Advanced Neuroendocrine CarcinomaPhase 1/2NCT06157827
A Clinical Trial of LBL-024 Combined With Etoposide and Platinum in Patients With Advanced Neuroendocrine Carcinoma
A Phase 1/2 study testing LBL-024 for Injection, Etoposide Injection and Carboplatin Injection in people with Advanced Neuroendocrine Carcinoma, run by Nanjing Leads Biolabs Co.,Ltd at 25 sites in China.
Trial summary
An open-label, multicenter phase Ib/II clinical study to evaluate the safety and efficacy of LBL-024 combined with etoposide and platinum in the first-line treatment of patients with advanced neuroendocrine carcinoma (NEC) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Neuroendocrine Carcinoma
- What is being tested?
- LBL-024 for Injection, Etoposide Injection and Carboplatin Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 25 sitesChina
- Study dates
- 8 Dec 2023to 28 Mar 2027
- 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
- Agree to follow the trial treatment regimen and visit schedule, voluntarily enroll, and sign the written informed consent.
- aged 18-75 years (including borderline values) at the time of signing the 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 （Response Evaluation Criteria in Solid Tumours），the subjects enrolled have at least one measurable target lesion.
- Fertile men and women of childbearing age are willing to take effective contraceptive measures from the signing of the informed consent form to 6 months after the last dose of the investigational drug; women of childbearing age include premenopausal women and women who had menopause less than two years ago. Blood pregnancy test results must be negative for women of childbearing age within 7 days prior to the initial dose of the investigational drug.
Who cannot join
- Subjects who underwent major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the initial use of the investigational drug, or require elective surgery during the trial period
- Use of immunomodulatory drugs within 14 days prior to the initial use of the investigational drug, including but not limited to thymosin, interleukin, and interferon
- Subjects with an active infection that currently requires intravenous anti-infective therapy.
- Clinically uncontrollable pleural effusion, pericardial effusion, and requiring repeated drainage or medical intervention.
- medical history of immunodeficiency including HIV antibody positive.
- Pregnant or lactating women.
- The investigator believes that the subject has other conditions that may affect compliance or that are not suitable for participating in this study.
Trial locations and contacts
25 sites in 1 country. Contact the study team or a site near you to ask about taking part.
25 sites in 1 country
China25 sites, 25 recruiting
- Recruiting
Beijing GoBroad Hospital
Beijing, Beijing Municipality, 100070
xue kong, 02583378099, kongxue@leadsbiolabs.com
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
xue kong, 02583378099, kongxue@leadsbiolabs.com
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610044
xue kong, 02583378099, kongxue@leadsbiolabs.com
- Recruiting
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030
xue kong, 02583378099, kongxue@leadsbiolabs.com
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
xue kong, 02583378099, kongxue@leadsbiolabs.com
- Recruiting
Sun Yat-sen University Cancer Center (SYSUCC)
Guangzhou, Guangdong, 510060
xue kong, 02583378099, kongxue@leadsbiolabs.com
- Recruiting
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, 510080
xue kong, 02583378099, kongxue@leadsbiolabs.com
- Recruiting
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
xue kong, 02583378099, kongxue@leadsbiolabs.com
- Recruiting
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
xue kong, 02583378099, kongxue@leadsbiolabs.com
- Recruiting
Sir Run Run Shaw Hospital，Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016
xue kong, 02583378099, kongxue@leadsbiolabs.com
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
xue kong, 02583378099, kongxue@leadsbiolabs.com
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
xue kong, 02583378099, kongxue@leadsbiolabs.com
- Recruiting
Anhui Provincial Hospital
Hefei, Anhui, 230001
xue kong, 02583378099, kongxue@leadsbiolabs.com
- Recruiting
Anhui Cancer Hospital
Hefei, Anhui, 230031
xue kong, 02583378099, kongxue@leadsbiolabs.com
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250063
xue kong, 02583378099, kongxue@leadsbiolabs.com
- Recruiting
Shandong Cancer Hospital
Jinan, Shandong, 250117
xue kong, 02583378099, kongxue@leadsbiolabs.com
- Recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471003
xue kong, 02583378099, kongxue@leadsbiolabs.com
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
xue kong, 02583378099, kongxue@leadsbiolabs.com
- Recruiting
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530021
xue kong, 02583378099, kongxue@leadsbiolabs.com
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
xue kong, 02583378099, kongxue@leadsbiolabs.com
- Recruiting
Liaoning Cancer Hospital
Shenyang, Liaoning, 110801
xue kong, 02583378099, kongxue@leadsbiolabs.com
- Recruiting
Shanxi Cancer hospital
Taiyuan, Shanxi, 030013
xue kong, 02583378099, kongxue@leadsbiolabs.com
- Recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430079
xue kong, 02583378099, kongxue@leadsbiolabs.com
- Recruiting
Xiangyang Central Hospital
Xiangyang, Hubei, 441000
Xue Kong, 02583378099, kongxue@leadsbiolabs.com
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
xue kong, 02583378099, kongxue@leadsbiolabs.com
About this study
Official title: An Open-label, Multicenter Phase Ib/II Clinical Study to Evaluate the Safety and Efficacy of LBL-024 Combined With Etoposide and Platinum in the First-line Treatment of Patients With Advanced Neuroendocrine Carcinoma (NEC)
An open-label, multicenter phase Ib/II clinical study to evaluate the safety and efficacy of LBL-024 combined with etoposide and platinum in the first-line treatment of patients with advanced neuroendocrine carcinoma (NEC)
Read the detailed description
This trial includes two parts: phase Ib and phase II study. Phase Ib is a dose-escalation and Phase II is the dose optimization and dose expansion .
