NCT05934331招募中2 期
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.
LaNova Medicines Zhejiang Co., Ltd.1 个研究点 分布在 1 个国家目标入组 276 人开始时间: 2023年7月27日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
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.
详细描述
Primary Objective:
To evaluate the efficacy of the LM-302 + Toripalimab regimen in subjects with CLDN18.2-positive advanced gastro-Intestinal cancer
Secondary Objectives:
To evaluate the correlation between CLDN18.2 and PD-L1 expression levels and the antitumor activity of the LM-302 + Toripalimab regimen.
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) .
- •Eastern Cooperative Oncology Group (ECOG) performance status of0-
- •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.
排除标准
- •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.
- •Present peripheral sensory or motor neuropathy ≥ grade
- •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.
研究组 & 干预措施
LM-302 in combination with Toripalimab
Experimental
干预措施: LM-302 (Drug)
LM-302 in combination with Toripalimab
Experimental
干预措施: Toripalimab (Drug)
LM-302 in combination with other therapies
Experimental
干预措施: LM-302 (Drug)
LM-302 in combination with other therapies
Experimental
干预措施: Toripalimab (Drug)
LM-302 in combination with other therapies
Experimental
干预措施: Capecitabine (Drug)
LM-302 in combination with other therapies
Experimental
干预措施: Tegafur, Gimeracil and Oteracil Potassium Capsules (Drug)
LM-302 in combination with other therapies
Experimental
干预措施: Nivolumab (Drug)
LM-302 in combination with other therapies
Experimental
干预措施: Apatinib (Drug)
LM-302 in combination with other therapies
Experimental
干预措施: Gemcitabine (Drug)
结局指标
主要结局
PFS
时间窗: 112 weeks
Progression free survival according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
次要结局
- OS(112 weeks)
- AEs(112 weeks)
- SAEs(112 weeks)
- Temperatures(112 weeks)
- Pulse in BPM(112 weeks)
- Blood Pressure(112 weeks)
- Weight(112 weeks)
- Height(112 weeks)
- QRS(112 weeks)
- QT(112 weeks)
- QTcF(112 weeks)
- ORR(112 weeks)
- DOR(112 weeks)
- DCR(112 weeks)
- Blood Routine examination(112 weeks)
- Urine Routine test(112 weeks)
- Blood biochemistry(112 weeks)
- Coagulation function(112 weeks)
- LVEF(112 weeks)
- HR(112 weeks)
- RR(112 weeks)
- PR(112 weeks)
- ECOG score(112 weeks)
- PK Parameter:Cmax(112 weeks)
- PK Parameter：Tmax(112 weeks)
- PK Parameter: AUC(112 weeks)
- PK Parameter: Cmax,ss(112 weeks)
- PK Parameter: Cmin,ss(112 weeks)
- PK Parameter: CLss(112 weeks)
- PK Parameter:Rac(112 weeks)
- PK Parameter: t1/2(112 weeks)
- PK Parameter: Vss(112 weeks)
- PK Parameter: DF(112 weeks)
- Immunogenicity of LM-302(112 weeks)
- Biomarker correlation(112 weeks)
- AE/SAE(112 weeks)
研究者
研究点 (1)
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