Advanced Malignant TumorsPhase 1/2NCT05223231
Evaluation of LBL-019 Monotherapy or Combined With Anti-PD-1 Antibody in the Treatment of Advanced Malignant Tumors
A Phase 1/2 study testing LBL-019 Injection and anti-PD-1 antibody injection in people with Advanced Malignant Tumors, run by Nanjing Leads Biolabs Co.,Ltd at 6 sites in China.
Trial summary
This trial is a phase I/II study, which is designed to evaluate the safety, tolerance, pharmacokinetic characteristics, receptor occupancy (RO), immunogenicity and effectiveness of LBL-019 monotherapy or combined with anti-PD-1 antibody in patients with advanced malignant tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Malignant Tumors
- What is being tested?
- LBL-019 Injection and anti-PD-1 antibody injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 6 sitesChina
- Study dates
- 19 Apr 2022to 9 Aug 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- 1.Agree to comply with the trial treatment plan and visit plan, voluntarily agree to sign the informed consent form;
- 2.18-75 years old (including boundary value), no gender limit;
- 3. previous standard treatment failed, no standard treatment or standard treatment is not applicable at this stage;
- 4.The expected survival time is at least 12 weeks;
Who cannot join
- Have received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks before using the study drug for the first time；
- Received any other investigational drug or treatment that is not on the market within 4 weeks prior to the initial use of the investigational drug;
- 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
6 sites in 1 country.
6 sites in 1 country
China6 sites
Hunan Cancer Hospital
Changsha, Hunan, 410006
Fujian Cancer Hospital
Fuzhou, Fujian, 350000
The first affiliated hospital with Nanjing medical university
Nanjing, Jiangsu, 210000
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Union hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Hubei Cancer Hospital
Wuhan, Hubei, 430079
About this study
Official title: A Multicenter, Open Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of LBL-019 Monotherapy or Combination Anti-PD-1 Antibody in Patients With Advanced Malignant Tumors
This trial is a phase I/II study, which is designed to evaluate the safety, tolerance, pharmacokinetic characteristics, receptor occupancy (RO), immunogenicity and effectiveness of LBL-019 monotherapy or combined with anti-PD-1 antibody in patients with advanced malignant tumors.
Read the detailed description
This trial is a phase I/II study , which is designed to evaluate the safety, tolerance, pharmacokinetic characteristics, receptor occupancy (RO), immunogenicity and effectiveness of LBL-019 monotherapy or combined with anti-PD-1 antibody in patients with advanced malignant tumors. Approximately 244-486 subjects with advanced malignant tumors will be enrolled.
The study was divided into two phases: Phase I (Part A single therapy dose escalation and Part B combination therapy dose escalation) and Phase II (Part A single therapy dose expansion and Part B combination therapy dose expansion) .
- Conditions
- Advanced Malignant Tumors
- Being tested
- LBL-019 Injection, anti-PD-1 antibody injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LBL-019 InjectionDrug
Also called LBL-019
initial dose-MTD
anti-PD-1 antibody injectionDrug
Also called anti-PD-1 antibody
provide medicine base on needs
| Study group | Role | What they receive |
|---|---|---|
| LBL-019 | Experimental | singal -arm Receives: Drug: LBL-019 Injection; Drug: anti-PD-1 antibody injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and tolerability
To evaluate the safety, tolerability of LBL-019 monotherapy or combined with anti-PD-1 antibody, which is according to the number of DLT and the number of treatment related AES
Measured: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months
Secondary outcomes (6)
Cmax
Maximum serum concentration
Measured: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months
immunogenicity
The immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects;
Measured: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months
Pharmacodynamics
Receptor occupancy
Measured: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months
ORR
Objective Response Rate
Measured: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months
DCR
Disease Control Rate
Measured: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months
DOR
To measure duration of response
Measured: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start19 Apr 2022
- Primary completion9 Aug 2024
- Study completion9 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant TumorsStudies 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Leads Biolabs Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- caicun zhou, Principal investigator, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05223231
- Sponsor's protocol ID
- LBL-019-CN001
- Status last verified
- Jan 2026
- First submitted
- 24 Jan 2022
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of LBL-019 Monotherapy or Combination Anti-PD-1 Antibody in Patients With Advanced Malignant Tumors
- ClinicalTrials.gov ID
- NCT05223231
- Acronym / sponsor ID
- LBL-019-CN001
- Conditions
- Advanced Malignant Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Nanjing Leads Biolabs Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 9 Aug 2024 (actual)
- Study completion
- 9 Aug 2024 (actual)
- First posted
- 3 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is a phase I/II study, which is designed to evaluate the safety, tolerance, pharmacokinetic characteristics, receptor occupancy (RO), immunogenicity and effectiveness of LBL-019 monotherapy or combined with anti-PD-1 antibody in patients with advanced malignant tumors.
Detailed description
This trial is a phase I/II study , which is designed to evaluate the safety, tolerance, pharmacokinetic characteristics, receptor occupancy (RO), immunogenicity and effectiveness of LBL-019 monotherapy or combined with anti-PD-1 antibody in patients with advanced malignant tumors. Approximately 244-486 subjects with advanced malignant tumors will be enrolled.
The study was divided into two phases: Phase I (Part A single therapy dose escalation and Part B combination therapy dose escalation) and Phase II (Part A single therapy dose expansion and Part B combination therapy dose expansion) .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LBL-019 | Experimental | Drug: LBL-019 Injection, Drug: anti-PD-1 antibody injectionsingal -arm |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1.Agree to comply with the trial treatment plan and visit plan, voluntarily agree to sign the informed consent form;
- 2.18-75 years old (including boundary value), no gender limit;
- 3. previous standard treatment failed, no standard treatment or standard treatment is not applicable at this stage;
- 4.The expected survival time is at least 12 weeks;
Key exclusion criteria (4 listed)
- Have received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks before using the study drug for the first time；
- Received any other investigational drug or treatment that is not on the market within 4 weeks prior to the initial use of the investigational drug;
- 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-019 InjectionAlso: LBL-019initial dose-MTD | Drug | LBL-019 |
| anti-PD-1 antibody injectionAlso: anti-PD-1 antibodyprovide medicine base on needs | Drug | LBL-019 |
Primary outcome
safety and tolerability
Time frame: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months
To evaluate the safety, tolerability of LBL-019 monotherapy or combined with anti-PD-1 antibody, which is according to the number of DLT and the number of treatment related AES
6 secondary outcomes
Cmax
Time frame: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months
immunogenicity
Time frame: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months
Pharmacodynamics
Time frame: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months
ORR
Time frame: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months
DCR
Time frame: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months
DOR
Time frame: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 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. This study is not recruiting at the moment.
caicun zhou principal investigator
Shanghai Pulmonary Hospital, Shanghai, China
6 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-019 Injection and anti-PD-1 antibody injection in people with Advanced Malignant Tumors, run by Nanjing Leads Biolabs Co.,Ltd at 6 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety and tolerability (time frame: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months). 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 2 Feb 2026.