Advanced Malignant TumorPhase 1NCT05042908
Evaluation of LBL-003 Phase I Study in Patients With Advanced Malignancies
A Phase 1 study testing LBL-003 Injection in people with Advanced Malignant Tumor, run by Nanjing Leads Biolabs Co.,Ltd at 3 sites in China.
Trial summary
This study is a single-arm, dose-escalation phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of LBL-003 injection 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 Tumor
- What is being tested?
- LBL-003 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 3 sitesChina
- Study dates
- 2 Dec 2021to 10 Apr 2023
- Phase
- Phase 1
- 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
- Both male and female aged 18-75 years (including borderline values) at the time of signing the informed consent form;
- ECOG score: 0-1;
- Agree to follow the study treatment plan and visit plan, voluntarily enrolls, and signs the written informed consent.
- Subjects with advanced malignant solid tumors confirmed by histology or cytology have failed the standard treatment or have no standard treatment protocol or are not suitable for standard treatment at this stage.
- Subjects should have at least one evaluable lesion as defined by RECIST V1.1;
- Subjects are expected to survive at least 12 weeks;
Who cannot join
- History of immunodeficiency, including positive HIV antibody test results；
- Active hepatitis (hepatitis B or C)；
- having undergone major surgery or still in the recovery phase of an earlier surgery within 4 weeks before the first administration;
- Women during pregnancy or lactation;
- The investigator's assessment that there may be other factors affecting compliance among participants or that some may not be suitable for inclusion in this study.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Hunan Cancer Hospital
Changsha, Hunan, 410031
Shangdong Cancer Hospital
Jinan, Shandong, 250117
Henan Cancer Hospital
Zhengzhou, Henan, 450003
About this study
Official title: Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of LBL-003 Injection in Patients With Advanced Malignancies
This study is a single-arm, dose-escalation phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of LBL-003 injection in patients with advanced malignant tumors.
Read the detailed description
The purpose of the single-dose escalation study of LBL-003 in subjects with advanced malignant tumors was to evaluate the safety and tolerability of monotherapy to determine the MTD (or MAD) and to determine the clinically recommended dose of LBL-003 monotherapy.
All subjects in this study underwent pharmacokinetic (PK) and pharmacodynamic (PD) studies. The dosing frequency of LBL-003 is once every 2 weeks (Q2W), and the subsequent dosing frequency is adjusted according to the obtained PK and tolerability results.
This study is expected to enroll 17-36 patients with solid tumors who have no standard treatment or have treatment failure with standard treatment or are not suitable for standard treatment at this stage.
- Conditions
- Advanced Malignant Tumor
- Being tested
- LBL-003 Injection
- Keywords
- Advanced Malignant Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LBL-003 InjectionDrug
Also called LBL-003
LBL-003 was given every two weeks for treatment
| Study group | Role | What they receive |
|---|---|---|
| LBL-003 | Experimental | Drug: LBL-003 injection ; Initial dose - MTD; Q2W Receives: Drug: LBL-003 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
MTD is defined as the hightest dose level at which no more than 1 out of 6 subjects experiences a DLT during the first cycles.
Measured: Within 4 weeks after receiving the first dose of the test drug
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.
Measured: Within 4 weeks after receiving the first dose of the test drug
Secondary outcomes (6)
Number of subjcects with adverse events and serious adverse events
The safety profile of LBL-003 will be assessed by monitoring the adverse event(AE)
Measured: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy
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 (30 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 (30 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 (30 days after drug withdrawal or before the start of new anti-tumor therapy
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.
Measured: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy).
