ZE50-0134 治疗复发性和难治性慢性淋巴细胞白血病、小淋巴细胞淋巴瘤和部分低度淋巴瘤的 1 期研究
2026年7月30日 更新者：Lomond Therapeutics Holdings, Inc.
ZE50-0134 治疗复发性和难治性慢性淋巴细胞白血病 (CLL)、小淋巴细胞淋巴瘤 (SLL) 和部分低级别淋巴瘤的 1 期研究
这是一项临床研究，旨在评估ZE50-0134治疗复发难治性慢性淋巴细胞白血病、小淋巴细胞淋巴瘤和选择低度恶性淋巴瘤的安全性、药代动力学、药效学和初步疗效。
研究概览
地位
招聘中
详细说明
一项开放标签、剂量递增和剂量扩展、多中心临床试验，评估 ZE50-0134 在复发性和难治性慢性淋巴细胞白血病、小淋巴细胞淋巴瘤和选择性低度恶性淋巴瘤中的安全性、药代动力学、药效学和初步疗效淋巴瘤。 该研究是一项开放标签研究，分为两部分。
第 1 部分将采用 3+3 设计。 符合条件的患者将依次入组 5 个计划剂量水平组。 第 1 部分剂量递增的目的是确定 ZE50-0134 的最大耐受剂量。
IPart 2 是 ZE50-0134 的剂量扩展，将包括以生物有效剂量或最大耐受剂量进行维奈托克初始治疗的两种不同剂量以及较低的一种剂量。 第2部分的目的是确定ZE50-0134在CLL/SLL受试者中的安全性、耐受性、药代动力学、药效学和初步抗肿瘤活性。
研究类型
介入性
注册 (估计的)
84
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Ekaterina Dokukina, PhD MD
- 电话号码：+1 858 353 4108
- 邮箱：kdokukina@eileanther.com
学习地点
-
-
Kentucky
-
Louisville、Kentucky、美国、40207
- 招聘中
- Norton Cancer Institute, St. Matthews Campus
-
-
North Carolina
-
Chapel Hill、North Carolina、美国、27599
- 招聘中
- University of North Carolina at Chapel Hill
-
-
Ohio
-
Cincinnati、Ohio、美国、45221
- 招聘中
- University of Cincinnati
-
Columbus、Ohio、美国、43210
- 招聘中
- The Ohio State University
-
-
Texas
-
Dallas、Texas、美国、75390
- 尚未招聘
- UT Southwestern Medical Center
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
纳入标准：
- 年龄≥18岁的男性和女性。
疾病定义如下：
第 1 部分：没有 del(17p)/TP53 的症状性 CLL 或 SLL（由 iwCLL 定义）患者必须接受过 ≥ 2 种既往治疗，其中包括 BTKi 和维奈托克（或拒绝），或患有进行性低度淋巴瘤的患者，其中包括边缘区淋巴瘤、淋巴浆细胞淋巴瘤（包括华氏巨球蛋白血症）已接受至少 2 种治疗，包括基于 BTKi 和 CD20 抗体的治疗。
第 2 部分：有症状的 CLL 或 SLL（由 iwCLL 定义）患者必须已接受过 ≥1 种既往治疗，其中包括 BTKi，并且未接受过维奈托克治疗。
在开始第 2 部分之前，将向 FDA 提交一份激活修正案，其中包括第 1 部分中的安全性、药代动力学、药效学和早期疗效数据。 目前，我们还可能包括特定类型的低度淋巴瘤队列。 在首次给药研究药物前 7 天内，按照以下实验室要求评估足够的骨髓、肝脏和肾功能：
- 绝对中性粒细胞计数 (ANC) > 0.75 x 109/L。 对于有记录的骨髓受累≥ 0.5 x 109/L 的受试者
- 血小板计数 > 50 x 109/L。 对于有记录的骨髓受累≥ 30 x 109/L 的受试者
- 血清天冬氨酸转氨酶 (AST/SGOT) 或丙氨酸转氨酶 (ALT/SGPT) ≤ 3.0 x 正常上限 (ULN)
- 总胆红素 ≤ 1.5 x ULN
