2023to May 2026
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary signed informed consent (ICF) and follow protocol requirements
- Age is 18~75 years old (including the boundary value), gender is not limited
- Patients with advanced solid tumors who have histologically or cytologically confirmed standard therapy failure (progressive treatment or intolerance), or no standard therapy regimen, or who are not suitable for standard therapy at this stage
- Dose escalation study (Phase Ia): Participants agreed to provide fresh or archived tumor tissue samples for assessment of CLDN18.2 expression levels before the first dose (central laboratory), and subjects enrolled in Phase Ia did not require positive CLDN18.2 expression. If the subject cannot provide samples or a sufficient number of slices, he may be evaluated by the investigator if other entry criteria are met
- Dose extension study (Phase Ib): The subject agreed to provide fresh or archived tumor tissue samples for the assessment of CLDN18.2 expression levels (before the central laboratory) and tested positive for CLDN18.2 by the central laboratory
- According to RECIST v1.1 standard, dose escalation studies (Phase Ia) have at least evaluable lesions; Dose extension study (Phase Ib) with at least one measurable lesion;
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- The ECOG physical strength score is 0-1 point
- The estimated survival time is not less than 3 months
- The toxicity of previous anti-tumor therapy has recovered to grade 1 as defined by CTCAE v5.0 (except for asymptomatic laboratory abnormalities, such as elevated ALP test, hyperuricemia, elevated blood glucose, etc.
- except for toxicity without safety risk judged by the investigator, such as hair loss, pigmentation, grade 2 peripheral neurotoxicity, thyrotoxicity after immune checkpoint inhibitor treatment, except for those who have been controlled after hormone replacement therapy)
- Within 7 days before the first dose, the functional levels of the bone marrow reserve and organs must meet the following requirements: Bone marrow reserve: Absolute neutrophil count (ANC) 1.5 109 / L, platelet count (PLT) 90109 / L, hemoglobin (HGB)> 90 g / L (no blood transfusion or hematopoietic stimulating factor therapy within 14 days) Coagulation function: activated partial prothrombin time (APTT) extended 1.5 upper limit of normal (ULN), international standardized ratio (INR) 1.5 Liver function: total bilirubin 1.5 ULN (direct bilirubin normal Gilbert syndrome can be enrolled), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 2.5 ULN (if liver metastases, ALT and AST 5 ULN) Renal function: creatinine clearance of 60 mL/min (using the Cockcroft-Gault formula, see Appendix 1) or serum creatinine of 1.5 ULN Qualified fertile patients (men and women) must agree to use reliable contraceptive methods (hormone or barrier method or abstinence, etc.) with their partner during the trial and at least 6 months after the last dose
- Qualified patients (male and female) with fertility must agree to use reliable contraceptive methods (such as hormone or barrier methods or abstinence) with their partners during the trial period and at least 6 months after the last medication; Female patients of childbearing age must have a negative serum pregnancy test within 7 days before the first use of the investigational drug.
Who cannot join
- Allergic or hypersensitivity to similar products or excipients
- Received other clinical trial drug or treatment within 28 days prior to the first dose
- They had received anti-tumor therapy such as chemotherapy, radiotherapy, biological therapy, endocrine therapy and immunotherapy within 28 days before the first dose. Enrollment may be judged by the investigator if:
- 1) Small local palliative radiotherapy (bone metastasis radiotherapy for pain control), more than 14 days since the first dose 2)Use of oral drugs, including fluorouracil and small molecule targeted drugs, more than 14 days or more than 5 half-lives since the first drug administration (whichever is longer) 3) It has been more than 14 days since the first administration of traditional Chinese medicine with anti-tumor indications 4) Nitrosourea or mitomycin C was used more than 6 weeks from the first administration.
- 4: Have received antitumor drugs for the CLDN18.2 target
- 5: Vaccination of any live vaccine within 28 days before the first dose (e. g., vaccines against infectious diseases, such as influenza, varicella, or COVID-19, etc.)
