Solid TumorPhase 1MEETCD8-001NCT05707676
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of LB4330 in Patients With Advanced Solid Tumors（MEETCD8-001）
A Phase 1 study testing LB4330 in people with Solid Tumor, run by L & L Bio Co., Ltd., Ningbo, China at 1 site in China.
Trial summary
This is a Phase I study designed to evaluate if LB4330, an anti-Claudin 18.2 and CD8 T cell activator fusion protein, is safe, tolerable and efficacious in participants with Advanced Solid Tumors Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- LB4330
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2022to 20 Dec 2024
- 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
- Subjects must meet all of the following criteria to be eligible for enrollment:
- 1. Age between 18 and 75 years (inclusive), regardless of sex. 2.
- Dose-Escalation Phase: Histologically or cytologically confirmed advanced malignant solid tumors.
- Monotherapy Expansion Phase: Histologically or cytologically confirmed advanced gastric/gastroesophageal junction adenocarcinoma, pancreatic ductal adenocarcinoma, or other solid tumors that have failed standard treatment, or for which there is no standard treatment, or for whom standard treatment is currently unsuitable. 3.
- Dose-Escalation Phase: At least one evaluable lesion based on RECIST v1.1.
- Monotherapy Expansion Phase: At least one measurable lesion based on RECIST v1.1 (lesions previously treated with radiotherapy or localized therapy are not considered measurable unless they have clearly progressed or persisted for at least 3 months post-radiotherapy).
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- Monotherapy Expansion Phase: Must provide a prior Claudin 18.2 test report; if unavailable, archived or fresh tumor tissue samples must be submitted.
- Cohort E: If Claudin 18.2 testing has been done previously, the result must show no Claudin 18.2 expression. If no test result is available and no sample can be provided, inclusion is allowed upon joint agreement between the sponsor and investigator.
- Cohorts A, B, C: Require Claudin 18.2 expression (≥1% of tumor cells with staining intensity of 1+ or above).
- Cohort D: Must be Claudin 18.2 negative.
- Cohort E: Must not have known Claudin 18.2 expression (≥1% of tumor cells with staining intensity of 1+ or above).
- 5. ECOG performance status of 0-1. 6. Expected survival time of at least 3 months. 7. Adequate organ function:
- Hematologic (no transfusion or hematopoietic growth factors within 14 days prior):
- ANC ≥ 1.5 × 10⁹/L
- Platelets ≥ 100 × 10⁹/L
- Hemoglobin ≥ 90 g/L
- Liver Function:
- Total bilirubin (TBIL) ≤ 1.5 × ULN; ≤ 3 × ULN if hepatic metastases or Gilbert's syndrome present
- ALT ≤ 3 × ULN (≤ 5 × ULN for liver metastases or HCC)
- AST ≤ 3 × ULN (≤ 5 × ULN for liver metastases or HCC)
- Renal Function:
- Serum creatinine ≤ 1.5 × ULN
- Creatinine clearance ≥ 50 mL/min (using Cockcroft-Gault formula)
- Coagulation:
- APTT ≤ 1.5 × ULN
- INR ≤ 1.5 × ULN 8. Fertile patients (male and female) must agree to use reliable contraception (e.g., hormonal, barrier, or abstinence) during the study and for at least 90 days after the last dose. Women of childbearing potential must have a negative blood or urine pregnancy test within 7 days prior to the first dose.
- 9. Subjects must voluntarily sign the written informed consent form after being informed about the study.
Who cannot join
- Subjects meeting any of the following criteria will be excluded:
- Received chemotherapy, biologic therapy, targeted therapy, or immunotherapy within 4 weeks prior to first dose; radiotherapy, endocrine therapy, or oral fluoropyrimidines within 2 weeks;traditional Chinese medicine with antitumor indications within 1 week;or nitrosoureas/mitomycin C within 6 weeks.
- Participation in another investigational drug or therapy trial within 4 weeks prior to first dose.
- Major surgery (excluding biopsy) or significant trauma within 4 weeks prior to first dose, or scheduled elective surgery during the study.
- Prior treatment with IL-10-targeted agents.
- Systemic corticosteroids (prednisone >10 mg/day or equivalent) or immunosuppressants within 14 days prior to first dose, except for: topical, ophthalmic, intra-articular, intranasal, or inhaled corticosteroids; short-term prophylactic steroids (e.g., to prevent contrast reactions).
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- Immunomodulatory agents (e.g., thymosin, IL-2, interferons) within 14 days prior to first dose.
- Live or attenuated vaccines within 4 weeks prior to first dose.
- Prior allogeneic stem cell or organ transplantation.
- Unresolved adverse events from prior anticancer therapy (excluding alopecia, Grade 2 peripheral neuropathy, or well-controlled hypothyroidism), unless ≤ Grade 1 per CTCAE v5.0.