- 肌酐或胱抑素 C 肾小球滤过率 (GFR) ≥60 mL/min。 根据肾病饮食调整研究组 (MDRD) 公式估计的 GFR (eGFR)，以 mL/min 表示。 换算毫升/分钟/1.73 m2 换算为 mL/min 乘以使用适当公式计算出的个体 BSA，然后除以 1.73 东部肿瘤合作组 (ECOG) 的表现状态为 2 或更低 必须在首次研究剂量前 7 天内获得阴性血清或尿液妊娠测试育龄妇女用药。 每个周期之前还必须提供阴性结果。
绝经后妇女（定义如下）免于进行妊娠检测：
- 年龄 >50 岁且闭经至少 12 个月或
- 年龄 ≤ 50 岁，有 6 个月的自发性闭经且卵泡刺激素 (FSH) 水平在绝经后范围内 (>40 mIU/mL) 或
- 永久绝育的女性（例如子宫切除术、双侧输卵管切除术或子宫消融术） 有生育潜力的女性和男性必须同意在性活跃时使用高效避孕措施。 这适用于签署知情同意书至最后一次给予研究药物后 90 天的期间。 这些方法应记录在源文件中。 要求研究者或指定的同事就如何实现高效节育向受试者提供建议。 能够理解并愿意签署书面知情同意书。 签署的知情同意书（包括遗传生物标志物的同意书
排除标准：
如果受试者表现出以下任何标准，则他们将被排除在研究之外：
仅适用于第 2 部分
- 未接受过维奈托克治疗
对于这两个部分，以下所有内容均适用：
- 了解主动里氏变换。 因该诊断而接受治疗且病情缓解超过 2 年且无证据表明且仅患有 CLL 的患者被视为符合资格
- 已知对研究药物或制剂的赋形剂或与本研究相关的任何药物过敏。
- 临床上显着的心脏病，包括充血性心力衰竭 > 纽约心脏协会 (NYHA) II 级，未控制的冠状动脉疾病的证据（例如不稳定心绞痛（静息时的心绞痛症状）或新发心绞痛（过去 6 个月内或心肌梗死）首次给药前的过去 6 个月内，基线超声心动图显示的主要区域室壁运动异常），以及需要抗心律失常治疗的心律失常（β 受体阻滞剂和除外）地高辛。
- 已知活动性巨细胞病毒 (CMV)、乙型或丙型肝炎病毒感染。
- 已知活动性 SARS-CoV-2 感染；如果完全康复 > 14 天，则允许既往 SARS-CoV-2 感染。
- 活动性临床严重感染>2级，需要肠外治疗；感染消退后，受试者可能符合资格。
- 入组后 28 天内患有不受控制的自身免疫性溶血性贫血或特发性血小板减少性紫癜。
- 首次给药研究药物前4个月内进行同种异体骨髓移植（受试者入组前必须完成免疫抑制治疗）。
- 活动性癌症将预期生存期限制在 < 2 年或需要在本治疗的同时进行积极治疗。 排除范围包括已切除的局部皮肤癌、乳腺癌、前列腺癌或仅用激素或免疫疗法治疗的恶性肿瘤。 所有继发性癌症病例均应与医疗监察员讨论。
- 体检或实验室发现表明研究性治疗的使用禁忌或以其他方式使受试者面临过高的治疗风险（经研究者确定）。 对于此类病例，鼓励研究者和申办者就资格进行讨论。
- 既往治疗未解决的毒性（脱发病例除外）≥2 级。
- 需要持续的免疫抑制治疗，包括全身（例如静脉注射或口服）皮质类固醇治疗癌症或其他疾病。 注意：受试者可以使用局部或吸入皮质类固醇或低剂量类固醇（每天≤10毫克泼尼松或等效物）作为合并症的治疗。 首次给药前可使用短期类固醇治疗肿瘤复发。
- 首次服用研究药物前 4 周内接受过重大手术或重大创伤。
- 哺乳期妇女：哺乳期妇女必须在治疗开始前和治疗期间停止母乳喂养，并应在治疗结束后至少停止3个月。
- QTcF > 470 毫秒且无法通过电解质补充、水合或药物调整来纠正的受试者。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：顺序分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Part 1: Dose Level -1 - 75 mg QD
Optional de-escalation cohort.
Participants receive lonitoclax 25 mg once daily on Day 1, 50 mg once daily on Day 2, and 75 mg once daily on Day 3 and thereafter.