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- 6: Those who have received immunosuppressive agents or systemic corticosteroids (receiving more than 10mg of prednisone or equivalent glucocorticoids per day) within 14 days prior to the first dose
- 7: Major organ surgery or interventional therapy (excluding tumor biopsy, puncture, etc.) or significant trauma within 28 days before the first dose, or required elective surgery during the trial
- 8: Those who are using anticoagulants, vitamin K antagonists, or heparin treatment may receive prophylactic doses
- 9: Patients with gastrointestinal obstruction or persistent recurrent vomiting (defined as 3 vomiting at 24 hours) or uncontrolled / severe gastrointestinal bleeding or ulcer within 28 days prior to the first dose
- 10: Patients with active infection within 1 week prior to the first dose and currently requiring systemic anti-infection treatment
- 11: Patients with central nervous system metastasis or meningeal metastasis, or other evidence that CNS metastasis or meningeal metastasis has not been controlled and are not eligible by the investigator
- 12: Poor controlled pleural effusion, pericardial effusion or ascites requiring repeated drainage were judged by the investigator as not suitable for enrollment
- 13: Patients with a history of interstitial pneumonia, pulmonary fibrosis, radiation pneumonia or interstitial lung disease / pneumonia caused by drugs, as judged by the investigator
- 14: History of severe cardiovascular and cerebrovascular diseases, including but not limited to:
- Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, -degree atrioventricular block, etc.
- QT interval extension (Fridericia corrected QT value (QTc)> 450 msec in men or> 470 msec in women)
- Left ventricular ejection fraction was <50%
- Thromboembolic events requiring therapeutic anticoagulation, or subjects with venous filters
- According to the New York Cardiology Association (NYHA) standard, grade III to IV cardiac dysfunction
- Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other serious cardiovascular and cerebrovascular events within 6 months prior to the first dose
- Clinically uncontrolled hypertension (systolic blood pressure 150 mmHg and / or diastolic blood pressure 100mmHg after drug treatment)
- Any factor that increases the risk of QTc prolongation or arrhythmia, such as hypokalemia with poorly controlled hypokalemia, congenital long QT syndrome, use of any concomitant medication known or potentially prolonged QT interval (see Appendix 4)
- 15: Patients with a second primary tumor within 5 years before the first dose, except for the following conditions: radical treatment of skin basal cell carcinoma, squamous epithelial cell carcinoma of the skin, or radical resection of carcinoma in situ
- 16: Previous history of immunodeficiency, including other acquired or congenital immunodeficiency diseases, or a history of organ transplantation, or a history of allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation, or active autoimmune diseases and inflammatory diseases
- 17: HIV Infection, active HBV infection (HBV DNA 2000 IU / mL or 1104 copies / mL), active HCV infection (HCV RNA above the upper limit of normal), active syphilis infection (positive for syphilis-specific antibody)
- 18: A known history of substance abuse
- 19: People with mental illness disorders or poor compliance
- 20: Unable to tolerate venous blood collection
- 21: Female patients during pregnancy or lactation
- 22: The subject was not eligible for the clinical study in the opinion of a history of other serious systemic disease or other reasons.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of the Chinese People's Liberation Army Air Force Military Medical University
Xi'an, Shaanxi
gang Ji, PI
gang JI, Doctor
About this study
Official title: A Phase I Study of BIO-008 Injection for Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity in Patients With Advanced Solid Tumors
Phase 1: Dose escalation study (Phase Ia)
Main purpose:
Read more
Evaluate the safety and tolerability of BIO-008 in patients with advanced solid tumors, and determine the maximum tolerable dose (MTD) and dose limiting toxicity (DLT) of BIO-008.
Secondary purpose:
Evaluate the pharmacokinetic (PK) characteristics of BIO-008;
Evaluate the immunogenicity of BIO-008.
Exploratory purposes:
Preliminary evaluation of the anti-tumor activity of BIO-008 (if available);
Detect the expression of CLDN18.2 in tumor tissue and explore its correlation with BIO-008 anti-tumor activity indicators (only applicable to subjects who can provide fresh or archived tumor tissue samples before the first administration).
