NCT06035497进行中（未招募）1 期
A Phase 1/2 Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of BMS-986369 (Golcadomide) in Participants With Relapsed or Refractory T-cell Lymphomas in Japan (GOLSEEK-3)
Bristol-Myers Squibb55 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2023年11月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 85
- 试验地点
- 55
- 主要终点
- Number of participants with Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to test the safety, tolerability, efficacy, and drug levels of BMS-986369 (Golcadomide) in participants with relapsed or refractory T-cell lymphomas in Japan (GOLSEEK-3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Have one of the following subtypes of T-cell Lymphoma (TCL) with relapsed or refractory disease, as assessed by the investigator:.
- •i) Adult T-cell leukemia-lymphoma (ATL).
- •ii) Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS).
- •iii) Angioimmunoblastic T-cell lymphoma (AITL) and other nodal lymphomas of T follicular helper phenotype (TFH) cell origin.
- •iv) Anaplastic large cell lymphoma (ALCL), anaplastic lymphoma kinase-positive (ALK+).
- •v) ALCL, anaplastic lymphoma kinase-negative (ALK-).
- •vi) Breast implant-associated ALCL.
- •vii) Extranodal NK/T-cell lymphoma, nasal type (ENKL).
- •viii) Mycosis fungoides (MF) with advanced stage (stage IIB-IVB).
- •Phase 1 participants must not be responsive, intolerant, or ineligible to standard therapies that may prolong life or provide symptomatic relief, or for whom no standard therapeutic option is available in the clinical practice guidelines in the opinion of the investigator.
- •Phase 2 participants must have been treated by at least 1 prior line of systemic therapy.
- •Have an Eastern Cooperative Oncology Group performance status of 0, 1 or 2.
排除标准
- •Have any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participants from participating in the study.
- •Have any condition, including active or uncontrolled infection, or the presence of laboratory abnormalities, which places the participants at unacceptable risk if he/she were to participate in the study.
- •Have a life expectancy ≤ 3 months.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Administration of BMS-986369
Experimental
干预措施: BMS-986369 (Drug)
结局指标
主要结局
Number of participants with Adverse Events (AEs)
时间窗: Up to 5 weeks after last dose of treatment
Phase 1 participants
Number of participants with treatment-emergent adverse events (TEAEs)
时间窗: Up to 5 weeks after last dose of treatment
Phase 1 participants
Number of participants with Dose-Limiting Toxicity (DLT)
时间窗: Up to 28 days after first dose
Phase 1 participants
Number of participants with laboratory abnormalities
时间窗: Up to 5 weeks after last dose of treatment
Phase 1 participants
Number of participants with vital sign abnormalities
时间窗: Up to 5 weeks after last dose of treatment
Phase 1 participants
Number of participants with Electrocardiogram (ECG) abnormalities
时间窗: Up to 5 weeks after last dose of treatment
Phase 1 participants
Eastern Cooperative Oncology Group Performance Status (ECOG PS)
时间窗: Up to 5 weeks after last dose of treatment
Phase 1 participants
Number of participants with Left Ventricular Ejection Fraction (LVEF) assessment abnormalities
时间窗: Up to 5 weeks after last dose of treatment
Phase 1 participants
Number of participants with Physical Examination (PE) abnormalities
时间窗: Up to 5 weeks after last dose of treatment
Phase 1 participants
Number of participants who achieve Objective Response (OR) as assessed by central review per international consensus response criteria for ATL
时间窗: Up to 2 years after last does of treatment
Phase 2: Adult T-cell Leukemia-Lymphoma (ATL) cohort OR is defined as the achievement of Partial Response (PR), complete response unconfirmed (CRu), or Complete Response (CR)
Number of participants who achieve OR as assessed by central review per protocol-defined response criteria according to Lugano classification (Computed Tomography(CT)-based)
时间窗: Up to 2 years after last dose of treatment
Phase 2: Peripheral T-cell Lymphoma (PTCL) cohort OR is defined as the achievement of PR or CR
次要结局
- Progression Free Survival (PFS) as assessed by central review per international consensus response criteria for ATL(Up to 4 years after last dose of treatment)
- PFS as assessed by investigator per international consensus response criteria for ATL(Up to 4 years after last dose of treatment)
- Number of participants who achieve disease control as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based)(Up to 4 years after last dose of treatment)
