Advanced Lung CancerPhase 1/2NCT07367529

A Clinical Trial on the Efficacy and Safety of TQB6411 for Injection

A Phase 1/2 study testing TQB6411 for Injection in people with Advanced Lung Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 38 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

To evaluate the efficacy and safety of TQB6411 for injection in trial participant with advanced lung cancer Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Advanced Lung Cancer
What is being tested?: TQB6411 for Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 465 participants
Where: 38 sitesChina
Study dates: 26 Feb 2026to Dec 2028
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants voluntarily participate in this study, sign the informed consent form, and demonstrate good compliance;
Age between 18 and 75 years (calculated based on the date of signing the informed consent form);
Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
Expected survival greater than 12 weeks;
At least one measurable lesion according to RECIST v1.1 criteria;
Laboratory test results meeting the following criteria (no blood transfusion within 14 days or hematopoietic growth factor administration within 7 days prior to screening):

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Hemoglobin (HGB) ≥ 90 g/L;
Absolute neutrophil count (NEUT) ≥ 1.5×10⁹/L;
Platelet count (PLT) ≥ 90×10⁹/L;
Total bilirubin (TBIL) ≤ 1.5×Upper Limit of Normal (ULN);
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN (≤ 5×ULN if liver metastases are present);
Serum creatinine (CR) ≤ 1.3×ULN or creatinine clearance rate (CCR) ≥ 50 mL/min;
Prothrombin time (PT), activated partial thromboplastin time (APTT), and international normalized ratio (INR) ≤ 1.5×ULN (no anticoagulant therapy within the past 2 weeks);
Lung cancer confirmed by histology or cytology；
Willing to provide qualified tumor tissue samples for immunohistochemical and amplification testing, unless the participant has no eligible archived specimens and is unsuitable or refuses re-biopsy;
Women of childbearing potential must agree to use effective contraception during the study and for 6 months after study completion, with a negative serum or urine pregnancy test within 7 days before enrollment; male participants must agree to use effective contraception during the study and for 6 months after study completion (see Section 5.5 for details).

Who cannot join

History of or concurrent other malignancies, except for: other malignancies treated with surgery alone and achieving ≥5 years of disease-free survival (DFS); or cured carcinoma in situ of cervix, non-melanoma skin cancer, or superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading basement membrane)].
Diseases affecting intravenous injection or blood sampling.
Adverse reactions from prior therapies not recovered to Common Terminology Criteria for Adverse Events (CTCAE) v6.0 grade ≤1, except for: grade 2 alopecia, grade 2 peripheral neuropathy, grade 2 anemia, non-clinically significant asymptomatic grade 2 laboratory abnormalities, hypothyroidism stabilized with hormone replacement, or other toxicities judged by investigator as non-safety risks.
Major surgery (Grade 3 or above per National Surgical Classification Catalog 2022), significant traumatic injury within 4 weeks prior to first dose, planned major surgery during study (except protocol-specified procedures), or presence of unhealed wounds/fractures.
Any bleeding or hemorrhagic events ≥CTCAE grade 3 within 4 weeks prior to first dose.
Arterial/venous thromboembolic events within 6 months prior to first dose, including: cerebrovascular accidents (including transient ischemic attack (TIA), excluding lacunar infarction), deep vein thrombosis, or pulmonary embolism (implantable venous port- or catheter-related thrombosis or superficial venous thrombosis not considered "severe" thromboembolism).