Phase 2: Dose Extension Study (Phase Ib)
Main purpose:
- Preliminary evaluation of ORR of BIO-008 in patients with CLDN18.2 positive advanced gastric cancer or gastroesophageal junction cancer (GC/GEJ), pancreatic cancer (PC) and other solid tumors;
Determine the recommended dose for clinical phase II (RP2D).
Secondary purpose:
Evaluate the safety and tolerability of BIO-008;
Evaluate the PK characteristics of BIO-008;
Evaluate the immunogenicity of BIO-008;
- Evaluate other anti-tumor activity indicators of BIO-008 in patients with CLDN18.2 positive advanced gastric cancer or gastroesophageal junction cancer, pancreatic cancer and other solid tumors;
Evaluate the correlation between the anti-tumor activity of BIO-008 and the expression of CLDN18.2.
- Conditions
- Solid Tumor, Adult
- Being tested
- Bio-008
- Keywords
- Tolerance, Pharmacokinetic characteristics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bio-008Biological
The subjects in each dose group received the corresponding dose of BIO-008 monotherapy, administered intravenously (ivd) for a duration of 0.5 to 3 hours (the researchers can adjust the administration time according to the patient's tolerance). If there is an infusion reaction, the infusion can be suspended and completed within 12 hours. Administer on the first day of each cycle, once every 3 weeks (1 cycle, i.e. 21 days) (Q3W) until the criteria for termination of treatment or withdrawal from the study are met, whichever occurs first.
| Study group | Role | What they receive |
|---|---|---|
| Bio-008 0.3mg/kg | Experimental | group1 Receives: Biological: Bio-008 |
| Bio-008 1.0mg/kg | Experimental | group2 Receives: Biological: Bio-008 |
| Bio-008 3.3mg/kg | Experimental | group3 Receives: Biological: Bio-008 |
| Bio-008 10.0mg/kg | Experimental | group4 Receives: Biological: Bio-008 |
| Bio-008 20.0mg/kg | Experimental | group5 Receives: Biological: Bio-008 |
| Bio-008 30.0mg/kg | Experimental | group6 Receives: Biological: Bio-008 |
| Bio-008 40.0mg/kg | Experimental | group7 Receives: Biological: Bio-008 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AE)/severe adverse events (SAE)
To evaluate the safety of Bio-008
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Incidence of dose limiting toxicity (DLT)
To collect dose limiting toxicities (DLTs) occurring within 21 days after the first dose
Measured: From day 1 to day 21 after the first dose
Maximum Tolerated Dose (MTD）
The maximum tolerated dose (MTD) is commonly estimated to be the maximum dose that can be determined through DLT of two among 6 subjects administered with Bio-008 once every 3 weeks in 21 days cycles.
Measured: From day 1 to day 21 after the first dose
Objective response rate (ORR) (RECIST 1.1)
These measure are defined as the proportion of subjects with complete response (CR) or partial response (PR)
Measured: From date of randomization until the date of first documented progression, up to 3 months
Recommended Phase 2 Dose (RP2D)
The RP2D will be determined during the dose expansion stage of the study. RP2D will be determined using available safety and efficacy data.
