Advanced Solid TumourPhase 2NCT06783647
A Clinical Trial of LBL-024 Combination Drug in Patients With Advanced Solid Tumours[Substudy 01(NSCLC)]
A Phase 2 study testing LBL-024 for Injection, Docetaxel Injection and Bevacizumab Injection in people with Advanced Solid Tumour, run by Nanjing Leads Biolabs Co.,Ltd at 24 sites in China.
Trial summary
An open-label, multicenter, phase II clinical study to evaluate the efficacy and safety of LBL-024 in combination with other drugs for the treatment of patients with advanced solid tumour. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumour
- What is being tested?
- LBL-024 for Injection, Docetaxel Injection and Bevacizumab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 24 sitesChina
- Study dates
- 11 Jun 2025to 24 Dec 2026
- Phase
- Phase 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
- Agree to follow the trial treatment regimen, visit schedule, laboratory test, and other requirements of the protocol, and voluntarily enroll in the study and sign the written informed consent.
- Age 18-75 years (inclusive of boundaries) at the time of signing informed consent form.
- The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0~1.
- The expected survival time is at least 12 weeks.
- According to the evaluation of RECIST 1.1 standard, the subjects enrolled have at least one measurable lesion.
- There is adequate organ and bone marrow function,Conforms to laboratory test results.
- Males with fertility and females of childbearing age are willing to take effective contraceptive measures From the signing of the informed consent form to within 6 months after the last administration of the trial drug (including abstinence, intrauterine device, various hormonal contraception, correct use of contraception Sets，etc）; Women of childbearing age include pre-menopausal women and women within 2 years after menopause. Women of childbearing age must have a negative pregnancy test within 7 days before the first trial drug is administered.
Who cannot join
- Participation in clinical studies of antineoplastic agents within 4 weeks before the first use of study drug,or Subject is expected to receive any other form of systemic or local anti-tumor therapy outside the protocol during the study.
- Use of immunomodulatory drugs within 2 weeks before the first use of study drug,Including but not limited to thymopeptide, interleukins, interferon, etc.
- Patients with active infection.
- Patients with clinically uncontrollable pleural effusion, pericardial effusion, ascites, and those requiring repeated drainage or medical intervention.
- The patient has a Medical history of immunodeficiency, including HIV antibody positive.
- Active hepatitis B or active hepatitis C.
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- Women during pregnancy or lactation.
- History of mental illness (interfering with understanding or giving informed consent), drug abuse, alcoholism or drug addiction.
- The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.
Trial locations and contacts
24 sites in 1 country. Contact the study team or a site near you to ask about taking part.
24 sites in 1 country
China24 sites, 24 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
lei liu, 025-83378099, liulei@leadsbiolabs.com
- Recruiting
Beijing Chest Hospital，Capital Medical University
Beijing, Beijing Municipality, 101100
lei liu, 025-83378099, liulei@leadsbiolabs.com
- Recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
lei liu, 025-83378099, liulei@leadsbiolabs.com
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
lei liu, 025-83378099, liulei@leadsbiolabs.com
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
dongtao meng, 025-83378099, mengdongtao@leadsbiolabs.com
- Recruiting
Ganzhou People's Hospital
Ganzhou, Jiangxi, 341006
lei liu, 025-83378099, liulei@leadsbiolabs.com
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
dongtao meng, 025-83378099, mengdongtao@leadsbiolabs.com
- Recruiting
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, 510062
lei liu, 025-83378099, liulei@leadsbiolabs.com
- Recruiting
Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, 541001
lei liu, 025-83378099, liulei@leadsbiolabs.com
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
lei liu, 025-83378099, liulei@leadsbiolabs.com
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
dongtao meng, 025-83378099, mengdongtao@leadsbiolabs.com
- Recruiting
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230031
lei liu, 025-83378099, liulei@leadsbiolabs.com
- Recruiting
Shandong Cancer Hospital
Jinan, Shandong, 250117
dongtao meng, 025-83378099, mengdongtao@leadsbiolabs.com
- Recruiting
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, 471023
dongtao meng, 025-83378099, mengdongtao@leadsbiolabs.com
- Recruiting
Mianyang Central Hospital
Mianyang, Sichuan, 621000
dongtao meng, 025-83378099, mengdongtao@leadsbiolabs.com
- Recruiting
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029
lei liu, 025-83378099, liulei@leadsbiolabs.com
- Recruiting
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530021
dongtao meng, 025-83378099, mengdongtao@leadsbiolabs.com
- Recruiting
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, 110167
dongtao meng, 025-83378099, mengdongtao@leadsbiolabs.com
- Recruiting
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030012
dongtao meng, 025-83378099, mengdongtao@leadsbiolabs.com
- Recruiting
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, 317000
lei liu, 025-83378099, liulei@leadsbiolabs.com
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
lei liu, 025-83378099, liulei@leadsbiolabs.com
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361102
lei liu, 025-83378099, liulei@leadsbiolabs.com
- Recruiting
Xiangyang Central Hospital
Xiangyang, Hubei, 441106
dongtao meng, 025-83378099, mengdongtao@leadsbiolabs.com
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450003
dongtao meng, 025-83378099, mengdongtao@leadsbiolabs.com
About this study
Official title: An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of LBL-024 in Combination With Other Drugs for the Treatment of Patients With Advanced Solid Tumour[Substudy Number 01(NSCLC)]
An open-label, multicenter, phase II clinical study to evaluate the efficacy and safety of LBL-024 in combination with other drugs for the treatment of patients with advanced solid tumour.
