Solid TumorPhase 1NCT05357651
A Study to Assess the Safety and Efficacy of LB1410 in Participants With Advanced Solid Tumor or Lymphoma（Keyplus-001）
A Phase 1 study testing LB1410 in people with Solid Tumor and Lymphoma, 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 experimental anti-PD-1 and anti-TIM-3 bispecific antibody, LB1410, is safe, tolerable and efficacious in participants with advanced solid tumors or lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Lymphoma
- What is being tested?
- LB1410
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 12 Aug 2022to 30 Dec 2028
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be ≥ 18 years of age
- For dose escalation and safety expansion phases only, patient must have histologically or cytologically confirmed advanced and/or metastatic solid tumor malignancies or lymphoma for which standard treatment fails, or no standard treatment is available, or standard treatment is not applicable at this stage
- Cohort specific inclusion criteria:
- Cohort A: NSCLC patients with histologically confirmed advanced or metastatic NSCLC who have previously failed anti-PD1/anti-PD-L1 antibody and platinum-based chemotherapy, and have not discontinued treatment due to AEs
- Cohort B: NSCLC patients with histologically confirmed advanced or metastatic NSCLC who have failed previous platinum-containing doublet chemotherapy but have not received PD1/PD-L1 antibody therapy；PD-L1 positive
- Cohort C: CRC patients with advanced colorectal cancer who have received no more than 2 lines of systemic therapy in the past; TIM-3≥10%
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- Cohort D: Other advanced solid tumors patients who have received no more than two lines of systemic therapy, including but not limited to small cell lung cancer, endometrial cancer, anal cancer, ovarian cancer, head and neck squamous cell carcinoma, gastric adenocarcinoma or gastroesophageal junction cancer patients
- During the screening period, tumor tissue wax blocks or white slices of pathological biopsy sections shall be provided, or tumor tissue biopsy materials shall be allowed to be collected for PD-L1 and TIM-3 detection
- Eastern Cooperative Oncology Group Performance Status 0-1
- Patients with a life expectancy≥12 weeks
- Must have at least one measurable lesion for assessment by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or standard criteria for lymphoma (RECIL 2017)
- Adequate hematological and organ function measured within 7 days prior to first dose
- Non-pregnant women and willingness of female participants to avoid pregnancy or male participants willing to avoid fathering children through highly effective methods of contraception
Who cannot join
- Pregnancy, lactation, or breastfeeding
- Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments
- Treatment with anti-cancer therapy or investigational therapy within 28 days prior to the first dose of LB1410
- Patients who have used PD1 monoclonal antibody and TIM3 monoclonal antibody (both simultaneously or sequentially) in the past, and patients who have used one of them alone can be included
- Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 2 weeks prior to the first dose of LB1410
- Active infection , including known infection with human immunodeficiency virus (HIV), or active infection with hepatitis B HBV (HBV DNA> 1000 copy/mL or 200 IU/mL) or hepatitis C virus (HCV)
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- Previous malignant disease (other than the target malignancy to be investigated in this trial) within the last 3 years. Subjects with history of cervical carcinoma in situ, superficial, or non-invasive bladder cancer, or basal cell, or squamous cell cancer in situ or other in situ cancers previously treated with curative intent may be included at the judgment of Investigator
- History of documented allergic reactions or acute hypersensitivity reactions attributed to treatment with antibody therapies in general, or to any of the components of LB1410
- Symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment, including but not limited to surgery, radiation, and/or corticosteroids (participants receiving anticonvulsants are eligible)
- Participant has not recovered (i.e., to <= Grade 1 or Baseline) from radiation- and chemotherapy-induced AEs (except alopecia, peripheral neuropathy, and ototoxicity, which are excluded if ≥ CTCAE grade 3)
- History of organ transplantation
- Inadequate recovery from any prior surgical procedure or having undergone any major surgical procedure within 4 weeks prior to the study drug treatment
- Impaired cardiac function or clinically significant cardiac disease, including any of the following
- Interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention)
- Type 2 diabetes mellitus or type 2 diabetes patients with poor glycemic control.
