Cancer CachexiaPhase 1/2NCT07584057
An Phase I/IIa Clinical Study to Evaluate the Safety/Tolerability, Pharmacokinetics and Preliminary Efficacy of INB301 Injection in Patients With Cancer Cachexia
A Phase 1/2 study testing INB301 Injection in people with Cancer Cachexia, run by Yunnan Baiyao Group Co., Ltd. at 1 site in China.
Trial summary
This is an open-label, multicenter, multiple-dose Phase I/IIa clinical study to assess the safety/tolerability, PK characteristics,immunogenicity, and preliminary efficacy of INB301 Injection in patients with cancer cachexia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Cachexia
- What is being tested?
- INB301 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteChina
- Study dates
- May 2026to Mar 2030
- Phase
- Phase 1/2
- 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
- Subjects who voluntarily participate in the study and voluntarily sign the informed consent form;
- Male or female ≥ 18 years of age;
- Subjects with histologically or cytologically confirmed malignant solid tumors (including pathologically confirmed non-small cell lung cancer, colorectal cancer, pancreatic cancer, esophageal cancer or breast cancer, etc.) who are receiving or have completed anti-cancer treatment and have no significant cancer progression 28 days before the first dose, and in the investigator's expectation are unlikely to change the anti-cancer regimen due to disease progression or do not require any anti-cancer treatment within the first cycle (21 days) of the study;
- Definitely diagnosed as cancer cachexia according to the 2025 Definition and Classification of Cancer Cachexia: An International Consensus" combined with clinical practice: one of the following occurs within 6 months (recognized documentation is required for past weight data): involuntary weight loss > 5%, or weight loss > 2% when BMI < 18.5 kg/m² ;
- Serum GDF-15 level ≥ 1200 pg/mL within 28 days prior to the first dose (only applicable to Phase I dose expansion and Phase IIa);
- Adequate organ function, i.e., meeting laboratory criteria:
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- Hematology: absolute neutrophil count ≥ 1.0×10⁹/L, platelets ≥ 75×10⁹/L, hemoglobin ≥ 80 g/L;
- Renal: serum creatinine ≤ 1.5 × ULN (if serum creatinine > 1.5 × ULN, creatinine clearance calculated with Cockcroft formula ≥ 30 mL/min is required);
- Hepatic: total bilirubin ≤ 1.5 × ULN, AST and ALT ≤ 3 × ULN or AST and ALT ≤ 5 × ULN in case of liver metastasis;
- Coagulation function: activated partial thromboplastin time (APTT) ≤ 1.5 × ULN, international normalized ratio (INR) ≤ 1.5;
- ECOG PS score ≤ 2;
- Expected survival ≥ 4 months;
- Eligible subjects of childbearing potential should take adequate contraceptive measures from the time of signing the informed consent form until 6 months after the last dose: for female patients of childbearing age, the blood pregnancy test must be negative within 7 days before the first dose. In addition, subjects should avoid donating sperm/eggs for the time period specified above.
Who cannot join
- Other causes that may lead to reduced food intake or seriously affect digestion and absorption during the screening period, as determined by the investigator, including but not limited to: oral mucositis of NCI CTCAE Grade 3 or above, gastrointestinal disease of NCI CTCAE Grade 3 or above (nausea, vomiting, diarrhea and constipation, etc.), gastrointestinal obstruction, and active inflammatory bowel disease;
- Radiotherapy is planned as part of the primary anti-cancer treatment regimen (except local radiotherapy for symptom relief);
- Known active/symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis (for subjects with previously treated brain metastases, enrollment may be considered if all of the following criteria are met: the clinical condition has remained stable with no imaging evidence of disease progression within 4 weeks before the first investigational drug treatment, and corticosteroid treatment has not been required within 4 weeks before first dose; asymptomatic subjects with brain metastases (i.e., no neurologic symptoms, no requirement for corticosteroids, and no brain metastatic lesion with a longest diameter > 1.5 cm) may be enrolled, provided that regular imaging examination and assessment for brain metastatic lesions are performed);
- Gavage or parenteral nutrition (total or partial) is received during the screening period;
- History of other diseases that may cause cachexia within 6 months prior to screening, including but not limited to: severe and above COPD, NYHA class 3-4 heart failure;
- Human immunodeficiency virus antibody (HIVAb) positive, active hepatitis B (HBsAg and/or HBcAb positive and HBV-DNA > 500IU/mL or upper limit of normal, whichever is higher), or hepatitis C (anti-HCV positive and HCV-RNA above lower limit of detection). History of hepatitis B vaccination is acceptable;