- Meningeal metastases, spinal cord compression, or unstable brain metastases requiring steroids or anti-epileptic drugs within 4 weeks before enrollment. Stable brain metastases off steroids/anti-epileptics for ≥4 weeks are allowed.
- Active infection requiring systemic treatment.
- Tumor thrombus involving major blood vessels or adjacent organ invasion (e.g., stomach, aorta, trachea) posing high risk of bleeding/perforation, or existing bleeding/perforation/fistula.
- Known gastrointestinal disorders such as irritable bowel syndrome with symptoms (e.g., chronic nausea, vomiting, diarrhea) or gastric outlet obstruction.
- History of immunodeficiency, including HIV antibody positivity.
- Active syphilis, active hepatitis B [HBsAg-positive and HBV DNA >200 IU/mL or above assay's lower limit of detection], or active hepatitis C (HCV antibody positive but HCV RNA below assay limit is allowed). Patients on non-interferon antiviral therapy are eligible.
- Interstitial lung disease (excluding radiation-induced fibrosis not requiring steroids).
- Serious cardiovascular or cerebrovascular conditions, including but not limited to:
- Significant arrhythmia or conduction abnormalities (e.g., Grade II-III AV block requiring intervention)
- QTcF >470 ms (female) or >450 ms (male)
- Acute coronary syndrome, heart failure, aortic dissection,stroke, or other Grade ≥3 events within 6 months
- NYHA class ≥II heart failure or LVEF <50%
- Uncontrolled hypertension (resting BP ≥160/100 mmHg)
- Active or recurrent autoimmune disease (e.g., SLE, RA, Crohn's, UC, vasculitis), except for: hypothyroidism requiring hormone replacement or stable type 1 diabetes on insulin.
- Prior immune-related adverse event (irAE) of Grade ≥3 due to immunotherapy.
- Clinically uncontrolled third-space or pericardial effusion requiring repeated drainage.
- Grade ≥3 infusion-related reaction to previous biologic/protein therapy.
- Known alcohol or substance abuse.
- Psychiatric illness or poor compliance.
- Pregnant or breastfeeding women.
- History of other malignancies within the past 3 years, except for: non- melanoma skin cancer, biopsy-confirmed cervical carcinoma in situ, squamous intraepithelial lesion on Pap test, localized prostate cancer (Gleason <6), or completely resected in situ melanoma. Other low-risk or in-situ cancers may be allowed after sponsor consultation. 26. Other serious systemic diseases or conditions deemed unsuitable by the investigator.
- 27. Known HER2 positivity, MSI-H/dMMR, or mutations (e.g., KRAS) for which approved targeted therapies are available per guidelines.
- 28. Grade IV myelosuppression related to prior antitumor therapy. 29. Primary or secondary platelet count decreased or platelet-destructive diseases (e.g., Fanconi anemia, congenital platelet count decreased without megakaryocytes, May-Hegglin anomaly, aplastic anemia, bone marrow infiltration, radiation to bone marrow, megakaryocytic hypoplasia, ITP). 30. Arterial or venous thrombotic events within 6 months, including stroke (TIA, cerebral hemorrhage, infarction), DVT, or pulmonary embolism.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200120
About this study
Official title: A Phase I，Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of LB4330 in Patients With Advanced Solid Tumors（MEETCD8-001）
This is a Phase I study designed to evaluate if LB4330, an anti-Claudin 18.2 and CD8 T cell activator fusion protein, is safe, tolerable and efficacious in participants with Advanced Solid Tumors
Read the detailed description
This first time in patients, open-label, multi-center study will have LB4330 administered intravenously (IV) in Patients with Advanced Solid Tumors. This study will have 2 parts: Part A which will have dose escalation cohorts and Part B which will have the dose expansion cohorts.
- Conditions
- Solid Tumor
- Being tested
- LB4330
- Keywords
- LB4330
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LB4330Drug
LB4330
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | Dose escalation uses an accelerated titration design combined with the standard 3+3 method.The planned maximum sample size for the dose-escalation phase is 39 subjects, with a maximum of 6 subjects per dose level. Receives: Drug: LB4330 |
| Single Drug Expansion | Experimental | Planned cohorts and subject numbers:Cohort A: Advanced gastric and gastroesophageal junction adenocarcinoma with Claudin 18.2 expression that has failed standard treatment, with no more than three prior lines of therapy (up to 15 patients); Cohort B: Advanced pancreatic ductal adenocarcinoma with Claudin 18.2 expression that has failed standard treatment, with no more than three prior lines of therapy (up to 30 patients); Cohort C: Other advanced solid tumors with Claudin 18.2 expression that have failed standard treatment, with no more than three prior lines of therapy (a total of up to 15 patients); Cohort D: Advanced solid tumors without Claudin 18.2 expression (limited to ovarian cancer, cholangiocarcinoma, pancreatic cancer, gastric and gastroesophageal junction cancer) that have failed treatment, with no more than three prior lines of therapy (a total of up to 20 patients). Receives: Drug: LB4330 |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD/RP2D
MTD is determined based on the occurrence of DLTs. In this study, MTD is defined as the dose level at which 0/3 or 1/6 subjects experience a DLT, and at the next higher dose level, at least 2/3 or 2/6 subjects experience a DLT.
