JPRN-jRCT2031220086进行中（未招募）1 期
A Phase 1b Study Evaluating the Safety and Efficacy of AMG 757 in Combination With AMG 404 in Subjects With Small Cell Lung Cancer (SCLC)
Tagashira Shuzo0 个研究点目标入组 50 人开始时间: 2022年5月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Participant has provided informed consent/assent prior to initiation of any study specific activities/procedures
- •2. Age greater than or equal to 18 years old at the same time of signing the informed consent
- •3. Participants with histologically or cytologically confirmed Small Cell Lung Cancer (SCLC) who progressed or recurred following at least 1 platinum-based regimen
- •4. Eastern Cooperative Oncology Group (ECOG) 0 to 1
- •5. Participants with treated brain metastases are eligible provided they meet defined criteria
- •6. Adequate organ function as defined in protocol
排除标准
- •1. History of other malignancy within the past 2 years with exceptions
- •2. Major surgery within 28 days of first dose of tarlatamab
- •3. Untreated or symptomatic brain metastases and leptomeningeal disease
- •4. Prior anti-cancer therapy, including anti-PD1 or anti-PDL1 antibody therapy: at least 28 days must have elapsed between any prior anti- cancer therapy and the first planned dose of tarlatamab
- •Exceptions:
- •- Participants who received prior chemotherapy must have completed at least 14 days before the first dose of tarlatamab and all treatment-related toxicity resolved to grade <= 1.
- •- Participants who received prior palliative radiotherapy must have completed at least 7 days before the first dose of tarlatamab
- •5. Participants who received prior tarlatamab therapy or prior delta-like ligand 3 (DLL3) x cluster of differentiation 3 (CD3) bispecific therapy are not eligible
- •6. Participants who experienced recurrent grade 2 pneumonitis or severe or life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents
- •7. History of any immune-related colitis. Infectious colitis is allowed if evidence of adequate treatment and clinical recovery exists and at least 3 months interval observed since diagnosis of colitis
- •8. Participants with evidence of interstitial lung disease or active, non-infectious pneumonitis
- •9. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of tarlatamab
- •10. History of solid organ transplantation
- •11. History of hypophysitis or pituitary dysfunction
- •12. Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study. Participants with Type I diabetes, vitiligo, psoriasis, hypo- or hyper-thyroid disease not requiring immunosuppressive treatment are permitted
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