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- Blood pressure ≥ 140 mmHg (systolic) or ≥ 90 mmHg (diastolic) at screening, measured after at least 5 minutes of rest. If the blood pressure exceeds the standard, the measurement should be repeated twice, and the mean of the three measurements is used to determine whether the subject meets the criterion;
- Screening 12-lead electrocardiogram (ECG) shows clinically relevant abnormalities that may affect subject safety or interpretation of study results (e.g., baseline QTcF > 450 milliseconds or QRS > 120 milliseconds). If the baseline uncorrected QT interval is > 450 milliseconds, Fridericia's method should be used for correction and QTcF should be used for decision-making. If QTcF > 450 milliseconds or QRS > 120 milliseconds, the ECG should be repeated twice, and the mean of the three measurements should be used for judgment. Computer-read ECG should be reviewed by experienced physician before excluding a subject;
- Serious infection for which intravenous antibiotics, antivirals, or antifungals are being administered within 14 days prior to screening or during the screening period;
- Subjects who have taken any prescription drugs that affect appetite or improve body weight within 28 days before the first dose or 5 half-lives, including but not limited to anamorelin, megestrol acetate, cannabinol, medical marijuana, Chinese patent medicines to improve appetite and traditional Chinese medicine preparations;
- Subjects who have received systemic glucocorticoids (prednisone > 10 mg/day or equivalent dose of similar product) or other immunosuppressants within 28 days before the first dose, except for anti-cancer treatment or pretreatment of examination;
- Baseline BMI > 26 kg/m² (for Chinese people)；
- Previously received anti-GDF-15, GFRAL and iso-mechanism antibodies;
- Subjects with massive serous effusion within 14 days before screening or during screening, such as pericardial effusion or pleural/peritoneal effusion;
- Received major surgery within 28 days before the first dose, or major surgery is expected during the study;
- History of serious cardiovascular and cerebrovascular diseases, including but not limited to:
- Serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, second-third degree atrioventricular block;
- Acute coronary syndrome, congestive heart failure, stroke or other grade 3 or above cardiovascular and cerebrovascular events occurred within 6 months prior to the first dose of study drug;
- Left ventricular ejection fraction (LVEF) < 50%;
- Treated with other clinical investigational drug within 28 days before the first dose or 5 half-lives (whichever is longer);
- Known allergy to INB301 or its components, or a history of severe allergic reactions or uncontrolled allergic asthma;
- Other serious physical or mental illness or laboratory abnormality at screening that may increase the risk of study participation or interfere with study results, and other causes that make the subject unsuitable for this clinical study in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
52 Fucheng Road, Haidian District
Beijing, Beijing Municipality, 100142
Lin Shen, Doctor of Medicine (M.D.), +86 10 88121122, doctorshenlin@sina.cn
Lin Shen, Doctor of Medicine (M.D.)
About this study
Official title: An Open-label, Multicenter Phase I/IIa Clinical Study to Evaluate the Safety/Tolerability, Pharmacokinetics and Preliminary Efficacy of INB301 Injection in Patients With Cancer Cachexia
This is an open-label, multicenter, multiple-dose Phase I/IIa clinical study to assess the safety/tolerability, PK characteristics,immunogenicity, and preliminary efficacy of INB301 Injection in patients with cancer cachexia.
The indication to be explored for Phase I is malignant solid tumor with cachexia; Phase IIa will determine the specific study cohort after discussion between the investigator and the sponsor based on the previously obtained clinical trial data and the benefit/risk ratio of the subjects, and preliminarily consider 3 cohorts of tentative 20-30 patients each, including non-small cell lung cancer, pancreatic cancer and colorectal cancer with cachexia.
Read the detailed description
The screening will be completed within 28 days before administration. Subjects who pass the screening will receive subcutaneous injection of INB301 until the investigator determines that the risk of continued treatment outweighs the benefit, toxicity becomes intolerable, or other criteria for withdrawal or treatment discontinuation are met, whichever occurs first. The end-of-study/early withdrawal visit will be completed at 28 days (±7 days) after the last dose.
