A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Amgen
- 入组人数
- 380
- 试验地点
- 28
- 主要终点
- Dose Exploration: Number of Participants with Dose-limiting Toxicities (DLTs)
研究概览
简要总结
The primary objective for dose exploration and dose expansion is to evaluate the safety and tolerability of tarlatamab in combination with AB248.
The primary objective for dose exploration only is to determine the recommended dose for expansion and/or maximum tolerated combination dose (MTCD) of AB248 in combination with 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has provided informed consent before initiation of any study-specific activities/procedures.
- •Participants ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent.
- •Participants with histologically or cytologically confirmed ES-SCLC that has progressed or recurred following at least 1 line of anti-cancer therapy for ES-SCLC.
- •Participants must have at least 1 measurable lesion as defined by RECIST 1.1 within 21-day screening period, not previously irradiated.
- •Participants must have adequate organ function (hematological, coagulation, cardiac, pulmonary, kidney, and liver).
- •Participants must submit a fresh tumor biopsy at screening unless a new biopsy cannot be performed safely or is infeasible. Participants who cannot provide fresh tissue may provide archival tissue that was collected after last anticancer therapy.
排除标准
- •Symptomatic central nervous system (CNS) metastases.
- •Participants with brain metastases may be eligible if criteria defined in the protocol are met.
- •Prior therapy with any delta-like ligand 3 (DLL3)-directed therapy (including tarlatamab).
- •Prior interleukin (IL)-2, IL-7 or IL-15 targeted therapy.
- •Baseline (at rest) requirement of supplemental oxygen.
研究组 & 干预措施
Dose Exploration
Multiple dose levels of AB248 will be explored in combination with tarlatamab administered via intravenous (IV) infusion.
干预措施: Tarlatamab (Drug)
Dose Exploration
Multiple dose levels of AB248 will be explored in combination with tarlatamab administered via intravenous (IV) infusion.
干预措施: AB248 (Drug)
Dose Expansion
The dose expansion part will test tarlatamab in combination with the MTCD/recommended dose for expansion of AB248 identified in the dose exploration part.
An optional cohort may be opened based on emerging data to study tarlatamab in combination with AB248 at a lower dose than the MTCD/recommended dose for expansion or with an alternative dose regimen at a AB248 dose lower than or equal to MTCD/recommended dose for expansion.
干预措施: Tarlatamab (Drug)
Dose Expansion
The dose expansion part will test tarlatamab in combination with the MTCD/recommended dose for expansion of AB248 identified in the dose exploration part.
An optional cohort may be opened based on emerging data to study tarlatamab in combination with AB248 at a lower dose than the MTCD/recommended dose for expansion or with an alternative dose regimen at a AB248 dose lower than or equal to MTCD/recommended dose for expansion.
干预措施: AB248 (Drug)
结局指标
主要结局
Dose Exploration: Number of Participants with Dose-limiting Toxicities (DLTs)
时间窗: Up to 35 days
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
时间窗: Up to 2.5 years
Clinically significant changes in vital signs and clinical laboratory tests will be reported as adverse events.
次要结局
- Time to Response (TTR) per RECIST 1.1(Up to 2.5 years)
- Disease Control (DC) per RECIST 1.1(Up to 2.5 years)
- Progression-free Survival (PFS) per RECIST 1.1(Up to 2.5 years)
- Time to Progression (TTP) per RECIST 1.1(Up to 2.5 years)
- Time to Subsequent Therapy(Up to 2.5 years)
- Overall Survival (OS)(Up to 2.5 years)
- Minimum Serum Concentration (Cmin) of Tarlatamab(Up to approximately 21 weeks)
- Area Under the Concentration-time Curve (AUC) of Tarlatamab(Up to approximately 21 weeks)
- Half-life (t1/2) of Tarlatamab(Up to approximately 21 weeks)
- Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1(Up to 2.5 years)
- Duration of Response (DOR) per RECIST 1.1(Up to 2.5 years)
- Maximum Serum Concentration (Cmax) of Tarlatamab(Up to approximately 21 weeks)
- Number of Participants with Anti-AB248 Antibody Formation(Up to 2.5 years)