Treatment is administered orally in a fed state in 28-day cycles.
|
Lonitoclax is supplied as immediate-release white opaque soft gelatin capsules in 25 mg, 100 mg, and 250 mg strengths.
Participants receive a 3-day step-up regimen followed by the assigned oral dose once daily (QD) or twice daily (BID) in a fed state, administered within 1 hour of food.
Each cycle is 28 days.
Treatment continues for up to 12 cycles and may continue for up to 24 cycles in participants deriving clinical benefit, at the investigator's discretion with Medical Monitor approval.
Participants receive inpatient monitoring and tumor lysis syndrome prophylaxis during the initial step-up period.
|
|
实验性的：Part 1: Dose Level 1 - 100 mg QD
Participants receive lonitoclax 25 mg once daily on Day 1, 50 mg once daily on Day 2, and 100 mg once daily on Day 3 and thereafter.
Treatment is administered orally in a fed state in 28-day cycles.
|
Lonitoclax is supplied as immediate-release white opaque soft gelatin capsules in 25 mg, 100 mg, and 250 mg strengths.
Participants receive a 3-day step-up regimen followed by the assigned oral dose once daily (QD) or twice daily (BID) in a fed state, administered within 1 hour of food.
Each cycle is 28 days.
Treatment continues for up to 12 cycles and may continue for up to 24 cycles in participants deriving clinical benefit, at the investigator's discretion with Medical Monitor approval.
Participants receive inpatient monitoring and tumor lysis syndrome prophylaxis during the initial step-up period.
|
|
实验性的：Part 1: Dose Level 2 - 200 mg QD
Participants receive lonitoclax 50 mg once daily on Day 1, 100 mg once daily on Day 2, and 200 mg once daily on Day 3 and thereafter.
Treatment is administered orally in a fed state in 28-day cycles.
|
Lonitoclax is supplied as immediate-release white opaque soft gelatin capsules in 25 mg, 100 mg, and 250 mg strengths.
Participants receive a 3-day step-up regimen followed by the assigned oral dose once daily (QD) or twice daily (BID) in a fed state, administered within 1 hour of food.
Each cycle is 28 days.
Treatment continues for up to 12 cycles and may continue for up to 24 cycles in participants deriving clinical benefit, at the investigator's discretion with Medical Monitor approval.
Participants receive inpatient monitoring and tumor lysis syndrome prophylaxis during the initial step-up period.
|
|
实验性的：Part 1: Dose Level 3 - 400 mg QD
Participants receive lonitoclax 50 mg once daily on Day 1, 100 mg once daily on Day 2, and 400 mg once daily on Day 3 and thereafter.
Treatment is administered orally in a fed state in 28-day cycles.
|
Lonitoclax is supplied as immediate-release white opaque soft gelatin capsules in 25 mg, 100 mg, and 250 mg strengths.
Participants receive a 3-day step-up regimen followed by the assigned oral dose once daily (QD) or twice daily (BID) in a fed state, administered within 1 hour of food.
Each cycle is 28 days.
Treatment continues for up to 12 cycles and may continue for up to 24 cycles in participants deriving clinical benefit, at the investigator's discretion with Medical Monitor approval.
Participants receive inpatient monitoring and tumor lysis syndrome prophylaxis during the initial step-up period.
|
|
实验性的：Part 1: Dose Level 4 - 600 mg QD
Participants receive lonitoclax 50 mg once daily on Day 1, 100 mg once daily on Day 2, and 600 mg once daily on Day 3 and thereafter.
Treatment is administered orally in a fed state in 28-day cycles.
|
Lonitoclax is supplied as immediate-release white opaque soft gelatin capsules in 25 mg, 100 mg, and 250 mg strengths.
Participants receive a 3-day step-up regimen followed by the assigned oral dose once daily (QD) or twice daily (BID) in a fed state, administered within 1 hour of food.
Each cycle is 28 days.
Treatment continues for up to 12 cycles and may continue for up to 24 cycles in participants deriving clinical benefit, at the investigator's discretion with Medical Monitor approval.
Participants receive inpatient monitoring and tumor lysis syndrome prophylaxis during the initial step-up period.
|
|
实验性的：Part 1: Dose Level 5 - 800 mg QD
Participants receive lonitoclax 50 mg once daily on Day 1, 100 mg once daily on Day 2, and 800 mg once daily on Day 3 and thereafter.