Measured: From day 1 to day 21 after the first dose
Secondary outcomes (8)
Area under plasma concentration vs time curve (AUC)
Changes in AUC over time in participants
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Peak plasma concentration (Cmax)
Cmax is the maximum plasma concentration
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Time to maximum observed plasma concentration(Tmax)
Tmax is the time in hrs/days it takes to reach Cmax after dosing
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Terminal elimination half life (T1/2)
Time for the plasma level of Bio-008 to decrease b y 1/2 during the terminal elimination phase
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Immunogenicity
by measurement of Incidence of anti-drug antibodies (ADA) and neutralizing antibody（Nad）
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Disease control rate (DCR) (RECIST 1.1)
These measure are defined as the proportion of subjects with CR, PR and stable disease (SD)
Measured: From date of randomization until the date of first documented progression, up to 3 months
Duration of response (DOR) (RECIST 1.1)
These measure are defined as the duration from the first occurrence of confirmed CR or PR until the date of disease progression or death (from any cause)
Measured: From date of randomization until the date of first documented progression, up to 3 months
Progression free survival (PFS) (RECIST 1.1)
These measure are defined as time from start of treatment to tumor progression or death from any cause
Measured: From date of randomization until the date of first documented progression, up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start17 Jul 2023
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies 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
- Shijiazhuang Yiling Pharmaceutical Co. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- gang Ji, PI, Principal investigator, The First Affiliated Hospital of the Chinese People's Liberation Army Air Force Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06027346
- Sponsor's protocol ID
- BIO-008ONC1001
- Status last verified
- Aug 2023
- First submitted
- 14 Aug 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of BIO-008 Injection for Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06027346
- Acronym / sponsor ID
- BIO-008ONC1001
- Conditions
- Solid Tumor, Adult
- Keywords
- Tolerance, Pharmacokinetic characteristics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shijiazhuang Yiling Pharmaceutical Co. LtdIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 7 Sep 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.
Phase 1: Dose escalation study (Phase Ia)
Main purpose:
Evaluate the safety and tolerability of BIO-008 in patients with advanced solid tumors, and determine the maximum tolerable dose (MTD) and dose limiting toxicity (DLT) of BIO-008.
Secondary purpose:
Evaluate the pharmacokinetic (PK) characteristics of BIO-008;
Evaluate the immunogenicity of BIO-008.
Exploratory purposes:
Preliminary evaluation of the anti-tumor activity of BIO-008 (if available);
Detect the expression of CLDN18.2 in tumor tissue and explore its correlation with BIO-008 anti-tumor activity indicators (only applicable to subjects who can provide fresh or archived tumor tissue samples before the first administration).
Phase 2: Dose Extension Study (Phase Ib)
Main purpose:
- Preliminary evaluation of ORR of BIO-008 in patients with CLDN18.2 positive advanced gastric cancer or gastroesophageal junction cancer (GC/GEJ), pancreatic cancer (PC) and other solid tumors;
Determine the recommended dose for clinical phase II (RP2D).
Secondary purpose:
Evaluate the safety and tolerability of BIO-008;
Evaluate the PK characteristics of BIO-008;
Evaluate the immunogenicity of BIO-008;
- Evaluate other anti-tumor activity indicators of BIO-008 in patients with CLDN18.2 positive advanced gastric cancer or gastroesophageal junction cancer, pancreatic cancer and other solid tumors;
Evaluate the correlation between the anti-tumor activity of BIO-008 and the expression of CLDN18.2.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Bio-008 0.3mg/kg | Experimental | Biological: Bio-008group1 |
| Bio-008 1.0mg/kg | Experimental | Biological: Bio-008group2 |
| Bio-008 3.3mg/kg | Experimental | Biological: Bio-008group3 |
| Bio-008 10.0mg/kg | Experimental | Biological: Bio-008group4 |
| Bio-008 20.0mg/kg | Experimental | Biological: Bio-008group5 |
| Bio-008 30.0mg/kg | Experimental | Biological: Bio-008group6 |
| Bio-008 40.0mg/kg | Experimental | Biological: Bio-008group7 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Voluntary signed informed consent (ICF) and follow protocol requirements
- Age is 18~75 years old (including the boundary value), gender is not limited
- Patients with advanced solid tumors who have histologically or cytologically confirmed standard therapy failure (progressive treatment or intolerance), or no standard therapy regimen, or who are not suitable for standard therapy at this stage
- Dose escalation study (Phase Ia): Participants agreed to provide fresh or archived tumor tissue samples for assessment of CLDN18.2 expression levels before the first dose (central laboratory), and subjects enrolled in Phase Ia did not require positive CLDN18.2 expression. If the subject cannot provide samples or a sufficient number of slices, he may be evaluated by the investigator if other entry criteria are met
- Dose extension study (Phase Ib): The subject agreed to provide fresh or archived tumor tissue samples for the assessment of CLDN18.2 expression levels (before the central laboratory) and tested positive for CLDN18.2 by the central laboratory
Key exclusion criteria (31 listed)
- Allergic or hypersensitivity to similar products or excipients
- Received other clinical trial drug or treatment within 28 days prior to the first dose
- They had received anti-tumor therapy such as chemotherapy, radiotherapy, biological therapy, endocrine therapy and immunotherapy within 28 days before the first dose. Enrollment may be judged by the investigator if:
- 1) Small local palliative radiotherapy (bone metastasis radiotherapy for pain control), more than 14 days since the first dose 2)Use of oral drugs, including fluorouracil and small molecule targeted drugs, more than 14 days or more than 5 half-lives since the first drug administration (whichever is longer) 3) It has been more than 14 days since the first administration of traditional Chinese medicine with anti-tumor indications 4) Nitrosourea or mitomycin C was used more than 6 weeks from the first administration.
