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

Официальное название

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.

Обзор

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.

Вмешательства

• Препарат LM-302
  Q2W/Q3W，Administered intravenously
• Препарат Toripalimab
  Q2W/Q3W,Administered intravenously
• Препарат Capecitabine
  BID,Oral Administration
• Препарат Tegafur, Gimeracil and Oteracil Potassium Capsules
  BID,Oral Administration
• Препарат Nivolumab
  Q4W,Administered intravenously
• Препарат Apatinib
  QD,Oral Administration
• Препарат Gemcitabine
  Q4W,Administered intravenously

Первичные конечные точки

• PFS [Срок оценки: 112 weeks]

Вторичные конечные точки (12)

• ORR [Срок оценки: 112 weeks]
• DOR [Срок оценки: 112 weeks]
• DCR [Срок оценки: 112 weeks]
• OS [Срок оценки: 112 weeks]
• AEs [Срок оценки: 112 weeks]
• SAEs [Срок оценки: 112 weeks]
• Temperatures [Срок оценки: 112 weeks]
• Pulse in BPM [Срок оценки: 112 weeks]
• Blood Pressure [Срок оценки: 112 weeks]
• Weight [Срок оценки: 112 weeks]
• Height [Срок оценки: 112 weeks]
• Blood Routine examination [Срок оценки: 112 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.
• Child-bearing potential female who have positive results in pregnancy test within 7 days before the first dose or are lactating.
• Subject who have a known psychiatric diseases or disorders that may affect compliance with the trial.
• Subject who is judged as not eligible to participate in this study by the investigator.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai East Hospital — Шанхай

Идентификаторы

NCT: NCT05934331 · LM302-02-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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