Treatment is administered orally in a fed state in 28-day cycles.
|
Lonitoclax is supplied as immediate-release white opaque soft gelatin capsules in 25 mg, 100 mg, and 250 mg strengths.
Participants receive a 3-day step-up regimen followed by the assigned oral dose once daily (QD) or twice daily (BID) in a fed state, administered within 1 hour of food.
Each cycle is 28 days.
Treatment continues for up to 12 cycles and may continue for up to 24 cycles in participants deriving clinical benefit, at the investigator's discretion with Medical Monitor approval.
Participants receive inpatient monitoring and tumor lysis syndrome prophylaxis during the initial step-up period.
|
|
实验性的：Part 1: Dose Level 6a - 1000 mg QD
Participants receive lonitoclax 100 mg once daily on Day 1, 250 mg once daily on Day 2, and 1000 mg once daily on Day 3 and thereafter.
Treatment is administered orally in a fed state in 28-day cycles.
Dose Levels 6a and 6b may enroll concurrently.
|
Lonitoclax is supplied as immediate-release white opaque soft gelatin capsules in 25 mg, 100 mg, and 250 mg strengths.
Participants receive a 3-day step-up regimen followed by the assigned oral dose once daily (QD) or twice daily (BID) in a fed state, administered within 1 hour of food.
Each cycle is 28 days.
Treatment continues for up to 12 cycles and may continue for up to 24 cycles in participants deriving clinical benefit, at the investigator's discretion with Medical Monitor approval.
Participants receive inpatient monitoring and tumor lysis syndrome prophylaxis during the initial step-up period.
|
|
实验性的：Part 1: Dose Level 6b - 500 mg BID
Participants receive lonitoclax 50 mg twice daily on Day 1, 100 mg twice daily on Day 2, and 500 mg twice daily on Day 3 and thereafter.
Treatment is administered orally in a fed state in 28-day cycles.
Dose Levels 6a and 6b may enroll concurrently.
|
Lonitoclax is supplied as immediate-release white opaque soft gelatin capsules in 25 mg, 100 mg, and 250 mg strengths.
Participants receive a 3-day step-up regimen followed by the assigned oral dose once daily (QD) or twice daily (BID) in a fed state, administered within 1 hour of food.
Each cycle is 28 days.
Treatment continues for up to 12 cycles and may continue for up to 24 cycles in participants deriving clinical benefit, at the investigator's discretion with Medical Monitor approval.
Participants receive inpatient monitoring and tumor lysis syndrome prophylaxis during the initial step-up period.
|
|
实验性的：Part 1: Dose Level 7b - 750 mg BID
Participants receive lonitoclax 100 mg twice daily on Day 1, 250 mg twice daily on Day 2, and 750 mg twice daily on Day 3 and thereafter.
Treatment is administered orally in a fed state in 28-day cycles.
|
Lonitoclax is supplied as immediate-release white opaque soft gelatin capsules in 25 mg, 100 mg, and 250 mg strengths.
Participants receive a 3-day step-up regimen followed by the assigned oral dose once daily (QD) or twice daily (BID) in a fed state, administered within 1 hour of food.
Each cycle is 28 days.
Treatment continues for up to 12 cycles and may continue for up to 24 cycles in participants deriving clinical benefit, at the investigator's discretion with Medical Monitor approval.
Participants receive inpatient monitoring and tumor lysis syndrome prophylaxis during the initial step-up period.
|
|
实验性的：Part 1: Dose Level 8b - 1000 mg BID
Participants receive lonitoclax 100 mg twice daily on Day 1, 250 mg twice daily on Day 2, and 1000 mg twice daily on Day 3 and thereafter.
Treatment is administered orally in a fed state in 28-day cycles.
|
Lonitoclax is supplied as immediate-release white opaque soft gelatin capsules in 25 mg, 100 mg, and 250 mg strengths.
Participants receive a 3-day step-up regimen followed by the assigned oral dose once daily (QD) or twice daily (BID) in a fed state, administered within 1 hour of food.
Each cycle is 28 days.
Treatment continues for up to 12 cycles and may continue for up to 24 cycles in participants deriving clinical benefit, at the investigator's discretion with Medical Monitor approval.
