NCT06350006招募中1 期
A Phase Ib/III Study of SHR-A1904 Combinations in CLDN18.2-Positive Advanced Solid Tumor
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 924
- 试验地点
- 1
- 主要终点
- Dose Limiting Toxicity (DLT)
研究概览
简要总结
This study consists of two research phases:
Phase Ib (includes dose escalation stage and efficacy expansion stage): To explore the safety, tolerability and initial efficacy of SHR-A1904 in the treatment of CLDN18.2-positive advanced solid tumors, and to determine the recommended dose and recommended population for the Phase III combination study.
Phase III: A randomized, Open-Label, multicenter clinical study of SHR-A1904 combined with chemotherapy and immunotherapy Versus chemotherapy combined with immunotherapy for CLDN18.2-positive advanced solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 75 years old (including boundary values);
- •Volunteer to participate in this clinical study and sign informed consent;
- •ECOG score 0-1;
- •Expected survival ≥3 months;
- •Pathologically confirmed locally advanced unresectable or metastatic solid tumors;
- •positive CLDN18.2 expression in tumor tissue;
- •There is at least one measurable lesion that meets the RECIST 1.1 criteria;
- •Adequate bone marrow and organ function.
排除标准
- •Plan to receive any other antitumor therapy during this trial; Received other investigational drugs or treatments that are not on the market within 4 weeks prior to the first administration; Anti-tumor therapy, such as chemotherapy, radiotherapy, biotherapy, targeted therapy or immunotherapy, was received within 4 weeks before the first administration of the study drug. Palliative radiotherapy or local therapy within 2 weeks before the first administration of the study drug; Had major surgery other than diagnosis or biopsy within the 4 weeks prior to the first administration or randomization and required elective surgery during the trial.
- •HER2 expression in tumor tissue is positive.
- •The adverse reactions of previous anti-tumor therapy has not recovered to NCI-CTCAE v5.0 grade≤
- •Has ≥ grade 2 peripheral sensory neuropathy.
- •Has an allergic reaction to any of the components treated in this study, or are allergic to humanized monoclonal antibody products.
- •Has a history or current history of meningeal metastasis; or active brain metastases.
- •Presence of dysphagia or other factors affecting the use of oral medications.
- •Additional malignancy within the five years prior to the first administration or randomization.
- •Has an active autoimmune disease or a history of autoimmune disease.
- •Received systemic use of corticosteroids or other immunosuppressants for immunosuppressive effects within 14 days prior to the first administration or randomization.
- •Has a history of clinically significant lung disease.
- •Has serosal effusion ≥ grade 3 (based on NCI CTCAE5.0 criteria).
- •There was an active infection requiring systemic treatment within 2 weeks prior to the first administration or randomization.
- •A history of immunodeficiency, including a positive HIV test; Presence of active hepatitis B or hepatitis C.
- •People who have previously received allogeneic hematopoietic stem cell transplantation or organ transplantation.
- •Has severe cardiovascular and cerebrovascular diseases.
- •Gastrointestinal perforation and/or gastrointestinal fistula within the last 6 months prior to the first administration or randomization; Active gastrointestinal bleeding occurred 3 months before the first administration or randomization.
- •In the investigator's judgment, the subject has other factors that could have affected the study results or led to the forced termination of the study.
研究组 & 干预措施
SHR-A1904 combined with Adebrelimab
Experimental
SHR-A1904+ Adebrelimab
干预措施: SHR-A1904; Adebrelimab (Drug)
SHR-A1904 combined with CAPOX and Adebrelimab
Experimental
SHR-A1904+ CAPOX+ Adebrelimab
干预措施: SHR-A1904; CAPOX; Adebrelimab (Drug)
结局指标
主要结局
Dose Limiting Toxicity (DLT)
时间窗: approximately 24 months
Phase 1b
Maximal Tolerable Dose (MTD)
时间窗: approximately 24 months
Phase 1b
Progression-free survival (PFS) assessed by blind Independent Center Review (BICR) based on RECIST 1.1 criteria
时间窗: approximately 36 months
Phase 3
Phase III Recommended Dose (RP3D)
时间窗: approximately 24 months
Phase 1b
Incidence and severity of AE
时间窗: Up to follow-up period, approximately 24 months
Phase 1b
次要结局
- SHR-A1904 Total antibody(approximately 24 months)
- Immunogenicity indicators of SHR-A1904: drug resistant antibody (ADA) and neutralizing antibody (NAb)(approximately 24 months)
- Overall survival (OS)(approximately 36 months)
- Incidence and severity of AE(approximately 36 months)
- SHR-A1904 toxin binding antibody(approximately 24 months)
- Expression level of CLDN18.2 in tumor tissues(approximately 24 months)
研究者
研究点 (1)
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