Actively Recruiting
A LM-302 Combination With Other Anti-Tumor Therapies Phase ll Study
Led by LaNova Medicines Zhejiang Co., Ltd. · Updated on 2025-09-12
276
Participants Needed
1
Research Sites
257 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is to evaluate the efficacy of the LM-302 Combination With Other Therapies in patients with CLDN18.2-positive Advanced Digestive Tract Tumor.
CONDITIONS
Official Title
A LM-302 Combination With Other Anti-Tumor Therapies Phase ll Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to participate and sign informed consent
- Aged 18 to 80 years old
- ECOG performance status of 0-1
- Life expectancy of at least 3 months
- Diagnosed with advanced gastrointestinal tumors confirmed by biopsy or cytology
- Failed or intolerant to prior standard first-line therapy (confirmed by imaging)
- CLDN18.2-positive tumor status
- At least one measurable tumor lesion
- Adequate organ and marrow function within 7 days before first treatment
- Able to communicate and follow study requirements
You will not qualify if you...
- Known HER2-positive gastric cancer or gastroesophageal junction adenocarcinoma
- Participation in another clinical trial within 28 days before first dose
- Anti-tumor treatment within 21 days before first dose
- Previous immunotherapy with severe immune-related adverse events
- Unresolved adverse events from prior therapy above grade 1
- Peripheral sensory or motor neuropathy grade 2 or higher
- Uncontrolled pain
- Active or symptomatic brain metastases
- Uncontrolled third space fluid buildup
- Known allergy to antibody therapy
- Prior treatment targeting the same molecule
- Use of strong CYP3A4 inhibitors or inducers within 14 days before first dose
- Use of live vaccines within 28 days before first dose
- History of interstitial lung disease or pneumonia requiring steroids
- Use of anticoagulants like heparin or vitamin K antagonists
- Uncontrollable vomiting
- Severe gastrointestinal bleeding, ulcers, or diarrhea within 28 days before first dose
- Major surgery or intervention within 28 days before first dose
- Other cancers within 2 years before screening
- Severe heart disease
- Uncontrolled or severe illness
- Use of systemic corticosteroids or immunosuppressants within 2 weeks before first dose
- History of autoimmune diseases
- History of immunodeficiency
- HIV, active hepatitis B or C infection
- Positive pregnancy test or breastfeeding females
- Psychiatric disorders affecting study compliance
- Investigator's judgment of ineligibility
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, China
Actively Recruiting
Research Team
A
Alex Yuan
CONTACT
P
Paul Kong
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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