Advanced Solid TumorPhase 1/2NCT05170958
A Phase I/II Clinical Study of LBL-024 in Patients With Advanced Malignant Tumors
A Phase 1/2 study testing LBL-024 for Injection in people with Advanced Solid Tumor, run by Nanjing Leads Biolabs Co.,Ltd at 49 sites in China.
Trial summary
To evaluate the phase I/II clinical study of LBL-024 in the treatment of patients with advanced malignant tumors Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- LBL-024 for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 396 participants
- Where
- 49 sitesChina
- Study dates
- 6 Jan 2022to Dec 2026
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Agree to comply with the trial treatment plan and visit plan, voluntarily agree to sign the informed consent form;
- 18-75 years old (including boundary value), no gender limit in the I/IIa trial phase；18-80 years old (including boundary value), no gender limit in the IIb trial phase；
- Subject has adequate organ and bone marrow function，Conforming to laboratory test results:
- The expected survival time is at least 12 weeks
- ECOG score is 0-1
- 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
- Receiving other unmarketed clinical research drugs or treatments within 4 weeks before using the research drug for the first time;
- Brain parenchymal metastases or meningeal metastases with clinical symptoms, which are not suitable for inclusion in the group by the investigator's judgment;
- medical history of immunodeficiency including positive HIV antibody test;
- Women who are pregnant or breastfeeding;
- The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in the study
Trial locations and contacts
49 sites in 1 country. Contact the study team or a site near you to ask about taking part.
49 sites in 1 country
China49 sites, 49 recruiting
- Recruiting
Anyang Tumor Hospital
Anyang, Henan, 455000
xiangyu ma, 02583378099, maxy@leadsbiolabs.com
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100005
xiangyu ma, 02583378099, maxy@leadsbiolabs.com
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
xiangyu ma, 02583378099, maxy@leadsbiolabs.com
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
xiangyu ma, 025-83378099-848, maxy@leadsbiolabs.com
- Recruiting
The First Hospital of Jilin University
Ch’ang-ch’un, Jilin, 130000
xiangyu ma, 02583378099, maxy@leadsbiolabs.com
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410031
xiangyu ma, 02583378099, maxy@leadsbiolabs.com
- Recruiting
Sichuan Cancer Hospital
Chengdu, Sichuan, 610000
xiangyu ma, 02583378099, maxy@leadsbiolabs.com
- Recruiting
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 400030
ji feng, 025-83378099, fengji@leadsbiolabs.com
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350000
xiangyu ma, 025-83378099, maxy@leadsbiolabs.com
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350000
xiangyu ma, 02583378099, maxy@leadsbiolabs.com
feng
- Recruiting
The First Affiliated Hospital,Sun Yat-sen University
Guangzhou, Guangdong, 510062
xiangyu ma, 02583378099, maxy@leadsbiolabs.com
- Recruiting
Sun Yat-sen University Cancer Center
Guanzhou, Guangdong, 510000
xiangyu ma, 02583378099, maxy@leadsbiolabs.com
- Recruiting
Sir Run Run Shaw Hospital
Hangzhou, Hangzhou, 310000
xiangyu ma, 02583378099, maxy@leadsbiolabs.com
- Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
xiangyu ma, 02583378099, maxy@leadsbiolabs.com
- Recruiting
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
xiangyu ma, 02583378099, maxy@leadsbiolabs.com
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310005
xiangyu ma, 02583378099, maxy@leadsbiolabs.com
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000
xiangyu ma, 02583378099, maxy@leadsbiolabs.com
- Recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230000
xiangyu ma, 02583378099, maxy@leadsbiolabs.com
- Recruiting
Anhui Provincial Hospital
Hefei, Anhui, 230002
xiangyu ma, 02583378099, maxy@leadsbiolabs.com
- Recruiting
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230601
xiangyu ma, 02583378099, maxy@leadsbiolabs.com
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250000
xiangyu ma, 02583378099, maxy@leadsbiolabs.com
- Recruiting
Shandong Cancer Hospital & Institute
Jinan, Shandong, 250000
xiangyu ma, 02583378099, maxy@leadsbiolabs.com
- Recruiting
Yunnan Cancer Hospital
Kunming, Yunnan, 650000
xiangyu ma, 02583378099, maxy@leadsbiolabs.com
- Recruiting
The First Affilated Hospital of Henan University of Science & Technology
Luoyang, Henan, 471003
xiangyu ma, 025-83378099, maxy@leadsbiolabs.com
- Recruiting
Mianyang Central Hospital
Mianyang, Sichuan, Mianyang
ji feng, 02583378099, fengji@leadsbiolabs.com
- Recruiting
The Second Affiliated Hospital Nanchang University
Nanchang, Jiangxi, 330000
xiangyu ma, 02583378099, maxy@leadsbiolabs.com
- Recruiting
The Ferst Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
xiangyu ma, 02583378099, maxy@leadsbiolabs.com
- Recruiting
