2024-516234-35-00招募中2 期
A Phase 1b/2, Open-Label, Master Protocol Study of BTK-Degrader BGB-16673 in Combination With Other Agents in Patients With Relapsed or Refractory B-Cell Malignancies
Beigene Ltd.15 个研究点 分布在 3 个国家目标入组 99 人开始时间: 2025年9月23日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 99
- 试验地点
- 15
- 主要终点
- Number of patients with dose-limiting toxicities (Part 1a)
研究概览
简要总结
- To evaluate safety and tolerability of and identify the recommended dose(s) for expansion (RDFE[s]) for BGB-16673 combination treatments in patients with selected relapsed/refractory (R/R) B-cell malignancies (Part 1a)
- To characterize the safety and tolerability of BGB-16673 combination treatments at the RDFE(s) in patients with selected R/R B-cell malignancies (Part 1b)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Must sign the informed consent form (ICF) and be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the ICF
- •Adequate renal function as indicated by eGFR of ≥ 30 mL/min (Sub-study 2)
- •Confirmed diagnosis of a R/R B-cell malignancy
- •Protocol-defined measurable disease
- •Stable Eastern Cooperative Oncology Group Performance Status of 0 to 1
- •Adequate organ function
- •Female participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for 30 days after the last dose of BGB-16673 or zanubrutinib, or 90 days after the last dose of sonrotoclax, 3 months after the last dose of mosunetuzumab or tocilizumab, 18 months after pretreatment with obinutuzumab, 2 months after the last dose of glofitamab. A negative urine or serum pregnancy test result must be provided 10-14 days before the first dose of study treatment
- •Nonsterile male participants must be willing to use a highly effective method of birth control and refrain from sperm donation for the duration of the study and for 30 days after the last dose of BGB-16673 or zanubrutinib, 90 days after the last dose of sonrotoclax, 3 months after the last dose of mosunetuzumab or tocilizumab, 18 months after pretreatment with obinutuzumab, 2 months after the last dose of glofitamab
- •Adequate renal function as indicated by estimated glomerular filtration rate (eGFR) of ≥ 50 mL/min (Sub-studies 1, 3 and 4)
- •Bruton tyrosine kinase (BTK) inhibitor-naive, or previously received treatment with a covalent BTK inhibitor and discontinued for reasons other than clinical progression (Sub-study 2)
排除标准
- •Treatment-naive B-cell malignancies
- •Prior exposure to a CD20 x CD3 T-cell engager antibody treatment (Sub-studies 3 and 4)
- •All participants with a prior allogeneic stem cell transplant (Sub-studies 3 and 4)
- •Unable to comply with the requirements of the protocol
- •Active leptomeningeal disease or uncontrolled, untreated brain metastasis
- •Any malignancy ≤ 2 years before first dose of study treatment except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively
- •Autologous stem cell transplant ≤ 3 months prior to screening or chimeric antigen T-cell therapy ≤ 3 months prior to screening
- •Prior allogeneic stem cell transplant with active graft-versus-host disease (GVHD), or requiring immunosuppressive drugs for treatment of GVHD, or who have taken calcineurin inhibitors within 4 weeks prior to consent (Sub-studies 1 and 2)
- •Participants who have a history of severe allergic reactions or hypersensitivity to the active ingredient and excipients of BGB-16673, sonrotoclax, zanubrutinib, mosunetuzumab, or glofitamab
- •Prior treatment with a B-cell lymphoma-2 (Bcl-2) inhibitor (with exception for participants who relapsed ≥ 24 months after completion of a full course of a prior Bcl-2 inhibitor containing regimen) (Sub-study 1)
- •Participants who discontinued prior zanubrutinib treatment due to intolerance (Sub-study 2)
结局指标
主要结局
Number of patients with dose-limiting toxicities (Part 1a)
Number of patients with dose-limiting toxicities (Part 1a)
Number of patients with treatment-emergent adverse events (Part 1a, part 1b)
Number of patients with treatment-emergent adverse events (Part 1a, part 1b)
Number of patients with treatment-related adverse events (Part 1a, part 1b)
Number of patients with treatment-related adverse events (Part 1a, part 1b)
Number of patients with serious adverse events (Part 1a, part 1b)
Number of patients with serious adverse events (Part 1a, part 1b)
次要结局
- Derived PK parameters of BGB-16673 (Part 1a)
- Overall response rate (ORR) as assessed by the investigator (Part 1a, part 1b)
- Duration of response (DOR) (Part 1a, part 1b)
- Time-to-response (TTR) (Part 1a, part 1b)
- Plasma concentration data (Part 1a, part 1b)
- Number of patients with complete response/complete response with incomplete count recovery (CR/CRi) who achieve uMRD status with < 10^(-4) sensitivity in peripheral blood and/or bone marrow (Part 1b, sub-study 1 only)
- Derived PK parameters of sonrotoclax (Part 1a, sub-study 1 only)
研究者
BeOne Medical Officer
Scientific
BeOne Medicines AG
研究点 (15)
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