An Open-label, Single-arm, Multicenter, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BMS-986489 (BMS-986012 + Nivolumab Fixed Dose Combination) in Chinese Participants With Relapsed/Refractory Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 5
- 主要终点
- Number of deaths
研究概览
简要总结
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, and preliminary efficacy of BMS-986489 in Chinese participants with R/R SCLC (Relapsed/Refractory Small Cell Lung Cancer).
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
- •- Participants must have histologically or cytologically documented SCLC (small cell lung cancer). Participants with either limited or extensive disease stage at the initial diagnosis, who have received at least one prior line of systemic therapy, are eligible.
- •i) For initial limited stage (LS) SCLC:.
- •A. Those who progressed or recurred after more than 6 months treatment-free interval following treatment of curative surgical resection, systemic therapy, or radiotherapy, and subsequently received at least one line of systemic therapy to treat the recurrence or progression, and then progressed, or were intolerant to the prior systemic therapy per the assessment of investigators, these participants will be eligible, or
- •B. Who progressed or recurred within 6 months after treatment of curative surgical resection, systemic therapy, or radiotherapy, no matter if these participants have received subsequent systemic therapy, these participants will be eligible.
- •ii) For initial extensive stage (ES) SCLC, participants must have received at least one line of platinum-based systemic therapy (with/without immunotherapy), and then progressed, or been intolerant to the prior systemic therapy per the assessment of investigators.
- •A. Note: 1) For ES-SCLC with only one line of platinum-based regimen as well as chemotherapy-free interval is more than 6months when progression, only when participants refuse or are ineligible for re-treatment with platinum-based doublet per the assessment of investigators, these participants will be eligible. 2) If participants receive re-treatment with a platinum-based regimen, it is considered a second line of therapy.
- •Participants must have a life expectancy of ≥12 weeks.
- •Participants must have at least 1 measurable lesion outside the central nervous system (CNS) by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
排除标准
- •Untreated symptomatic CNS metastases.
- •Leptomeningeal disease.
- •Pleural effusion which cannot be controlled with appropriate interventions.
- •Malignancy-related superior vena cava syndrome.
- •Participants with an active, known or suspected, autoimmune disease.
- •Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to first study treatment.
- •Unresolved toxicity from prior anti-tumor therapy.
- •Prior treatment with an anti-fuc-GM1 therapy or any other drug specifically targeting fuc-GM
- •Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
BMS-986489
干预措施: BMS-986489 (Drug)
结局指标
主要结局
Number of deaths
时间窗: Up to 19 months after last participant's first treatment
Number of participants with laboratory abnormalities
时间窗: Up to 19 months after last participant's first treatment
Maximum observed concentration (Cmax) for BMS-986012
时间窗: Up to 19 months after last participant's first treatment
Time of maximum observed concentration (Tmax) for BMS-986012
时间窗: Up to 19 months after last participant's first treatment
Trough observed plasma concentration (Ctrough) for BMS-986012
时间窗: Up to 19 months after last participant's first treatment
Concentration at the end of a dosing interval (Ctau) for BMS-986012
时间窗: Up to 19 months after last participant's first treatment
Number of participants with adverse events (AEs)
时间窗: Up to 19 months after last participant's first treatment
Number of participants with Serious AEs (SAEs)
时间窗: Up to 19 months after last participant's first treatment
Number of participants with AEs leading to discontinuation of study treatment
时间窗: Up to 19 months after last participant's first treatment
Number of participants with select AEs
时间窗: Up to 19 months after last participant's first treatment
Number of participants with immune-mediated AEs (IMAEs)
时间窗: Up to 19 months after last participant's first treatment
Average concentration over a dosing interval ([AUC(TAU)/TAU]) (Cavg(TAU)) for BMS-986012
时间窗: Up to 19 months after last participant's first treatment
Area under the concentration-time curve within one dosing interval (AUC(TAU)) for BMS-986012
时间窗: Up to 19 months after last participant's first treatment
Total body clearance (CLT) for BMS-986012
时间窗: Up to 19 months after last participant's first treatment
Observed concentration at end of infusion (Ceoi) for BMS-986012
时间窗: Up to 19 months after last participant's first treatment
次要结局
- Number of participants with anti-drug antibodies (ADAs) to BMS-986012(Up to 19 months after last participant's first treatment)
- Number of participants with ADAs to nivolumab(Up to 19 months after last participant's first treatment)
- Ctrough for nivolumab(Up to 19 months after last participant's first treatment)
- Ceoi for nivolumab(Up to 19 months after last participant's first treatment)
- Overall Response (OR)(Up to 19 months after last participant's first treatment)
- Disease Control (DC)(Up to 19 months after last participant's first treatment)
- Duration of Response (DOR)(Up to 19 months after last participant's first treatment)