jRCT2061240070招募中不适用
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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Amgen K.K.
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized Controlled Trial
- 干预模型
- Single Assignment
- 主要目的
- Basic Science
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
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 regimen.
- •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 (and/or thigh).
- •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.
研究者
相似试验
招募中
不适用
Retreatment with subcutaneous Infliximab in patients with refractory Crohn’s diseaseK50Crohn disease [regional enteritis]DRKS00030670niversitätsklinikum Freiburg30
已完成
1 期
Clinical study with subsequent subcutaneous administration of GEN0101 in the patients enrolled in the Phase 1 dose-escalation, safety / tolerability and preliminary efficacy study of intratumoral and subcutaneous administration of GEN0101 (GEN0101-JM003).JPRN-UMIN000026892Osaka University Hospital, Center for respiratory6
招募中
3 期
A Phase 3 Randomized Study Comparing Talquetamab in Combination with Daratumumab (SC) and Pomalidomide (Tal-DP) or Talquetamab (SC) in combination with Daratumumab SC (Tal-D) versus Daratumumab SC, Pomalidomide and Dexamethasone (DPd), in Participants With Relapsed or Refractory Multiple Myeloma who Have Received at Least 1 Prior Line of Therapy10018865Multiple MyelomaNL-OMON53729Janssen-Cilag25
招募中
3 期
A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants with Relapsed or Refractory Myeloma who Have Received an Anti-CD38 Antibody and LenalidomideCTRI/2024/02/063266Johnson and Johnson Private Limited
招募中
1 期
A Phase 3 Randomized Study Comparing Talquetamab in Combination with Pomalidomide (Tal-P), Talquetamab in Combination with Teclistamab (Tal-Tec), and Investigator’s Choice of Either Elotuzumab, Pomalidomide, and Dexamethasone (EPd) or Pomalidomide, Bortezomib, and Dexamethasone (PVd) in Participants with Relapsed or Refractory Myeloma who Have Received 1 to 4 Prior Lines of Therapy Including an Anti-CD38 Antibody and LenalidomideRelapsed or Refractory MyelomaMedDRA version: 21.1Level: PTClassification code: 10035226Term: Plasma cell myeloma Class: 100000004864CTIS2022-502446-27-00Janssen - Cilag International827