Actively Recruiting
A Study to Assess the Safety and Efficacy of LB1410 in Participants With Advanced Solid Tumor or Lymphoma（Keyplus-001）
Led by L & L Bio Co., Ltd., Ningbo, China · Updated on 2025-09-11
100
Participants Needed
1
Research Sites
333 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Assess the Safety and Efficacy of LB1410 in Participants With Advanced Solid Tumor or Lymphoma（Keyplus-001）
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be 18 years of age or older
- Have histologically or cytologically confirmed advanced or metastatic solid tumor malignancies or lymphoma with no effective standard treatment options (for dose escalation and safety expansion phases)
- Specific criteria for cohorts: Cohort A: advanced/metastatic NSCLC with prior anti-PD1/PD-L1 and chemotherapy failure without discontinuation due to adverse events; Cohort B: advanced/metastatic NSCLC with prior chemotherapy failure, PD-L1 positive, no prior PD1/PD-L1 antibody therapy; Cohort C: advanced colorectal cancer with no more than 2 prior systemic therapies, TIM-3 expression ≥10%; Cohort D: other advanced solid tumors with no more than two prior systemic therapies
- Must provide tumor tissue samples for PD-L1 and TIM-3 testing
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Life expectancy of at least 12 weeks
- At least one measurable lesion for tumor response assessment
- Adequate blood and organ function within 7 days before first dose
- Non-pregnant women and willingness to use effective contraception; male participants must agree to avoid fathering children
You will not qualify if you...
- Pregnant, lactating, or breastfeeding women
- Significant autoimmune disease requiring systemic immunosuppressive treatment within the past 5 years
- Anti-cancer or investigational therapy within 28 days before first LB1410 dose
- Prior use of both PD1 and TIM3 monoclonal antibodies; prior use of only one is allowed
- Use of immunosuppressive corticosteroids over 10 mg prednisone daily within 2 weeks before first dose
- Active infections including HIV, hepatitis B, or hepatitis C
- Other cancers within 3 years except certain treated in situ cancers
- History of severe allergic reactions to antibody therapies or components of LB1410
- Symptomatic or uncontrolled brain metastases or spinal cord conditions requiring treatment
- Incomplete recovery from prior radiation or chemotherapy side effects except specified exceptions
- History of organ transplantation
- Major surgery within 4 weeks before study drug treatment or inadequate recovery from surgery
- Significant heart disease or impaired cardiac function
- Interstitial lung disease or significant radiation pneumonitis
- Poorly controlled type 2 diabetes
- Medical conditions that may interfere with study drug safety or evaluation
- Active tuberculosis within 1 year before enrollment
- Neurological or mental disorders with poor compliance
- Chronic or active gastrointestinal inflammation or severe gastrointestinal reactions after prior immunotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
Y
Yan Luan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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