If the anti-cancer treatment is suspended, modified, interrupted, or the protocol is changed during INB301 treatment, it is not considered a protocol deviation, and administration of INB301 will continue as specified in the protocol. Adjustments to standard of care, drug dosage or course of anti-cancer treatment, including treatment breaks, are at the discretion of the investigator.
Phase I dose escalation phase:
The dose escalation phase uses a standard 3+3 design to determine the maximum tolerated dose (MTD) or recommended expansion dose(RED). Enrolled subjects are sequentially assigned to 6 dose levels (50 mg, 100 mg, 200 mg, 300 mg, 400 mg, and 500 mg) to receive subcutaneous injection of INB301 every 3 weeks as a cycle. The starting dose of INB301 is based on a Minimum Anticipated Biological Effect Level (MABEL) approach, integrating nonclinical pharmacokinetic/pharmacodynamic (PK/PD) modeling, target engagement considerations, and available safety margins.
Phase I dose expansion phase:
In the dose expansion phase, the dose level (e.g., 200 mg, 400 mg) and dosing frequency will be determined based on the dose-escalation results, following discussion and consensus by the SMC, which is composed of the Investigator and the Sponsor. The RP2D will be confirmed during the dose expansion phase. It is tentatively planned to enroll 7-10 subjects per dose cohort.
Phase IIa:
After the RP2D is determined (e.g., 400 mg Q4W) based on the Phase I data, a cohort study in single tumor type with cachexia will be conducted to further evaluate the efficacy, safety, and tolerability of the investigational medicinal product.
- Conditions
- Cancer Cachexia
- Being tested
- INB301 Injection
- Keywords
- Cancer Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INB301 InjectionBiological
The screening will be completed within 28 days before administration. Subjects who pass the screening will receive subcutaneous injection of INB301 until the investigator determines that the risk of continued treatment outweighs the benefit, toxicity becomes intolerable, or other criteria for withdrawal or treatment discontinuation are met, whichever occurs first. The end-of-study/early withdrawal visit will be completed at 28 days (±7 days) after the last dose.
Each 1 mL of INB301 Injection contains 100 mg of the drug, and 2 mL of the drug can be injected at each subcutaneous injection site, which is at the left and right abdominal subcutaneous tissue, as well as the left and right arm subcutaneous tissue. The specific dose is determined according to the dose cohort. Dosing every 3 or 4 weeks is proposed.
| Study group | Role | What they receive |
|---|---|---|
| RP2D (Recommended Phase II dose) | Experimental | The dose escalation phase uses a standard 3+3 design to determine the maximum tolerated dose (MTD) or recommended expansion dose(RED). Enrolled subjects are sequentially assigned to 6 dose levels (50 mg, 100 mg, 200 mg, 300 mg, 400 mg, and 500 mg) to receive subcutaneous injection of INB301 every 3 weeks as a cycle.
In the dose expansion phase, the dose level (e.g., 200 mg, 400 mg) and dosing frequency will be determined based on the dose-escalation results, following discussion and consensus by the SMC, which is composed of the Investigator and the Sponsor. The RP2D will be confirmed during the dose expansion phase.
After the RP2D is determined (e.g., 400 mg Q4W) based on the Phase I data, a cohort study in single tumor type with cachexia. Receives: Biological: INB301 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Measured: Through study completion, an average of 1 year.
Mean change in body weight from baseline during each assessment period within 12 weeks.
Measured: Through study completion, an average of 1 year.
Secondary outcomes (12)
Area under the plasma concentration-time curve (AUC)
Measured: Up to 15 weeks.
Half-life (t1/2)
Measured: Up to 15 weeks.
Peak concentration (Cmax)
Measured: Up to 15 weeks.
Time to peak concentration (Tmax)
Measured: Up to 15 weeks.
Apparent volume of distribution (Vd)
Measured: Up to 15 weeks.
Clearance (CL)
Measured: Up to 15 weeks.
Mean residence time (MRT)
Measured: Up to 15 weeks.
Elimination rate constant (Kel)
Measured: Up to 15 weeks.
Safety evaluation indicators
Measured: Through study completion, an average of 1 year.
Immunogenicity evaluation indicators
Measured: Through study completion, an average of 1 year.
Patient-reported outcome (FAACT)
Measured: Through study completion, an average of 1 year.