Measured: up to study completion,approximately 24 months
DLT occurrence and frequency (dose escalation phase)
The DLT evaluation period is the first cycle of LB4330 treatment (28 days for the first subject in the first dose cohort, and 21 days for all other subjects. If a dosing delay occurs, the DLT evaluation period should be extended accordingly to 7 days after the third administration).
Measured: The first period of LB4330 treatment (28 days for the first subject in the first dose group, 21 days for the rest subjects. If the administration is delayed, the DLT evaluation period should be extended to 7 days after the third administration)
AE, SAE occurrence and frequency (according to NCI CTCAE 5.0)
According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Measured: up to 90 days following last dose
Secondary outcomes (9)
Serum PK parameters
AUC0-t and so on.
Measured: Up to finished treatment
Pharmacodynamic index
Pharmacodynamic index: percentage of monocytes
Measured: through study completion, an average of 8 months.
Immunogenicity
Immunogenicity index: positive rate, titer and duration of ADA; neutralizing antibody (NAb) analysis will be conducted if necessary.
Measured: up to 90 days following last dose
Overall response rate (ORR)
Evaluation Criteria in Solid Tumors (RECIST) v 1.1 and Immunotherapeutics Response Evaluation Criteria in Solid Tumors (iRECIST).
Measured: through study completion, an average of 8 months.
Disease control rate (DCR)
Evaluation Criteria in Solid Tumors (RECIST) v 1.1 and Immunotherapeutics Response Evaluation Criteria in Solid Tumors (iRECIST).
Measured: through study completion, an average of 8 months.
Progression-free survival (PFS)
Evaluation Criteria in Solid Tumors (RECIST) v 1.1 and Immunotherapeutics Response Evaluation Criteria in Solid Tumors (iRECIST).
Measured: through study completion, an average of 8 months.
Duration of response (DOR)
Evaluation Criteria in Solid Tumors (RECIST) v 1.1 and Immunotherapeutics Response Evaluation Criteria in Solid Tumors (iRECIST).
Measured: through study completion, an average of 8 months.
OS
Total survival period (OS): It is defined as the time from the start of using the study drug to the death due to any reason.
Measured: through study completion，an average of 1 year
Biomarker
Biomarker: relationship between Claudin 18.2 expression level in tumor tissue and clinical response
Measured: through study completion, an average of 8 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start30 Nov 2022
- Primary completion20 Dec 2024
- Study completion20 Dec 2024
Why it stopped: Due to adjustments in the sponsor's development strategy, it has been decided to terminate the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- L & L Bio Co., Ltd., Ningbo, China
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xianjun Yu, Doctor, Principal investigator, Fudan UniversityJian Zhang, Doctor, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05707676
- Sponsor's protocol ID
- LB4330-CHN-I-01
- Acronym
- MEETCD8-001
- Status last verified
- Sep 2025
- First submitted
- 28 Dec 2022
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I，Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of LB4330 in Patients With Advanced Solid Tumors（MEETCD8-001）
- ClinicalTrials.gov ID
- NCT05707676
- Acronym / sponsor ID
- MEETCD8-001 / LB4330-CHN-I-01
- Conditions
- Solid Tumor
- Keywords
- LB4330
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to adjustments in the sponsor's development strategy, it has been decided to terminate the study.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- L & L Bio Co., Ltd., Ningbo, ChinaIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 1 Feb 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.