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Active viral hepatitis with poor control, except: hepatitis B surface antigen (HBsAg)-positive participants with HepatitisBvirus Deoxyribonucleic acid (HBV DNA) <500 IU/mL (2500 copies/mL) who agree to receive anti-HBV therapy throughout study; or hepatitis C virus (HCV)-infected participants (Hepatitis C Virus Antibody or Ribonucleic Acid positive) with hepatitis C virus Ribonucleic Acid (HCV RNA) ≤ULN continuing approved antiviral therapy.
Active syphilis requiring treatment.
Active tuberculosis, history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced/radiation pneumonitis requiring treatment, clinically significant active pneumonia, history of interstitial lung disease (ILD) requiring treatment, or current ILD.
History of psychotropic drug abuse or mental disorders.
Prior or planned allogeneic bone marrow or solid organ transplantation.
History of hepatic encephalopathy.
Significant cardiovascular diseases including:
Cardiac dysfunction ≥New York Heart Association (NYHA) class II or Left Ventricular Ejection Fractions (LVEF) <50% by echocardiography;
Clinically significant ventricular arrhythmia history (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes) or arrhythmias requiring continuous antiarrhythmic therapy (participants with stable atrial fibrillation controlled solely by β-blockers may be included after investigator assessment);
Unstable angina;
Myocardial infarction within 12 months;
Cardio contraction time (QTc) >450ms (male) or >470ms (female) (if abnormal, measure three times at ≥2-minute intervals and average; corrected by Fridericia or Bazett method);
Congenital long QT syndrome or family history.
Active or uncontrolled severe infection (≥CTCAE grade 2).
Renal failure requiring hemodialysis or peritoneal dialysis.
Immunodeficiency including HIV positivity or other acquired/congenital immunodeficiency diseases.
Uncontrolled autoimmune diseases requiring immunosuppressants or systemic corticosteroids (>10mg prednisone/day equivalent) within 7 days prior to first dose.
Epilepsy requiring treatment.
Poorly controlled diabetes (fasting blood glucose >10mmol/L).
Tumor-related conditions and treatments:
Chemotherapy, immunotherapy, or small-molecule targeted therapy within 3 weeks prior to first dose or within 5 half-lives (whichever shorter); prior local radiotherapy allowed if: completed >4 weeks (>2 weeks for brain) before study treatment, and target lesions are outside radiation field or show progression within field;
National Medical Products Administration (NMPA)-approved traditional Chinese medicines with antitumor indications within 1 week prior to first dose;
Tumor invading major vessels or judged likely to cause fatal hemorrhage;
Uncontrolled effusions/ascites requiring recurrent drainage;
Spinal cord compression, leptomeningeal metastases, or brain metastases with symptoms controlled <4 weeks, or requiring steroids/dehydrating agents within 2 weeks before treatment.
Known hypersensitivity to study drug or excipients.
Prior treatment with: Epidermal Growth Factor Receptor/cellular-mesenchymal epithelial transition factor (EGFR/c-Met)-targeted antibody-drug conjugates (ADCs); or topoisomerase I inhibitors (Non-Small Cell Lung Cancer only) or topoisomerase I inhibitor-based ADCs.
Prior EGFR/c-Met-targeted Monoclonal Antibody (mAbs)/bispecifics with: ≥grade 4 toxicity, permanent discontinuation due to toxicity, ≥grade 3 infusion reactions, or ≥grade 3 myalgia.
Participation in other antitumor clinical trials within 4 weeks prior to first dose.
Other conditions judged by investigator to jeopardize participant safety or study completion.

Trial locations and contacts

38 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Shengxiang Ren, Doctor contact

