A LM-302 Combination With Other Anti-Tumor Therapies Phase ll Study

Recruiting now · Phase 2

Conditions studied: Malignant Neoplasms of Digestive Organs

In brief

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.

Key facts

Study ID

NCT05934331

Run by

LaNova Medicines Zhejiang Co., Ltd.

People needed

276

Starts

2023-07-27

Expected to finish

2028-07-01

Last updated by the study team

2025-09-12

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
• Aged 18-80 years old (including boundary values) .
• Eastern Cooperative Oncology Group (ECOG) performance status of0-1.
• Life expectancy ≥ 3 months.
• 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)
• CLDN18.2-positive subjects.
• At least one measurable lesion.
• Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose.
• Subjects who are able to communicate well with investigators and understand and adhere to the requirements of this study.

You may not qualify if…

• Subjects with known HER2-positive gastric cancer/adenocarcinoma of the gastroesophageal junction
• Subjects have participated in any other clinical trial within 28 days prior to 1st dosing of investigational medicinal product (IMP).
• Subjects with anti-tumor treatment within 21 days prior to 1st dosing of IMP.
• Previous immunotherapy and grade ≥3 irAE or grade ≥2 immune-related myocarditis. (for cohorts treated with combination PD-1).
• Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.
• Present peripheral sensory or motor neuropathy ≥ grade 2.
• Subjects with uncontrolled pain.
• Subjects with symptomatic/active central nervous system(CNS)metastases.
• Subject who have uncontrollable third space effusion.
• Subjects with known hypersensitivity to antibody therapy.
• Subjects have treated with the same target.
• Subjects have received Strong inhibitor/strong inducer of CYP3A4 within 14 days prior to first dose.
• Use of any live vaccines within 28 days prior to 1st dosing of IMP.
• Subjects with current or previous interstitial lung diseases or pneumonia requiring oral or intravenous glucocorticoids for adjuvant therapy.
• Subjects on anticoagulants, such as heparin and vitamin K antagonists.
• Clinically uncontrollable persistent recurrent vomiting.
• Uncontrollable/severe gastrointestinal bleeding, ulceration or diarrhea within 28 days prior to first dose of IMP.
• Subjects who received major surgery or interventional treatment within28 days prior to the first dosing of IMP.
• Subjects who have other cancers, other than the one treated in this trial, within 2 years prior to screening.
• Subjects who have severe cardiovascular disease.
• Subjects who have uncontrolled or severe illness.
• 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.
• Subjects with a known history of autoimmune diseases.
• Subjects who have a history of immunodeficiency disease.
• Subjects with HIV infection, active HBV or HCV infection.

Where it is running

• Shanghai East Hospital — Shanghai, China (enrolling)

Full record on ClinicalTrials.gov

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