Actively Recruiting
A Study to Evaluate LB1410 in Combination With LB4330 in Patients With Advanced or Metastatic Solid Tumors
Led by L & L Bio Co., Ltd., Ningbo, China · Updated on 2025-09-11
194
Participants Needed
1
Research Sites
184 weeks
Total Duration
On this page
Sponsors
L
L & L Bio Co., Ltd., Ningbo, China
Lead Sponsor
S
Shanghai East Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a phase Ib/II, open, dose-escalation and expansion study of an anti-PD1/TIM3 bispecific antibody，LB1410 in combination with an anti-Claudin18.2/IL-10 fusion protein, LB4330 in patients with advanced or metastatic solid tumors.
CONDITIONS
Official Title
A Study to Evaluate LB1410 in Combination With LB4330 in Patients With Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years at informed consent signing
- ECOG performance status of 0 or 1 without recent deterioration
- Estimated life expectancy of at least 12 weeks
- Baseline IL-6 levels below 40 pg/mL
- Histologically or cytologically confirmed advanced or metastatic solid tumors without standard treatment options or after standard treatment failure
- At least one measurable lesion per RECIST v1.1
- Adequate blood counts and organ function as defined by study criteria
- No recent use of granulocyte colony-stimulating factor, platelet growth factors, erythropoietin, or transfusions within 14 days prior to treatment
- Prior anti-tumor therapies washed out according to specific timelines
- Specific prior treatment and biomarker criteria for dose escalation and dose expansion cohorts
- Non-pregnant women and men willing to use effective contraception during and for 6 months after treatment
- Ability and willingness to comply with study visits, treatments, and procedures
- Signed informed consent
You will not qualify if you...
- Pregnancy, lactation, or breastfeeding
- History of severe immune-related adverse events or grade 4 myelosuppression from prior therapies
- Known allergies to monoclonal antibodies or components of study drugs
- Active or symptomatic autoimmune disease requiring systemic immunosuppression
- Use of systemic corticosteroids or immunosuppressants within 14 days before study treatment
- Recent major surgery, severe trauma, or planned significant surgery within specified timeframes
- Receipt of live vaccines within 4 weeks prior to study treatment
- History of organ or stem cell transplants
- Prior use of drugs with the same mechanism as study drugs
- Active infections including hepatitis B or C, syphilis, HIV
- Other malignancies within past 3 years
- Unstable brain metastases or neurological conditions requiring steroids or antiepileptic drugs
- Severe infections requiring systemic antibiotics within 14 days prior to treatment
- Uncontrolled chronic diseases posing risk to participants
- Recent syncope or seizures
- Known gastric bleeding or high risk for bleeding
- Serious cardiovascular or cerebrovascular diseases within specified timeframes
- Evidence of interstitial lung disease or active tuberculosis
- Positive HIV status
- History of thrombotic events within 6 months
- Uncontrolled pleural, pericardial effusions, or ascites
- Severe psychiatric disorders or substance abuse
- Grade 3 or higher infusion-related reactions to protein therapies
- Other medical or psychiatric conditions affecting safety or study integrity
- Known MSI-H/dMMR or HER-2 positive status
- Significant proteinuria as defined by urine tests
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai East Hospital
Shanghai, Shanghai Municipality, China, 201114
Actively Recruiting
Research Team
Y
Yan Luan
CONTACT
C
Caicun Zhou
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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