Phase Ib program to enroll patients with advanced neuroendocrine carcinoma (NEC) without systemic therapy.To sequentially evaluate the safety and tolerability of LBL-024 in combination with etoposide and platinum (cisplatin or carboplatin) at different doses by the dose-escalation method.
Phase II includes two stages, dose optimization and dose expansion.
The dose optimization part will conduct combination of LBL-024, which is a further optimization study in two dose groups, enrolling patients with EP-NEC who have not received systemic treatment, to fully assess the dose-exposure-effect relationship, and in combination with the target binding characteristics of LBL-024, pharmacokinetic/pharmacodynamic, efficacy and/or safety profile, considering multiple dimensions,To confirm the rationale for the recommended Phase 2 dose (RP2D).
The dose expansion:the recommended Phase 2 dose (RP2D) will be determined based on the safety, tolerability, efficacy and PK data from the clinical studies of LBL-024.After obtaining the RP2D, a dose expansion study of combination dosing at the RP2D will be conducted to obtain adequate efficacy data.
This trial will enroll 178 patients in Phase Ib and Phase II study.
- Conditions
- Advanced Neuroendocrine Carcinoma
- Being tested
- LBL-024 for Injection, Etoposide Injection, Carboplatin Injection, Atezolizumab injection, Cisplatin 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
Etoposide InjectionDrug
Also called Etoposide
intravenous infusion
Carboplatin InjectionDrug
Also called Carboplatin
intravenous infusion
Atezolizumab injectionDrug
Also called Atezolizumab
intravenous infusion
Cisplatin injectionDrug
Also called Cisplatin
intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| LBL-024+Etoposide+Carboplatin/Cisplatin | Experimental | LBL-024+Etoposide+Carboplatin/Cisplatin
Intravenous infusion. Receives: Drug: LBL-024 for Injection; Drug: Etoposide Injection; Drug: Carboplatin Injection; Drug: Cisplatin injection |
| Atezolizumab+Etoposide+Carboplatin | Active comparator | Atezolizumab+Etoposide+Carboplatin
Intravenous infusion. Receives: Drug: Etoposide Injection; Drug: Carboplatin Injection; Drug: Atezolizumab injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
ORR (including the rates of complete response (CR) and partial response (PR)), evaluated based on the RECIST 1.1, refers to the percentage of study subjects who achieve a complete response or partial response. It was used to evaluate the efficacy in Phase II .
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).
Dose-limiting toxicities（DLT）
DLT describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment. It was used to evaluate the safety in Phase Ib.
Measured: Within 3 weeks after receiving the first dose of the test drug (DLT assessment for subjects in dose escalation phase).
Progression-Free Survival(PFS)
PFS is defined as the time from randomization to disease progression or death from any cause.It was used to evaluate the efficacy in Phase II .
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).
Occurrence of adverse event (AE) and serious adverse event (SAE)
Adverse event (AE) will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0.The safety profile of LBL-024 Combination Administration will be assessed by monitoring the adverse event (AE) and serious adverse event (SAE) in Phase Ib study.
Measured: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (90 days after drug withdrawal or before the start of new anti-tumor therapy)
The recommended Phase 2 dose (RP2D)
The recommended Phase 2 dose (RP2D) will be determined comprehensively based on the safety, tolerability, efficacy and PK data from the clinical studies of LBL-024 in advance.
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)
Cmax
Maximum serum concentration
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 taking a single dose, Time to reach maximum plasma concentration
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
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
Disease Control Rate(DCR)
Percentage of participants achieving CR, PR, iCR, iPR and stable disease (SD) after treatment.
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 posted6 Dec 2023
- Study start8 Dec 2023
- Primary completion28 Dec 2026 (estimated)
- Study completion28 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Neuroendocrine CarcinomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Leads Biolabs Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- lin shen, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157827
- Sponsor's protocol ID
- LBL-024-CN002
- Status last verified
- Mar 2026
- First submitted
- 27 Nov 2023
- Last updated
- 12 Mar 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 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter Phase Ib/II Clinical Study to Evaluate the Safety and Efficacy of LBL-024 Combined With Etoposide and Platinum in the First-line Treatment of Patients With Advanced Neuroendocrine Carcinoma (NEC)
- ClinicalTrials.gov ID
- NCT06157827
- Acronym / sponsor ID
- LBL-024-CN002
- Conditions
- Advanced Neuroendocrine Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Nanjing Leads Biolabs Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2023 (actual)
- Primary completion
- 28 Dec 2026 (estimated)
- Study completion
- 28 Mar 2027 (estimated)
- First posted
- 6 Dec 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.
