NCT07387081招募中2 期
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
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- ORR
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •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.
排除标准
- •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-24C
- •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.
- •Present peripheral sensory or motor neuropathy ≥ grade
- •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.
研究组 & 干预措施
LM-24C5 in combination with anti-tumor therapies
Experimental
干预措施: LM-24C5 (Drug)
LM-24C5 in combination with other anti-tumor therapies
Experimental
干预措施: LM-24C5 (Drug)
结局指标
主要结局
ORR
时间窗: 110weeks
Objective response rate
次要结局
- Anti-tumor Activity(110weeks)
- PK Parameter（AUClast）(baseline and 110 weeks)
- Immunogenicity of LM-24C5(baseline and 110 weeks)
- Correlation between CEACAM5 and/or PD-L1 expression levels and treatment efficacy.(baseline and 110 weeks)
- PK Parameter（AUCtau）(baseline and 110 weeks)
- PK Parameter（Cmax）(baseline and 110 weeks)
- PK Parameter（Tmax）(baseline and 110 weeks)
- PK Parameter（T1/2）(baseline and 110 weeks)
- PK Parameter（ss）(baseline and 110 weeks)
- PK Parameter（Cmin）(baseline and 110 weeks)
- PK Parameter（CLss）(baseline and 110 weeks)
- PK Parameter（Vss）(baseline and 110 weeks)
- PK Parameter（Rac）(baseline and 110 weeks)
- PK Parameter（AUC）(baseline and 110 weeks)
- PK Parameter（DF）(baseline and 110 weeks)
研究者
研究点 (2)
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