NCT06598306招募中1 期
A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of Subcutaneous Tarlatamab in Subjects With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Amgen
- 入组人数
- 220
- 试验地点
- 55
- 主要终点
- Number of Participants with Dose-limiting toxicities (DLTs)
研究概览
简要总结
The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants ≥ 18 years of age (or ≥ legal adult age within country if it is older than 18 years) at time of signing informed consent.
- •Participants with histologically or cytologically confirmed ES-SCLC that progressed or recurred following at least one line of platinum-based anti-cancer therapy for SCLC.
- •Note: Participants with prior treatment for LS-SCLC should have also received another regimen for their recurrent, ES-SCLC disease.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or
- •Participants must have adequate organ function (cardiac, pulmonary, kidney, and liver).
- •Participants must be able to have SC injections administered in the abdomen.
- •Participants without measurable disease or tumor tissue (fresh biopsy or archival) available may be permitted after discussion with and approval by Amgen Medical Monitor.
排除标准
- •Participants that have received prior DLL3 targeted therapy.
- •Participants with untreated or symptomatic brain metastases or those requiring therapy with steroids.
- •Note: Participants with asymptomatic brain metastatic lesions are allowed following definitive treatment (Amgen Medical Monitor may approve untreated, asymptomatic brain metastasis if local therapy is not required per investigator judgment).
- •Participants with leptomeningeal disease.
- •Participants with baseline oxygen requirement.
研究组 & 干预措施
Part 3 Alternative Dosing
Experimental
Following the selection of a SC dosing regimen from Part 1 that will be used in Part 2 dose expansion, Part 3 may open to test alternative dosing of SC tarlatamab.
干预措施: Tarlatamab (Drug)
Part 2 Dose Expansion
Experimental
Following the selection of a SC dosing regimen in Part 1, tarlatamab will be administered in Part 2 at the dose deemed safe and tolerable in Part 1.
干预措施: Tarlatamab (Drug)
Part 1 Dose Exploration
Experimental
Tarlatamab will be administered as a SC injection in Part 1.
干预措施: Tarlatamab (Drug)
结局指标
主要结局
Number of Participants with Dose-limiting toxicities (DLTs)
时间窗: Up to day 21
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
时间窗: Up to approximately 24 months
Number of Participants with Changes in Vital Signs
时间窗: Up to approximately 24 months
Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
时间窗: Up to approximately 24 months
次要结局
- Maximum Serum Concentration (Cmax) of Tarlatamab(Up to approximately 12 months)
- Serum Concentration Prior to Dosing (Ctrough) of Tarlatamab(Up to approximately 12 months)
- Time to Cmax (Tmax) of Tarlatamab(Up to approximately 12 months)
- Area Under the Concentration-time Curve (AUC) of Tarlatamab(Up to approximately 12 months)
- Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1(Up to approximately 24 months)
- Duration of Response (DOR) per RECIST 1.1(Up to approximately 24 months)
- Time to Subsequent Therapy(Up to approximately 24 months)
- Time to Response (TTR) per RECIST 1.1(Up to approximately 24 months)
- Progression-free Survival (PFS) per RECIST 1.1(Up to approximately 24 months)
- Time to Progression per RECIST 1.1(Up to approximately 24 months)
- Overall Survival (OS)(Up to approximately 24 months)
- Number of Participants with Anti-tarlatamab Antibody Formation(Up to approximately 24 months)
研究者
研究点 (55)
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