- Underlying medical conditions that, in the Investigator's opinion, will make the administration of the study drug hazardous or obscure the interpretation of toxicity determination or adverse events
- Patients with a history of active tuberculosis infection within 1 year before enrollment
- Those with a clear history of neurological or mental disorders, such as epilepsy and dementia, and poor compliance
- Patients with a history of chronic gastrointestinal inflammation, any active inflammation during screening, or grade 3 or above gastrointestinal reaction after previous immunotherapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality
Wei LI, 86-13817918714, leewluck@gmail.com
About this study
Official title: A Phase 1, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of LB1410, A Recombinant Anti-PD-1 and Anti-TIM-3 Humanized Bispecific Antibody for Injection in Patients With Advanced Solid Tumors or Lymphoma（Keyplus-001）
This is a Phase I study designed to evaluate if experimental anti-PD-1 and anti-TIM-3 bispecific antibody, LB1410, is safe, tolerable and efficacious in participants with advanced solid tumors or lymphoma.
Read the detailed description
This first time in patients, open-label, multi-centre study will have LB1410 administered intravenously (IV) to participants with advanced solid tumors or lymphoma. 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, Lymphoma
- Being tested
- LB1410
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LB1410Drug
anti-PD-1 and anti-TIM-3 bispecific antibody
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | Up to 9 dose cohorts will be sequentially enrolled in the dose escalation part using an accelerated titration combined with the standard 3+3 dose escalation algorithm approach. Receives: Drug: LB1410 |
| Safety Expansion | Experimental | 2-3 doses were initially selected for safety expansion, with patients with advanced solid tumors as the main research population. Each dose cohort is expected to enroll 9-12 patients. Receives: Drug: LB1410 |
| Exploratory Expansion | Experimental | The Cohort Exploratory Expansion will enroll subjects by cohort at the RP2D dose, and a total of 4 cohorts (cohorts A, B, C, D) are expected. Receives: Drug: LB1410 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment-emergent adverse events (TEAEs)
According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Measured: up to 30 days following last dose.
Incidence and severity of serious adverse events (SAEs)
According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Measured: up to 90 days following last dose.
AEs of special interest (immune-related AEs)
Incidence and severity of immune-related AEs.
Measured: up to 90 days following last dose.
Incidence of DLTs
The DLT for this study is defined according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0 and will be evaluated in the dose escalation part, the first 28 days (Cycle 1) of treatment.
Measured: in the first 28 days (Cycle 1).
Secondary outcomes (6)
Serum PK parameters
AUC0-t and so on.
Measured: Up to finished treatment (each cycle is 28 days).
Overall response rate (ORR)
Evaluation Criteria in Solid Tumors (RECIST) v 1.1 and Immunotherapeutics Response Evaluation Criteria in Solid Tumors (iRECIST) and Response Evaluation Criteria in Lymphoma (2017) (RECIL 2017).
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) and Response Evaluation Criteria in Lymphoma (2017) (RECIL 2017).
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) and Response Evaluation Criteria in Lymphoma (2017) (RECIL 2017).
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) and Response Evaluation Criteria in Lymphoma (2017) (RECIL 2017).
Measured: through study completion, an average of 8 months.
Immunogenicity
Incidence of anti-drug anti-body (ADA) including the number and percentage of participants who develop detectable ADA.