Lumbar skeletal muscle index (LSMI)
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study startMay 2026 (estimated)
- Primary completionFeb 2030 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer CachexiaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yunnan Baiyao Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07584057
- Sponsor's protocol ID
- INB301-I/IIa-01
- Status last verified
- May 2026
- First submitted
- 19 Apr 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter Phase I/IIa Clinical Study to Evaluate the Safety/Tolerability, Pharmacokinetics and Preliminary Efficacy of INB301 Injection in Patients With Cancer Cachexia
- ClinicalTrials.gov ID
- NCT07584057
- Acronym / sponsor ID
- INB301-I/IIa-01
- Conditions
- Cancer Cachexia
- Keywords
- Cancer Cachexia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Yunnan Baiyao Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2026 (estimated)
- Primary completion
- Feb 2030 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 13 May 2026 (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 an open-label, multicenter, multiple-dose Phase I/IIa clinical study to assess the safety/tolerability, PK characteristics,immunogenicity, and preliminary efficacy of INB301 Injection in patients with cancer cachexia.
The indication to be explored for Phase I is malignant solid tumor with cachexia; Phase IIa will determine the specific study cohort after discussion between the investigator and the sponsor based on the previously obtained clinical trial data and the benefit/risk ratio of the subjects, and preliminarily consider 3 cohorts of tentative 20-30 patients each, including non-small cell lung cancer, pancreatic cancer and colorectal cancer with cachexia.
Detailed description
The screening will be completed within 28 days before administration. Subjects who pass the screening will receive subcutaneous injection of INB301 until the investigator determines that the risk of continued treatment outweighs the benefit, toxicity becomes intolerable, or other criteria for withdrawal or treatment discontinuation are met, whichever occurs first. The end-of-study/early withdrawal visit will be completed at 28 days (±7 days) after the last dose.
If the anti-cancer treatment is suspended, modified, interrupted, or the protocol is changed during INB301 treatment, it is not considered a protocol deviation, and administration of INB301 will continue as specified in the protocol. Adjustments to standard of care, drug dosage or course of anti-cancer treatment, including treatment breaks, are at the discretion of the investigator.
Phase I dose escalation phase:
The dose escalation phase uses a standard 3+3 design to determine the maximum tolerated dose (MTD) or recommended expansion dose(RED). Enrolled subjects are sequentially assigned to 6 dose levels (50 mg, 100 mg, 200 mg, 300 mg, 400 mg, and 500 mg) to receive subcutaneous injection of INB301 every 3 weeks as a cycle. The starting dose of INB301 is based on a Minimum Anticipated Biological Effect Level (MABEL) approach, integrating nonclinical pharmacokinetic/pharmacodynamic (PK/PD) modeling, target engagement considerations, and available safety margins.
Phase I dose expansion phase:
In the dose expansion phase, the dose level (e.g., 200 mg, 400 mg) and dosing frequency will be determined based on the dose-escalation results, following discussion and consensus by the SMC, which is composed of the Investigator and the Sponsor. The RP2D will be confirmed during the dose expansion phase. It is tentatively planned to enroll 7-10 subjects per dose cohort.
Phase IIa:
After the RP2D is determined (e.g., 400 mg Q4W) based on the Phase I data, a cohort study in single tumor type with cachexia will be conducted to further evaluate the efficacy, safety, and tolerability of the investigational medicinal product.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RP2D (Recommended Phase II dose) | Experimental | Biological: INB301 InjectionThe dose escalation phase uses a standard 3+3 design to determine the maximum tolerated dose (MTD) or recommended expansion dose(RED). Enrolled subjects are sequentially assigned to 6 dose levels (50 mg, 100 mg, 200 mg, 300 mg, 400 mg, and 500 mg) to receive subcutaneous injection of INB301 every 3 weeks as a cycle. In the dose expansion phase, the dose level (e.g., 200 mg, 400 mg) and dosing frequency will be determined based on the dose-escalation results, following discussion and consensus by the SMC, which is composed of the Investigator and the Sponsor. The RP2D will be confirmed during the dose expansion phase. After the RP2D is determined (e.g., 400 mg Q4W) based on the Phase I data, a cohort study in single tumor type with cachexia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects who voluntarily participate in the study and voluntarily sign the informed consent form;
- Male or female ≥ 18 years of age;