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210000
xiangyu ma, 02583378099, maxy@leadsbiolabs.com
- Recruiting
Nanjing First Hospital
Nanjing, Jiangsu, 210000
xiangyu ma, 02583378099, maxy@leadsbiolabs.com
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
xiangyu Ma, 025-83378099-848, maxy@leadsbiolabs.com
- Recruiting
Guangxi Medical University Cancer Hospital & Guangxi Cancer Institute
Nanning, Guangxi, 530000
xiangyu ma, 02583378099, maxy@leadsbiolabs.com
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
xiangyu ma, 02583378099, maxy@leadsbiolabs.com
- Recruiting
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110000
xiangyu ma, 02583378099, maxy@leadsbiolabs.com
- Recruiting
The First Hospital of China Medical University
Shenyang, Liaoning, 110000
xiangyu ma, 02583378099, maxy@leadsbiolabs.com
- Recruiting
Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011
xiangyu ma, 02583378099, maxy@leadsbiolabs.com
- Recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030000
xiangyu ma, 02583378099, maxy@leadsbiolabs.com
- Recruiting
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030000
xiangyu ma, 02583378099, maxy@leadsbiolabs.com
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300181
xiangyu ma, 02583378099, maxy@leadsbiolabs.com
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325015
xiangyu ma, 02583378099, maxy@leadsbiolabs.com
- Recruiting
Tongji Hospital
Wuhan, Hubei, 430000
xiangyu ma, 02583378099, maxy@leadsbiolabs.com
- Recruiting
Wuhan Union Hospital of China
Wuhan, Hubei, 430000
xiangyu ma, 02583378099, maxy@leadsbiolabs.com
- Recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430079
xiangyu O ma, 02583378099, maxy@leadsbiolabs.com
- Recruiting
The First Affiliated Hospital of Xi'An Jiaotong University
Xi’an, Shanxi, 710061
xiangyu ma, 02583378099, maxy@leadsbiolabs.com
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361000
xiangyu ma, 02583378099, maxy@leadsbiolabs.com
- Recruiting
Xiangyang Central Hospital
Xiangyang, Hubei, 441000
xiangyu ma, 02583378099, maxy@leadsbiolabs.com
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
xiangyu ma, 02583378099, maxy@leadsbiolabs.com
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
xiangyu ma, 02583378099, maxy@leadsbiolabs.com
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan
ji feng, 02583378099, fengji@leadsbiolabs.com
- Recruiting
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563000
xiangyu ma, 02583378099, maxy@leadsbiolabs.com
About this study
Official title: A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of LBL-024 in Patients With Advanced Malignant Tumors
To evaluate the phase I/II clinical study of LBL-024 in the treatment of patients with advanced malignant tumors
Read the detailed description
This trial is a single-arm, open-label, phase I/II clinical study of LBL-024 in patients with advanced malignant tumors. The phase I dose escalation and PK expansion phase plans to include patients with advanced malignant tumors who have failed previous standard treatment or do not have standard treatment or are not applicable to standard treatment at this stage. The phase IIa indication expansion phase plans to include patients with advanced malignant tumors , and evaluate the safety, tolerability, pharmacokinetic (PK) characteristics, immunogenicity and preliminary efficacy. Single-arm registry clinical study to be conducted in Phase IIb.
This trial includes two parts:
Part I: A Phase I/IIa clinical study on the safety, tolerability, PK and efficacy of LBL-024 in patients with advanced malignant tumor.
Part II:Phase IIb is a pivotal single-arm clinical study.
- Conditions
- Advanced Solid Tumor
- Being tested
- LBL-024 for 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
LBL-024 was given every three weeks for treatment
| Study group | Role | What they receive |
|---|---|---|
| LBL-024 | Experimental | LBL-024 injection; Initial dose - MTD; Q3W Receives: Drug: LBL-024 for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
During the dose-escalation phase, the highest dose of dose-limiting toxicity for subjects less than or equal to 1/6 of the study drug within 3 weeks of starting treatment in Phase I study.
Measured: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit）
Dose-limiting toxicities（DLT)
During the DLT observation period, the subject has an event that is reasonably related to the test drug (possibly, likely or definitely related) in Phase I study.
Measured: Within 3 weeks after receiving the first dose of the test drug
Objective Response Rate (ORR)
Defined as the percentage of subjects having a Complete Response or Partial Response(ORR, including after immunotherapy complete response (iCR) and partial response (iPR)),will be determined by investigator assessment of radiographic disease assessments per RECIST V1.1. It was used to evaluate the efficacy of LBL-024 in Phase II study.
