Phase II Study of LM-24C5

Официальное название

An Open-label, Multicenter Phase II Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of LM-24C5 in Combination With Other Anti-tumor Treatment in Subjects With CEACAM5-positive Advanced Solid Tumors

Обзор

This study is to evaluate the efficacy and safety of the LM-24C5 in combination with other therapies in subjects with CEACAM5-positive advanced solid tumor

Вмешательства

• Препарат LM-24C5
  Q2W Administered intravenously Drug: Penpulimab Q2W Administered intravenously Drug: Docetaxel Q3W Administered intravenously
• Препарат LM-24C5
  Q2W Administered intravenously Drug: Penpulimab Q2W Administered intravenously Drug:Trifluridine and Tipiracil Hydrochloride Tablets BID,Oral Administration Drug:Bevacizumab Injection Q2W Administered intravenously

Первичные конечные точки

• ORR [Срок оценки: 110weeks]

Вторичные конечные точки (12)

• Anti-tumor Activity [Срок оценки: 110weeks]
• PK Parameter（AUClast） [Срок оценки: baseline and 110 weeks]
• Immunogenicity of LM-24C5 [Срок оценки: baseline and 110 weeks]
• Correlation between CEACAM5 and/or PD-L1 expression levels and treatment efficacy. [Срок оценки: baseline and 110 weeks]
• PK Parameter（AUCtau） [Срок оценки: baseline and 110 weeks]
• PK Parameter（Cmax） [Срок оценки: baseline and 110 weeks]
• PK Parameter（Tmax） [Срок оценки: baseline and 110 weeks]
• PK Parameter（T1/2） [Срок оценки: baseline and 110 weeks]
• PK Parameter（ss） [Срок оценки: baseline and 110 weeks]
• PK Parameter（Cmin） [Срок оценки: baseline and 110 weeks]
• PK Parameter（CLss） [Срок оценки: baseline and 110 weeks]
• PK Parameter（Vss） [Срок оценки: baseline and 110 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) , male or female.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Life expectancy ≥ 3 months.
• Subjects must have histological or cytological confirmation of recurrent or refractory advanced solid tumors, or currently lack or are intolerant of, standard therapy.
• CEACAM5-positive subjects.
• At least one evaluable lesion.
• Subjects must show appropriate organ and marrow function inlaboratory examinations within 7 days prior to the first dose.
• Subjects who can communicate well with investigators and understand and adhere to the requirements of this study.

Критерии исключения

• Subjects with a history of other malignancies within 5 years prior to first dosing of LM-24C5, excluding cured squamous cell carcinoma of the skin, basal cell carcinoma, non-muscle-invasive bladder cancer, or localized low-risk prostate cancer, carcinoma in situ of the cervix/breast, and other malignancies deemed by the investigator to potentially benefit from participation in this study.
• Subjects who have received other anti-tumor treatments before the first dosing of LM-24C5.
• Previous immunotherapy and grade ≥3 irAE or grade ≥2 immune-related myocarditis.
• 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 and untreated central nervous system metastases, and/or meningeal metastases.
• Subjects who have uncontrollable third space effusion.
• Previously received targeted therapy for same target.
• . 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 within 28 days prior to the first dosing of IMP.
• 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 · 2 центра

• Fujian Cancer Hospital — Фучжоу
• Shanghai East Hospital — Шанхай

Идентификаторы

NCT: NCT07387081 · LM24C5-02-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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