- Number of participants who achieve disease control as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based)(Up to 4 years after last dose of treatment)
- Number of participants who achieve CR as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based)(Up to 4 years after last dose of treatment)
- Number of participants who achieve CR as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based)(Up to 4 years after last dose of treatment)
- TTR as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based)(Up to 4 years after last dose of treatment)
- TTR as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based)(Up to 4 years after last dose of treatment)
- DOR as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based)(Up to 4 years after last dose of treatment)
- DOR as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based)(Up to 4 years after last dose of treatment)
- PFS as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based)(Up to 4 years after last dose of treatment)
- PFS as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based)(Up to 4 years after last dose of treatment)
- Time to next treatment (TTNT)(From the date of last dose until the date of death, lost to follow-up, withdrawal of consent from the entire study, time to next treatment or the end of the trial, whichever occurs first, assessed up to 2 years after end of treatment.)
- Maximum observed plasma concentration (Cmax)(Up to Day 8 of Cycle 2 (each cycle is 28 days))
- Area under the plasma concentration time-curve (AUC)(Up to Day 8 of Cycle 2 (each cycle is 28 days))
- Time to peak (maximum) plasma concentration (Tmax)(Up to Day 8 of Cycle 2 (each cycle is 28 days))
- Number of participants with AEs(Up to 5 weeks after last dose of treatment)
- Number of participants with TEAEs(Up to 5 weeks after last dose of treatment)
- Number of participants with laboratory abnormalities(Up to 5 weeks after last dose of treatment)
- Number of participants with vital sign abnormalities(Up to 5 weeks after last dose of treatment)
- Number of participants with ECG abnormalities(Up to 5 weeks after last dose of treatment)
- ECOG PS(Up to 5 weeks after last dose of treatment)
- Number of participants with LVEF assessment abnormalities(Up to 5 weeks after last dose of treatment)
- Number of participants with PE abnormalities(Up to 5 weeks after last dose of treatment)
- Number of participants who achieve OR as assessed by central review per international consensus response criteria for ATL(Up to 4 years after last dose of treatment)
- Number of participants who achieve OR as assessed by investigator per international consensus response criteria for ATL(Up to 4 years after last dose of treatment)
- Number of participants who achieve OR as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based).(Up to 4 years after last dose of treatment)
- Number of participants who achieve OR as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based).(Up to 4 years after last dose of treatment)
- Overall survival (OS)(From the date of last dose until the date of death, lost to follow-up, withdrawal of consent from the entire study, or the end of the trial, whichever occurs first, assessed up to 2 years after end of treatment.)
- Number of participants who achieve disease control as assessed by central review per international consensus response criteria for ATL(Up to 4 years after last dose of treatment)
- Number of participants who achieve disease control as assessed by investigator per international consensus response criteria for ATL(Up to 4 years after last dose of treatment)
- Number of participants who achieve CR as assessed by central review per international consensus response criteria for ATL(Up to 4 years after last dose of treatment)
- Number of participants who achieve CR as assessed by investigator per international consensus response criteria for ATL(Up to 4 years after last dose of treatment)
- Time to response (TTR) as assessed by central review per international consensus response criteria for ATL(Up to 4 years after last dose of treatment)
- TTR as assessed by investigator per international consensus response criteria for ATL(Up to 4 years after last dose of treatment)
- Duration of response (DOR) as assessed by central review per international consensus response criteria for ATL(Up to 4 years after last dose of treatment)
- DOR as assessed by investigator per international consensus response criteria for ATL(Up to 4 years after last dose of treatment)
研究者
研究点 (55)
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