Measured: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit）
Secondary outcomes (5)
Adverse events and serious adverse events
Laboratory examination, physical examination, vital signs and electrocardiogram, etc.
Measured: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit）
Maximum serum concentration (Cmax)
To determine the PK profile of LBL-024
Measured: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit）
Immunogenicity
Incidence of subjects with anti-drug antibody (ADA) and neutralizing antibody (if applicable)
Measured: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit）
Disease Control Rate(DCR)
Defined as percentage of participants having CR, PR, iCR，iPR or SD as best on-study response
Measured: Visit 30 days after discontinuation of treatment or withdraw from the visit
Progression-free survival (PFS)
Defined as the time from random assignment in a clinical trial to disease progression or death from any cause, has recently become an endpoint of considerable interest in the study of new oncology drugs.
Measured: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal（Visit 30 days after discontinuation of treatment or withdraw from the visit）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start6 Jan 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 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 TumorStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 396 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
- NCT05170958
- Sponsor's protocol ID
- LBL-024-CN001
- Status last verified
- Jun 2026
- First submitted
- 17 Nov 2021
- Last updated
- 30 Jun 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 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of LBL-024 in Patients With Advanced Malignant Tumors
- ClinicalTrials.gov ID
- NCT05170958
- Acronym / sponsor ID
- LBL-024-CN001
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 396 participants (estimated)
- Lead sponsor
- Nanjing Leads Biolabs Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Dec 2021 (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 phase I/II clinical study of LBL-024 in the treatment of patients with advanced malignant tumors
Detailed description
This trial is a single-arm, open-label, phase I/II clinical study of LBL-024 in patients with advanced malignant tumors. The phase I dose escalation and PK expansion phase plans to include patients with advanced malignant tumors who have failed previous standard treatment or do not have standard treatment or are not applicable to standard treatment at this stage. The phase IIa indication expansion phase plans to include patients with advanced malignant tumors , and evaluate the safety, tolerability, pharmacokinetic (PK) characteristics, immunogenicity and preliminary efficacy. Single-arm registry clinical study to be conducted in Phase IIb.
This trial includes two parts:
Part I: A Phase I/IIa clinical study on the safety, tolerability, PK and efficacy of LBL-024 in patients with advanced malignant tumor.
Part II:Phase IIb is a pivotal single-arm clinical study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LBL-024 | Experimental | Drug: LBL-024 for InjectionLBL-024 injection; Initial dose - MTD; Q3W |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Agree to comply with the trial treatment plan and visit plan, voluntarily agree to sign the informed consent form;
- 18-75 years old (including boundary value), no gender limit in the I/IIa trial phase；18-80 years old (including boundary value), no gender limit in the IIb trial phase；
- Subject has adequate organ and bone marrow function，Conforming to laboratory test results:
- The expected survival time is at least 12 weeks
- ECOG score is 0-1
Key exclusion criteria (5 listed)
- Receiving other unmarketed clinical research drugs or treatments within 4 weeks before using the research drug for the first time;
- Brain parenchymal metastases or meningeal metastases with clinical symptoms, which are not suitable for inclusion in the group by the investigator's judgment;
- medical history of immunodeficiency including positive HIV antibody test;
- Women who are pregnant or breastfeeding;
- The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in the study
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-024LBL-024 was given every three weeks for treatment | Drug | LBL-024 |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit）
During the dose-escalation phase, the highest dose of dose-limiting toxicity for subjects less than or equal to 1/6 of the study drug within 3 weeks of starting treatment in Phase I study.
Dose-limiting toxicities（DLT)
Time frame: Within 3 weeks after receiving the first dose of the test drug
During the DLT observation period, the subject has an event that is reasonably related to the test drug (possibly, likely or definitely related) in Phase I study.
Objective Response Rate (ORR)
Time frame: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit）
Defined as the percentage of subjects having a Complete Response or Partial Response(ORR, including after immunotherapy complete response (iCR) and partial response (iPR)),will be determined by investigator assessment of radiographic disease assessments per RECIST V1.1. It was used to evaluate the efficacy of LBL-024 in Phase II study.
5 secondary outcomes
Adverse events and serious adverse events
Time frame: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit）
Maximum serum concentration (Cmax)
Time frame: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit）
Immunogenicity
Time frame: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit）
Disease Control Rate(DCR)
Time frame: Visit 30 days after discontinuation of treatment or withdraw from the visit
Progression-free survival (PFS)
Time frame: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal（Visit 30 days after discontinuation of treatment or withdraw from the visit）
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 30 Jun 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
49 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 in people with Advanced Solid Tumor, run by Nanjing Leads Biolabs Co.,Ltd at 49 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 5 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 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 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 xue kong (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?
Maximum tolerated dose (MTD) (time frame: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit）). The study lists 3 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 30 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.