Read the detailed description
This trial is an open-label, multicenter, phase II clinical study of LBL-024 combination therapy in patients with advanced NSCLC, to evaluate the efficacy and safety of LBL-024 combination therapy .The trial includes 4 cohorts.
Cohort 1 A:This cohort will have a safety run-in period in which a small number of subjects will be enrolled to receive LBL-024 Combination Administration. After the subjects completed the 21-day safety observation, the sponsor and investigator jointly assessed the safety and tolerability of the combination drugs. If the safety and tolerability of combination drugs are good, the Cohort will continue to enroll subjects for the extension study of combination administration. Eligible subjects will be randomized in a 1: 1 ratio to Arm A or Arm B.
Cohort 1 B:This cohort will have a safety run-in period, a small number of subjects will be enrolled to receive LBL-024 Combination Administration.After the subjects completed the 21-day safety observation, the sponsor and investigator jointly assessed the safety and tolerability of the combination drugs.If the safety and tolerability of combination drugs are good, the Cohort will continue to enroll subjects for the extension study of combination administration.
Cohort 2 A:This cohort will have a safety run-in period, a small number of subjects will be enrolled to receive LBL-024 Combination Administration, and after a period of time, LBL-024 and pemetrexed will be used for maintenance treatment.After completing the 21-day safety observation, the safety and tolerability of combination drugs will be assessed. If the safety and tolerability of combination drugs are good, this cohort will continue to enroll subjects.
Cohort 2 B: This cohort will have a safety run-in period, a small number of subjects will be enrolled to receive LBL-024 Combination Administration and after a period of time, and then use LBL-024 for maintenance treatment. After completing the 21-day safety observation, the safety and tolerability of combination drugs will be assessed. If the safety and tolerability of combination drugs are good, this cohort will continue to enroll subjects.
This study will enroll up to 250 subjects.
- Conditions
- Advanced Solid Tumour
- Being tested
- LBL-024 for Injection, Docetaxel Injection, Bevacizumab Injection, Pemetrexed Disodium for Injection, Paclitaxel Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LBL-024 for InjectionDrug
Also called LBL-024
intravenous infusion.
Docetaxel InjectionDrug
Also called Docetaxel
intravenous infusion.
Bevacizumab InjectionDrug
Also called Bevacizumab
intravenous infusion.
Pemetrexed Disodium for InjectionDrug
Also called Pemetrexed Disodium
intravenous infusion.
Paclitaxel InjectionDrug
Also called Paclitaxel
intravenous infusion.
Carboplatin InjectionDrug
Also called Carboplatin
intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| LBL-024+Docetaxel/LBL-024+Bevacizumab+Docetaxel | Experimental | Subjects were treated with LBL-024 combined with docetaxel
or LBL-024 combined with bevacizumab and docetaxel,
Intravenous infusion. Receives: Drug: LBL-024 for Injection; Drug: Docetaxel Injection; Drug: Bevacizumab Injection |
| LBL-024+Docetaxel | Experimental | Subjects were treated with LBL-024 combined with docetaxel,
Intravenous infusion. Receives: Drug: LBL-024 for Injection; Drug: Docetaxel Injection |
| LBL-024+Pemetrexed Disodium+Carboplatin/LBL-024+pemetrexed Disodium | Experimental | Subjects were treated with LBL-024 combined with pemetrexed and carboplatin,
after a period of time,LBL-024 and pemetrexed were used for maintenance treatment.