13816756732

harry_ren@126.com

Zhijie Wang, Doctor contact

13466323860

wangzj@cicams.ac.cn

City, postcode or hospital

Sites recruiting now only

38 sites in 1 country

China38 sites, 38 recruiting

Anyang People's Hospital
Anyang, Henan, 455000
Minyong Jia, Master, 16637232623, jiaminyong@163.com
Not yet recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Zhijie Wang, Doctor, 13466323860, wangzj@cicams.ac.cn
Recruiting
Beijing Chest Hospital，Capital Medical University
Beijing, Beijing Municipality, 101100
Gen Lin, Doctor, 13313786157, lingen@bjxkyy.cn
Not yet recruiting
Cangzhou Central hospital
Cangzhou, Hebei, 61000
Xiang Song, Master, 13315777385, 1019018188@qq.com
Not yet recruiting
Cangzhou Central hospital
Cangzhou, Hebei, 61000
Yanrong Wang, Master, 13613173112, 13613173112@126.com
Not yet recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410000
XueWen Liu, Doctor, 18711033808, aveinliu@163.com
Not yet recruiting
Sichuan cancer hosipital
Chengdu, Sichuan, 610040
Qifeng Wang, Doctor, 18227667667, littlecancer@163.com
Not yet recruiting
Chongqing University Affiliated Three Gorges Hospital
Chongqing, Chongqing Municipality, 404000
Minghui Zhang, Doctor, 13945684110, zhmhuigcp@163.com
Not yet recruiting
Affiliated Zhongshan Hospital Of dalian University
Dalian, Liaoning, 116001
Ruoyu Wang, Doctor, 15842465751, 357122231@qq.com
Not yet recruiting
Affiliated Zhongshan Hospital Of dalian University
Dalian, Liaoning, 116001
Xiang Li, Master, 18018931093, 94207842@qq.com
Not yet recruiting
The first affiliated hospital of Guangzhou medical university
Guangzhou, Guangdong, 510120
Shunjun Jiang, Bachelor, 13660202355, singsinger@126.com
Not yet recruiting
The first affiliated hospital of Guangzhou medical university
Guanzhou, Guangdong, 510120
Wenhua Liang, Doctor, 020-83062807, liangwh@gird.cn
Not yet recruiting
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Yong Fang, Doctor, 13588491264, fangyong@srrsh.com
Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000
Yanbin Zhao, Doctor, 13904811741, zhaoyb_gcp@126.com
Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000
Xuan Hong, Doctor, 13946066560, hongxuan_1218@sina.com
Not yet recruiting
Shandong First Medical University Affiliated Tumor Hospital
Jinan, Shandong, 250117
Yan Zhang, Doctor, 13853110681, zhangyan0681@163.com
Not yet recruiting
Shandong First Medical University Affiliated Tumor Hospital
Jinan, Shandong, 250117
Aiqin Gao, Doctor, 13954196383, 1395419683@163.com
Not yet recruiting
Linyi cancer Hospital
Linyi, Shandong, 276034
JianHua Shi, Master, 15963998868, shijianhualy@126.com
Not yet recruiting
Luoyang Central Hospital (Zhengzhou University Affiliated Luoyang Central Hospital)
Luoyang, Henan, 471000
Mingli Ni, Doctor, 15803795310, 928718761@qq.com
Not yet recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Fangpeng Liu, Doctor, 13767043353, 21290656@qq.com
Not yet recruiting
Jiangsu Provincial Hospital of Traditional Chinese Medicine
Nanjin, Jiangsu, 210019
Jun Qian, Doctor, 13951702380, 1836141816@qq.com
Not yet recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210000
Yongsheng Wang, Doctor, 15150580136, dolphin8012@yahoo.com
Not yet recruiting
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 53000
Ruiling Ning, Master, 13517662412, rlning@163.com
Not yet recruiting
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 53000
Cuiyun Su, Master, 13737080525, 503893236@qq.com
Not yet recruiting
Nanyang Second General Hospital
Nanyang, Henan, 473012
Qichuan Wang, Master, 15503778233, chuan12616@126.com
Not yet recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Sheng xiang Ren, Doctor, 13816756732, harry_ren@126.com
Not yet recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Haiwen Lu, Doctor, 13917110982, haiwen_lu@163.com
Not yet recruiting
Liaoning Cancer Research Institute
Shenyang, Liaoning, 110000
Hongxu Liu, Doctor, 13840004476, liuhongxu3366@163.com
Not yet recruiting
First Hospital of Shangxi Medical University
Taiyuan, Shangxi, 030001
Junmei Jia, Master, 13934249371, jiajunmei1972@163.com
Not yet recruiting
Shanxi Cancer hospital
Taiyuan, Shanxi, 030000
Xin Wang, Doctor, 13811176181, WXCAMS@126.com
Not yet recruiting
Shanxi Cancer hospital
Taiyuan, Shanxi, 030000
Wei Guo, Master, 13834563396, guowei812@126.com
Not yet recruiting
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, 317000
Dong qing Lv, Master, 13867622009, lvdq@enzemed.com
Not yet recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300000
Xiubao Ren, Doctor, 18622221235, rwziyi@163.com
Not yet recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Conghua Xie, Doctor, 13638607566, Chxie_65@hotmail.com
Not yet recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710000
Yu Yang
Not yet recruiting
The Second Affiliated Hospital of Air Force Medical University
Xi’an, Shanxi, 710000
Haichuan Su, Doctor, 18629190366, cntdgcp@163.com
Not yet recruiting
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225000
Lingfeng Min, Doctor, 18051061783, minlingfeng@126.com
Not yet recruiting
Zhongshan City People's Hospital
Zhongshan, Guangdong, 528445
Guinan Lin, Master, 13631147364, lgn83@163.com
Not yet recruiting