Measured: up to 90 days following last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start12 Aug 2022
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2028 (estimated)
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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- L & L Bio Co., Ltd., Ningbo, China
- 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
- NCT05357651
- Sponsor's protocol ID
- LB1410-CHN-Ⅰ-01
- Status last verified
- Sep 2025
- First submitted
- 27 Apr 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 1, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of LB1410, A Recombinant Anti-PD-1 and Anti-TIM-3 Humanized Bispecific Antibody for Injection in Patients With Advanced Solid Tumors or Lymphoma（Keyplus-001）
- ClinicalTrials.gov ID
- NCT05357651
- Acronym / sponsor ID
- LB1410-CHN-Ⅰ-01
- Conditions
- Solid Tumor, Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- L & L Bio Co., Ltd., Ningbo, ChinaIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2022 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 3 May 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 is a Phase I study designed to evaluate if experimental anti-PD-1 and anti-TIM-3 bispecific antibody, LB1410, is safe, tolerable and efficacious in participants with advanced solid tumors or lymphoma.
Detailed description
This first time in patients, open-label, multi-centre study will have LB1410 administered intravenously (IV) to participants with advanced solid tumors or lymphoma. 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
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: LB1410Up to 9 dose cohorts will be sequentially enrolled in the dose escalation part using an accelerated titration combined with the standard 3+3 dose escalation algorithm approach. |
| Safety Expansion | Experimental | Drug: LB14102-3 doses were initially selected for safety expansion, with patients with advanced solid tumors as the main research population. Each dose cohort is expected to enroll 9-12 patients. |
| Exploratory Expansion | Experimental | Drug: LB1410The Cohort Exploratory Expansion will enroll subjects by cohort at the RP2D dose, and a total of 4 cohorts (cohorts A, B, C, D) are expected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Must be ≥ 18 years of age
- For dose escalation and safety expansion phases only, patient must have histologically or cytologically confirmed advanced and/or metastatic solid tumor malignancies or lymphoma for which standard treatment fails, or no standard treatment is available, or standard treatment is not applicable at this stage
- Cohort specific inclusion criteria:
- Cohort A: NSCLC patients with histologically confirmed advanced or metastatic NSCLC who have previously failed anti-PD1/anti-PD-L1 antibody and platinum-based chemotherapy, and have not discontinued treatment due to AEs
- Cohort B: NSCLC patients with histologically confirmed advanced or metastatic NSCLC who have failed previous platinum-containing doublet chemotherapy but have not received PD1/PD-L1 antibody therapy；PD-L1 positive
Key exclusion criteria (19 listed)
- Pregnancy, lactation, or breastfeeding
- Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments
- Treatment with anti-cancer therapy or investigational therapy within 28 days prior to the first dose of LB1410
- Patients who have used PD1 monoclonal antibody and TIM3 monoclonal antibody (both simultaneously or sequentially) in the past, and patients who have used one of them alone can be included
- Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 2 weeks prior to the first dose of LB1410
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 |
|---|---|---|
| LB1410anti-PD-1 and anti-TIM-3 bispecific antibody | Drug | Dose Escalation, Exploratory Expansion, Safety Expansion |
Primary outcome
Incidence and severity of treatment-emergent adverse events (TEAEs)
Time frame: up to 30 days following last dose.
According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Incidence and severity of serious adverse events (SAEs)
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.
AEs of special interest (immune-related AEs)
Time frame: up to 90 days following last dose.
Incidence and severity of immune-related AEs.
Incidence of DLTs
Time frame: in the first 28 days (Cycle 1).
The DLT for this study is defined according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0 and will be evaluated in the dose escalation part, the first 28 days (Cycle 1) of treatment.
6 secondary outcomes
Serum PK parameters
Time frame: Up to finished treatment (each cycle is 28 days).
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.
Immunogenicity
Time frame: up to 90 days following last dose.
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 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.
Caicun Zhou principal investigator
Shanghai Pulmonary Hospital, Shanghai, China
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 LB1410 in people with Solid Tumor and Lymphoma, 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 13 inclusion and 19 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 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?
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 Yan Luan (+86-21-54152522, luanyn2@lnlbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment-emergent adverse events (TEAEs) (time frame: up to 30 days following last dose.). The study lists 4 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.