- 4: Have received antitumor drugs for the CLDN18.2 target
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 |
|---|---|---|
| Bio-008The subjects in each dose group received the corresponding dose of BIO-008 monotherapy, administered intravenously (ivd) for a duration of 0.5 to 3 hours (the researchers can adjust the administration time according to the patient's tolerance). If there is an infusion reaction, the infusion can be suspended and completed within 12 hours. Administer on the first day of each cycle, once every 3 weeks (1 cycle, i.e. 21 days) (Q3W) until the criteria for termination of treatment or withdrawal from the study are met, whichever occurs first. | Biological | Bio-008 0.3mg/kg, Bio-008 1.0mg/kg, Bio-008 10.0mg/kg, Bio-008 20.0mg/kg, Bio-008 3.3mg/kg, Bio-008 30.0mg/kg, Bio-008 40.0mg/kg |
Primary outcome
Adverse events (AE)/severe adverse events (SAE)
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
To evaluate the safety of Bio-008
Incidence of dose limiting toxicity (DLT)
Time frame: From day 1 to day 21 after the first dose
To collect dose limiting toxicities (DLTs) occurring within 21 days after the first dose
Maximum Tolerated Dose (MTD）
Time frame: From day 1 to day 21 after the first dose
The maximum tolerated dose (MTD) is commonly estimated to be the maximum dose that can be determined through DLT of two among 6 subjects administered with Bio-008 once every 3 weeks in 21 days cycles.
Objective response rate (ORR) (RECIST 1.1)
Time frame: From date of randomization until the date of first documented progression, up to 3 months
These measure are defined as the proportion of subjects with complete response (CR) or partial response (PR)
Recommended Phase 2 Dose (RP2D)
Time frame: From day 1 to day 21 after the first dose
The RP2D will be determined during the dose expansion stage of the study. RP2D will be determined using available safety and efficacy data.
8 secondary outcomes
Area under plasma concentration vs time curve (AUC)
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Peak plasma concentration (Cmax)
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Time to maximum observed plasma concentration(Tmax)
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Terminal elimination half life (T1/2)
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Immunogenicity
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Disease control rate (DCR) (RECIST 1.1)
Time frame: From date of randomization until the date of first documented progression, up to 3 months
Duration of response (DOR) (RECIST 1.1)
Time frame: From date of randomization until the date of first documented progression, up to 3 months
Progression free survival (PFS) (RECIST 1.1)
Time frame: From date of randomization until the date of first documented progression, up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
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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.
gang Ji, PI principal investigator
The First Affiliated Hospital of the Chinese People's Liberation Army Air Force Military Medical University
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 Bio-008 in people with Solid Tumor, Adult, run by Shijiazhuang Yiling Pharmaceutical 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 12 inclusion and 31 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 7 Sep 2023. 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 wei Wang, master (086-0311-66703017, wangwei001@yiling.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AE)/severe adverse events (SAE) (time frame: from the start of the medication to the end of the study or 28 days after cessation of medication). The study lists 5 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 Sep 2023.