At a glance
ClinicalIndex Comparison RecordPhase 1Recruiting· 100 target
Drug / intervention
LB1410drug
Likely dose
Not stated in record
Key inclusion· 12
- ✓Age ≥18 years
- ✓Advanced/metastatic solid tumor or lymphoma with failed or unavailable standard treatment (dose escalation and safety expansion phases)
- ✓Cohort A: NSCLC with failed anti-PD1/anti-PD-L1 and platinum-based chemotherapy, no AE-related discontinuation
- ✓Cohort B: NSCLC with failed platinum-containing doublet, no prior PD1/PD-L1 therapy, PD-L1 positive
Key exclusion· 19
- ✕Pregnancy, lactation, or breastfeeding
- ✕Significant autoimmune disease requiring systemic immunosuppressive treatment within 5 years
- ✕Anti-cancer or investigational therapy within 28 days before first dose
- ✕Prior dual use (simultaneous or sequential) of PD1 and TIM3 monoclonal antibodies; monotherapy with either allowed
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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）
In Brief
A Phase 1 clinical trial evaluating LB1410 for Solid Tumor and Lymphoma. Currently recruiting, targeting 100 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumor, Lymphoma
CountriesChina
Collaborators--
Timeline
Phase 1Recruiting
2023202420252026202720282029
First PostedMay 2022
Enrollment StartAug 2022
TodayJul 2026
Primary CompletionDec 2026
Study CompletionDec 2028
First PostedMay 3, 2022
Enrollment StartAug 12, 2022
Primary CompletionDec 30, 2026
Study CompletionDec 30, 2028
TodayJul 1, 2026
Enrollment to primary: 4.4 yearsPosted 4.2 years agoPrimary completion in 6 months
Interventions
LB1410drug
anti-PD-1 and anti-TIM-3 bispecific antibody