OncoMatch/Clinical Trials/NCT05357651
A Study to Assess the Safety and Efficacy of LB1410 in Participants With Advanced Solid Tumor or Lymphoma（Keyplus-001）
Is NCT05357651 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies LB1410 for solid tumor.
Treatment: LB1410 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Non-Hodgkin Lymphoma
Biomarker criteria
Required: PD-L1 (CD274) positive (positive)
Cohort B: ... have not received PD1/PD-L1 antibody therapy; PD-L1 positive
Required: HAVCR2 TIM-3 ≥10% (≥10%)
Cohort C: ... TIM-3≥10%
Required: PD-L1 (CD274) expression testing required
tumor tissue ... shall be provided ... for PD-L1 and TIM-3 detection
Required: HAVCR2 expression testing required
tumor tissue ... shall be provided ... for PD-L1 and TIM-3 detection
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1 therapy — prior therapy
Cohort A: ... have previously failed anti-PD1/anti-PD-L1 antibody and platinum-based chemotherapy
Must have received: platinum-based chemotherapy — prior therapy
Cohort A: ... have previously failed anti-PD1/anti-PD-L1 antibody and platinum-based chemotherapy
Must have received: platinum-based chemotherapy — prior therapy
Cohort B: ... have failed previous platinum-containing doublet chemotherapy
Cannot have received: anti-PD-1 therapy
Exception: patients who have used one of them alone can be included
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
Cannot have received: anti-TIM-3 therapy
Exception: patients who have used one of them alone can be included
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
Cannot have received: anti-cancer therapy
Treatment with anti-cancer therapy or investigational therapy within 28 days prior to the first dose of LB1410
Lab requirements
Blood counts
Adequate hematological function measured within 7 days prior to first dose
Kidney function
Adequate organ function measured within 7 days prior to first dose
Liver function
Adequate organ function measured within 7 days prior to first dose
Cardiac function
Impaired cardiac function or clinically significant cardiac disease, including any of the following [excluded]
Adequate hematological and organ function measured within 7 days prior to first dose; Impaired cardiac function or clinically significant cardiac disease, including any of the following [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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