Other trials in China

About this study

Official title: A Phase Ib/II Clinical Trial to Evaluate the Efficacy and Safety of TQB6411 for Injection in Patients With Advanced Lung Cancer

To evaluate the efficacy and safety of TQB6411 for injection in trial participant with advanced lung cancer

Conditions: Advanced Lung Cancer
Being tested: TQB6411 for Injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TQB6411 for InjectionDrug
TQB6411 for Injection is administered every 21 days as a treatment cycle. TQB6411 for injection is administered every 28 days as a treatment cycle.

Study groups in NCT07367529
Study group	Role	What they receive
TQB6411 for Injection	Experimental	TQB6411 for Injection is administered every 21 days as a treatment cycle. TQB6411 for injection is administered every 28 days as a treatment cycle. Receives: Drug: TQB6411 for Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Recommended Phase II Dosage for the Treatment (RP2D)
Recommended phase II dosage for the treatment of advanced Lung Cancer.
Measured: Baseline up to 21 days
Objective Response Rate (ORR)
Objective response rate for the treatment of advanced Lung Cancer.
Measured: Baseline up to 6 mouths

Secondary outcomes (8)

Disease Control Rate (DCR)
Disease control rate for the treatment of advanced Lung Cancer.
Measured: Baseline up to 6 mouths
Duration of Relief (DOR)
Duration of relief for the treatment of advanced Lung Cancer.
Measured: Baseline up to 2 years
Progression-Free Survival
Progression-free survival for the treatment of advanced Lung Cancer.
Measured: Baseline up to 2 years
Overall Survival (OS)
Overall survival for the treatment of advanced Lung Cancer.
Measured: Baseline up to 3 years
Adverse Events (AE)
Numbers of participant with incidence and severity of adverse events, serious adverse events, and adverse events associated with investigational drugs (including investigational drugs and control drugs), as well as abnormal laboratory indicators were evaluated.
Measured: Baseline up to 2 years
Incidence of Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb)
Immunogenicity in patients with advanced lung cancer, Incidence of Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb).
Measured: Cycle 1 day 1, Cycle 4 day 1, Cycle 6 day 1, Cycle 12 daye 1: 60 minutes before administration (21 days as a treatment cycle)
Peak concentration (Cmax)
The plasma concentration at which the rate of administration and rate of elimination are in equilibrium.
Measured: Before administration, 30 minuets, 15 minuets after administration
Plasma concentration at steady state (Cav, SS)
The plasma concentration at which the rate of administration and rate of elimination are in equilibrium.
Measured: Pre-dose of day 1 on multiple dose and 2, 6, 24, 72 hours, 7, 14 days post-dose on multiple dose of day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Feb 2026Dec 2028

First posted26 Jan 2026
Study start26 Feb 2026
Primary completionDec 2028 (estimated)
Study completionDec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced Lung CancerStudies of the same condition, open and under way.
More trials run by Chia Tai Tianqing Pharmaceutical Group 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 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 465 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07367529
Sponsor's protocol ID: TQB6411-Ib/II-02
Status last verified: Mar 2026
First submitted: 16 Jan 2026
Last updated: 8 Sep 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase Ib/II Clinical Trial to Evaluate the Efficacy and Safety of TQB6411 for Injection in Patients With Advanced Lung Cancer
ClinicalTrials.gov ID: NCT07367529
Acronym / sponsor ID: TQB6411-Ib/II-02
Conditions: Advanced Lung Cancer
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 465 participants (estimated)
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
Study start: 26 Feb 2026 (actual)
Primary completion: Dec 2028 (estimated)
Study completion: Dec 2028 (estimated)
First posted: 26 Jan 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.