Participants receive inpatient monitoring and tumor lysis syndrome prophylaxis during the initial step-up period.
|
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实验性的：Part 2: Selected Dose A - BED/MTD
Participants with relapsed or refractory CLL/SLL who are venetoclax naive are randomized to a selected lonitoclax dose corresponding to the biologically effective dose or maximum tolerated dose identified in Part 1.
The selected regimen may be once daily or twice daily.
Approximately 15 participants are planned.
|
Lonitoclax is supplied as immediate-release white opaque soft gelatin capsules in 25 mg, 100 mg, and 250 mg strengths.
Participants receive a 3-day step-up regimen followed by the assigned oral dose once daily (QD) or twice daily (BID) in a fed state, administered within 1 hour of food.
Each cycle is 28 days.
Treatment continues for up to 12 cycles and may continue for up to 24 cycles in participants deriving clinical benefit, at the investigator's discretion with Medical Monitor approval.
Participants receive inpatient monitoring and tumor lysis syndrome prophylaxis during the initial step-up period.
|
|
实验性的：Part 2: Selected Dose B - One Dose Level Lower
Participants with relapsed or refractory CLL/SLL who are venetoclax naive are randomized to one lonitoclax dose level below the biologically effective dose or maximum tolerated dose selected in Part 1, provided activity is observed.
The selected regimen may be once daily or twice daily.
Approximately 15 participants are planned.
|
Lonitoclax is supplied as immediate-release white opaque soft gelatin capsules in 25 mg, 100 mg, and 250 mg strengths.
Participants receive a 3-day step-up regimen followed by the assigned oral dose once daily (QD) or twice daily (BID) in a fed state, administered within 1 hour of food.
Each cycle is 28 days.
Treatment continues for up to 12 cycles and may continue for up to 24 cycles in participants deriving clinical benefit, at the investigator's discretion with Medical Monitor approval.
Participants receive inpatient monitoring and tumor lysis syndrome prophylaxis during the initial step-up period.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence and severity of treatment-emergent adverse events and serious adverse events
大体时间：From first dose through 30 days after the last dose; treatment may continue for up to 24 cycles (28 days per cycle).
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Number and percentage of participants with treatment-emergent adverse events, serious adverse events, clinically significant laboratory abnormalities, adverse events related to lonitoclax, and adverse events leading to treatment discontinuation.
Adverse events are graded using NCI CTCAE Version 5.0.
|
From first dose through 30 days after the last dose; treatment may continue for up to 24 cycles (28 days per cycle).
|
|
Incidence of dose-limiting toxicities in Part 1
大体时间：Cycle 1 (Days 1-28).
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Number and percentage of Part 1 participants experiencing a protocol-defined dose-limiting toxicity during the dose-limiting toxicity assessment period.
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Cycle 1 (Days 1-28).
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Determination of the biologically effective dose and/or maximum tolerated dose
大体时间：After completion of Cycle 1 for evaluable participants in each Part 1 dose cohort.
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The selected dose is determined from the totality of safety, dose-limiting toxicity, pharmacokinetic, pharmacodynamic, and early response data across Part 1 dose cohorts according to the protocol-defined dose-escalation rules.
|
After completion of Cycle 1 for evaluable participants in each Part 1 dose cohort.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall Response Rate (ORR)
大体时间：From first dose through end of treatment, up to 24 cycles (28 days per cycle).
|
Proportion of participants whose best overall response is partial response or better, as assessed by the investigator using iwCLL criteria for CLL, Lugano criteria for SLL and other applicable low-grade lymphomas, or Waldenstrom response criteria, as applicable.
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From first dose through end of treatment, up to 24 cycles (28 days per cycle).
|
|
Duration of response (DOR)
大体时间：From first documented response until progression, death, withdrawal, loss to follow-up, or sponsor termination; assessed during treatment and long-term follow-up.
|
For participants with partial response or better, time from the first documented response until disease progression or death from any cause.
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From first documented response until progression, death, withdrawal, loss to follow-up, or sponsor termination; assessed during treatment and long-term follow-up.
|
|
Progression-free survival (PFS)
大体时间：From first dose until progression, death, withdrawal, loss to follow-up, or sponsor termination; assessed during treatment and long-term follow-up.
