Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
NCT05934331

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

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Shanghai East Hospital

Shanghai, China

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here