2025-525105-20-00招募中2 期
A Phase 1/2, Open-Label, Platform Study to Evaluate Safety and Efficacy of the BCL-2 Inhibitor Surzetoclax (ABBV-453) given as Monotherapy or in Combination with Antimyeloma Regimens in Subjects with Multiple Myeloma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 88
- 试验地点
- 36
- 主要终点
- Dose Limiting Toxicities (DLT) of surzetoclax and etentamig in combination in biomarker-selected subjects with R/R MM.
研究概览
简要总结
• To characterize the safety, toxicity, and tolerability of surzetoclax in combination with etentamig in biomarker-selected subjects with relapsed or refractory (R/R) Multiple Myeloma (MM) • To determine the recommended doses of surzetoclax and etentamig when given in combination in biomarker-selected subjects with R/R MM
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
- 否
入选标准
- •Participants must have confirmed diagnosis of R/R MM with documented evidence of progression during or after the subject's last treatment regimen based on the investigator's determination of the IMWG 2016 criteria.
- •ECOG performance status 0 or
- •Centrally determined t(11;14) positive status and/or centrally determined BCL2high status.
排除标准
- •Participant who has received prior etentamig treatment or prior treatment with any BCMA bispecific.
- •Participant who has received an autologous stem cell transplant within 12 weeks, or an allogeneic SCT within ≤ 6 months of the first dose of study treatment. Participant who received an allogenic SCT should not have any symptoms of acute or chronic graft versus host disease.
- •Participant who has history of clinically significant renal, neurologic, psychiatric, endocrine, metabolic, immunologic, pulmonary, or hepatic disease within the last 6 months that, in investigator's opinion, would adversely affect the participant in the study
研究组 & 干预措施
Surzetoclax, Surzetoclax
Test
干预措施: Surzetoclax (Drug)
Etentamig
Test
干预措施: Etentamig (Drug)
结局指标
主要结局
Dose Limiting Toxicities (DLT) of surzetoclax and etentamig in combination in biomarker-selected subjects with R/R MM.
Dose Limiting Toxicities (DLT) of surzetoclax and etentamig in combination in biomarker-selected subjects with R/R MM.
次要结局
- Overall Response Rate (ORR)
- Progression-Free Survival (PFS)
- Rate of minimal residual disease (MRD) Negativity Determined Centrally, using Adaptive's clonoSEQ NGS assay
- Overall survival (OS)
- Pharmacokinetics (PK): Cmax, Tmax, t ½ , AUC.
- Duration of Response (DOR)
- Time-to-Progression (TTP)
- Time to Next Treatment
研究者
Global Clinical Trials Helpdesk
Scientific
AbbVie Deutschland GmbH & Co. KG
研究点 (36)
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