Intravenous infusion. Receives: Drug: LBL-024 for Injection; Drug: Pemetrexed Disodium for Injection; Drug: Carboplatin Injection |
| LBL-024+Paclitaxel+Carboplatin/LBL-024 | Experimental | Subjects were treated with LBL-024 combined with paclitaxel and carboplatin,
after a period of time,LBL-024 was used for maintenance treatment.
Intravenous infusion. Receives: Drug: LBL-024 for Injection; Drug: Paclitaxel Injection; Drug: Carboplatin Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Objective Response Rate (complete response (CR) + partial response (PR)), as assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1), refers to the percentage of study subjects who achieve a complete response or partial response.
Measured: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)
Secondary outcomes (5)
Disease Control Rate(DCR）
Percentage of participants achieving CR and PR and stable disease (SD).
Measured: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)
Duration of Response(DOR）
The period from the participants first achieving CR or PR to disease progression.
Measured: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)
Cmax
Maximum drug concentration in plasma after administration
Measured: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)
Tmax
After administration,Time to reach maximum drug concentration in plasma
Measured: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)
immunogenicity
The immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects.
Measured: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start11 Jun 2025
- Primary completion24 Dec 2026 (estimated)
- Study completion24 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumourStudies of the same condition, open and under way.
- More trials run by Nanjing Leads Biolabs Co.,LtdThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Leads Biolabs Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sun Yat-Sen University Cancer Center
- Responsible party
- Sponsor
- Investigators
- li Zhang, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783647
- Sponsor's protocol ID
- LBL-024-CN004_01(NSCLC)
- Status last verified
- Aug 2026
- First submitted
- 14 Jan 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of LBL-024 in Combination With Other Drugs for the Treatment of Patients With Advanced Solid Tumour[Substudy Number 01(NSCLC)]
- ClinicalTrials.gov ID
- NCT06783647
- Acronym / sponsor ID
- LBL-024-CN004_01(NSCLC)
- Conditions
- Advanced Solid Tumour
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Nanjing Leads Biolabs Co.,LtdIndustry (pharma, biotech, devices)
- Collaborators
- Sun Yat-Sen University Cancer Center
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- 24 Dec 2026 (estimated)
- Study completion
- 24 Dec 2026 (estimated)
- First posted
- 20 Jan 2025 (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.
An open-label, multicenter, phase II clinical study to evaluate the efficacy and safety of LBL-024 in combination with other drugs for the treatment of patients with advanced solid tumour.
Detailed description
This trial is an open-label, multicenter, phase II clinical study of LBL-024 combination therapy in patients with advanced NSCLC, to evaluate the efficacy and safety of LBL-024 combination therapy .The trial includes 4 cohorts.
Cohort 1 A:This cohort will have a safety run-in period in which a small number of subjects will be enrolled to receive LBL-024 Combination Administration. After the subjects completed the 21-day safety observation, the sponsor and investigator jointly assessed the safety and tolerability of the combination drugs. If the safety and tolerability of combination drugs are good, the Cohort will continue to enroll subjects for the extension study of combination administration. Eligible subjects will be randomized in a 1: 1 ratio to Arm A or Arm B.
Cohort 1 B:This cohort will have a safety run-in period, a small number of subjects will be enrolled to receive LBL-024 Combination Administration.After the subjects completed the 21-day safety observation, the sponsor and investigator jointly assessed the safety and tolerability of the combination drugs.If the safety and tolerability of combination drugs are good, the Cohort will continue to enroll subjects for the extension study of combination administration.
Cohort 2 A:This cohort will have a safety run-in period, a small number of subjects will be enrolled to receive LBL-024 Combination Administration, and after a period of time, LBL-024 and pemetrexed will be used for maintenance treatment.After completing the 21-day safety observation, the safety and tolerability of combination drugs will be assessed. If the safety and tolerability of combination drugs are good, this cohort will continue to enroll subjects.
Cohort 2 B: This cohort will have a safety run-in period, a small number of subjects will be enrolled to receive LBL-024 Combination Administration and after a period of time, and then use LBL-024 for maintenance treatment. After completing the 21-day safety observation, the safety and tolerability of combination drugs will be assessed. If the safety and tolerability of combination drugs are good, this cohort will continue to enroll subjects.