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Time from first dose until disease progression by the applicable disease-specific response criteria or death from any cause.
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From first dose until progression, death, withdrawal, loss to follow-up, or sponsor termination; assessed during treatment and long-term follow-up.
|
|
Time to next treatment (TTNT)
大体时间：From first dose until initiation of new anticancer treatment, death, withdrawal, loss to follow-up, or sponsor termination.
|
Time from first dose of lonitoclax to initiation of a non-protocol anticancer treatment for CLL/SLL or death.
|
From first dose until initiation of new anticancer treatment, death, withdrawal, loss to follow-up, or sponsor termination.
|
|
Maximum observed plasma concentration (Cmax) of lonitoclax
大体时间：Cycle 1 Days 1-4, 8, 15, and 22; Cycle 2 Days 1-2; and end-of-treatment/early-termination sampling as applicable.
|
Maximum observed plasma concentration derived from serial plasma concentration measurements after lonitoclax administration.
|
Cycle 1 Days 1-4, 8, 15, and 22; Cycle 2 Days 1-2; and end-of-treatment/early-termination sampling as applicable.
|
|
Area under the plasma concentration-time curve (AUC) of lonitoclax
大体时间：Cycle 1 Days 1-3 and Cycle 2 Day 1, based on protocol-specified serial PK sampling.
|
AUC derived from serial plasma concentration measurements.
For QD dosing, planned calculations include AUC0-8h or AUC0-6h and AUC0-24h.
For BID dosing, planned calculations include AUC0-8h or AUC0-6h after the morning dose.
|
Cycle 1 Days 1-3 and Cycle 2 Day 1, based on protocol-specified serial PK sampling.
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Rate of undetectable measurable residual disease in blood and bone marrow
大体时间：Peripheral blood at the ends of Cycles 3, 6, 9, and 12; bone marrow at the end of Cycle 12.
|
Proportion of evaluable participants with undetectable measurable residual disease by flow cytometry and/or next-generation sequencing, including bone marrow assessment after 12 cycles.
|
Peripheral blood at the ends of Cycles 3, 6, 9, and 12; bone marrow at the end of Cycle 12.
|
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Change from baseline in caspase 3 activation
大体时间：Screening/baseline through Cycle 1 Day 4.
|
Change in caspase 3 activation in CLL or lymphoma cells and exploratory relationship with lonitoclax pharmacokinetics and clinical response.
|
Screening/baseline through Cycle 1 Day 4.
|
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Change from baseline in immune-cell populations
大体时间：Baseline; Cycle 1 Day 1; Cycle 2 Day 1; Cycle 4 Day 1; Cycle 7 Day 1; and safety follow-up/end of treatment/early termination, as applicable.
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Change in absolute numbers of CD8 T cells, natural killer cells, and normal B cells during lonitoclax treatment.
|
Baseline; Cycle 1 Day 1; Cycle 2 Day 1; Cycle 4 Day 1; Cycle 7 Day 1; and safety follow-up/end of treatment/early termination, as applicable.
|
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Molecular and protein markers associated with resistance or response
大体时间：Baseline and serially during treatment, with additional sampling at relapse/progression and end of treatment, as available.
|
Exploratory evaluation of serial samples for BCL2, BAX, and other escape mutations; expression of alternative BCL2-family proteins; alternative biomarkers; and clonal evolution in relation to response, progression, and resistance.
|
Baseline and serially during treatment, with additional sampling at relapse/progression and end of treatment, as available.
|
|
Overall survival
大体时间：From first dose until death, withdrawal of consent, loss to follow-up, or sponsor termination; survival follow-up approximately every 3 months.
|
Time from first dose until death from any cause.
|
From first dose until death, withdrawal of consent, loss to follow-up, or sponsor termination; survival follow-up approximately every 3 months.
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年4月8日
初级完成 (估计的)
2028年1月1日
研究完成 (估计的)
2028年7月1日
研究注册日期
首次提交
2024年11月22日
首先提交符合 QC 标准的
2024年11月26日
首次发布 (实际的)
2024年11月27日
研究记录更新
最后更新发布 (实际的)
2026年7月31日
上次提交的符合 QC 标准的更新
2026年7月30日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- ZE50-0134-0002
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.