A Phase 1 interventional study of LB1410 in Solid Tumor and Lymphoma, sponsored by L & L Bio Co., Ltd., Ningbo, China. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-11.
Sponsored by L & L Bio Co., Ltd., Ningbo, China · Phase 1, Interventional, and Treatment
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.
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 100 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →L & L Bio Co., Ltd., Ningbo, China is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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%
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
Exclusion Criteria:
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.
Drug: LB1410
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.
Drug: LB1410
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.
Drug: LB1410
anti-PD-1 and anti-TIM-3 bispecific antibody
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.
Time frame: 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.
Time frame: up to 90 days following last dose.
AEs of special interest (immune-related AEs)
Incidence and severity of immune-related AEs.
Time frame: 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.
Time frame: in the first 28 days (Cycle 1).
Serum PK parameters
AUC0-t and so on.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: up to 90 days following last dose.
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L & L Bio Co., Ltd., Ningbo, China