- Subjects with histologically or cytologically confirmed malignant solid tumors (including pathologically confirmed non-small cell lung cancer, colorectal cancer, pancreatic cancer, esophageal cancer or breast cancer, etc.) who are receiving or have completed anti-cancer treatment and have no significant cancer progression 28 days before the first dose, and in the investigator's expectation are unlikely to change the anti-cancer regimen due to disease progression or do not require any anti-cancer treatment within the first cycle (21 days) of the study;
- Definitely diagnosed as cancer cachexia according to the 2025 Definition and Classification of Cancer Cachexia: An International Consensus" combined with clinical practice: one of the following occurs within 6 months (recognized documentation is required for past weight data): involuntary weight loss > 5%, or weight loss > 2% when BMI < 18.5 kg/m² ;
- Serum GDF-15 level ≥ 1200 pg/mL within 28 days prior to the first dose (only applicable to Phase I dose expansion and Phase IIa);
Key exclusion criteria (22 listed)
- Other causes that may lead to reduced food intake or seriously affect digestion and absorption during the screening period, as determined by the investigator, including but not limited to: oral mucositis of NCI CTCAE Grade 3 or above, gastrointestinal disease of NCI CTCAE Grade 3 or above (nausea, vomiting, diarrhea and constipation, etc.), gastrointestinal obstruction, and active inflammatory bowel disease;
- Radiotherapy is planned as part of the primary anti-cancer treatment regimen (except local radiotherapy for symptom relief);
- Known active/symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis (for subjects with previously treated brain metastases, enrollment may be considered if all of the following criteria are met: the clinical condition has remained stable with no imaging evidence of disease progression within 4 weeks before the first investigational drug treatment, and corticosteroid treatment has not been required within 4 weeks before first dose; asymptomatic subjects with brain metastases (i.e., no neurologic symptoms, no requirement for corticosteroids, and no brain metastatic lesion with a longest diameter > 1.5 cm) may be enrolled, provided that regular imaging examination and assessment for brain metastatic lesions are performed);
- Gavage or parenteral nutrition (total or partial) is received during the screening period;
- History of other diseases that may cause cachexia within 6 months prior to screening, including but not limited to: severe and above COPD, NYHA class 3-4 heart failure;
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 |
|---|---|---|
| INB301 InjectionThe screening will be completed within 28 days before administration. Subjects who pass the screening will receive subcutaneous injection of INB301 until the investigator determines that the risk of continued treatment outweighs the benefit, toxicity becomes intolerable, or other criteria for withdrawal or treatment discontinuation are met, whichever occurs first. The end-of-study/early withdrawal visit will be completed at 28 days (±7 days) after the last dose. Each 1 mL of INB301 Injection contains 100 mg of the drug, and 2 mL of the drug can be injected at each subcutaneous injection site, which is at the left and right abdominal subcutaneous tissue, as well as the left and right arm subcutaneous tissue. The specific dose is determined according to the dose cohort. Dosing every 3 or 4 weeks is proposed. | Biological | RP2D (Recommended Phase II dose) |
Primary outcome
Adverse Events
Time frame: Through study completion, an average of 1 year.
Mean change in body weight from baseline during each assessment period within 12 weeks.
Time frame: Through study completion, an average of 1 year.
12 secondary outcomes
Area under the plasma concentration-time curve (AUC)
Time frame: Up to 15 weeks.
Half-life (t1/2)
Time frame: Up to 15 weeks.
Peak concentration (Cmax)
Time frame: Up to 15 weeks.
Time to peak concentration (Tmax)
Time frame: Up to 15 weeks.
Apparent volume of distribution (Vd)
Time frame: Up to 15 weeks.
Clearance (CL)
Time frame: Up to 15 weeks.
Mean residence time (MRT)
Time frame: Up to 15 weeks.
Elimination rate constant (Kel)
Time frame: Up to 15 weeks.
Safety evaluation indicators
Time frame: Through study completion, an average of 1 year.
Immunogenicity evaluation indicators
Time frame: Through study completion, an average of 1 year.
Patient-reported outcome (FAACT)
Time frame: Through study completion, an average of 1 year.
Lumbar skeletal muscle index (LSMI)
Time frame: Through study completion, an average of 1 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 13 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing INB301 Injection in people with Cancer Cachexia, run by Yunnan Baiyao Group 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 13 inclusion and 22 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: opening soon, as of the sponsor's last update on 13 May 2026. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Lili Xu (+86 18518760326, xulili@ynby.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: Through study completion, an average of 1 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 13 May 2026.