JPRN-jRCT2031230249
招募中
1 期
[M23-647]First-in-Human Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of the BTK Degrader, ABBV-101, in Participants with B-cell Malignancies - [M23-647]First-in-Human Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of the BTK Degrader, ABBV-101, in Participants with B-cell Malignancies
Satomi Natsuko0 个研究点目标入组 128 人2023年7月21日
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Hematologic Cancer
- 发起方
- Satomi Natsuko
- 入组人数
- 128
- 状态
- 招募中
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •For Dose Escalation (Part 1\) only: Participants with documented diagnosis for one of the following 3L\+ B\-cell malignancies, from one of the following WHO\-defined histologies (Swerdlow et al 2016\):
- •\-\-Chronic lymphocytic leukemia (CLL)
- •\-\-Small lymphocytic lymphoma (SLL)
- •\-\-Chimeric antigen receptor T\-cells (CAR\-T)/hematopoietic cell transplant (HCT) relapsed/refractory (R/R) or ineligible diffuse large b\-cell lymphoma (DLBCL) from the following histologies: DLBCL not otherwise specified (NOS) (germinal center B cell \[GCB] and non\-GCB DLBCL), T\-cell/histiocyte\-rich large B\-cell lymphoma, primary mediastinal (thymic) large B\-cell lymphoma, intravascular large B\-cell lymphoma, anaplastic lymphoma kinase positive (ALK\+) large B\-cell lymphoma, high\-grade B\-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, and high\-grade B\-cell lymphoma NOS.
- •\-\-Mantle cell lymphoma (MCL)
- •\-\-Follicular lymphoma \[FL] (grades 1\-3b)
- •\-\-Marginal zone lymphoma \[MZL] (splenic, extranotal, and nodal)
- •\-\-Waldenstorm macroglobulinemia (WM)
- •\-\-Transformed indolent non\-Hodgkin's lymphoma (iNHL)
- •\-For Dose Expansion (Part 2\) only: Participants with documented diagnosis of CLL who are 3L\+ including those with Bruton's tyrosine kinase (BTK) mutations or CAR\-T/HCT R/R or ineligible non\-GCB DLBCL who are 3L\+ with histology based on criteria established by the World Health Organization (WHO).
排除标准
- •\-Previously treated with a Bruton's tyrosine kinase (BTK) degrader.
- •\-Known active CNS disease, or primary CNS lymphoma.
- •\-Uncontrolled active systemic infection, or active cytomegalovirus infection, known history of human immunodeficiency virus (HIV), active hepatitis B or C infection.
结局指标
主要结局
未指定
相似试验
已完成
1 期
AMG 176 First in Human Trial in Participants With Relapsed or Refractory Multiple Myeloma and Participants With Relapsed or Refractory Acute Myeloid LeukemiaRelapsed or Refractory Multiple MyelomaRelapsed or Refractory Acute Myeloid LeukemiaJPRN-jRCT2080224749Amgen K.K.175
暂停
1 期
A Phase 1 Study of AMG 330 in Subjects With Myeloid MalignanciesRelapsed/Refractory AML, Minimal Residual Disease Positive AML, Myelodysplastic SyndromeJPRN-jRCT2071210044Contact Local256
已完成
不适用
A first-in-human study to evaluate the safety and performance of placebo excipient-coated high-density microarray patches applied by an integrated application device.VaccinationsPublic Health - Other public healthACTRN12620000179932Vaxxas Pty Ltd43
暂停
1 期
Safety, Tolerability, PK, PD, and Efficacy of AMG 427 in Subjects With Relapsed/Refractory Acute Myeloid LeukemiaRelapsed/Refractory Acute Myeloid Leukemia (AML)JPRN-jRCT2031210152ocal Contact200
已完成
不适用
A phase 1 first-in-human study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of AMG232 in adult subjects with advanced solid tumors or multiple myelomasolide tumorentumor in the organsNL-OMON44939Amgen42