An Open-label, Multicenter Phase II Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of the LM-302 Combination With Other Anti-tumor Treatment in Subjects With CLDN18.2-positive Advanced Gastro-Intestinal Cancer.

Trial ID: NCT05934331

Interventional - Phase 2 - Recruiting

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

• Malignant Neoplasms of Digestive Organs

Interventions

• LM-302
• Toripalimab
• Capecitabine
• Tegafur, Gimeracil and Oteracil Potassium Capsules
• Nivolumab
• Apatinib
• Gemcitabine

Eligibility

Inclusion criteria

• 1. Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
• 2. Aged 18-80 years old (including boundary values) .
• 3. Eastern Cooperative Oncology Group (ECOG) performance status of0-1.
• 4. Life expectancy ≥ 3 months.
• 5. Subjects with advanced gastrointestinal tumors diagnosed histologically and/or cytologically and who have failed or are intolerant to prior standard first-line therapy (imaging confirmation required)
• 6. CLDN18.2-positive subjects.
• 7. At least one measurable lesion.
• 8. Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose.
• 9. Subjects who are able to communicate well with investigators and understand and adhere to the requirements of this study.

Exclusion criteria

• 1. Subjects with known HER2-positive gastric cancer/adenocarcinoma of the gastroesophageal junction
• 2. Subjects have participated in any other clinical trial within 28 days prior to 1st dosing of investigational medicinal product (IMP).
• 3. Subjects with anti-tumor treatment within 21 days prior to 1st dosing of IMP.
• 4. Previous immunotherapy and grade ≥3 irAE or grade ≥2 immune-related myocarditis. (for cohorts treated with combination PD-1).
• 5. Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.
• 6. Present peripheral sensory or motor neuropathy ≥ grade 2.
• 7. Subjects with uncontrolled pain.
• 8. Subjects with symptomatic/active central nervous system(CNS)metastases.
• 9. Subject who have uncontrollable third space effusion.
• 10. Subjects with known hypersensitivity to antibody therapy.
• 11. Subjects have treated with the same target.
• 12. Subjects have received Strong inhibitor/strong inducer of CYP3A4 within 14 days prior to first dose.
• 13. Use of any live vaccines within 28 days prior to 1st dosing of IMP.
• 14. Subjects with current or previous interstitial lung diseases or pneumonia requiring oral or intravenous glucocorticoids for adjuvant therapy.
• 15. Subjects on anticoagulants, such as heparin and vitamin K antagonists.
• 16. Clinically uncontrollable persistent recurrent vomiting.
• 17. Uncontrollable/severe gastrointestinal bleeding, ulceration or diarrhea within 28 days prior to first dose of IMP.
• 18. Subjects who received major surgery or interventional treatment within28 days prior to the first dosing of IMP.
• 19. Subjects who have other cancers, other than the one treated in this trial, within 2 years prior to screening.
• 20. Subjects who have severe cardiovascular disease.
• 21. Subjects who have uncontrolled or severe illness.
• 22. Subjects who take systemic corticosteroids (\> 10 mg daily prednisone equivalents) or other systemic immunosuppressive medications within 2 weeks prior to the first dosing of IMP.
• 23. Subjects with a known history of autoimmune diseases.
• 24. Subjects who have a history of immunodeficiency disease.
• 25. Subjects with HIV infection, active HBV or HCV infection.
• 26. Child-bearing potential female who have positive results in pregnancy test within 7 days before the first dose or are lactating.
• 27. Subject who have a known psychiatric diseases or disorders that may affect compliance with the trial.
• 28. Subject who is judged as not eligible to participate in this study by the investigator.

Sponsor

LaNova Medicines Zhejiang Co., Ltd.

Source: ClinicalTrials.gov

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