Pharmacodynamic (PD) index
The evaluation index is receptor occupancy rate in peripheral blood
Measured: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 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 posted13 Sep 2021
- Study start2 Dec 2021
- Primary completion10 Apr 2023
- Study completion10 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Leads Biolabs Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Henan Cancer Hospital, Hunan Cancer Hospital, Shandong Cancer Hospital and Institute
- Responsible party
- Sponsor
- Investigators
- Suxia Luo, Principal investigator, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042908
- Sponsor's protocol ID
- LBL-003-CN-001
- Status last verified
- May 2024
- First submitted
- 3 Sep 2021
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of LBL-003 Injection in Patients With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT05042908
- Acronym / sponsor ID
- LBL-003-CN-001
- Conditions
- Advanced Malignant Tumor
- Keywords
- Advanced Malignant Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Nanjing Leads Biolabs Co.,LtdIndustry (pharma, biotech, devices)
- Collaborators
- Henan Cancer Hospital, Hunan Cancer Hospital, Shandong Cancer Hospital and Institute
- Study start
- 2 Dec 2021 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 10 Apr 2023 (actual)
- First posted
- 13 Sep 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.
This study is a single-arm, dose-escalation phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of LBL-003 injection in patients with advanced malignant tumors.
Detailed description
The purpose of the single-dose escalation study of LBL-003 in subjects with advanced malignant tumors was to evaluate the safety and tolerability of monotherapy to determine the MTD (or MAD) and to determine the clinically recommended dose of LBL-003 monotherapy.
All subjects in this study underwent pharmacokinetic (PK) and pharmacodynamic (PD) studies. The dosing frequency of LBL-003 is once every 2 weeks (Q2W), and the subsequent dosing frequency is adjusted according to the obtained PK and tolerability results.
This study is expected to enroll 17-36 patients with solid tumors who have no standard treatment or have treatment failure with standard treatment or are not suitable for standard treatment at this stage.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LBL-003 | Experimental | Drug: LBL-003 InjectionDrug: LBL-003 injection ; Initial dose - MTD; Q2W |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Both male and female aged 18-75 years (including borderline values) at the time of signing the informed consent form;
- ECOG score: 0-1;
- Agree to follow the study treatment plan and visit plan, voluntarily enrolls, and signs the written informed consent.
- Subjects with advanced malignant solid tumors confirmed by histology or cytology have failed the standard treatment or have no standard treatment protocol or are not suitable for standard treatment at this stage.
- Subjects should have at least one evaluable lesion as defined by RECIST V1.1;
Key exclusion criteria (5 listed)
- History of immunodeficiency, including positive HIV antibody test results；
- Active hepatitis (hepatitis B or C)；
- having undergone major surgery or still in the recovery phase of an earlier surgery within 4 weeks before the first administration;
- Women during pregnancy or lactation;
- The investigator's assessment that there may be other factors affecting compliance among participants or that some may not be suitable for inclusion in this 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-003 InjectionAlso: LBL-003LBL-003 was given every two weeks for treatment | Drug | LBL-003 |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: Within 4 weeks after receiving the first dose of the test drug
MTD is defined as the hightest dose level at which no more than 1 out of 6 subjects experiences a DLT during the first cycles.
Dose-limiting toxicities（DLT）
Time frame: Within 4 weeks after receiving the first dose of the test drug
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.
6 secondary outcomes
Number of subjcects with adverse events and serious adverse events
Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 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 (30 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 (30 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 (30 days after drug withdrawal or before the start of new anti-tumor therapy
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 (30 days after drug withdrawal or before the start of new anti-tumor therapy).
Pharmacodynamic (PD) index
Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy
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 21 May 2024.
- Individual participant dataSharing planned: No
Related trials for Advanced Malignant Tumor
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Active, not recruitingPhase 1
Advanced or Recurrent Solid Tumors Treated With SHetA2
Solid Tumor, Adult
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.
Suxia Luo principal investigator
Henan Cancer Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LBL-003 Injection in people with Advanced Malignant Tumor, run by Nanjing Leads Biolabs Co.,Ltd at 3 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: finished, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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.
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?
Maximum tolerated dose (MTD) (time frame: Within 4 weeks after receiving the first dose of the test drug). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 May 2024.