This is a Phase I study designed to evaluate if LB4330, an anti-Claudin 18.2 and CD8 T cell activator fusion protein, is safe, tolerable and efficacious in participants with Advanced Solid Tumors
Detailed description
This first time in patients, open-label, multi-center study will have LB4330 administered intravenously (IV) in Patients with Advanced Solid Tumors. This study will have 2 parts: Part A which will have dose escalation cohorts and Part B which will have the dose expansion cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: LB4330Dose escalation uses an accelerated titration design combined with the standard 3+3 method.The planned maximum sample size for the dose-escalation phase is 39 subjects, with a maximum of 6 subjects per dose level. |
| Single Drug Expansion | Experimental | Drug: LB4330Planned cohorts and subject numbers:Cohort A: Advanced gastric and gastroesophageal junction adenocarcinoma with Claudin 18.2 expression that has failed standard treatment, with no more than three prior lines of therapy (up to 15 patients); Cohort B: Advanced pancreatic ductal adenocarcinoma with Claudin 18.2 expression that has failed standard treatment, with no more than three prior lines of therapy (up to 30 patients); Cohort C: Other advanced solid tumors with Claudin 18.2 expression that have failed standard treatment, with no more than three prior lines of therapy (a total of up to 15 patients); Cohort D: Advanced solid tumors without Claudin 18.2 expression (limited to ovarian cancer, cholangiocarcinoma, pancreatic cancer, gastric and gastroesophageal junction cancer) that have failed treatment, with no more than three prior lines of therapy (a total of up to 20 patients). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- 1. Age between 18 and 75 years (inclusive), regardless of sex. 2.
- Dose-Escalation Phase: Histologically or cytologically confirmed advanced malignant solid tumors.
- Monotherapy Expansion Phase: Histologically or cytologically confirmed advanced gastric/gastroesophageal junction adenocarcinoma, pancreatic ductal adenocarcinoma, or other solid tumors that have failed standard treatment, or for which there is no standard treatment, or for whom standard treatment is currently unsuitable. 3.
- Dose-Escalation Phase: At least one evaluable lesion based on RECIST v1.1.
- Monotherapy Expansion Phase: At least one measurable lesion based on RECIST v1.1 (lesions previously treated with radiotherapy or localized therapy are not considered measurable unless they have clearly progressed or persisted for at least 3 months post-radiotherapy).
Key exclusion criteria (33 listed)
- Received chemotherapy, biologic therapy, targeted therapy, or immunotherapy within 4 weeks prior to first dose; radiotherapy, endocrine therapy, or oral fluoropyrimidines within 2 weeks;traditional Chinese medicine with antitumor indications within 1 week;or nitrosoureas/mitomycin C within 6 weeks.
- Participation in another investigational drug or therapy trial within 4 weeks prior to first dose.
- Major surgery (excluding biopsy) or significant trauma within 4 weeks prior to first dose, or scheduled elective surgery during the study.
- Prior treatment with IL-10-targeted agents.
- Systemic corticosteroids (prednisone >10 mg/day or equivalent) or immunosuppressants within 14 days prior to first dose, except for: topical, ophthalmic, intra-articular, intranasal, or inhaled corticosteroids; short-term prophylactic steroids (e.g., to prevent contrast reactions).
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 |
|---|---|---|
| LB4330LB4330 | Drug | Dose Escalation, Single Drug Expansion |
Primary outcome
MTD/RP2D
Time frame: up to study completion,approximately 24 months
MTD is determined based on the occurrence of DLTs. In this study, MTD is defined as the dose level at which 0/3 or 1/6 subjects experience a DLT, and at the next higher dose level, at least 2/3 or 2/6 subjects experience a DLT.
DLT occurrence and frequency (dose escalation phase)
Time frame: The first period of LB4330 treatment (28 days for the first subject in the first dose group, 21 days for the rest subjects. If the administration is delayed, the DLT evaluation period should be extended to 7 days after the third administration)
The DLT evaluation period is the first cycle of LB4330 treatment (28 days for the first subject in the first dose cohort, and 21 days for all other subjects. If a dosing delay occurs, the DLT evaluation period should be extended accordingly to 7 days after the third administration).
AE, SAE occurrence and frequency (according to NCI CTCAE 5.0)
Time frame: up to 90 days following last dose
According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
9 secondary outcomes
Serum PK parameters
Time frame: Up to finished treatment
Pharmacodynamic index
Time frame: through study completion, an average of 8 months.
Immunogenicity
Time frame: up to 90 days following last dose
Overall response rate (ORR)
Time frame: through study completion, an average of 8 months.
Disease control rate (DCR)
Time frame: through study completion, an average of 8 months.
Progression-free survival (PFS)
Time frame: through study completion, an average of 8 months.
Duration of response (DOR)
Time frame: through study completion, an average of 8 months.
OS
Time frame: through study completion，an average of 1 year
Biomarker
Time frame: through study completion, an average of 8 months.
Results and safety
The study was stopped early (reason given: Due to adjustments in the sponsor's development strategy, it has been decided to terminate the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
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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.
Xianjun Yu, Doctor principal investigator
Fudan University
Jian Zhang, Doctor principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LB4330 in people with Solid Tumor, run by L & L Bio Co., Ltd., Ningbo, China at 1 site 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 27 inclusion and 33 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: stopped early, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: Due to adjustments in the sponsor's development strategy, it has been decided to terminate the study.). Results are not available in the source record.
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?
MTD/RP2D (time frame: up to study completion,approximately 24 months). 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 11 Sep 2025.