An open-label, multicenter phase Ib/II clinical study to evaluate the safety and efficacy of LBL-024 combined with etoposide and platinum in the first-line treatment of patients with advanced neuroendocrine carcinoma (NEC)
Detailed description
This trial includes two parts: phase Ib and phase II study. Phase Ib is a dose-escalation and Phase II is the dose optimization and dose expansion .
Phase Ib program to enroll patients with advanced neuroendocrine carcinoma (NEC) without systemic therapy.To sequentially evaluate the safety and tolerability of LBL-024 in combination with etoposide and platinum (cisplatin or carboplatin) at different doses by the dose-escalation method.
Phase II includes two stages, dose optimization and dose expansion.
The dose optimization part will conduct combination of LBL-024, which is a further optimization study in two dose groups, enrolling patients with EP-NEC who have not received systemic treatment, to fully assess the dose-exposure-effect relationship, and in combination with the target binding characteristics of LBL-024, pharmacokinetic/pharmacodynamic, efficacy and/or safety profile, considering multiple dimensions,To confirm the rationale for the recommended Phase 2 dose (RP2D).
The dose expansion:the recommended Phase 2 dose (RP2D) will be determined based on the safety, tolerability, efficacy and PK data from the clinical studies of LBL-024.After obtaining the RP2D, a dose expansion study of combination dosing at the RP2D will be conducted to obtain adequate efficacy data.
This trial will enroll 178 patients in Phase Ib and Phase II study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LBL-024+Etoposide+Carboplatin/Cisplatin | Experimental | Drug: LBL-024 for Injection, Drug: Etoposide Injection, Drug: Carboplatin Injection, Drug: Cisplatin injectionLBL-024+Etoposide+Carboplatin/Cisplatin Intravenous infusion. |
| Atezolizumab+Etoposide+Carboplatin | Active comparator | Drug: Etoposide Injection, Drug: Carboplatin Injection, Drug: Atezolizumab injectionAtezolizumab+Etoposide+Carboplatin Intravenous infusion. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Agree to follow the trial treatment regimen and visit schedule, voluntarily enroll, and sign the written informed consent.
- aged 18-75 years (including borderline values) at the time of signing the 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 （Response Evaluation Criteria in Solid Tumours），the subjects enrolled have at least one measurable target lesion.
Key exclusion criteria (7 listed)
- Subjects who underwent major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the initial use of the investigational drug, or require elective surgery during the trial period
- Use of immunomodulatory drugs within 14 days prior to the initial use of the investigational drug, including but not limited to thymosin, interleukin, and interferon
- Subjects with an active infection that currently requires intravenous anti-infective therapy.
- Clinically uncontrollable pleural effusion, pericardial effusion, and requiring repeated drainage or medical intervention.
- 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+Etoposide+Carboplatin/Cisplatin |
| Etoposide InjectionAlso: Etoposideintravenous infusion | Drug | Atezolizumab+Etoposide+Carboplatin, LBL-024+Etoposide+Carboplatin/Cisplatin |
| Carboplatin InjectionAlso: Carboplatinintravenous infusion | Drug | Atezolizumab+Etoposide+Carboplatin, LBL-024+Etoposide+Carboplatin/Cisplatin |
| Atezolizumab injectionAlso: Atezolizumabintravenous infusion | Drug | Atezolizumab+Etoposide+Carboplatin |
| Cisplatin injectionAlso: Cisplatinintravenous infusion | Drug | LBL-024+Etoposide+Carboplatin/Cisplatin |
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).
ORR (including the rates of complete response (CR) and partial response (PR)), evaluated based on the RECIST 1.1, refers to the percentage of study subjects who achieve a complete response or partial response. It was used to evaluate the efficacy in Phase II .
Dose-limiting toxicities（DLT）
Time frame: Within 3 weeks after receiving the first dose of the test drug (DLT assessment for subjects in dose escalation phase).
DLT describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment. It was used to evaluate the safety in Phase Ib.
Progression-Free Survival(PFS)
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).
PFS is defined as the time from randomization to disease progression or death from any cause.It was used to evaluate the efficacy in Phase II .
Occurrence of adverse event (AE) and serious adverse event (SAE)
Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (90 days after drug withdrawal or before the start of new anti-tumor therapy)
Adverse event (AE) will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0.The safety profile of LBL-024 Combination Administration will be assessed by monitoring the adverse event (AE) and serious adverse event (SAE) in Phase Ib study.
The recommended Phase 2 dose (RP2D)
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).
The recommended Phase 2 dose (RP2D) will be determined comprehensively based on the safety, tolerability, efficacy and PK data from the clinical studies of LBL-024 in advance.
5 secondary outcomes
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
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
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)
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 12 Mar 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.
lin shen principal investigator
Peking University Cancer Hospital & Institute
25 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 LBL-024 for Injection, Etoposide Injection and Carboplatin Injection in people with Advanced Neuroendocrine Carcinoma, run by Nanjing Leads Biolabs Co.,Ltd at 25 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 6 inclusion and 7 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 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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 lin shen (025-83378099, kongxue@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).). 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 12 Mar 2026.