This study will enroll up to 250 subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LBL-024+Docetaxel/LBL-024+Bevacizumab+Docetaxel | Experimental | Drug: LBL-024 for Injection, Drug: Docetaxel Injection, Drug: Bevacizumab InjectionSubjects were treated with LBL-024 combined with docetaxel or LBL-024 combined with bevacizumab and docetaxel, Intravenous infusion. |
| LBL-024+Docetaxel | Experimental | Drug: LBL-024 for Injection, Drug: Docetaxel InjectionSubjects were treated with LBL-024 combined with docetaxel, Intravenous infusion. |
| LBL-024+Pemetrexed Disodium+Carboplatin/LBL-024+pemetrexed Disodium | Experimental | Drug: LBL-024 for Injection, Drug: Pemetrexed Disodium for Injection, Drug: Carboplatin InjectionSubjects were treated with LBL-024 combined with pemetrexed and carboplatin, after a period of time,LBL-024 and pemetrexed were used for maintenance treatment. Intravenous infusion. |
| LBL-024+Paclitaxel+Carboplatin/LBL-024 | Experimental | Drug: LBL-024 for Injection, Drug: Paclitaxel Injection, Drug: Carboplatin InjectionSubjects were treated with LBL-024 combined with paclitaxel and carboplatin, after a period of time,LBL-024 was used for maintenance treatment. Intravenous infusion. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Agree to follow the trial treatment regimen, visit schedule, laboratory test, and other requirements of the protocol, and voluntarily enroll in the study and sign the written informed consent.
- Age 18-75 years (inclusive of boundaries) at the time of signing informed consent form.
- The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0~1.
- The expected survival time is at least 12 weeks.
- According to the evaluation of RECIST 1.1 standard, the subjects enrolled have at least one measurable lesion.
Key exclusion criteria (9 listed)
- Participation in clinical studies of antineoplastic agents within 4 weeks before the first use of study drug,or Subject is expected to receive any other form of systemic or local anti-tumor therapy outside the protocol during the study.
- Use of immunomodulatory drugs within 2 weeks before the first use of study drug,Including but not limited to thymopeptide, interleukins, interferon, etc.
- Patients with active infection.
- Patients with clinically uncontrollable pleural effusion, pericardial effusion, ascites, and those requiring repeated drainage or medical intervention.
- The patient has a Medical history of immunodeficiency, including HIV antibody positive.
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 |
|---|---|---|
| LBL-024 for InjectionAlso: LBL-024intravenous infusion. | Drug | LBL-024+Docetaxel, LBL-024+Docetaxel/LBL-024+Bevacizumab+Docetaxel, LBL-024+Paclitaxel+Carboplatin/LBL-024, LBL-024+Pemetrexed Disodium+Carboplatin/LBL-024+pemetrexed Disodium |
| Docetaxel InjectionAlso: Docetaxelintravenous infusion. | Drug | LBL-024+Docetaxel, LBL-024+Docetaxel/LBL-024+Bevacizumab+Docetaxel |
| Bevacizumab InjectionAlso: Bevacizumabintravenous infusion. | Drug | LBL-024+Docetaxel/LBL-024+Bevacizumab+Docetaxel |
| Pemetrexed Disodium for InjectionAlso: Pemetrexed Disodiumintravenous infusion. | Drug | LBL-024+Pemetrexed Disodium+Carboplatin/LBL-024+pemetrexed Disodium |
| Paclitaxel InjectionAlso: Paclitaxelintravenous infusion. | Drug | LBL-024+Paclitaxel+Carboplatin/LBL-024 |
| Carboplatin InjectionAlso: Carboplatinintravenous infusion. | Drug | LBL-024+Paclitaxel+Carboplatin/LBL-024, LBL-024+Pemetrexed Disodium+Carboplatin/LBL-024+pemetrexed Disodium |
Primary outcome
Objective Response Rate (ORR)
Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)
Objective Response Rate (complete response (CR) + partial response (PR)), as assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1), refers to the percentage of study subjects who achieve a complete response or partial response.
5 secondary outcomes
Disease Control Rate(DCR）
Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)
Duration of Response(DOR）
Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)
Cmax
Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)
Tmax
Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)
immunogenicity
Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)
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 27 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.
li Zhang principal investigator
Sun Yat-Sen University Cancer Center
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LBL-024 for Injection, Docetaxel Injection and Bevacizumab Injection in people with Advanced Solid Tumour, run by Nanjing Leads Biolabs Co.,Ltd at 24 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 7 inclusion and 9 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 27 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 24 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 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 li Zhang (025-83378099, mengdongtao@leadsbiolabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)). 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 27 Aug 2026.