To evaluate the efficacy and safety of TQB6411 for injection in trial participant with advanced lung cancer

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
TQB6411 for Injection	Experimental	Drug: TQB6411 for InjectionTQB6411 for Injection is administered every 21 days as a treatment cycle. TQB6411 for injection is administered every 28 days as a treatment cycle.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Participants voluntarily participate in this study, sign the informed consent form, and demonstrate good compliance;
Age between 18 and 75 years (calculated based on the date of signing the informed consent form);
Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
Expected survival greater than 12 weeks;
At least one measurable lesion according to RECIST v1.1 criteria;

Key exclusion criteria (36 listed)

History of or concurrent other malignancies, except for: other malignancies treated with surgery alone and achieving ≥5 years of disease-free survival (DFS); or cured carcinoma in situ of cervix, non-melanoma skin cancer, or superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading basement membrane)].
Diseases affecting intravenous injection or blood sampling.
Adverse reactions from prior therapies not recovered to Common Terminology Criteria for Adverse Events (CTCAE) v6.0 grade ≤1, except for: grade 2 alopecia, grade 2 peripheral neuropathy, grade 2 anemia, non-clinically significant asymptomatic grade 2 laboratory abnormalities, hypothyroidism stabilized with hormone replacement, or other toxicities judged by investigator as non-safety risks.
Major surgery (Grade 3 or above per National Surgical Classification Catalog 2022), significant traumatic injury within 4 weeks prior to first dose, planned major surgery during study (except protocol-specified procedures), or presence of unhealed wounds/fractures.
Any bleeding or hemorrhagic events ≥CTCAE grade 3 within 4 weeks prior to first dose.

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
TQB6411 for InjectionTQB6411 for Injection is administered every 21 days as a treatment cycle. TQB6411 for injection is administered every 28 days as a treatment cycle.	Drug	TQB6411 for Injection

Primary outcome

Recommended Phase II Dosage for the Treatment (RP2D)
Time frame: Baseline up to 21 days
Recommended phase II dosage for the treatment of advanced Lung Cancer.
Objective Response Rate (ORR)
Time frame: Baseline up to 6 mouths
Objective response rate for the treatment of advanced Lung Cancer.

8 secondary outcomes

Disease Control Rate (DCR)
Time frame: Baseline up to 6 mouths
Duration of Relief (DOR)
Time frame: Baseline up to 2 years
Progression-Free Survival
Time frame: Baseline up to 2 years
Overall Survival (OS)
Time frame: Baseline up to 3 years
Adverse Events (AE)
Time frame: Baseline up to 2 years
Incidence of Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb)
Time frame: Cycle 1 day 1, Cycle 4 day 1, Cycle 6 day 1, Cycle 12 daye 1: 60 minutes before administration (21 days as a treatment cycle)
Peak concentration (Cmax)
Time frame: Before administration, 30 minuets, 15 minuets after administration
Plasma concentration at steady state (Cav, SS)
Time frame: Pre-dose of day 1 on multiple dose and 2, 6, 24, 72 hours, 7, 14 days post-dose on multiple dose of day 1

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 8 Sep 2026.

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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.

Shengxiang Ren, Doctor contact

13816756732

harry_ren@126.com

Zhijie Wang, Doctor contact

13466323860

wangzj@cicams.ac.cn

38 sites 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 TQB6411 for Injection in people with Advanced Lung Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 38 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 16 inclusion and 36 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 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 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 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 Shengxiang Ren, Doctor (13816756732, harry_ren@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended Phase II Dosage for the Treatment (RP2D) (time frame: Baseline up to 21 days). 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?

On the ClinicalTrials.gov record for NCT07367529.

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 8 Sep 2026.