A Multicenter, Phase 1b, Open-label Study of Etentamig (ABBV-383) Administered Subcutaneously in Subjects With Relapsed or Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 55
- 试验地点
- 27
- 主要终点
- Percentage of Participants Experiencing Cytokine Release Syndrome (CRS) Events
研究概览
简要总结
Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine the safety and pharmacokinetics of Etentamig (ABBV-383) in adult participants with relapsed/refractory (R/R) MM.
Etentamig (ABBV-383) is an investigational drug being developed for the treatment of R/R MM. This study is broken into 3 Arms: Arm A with 2 parts and Arm B as an expansion. Participants will receive ABBV-383 as a subcutaneous (SC) injection and intravenous (IV) infusion in Arm A and SC injections of ABBV-383 in Arm B. Around 55 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 15 sites across the world
In Arm A participants will receive one of two doses of Etentamig (ABBV-383) as an SC injection and (IV) infusions, during the 151 week study duration. In Arm B, participants will receive the selected dose from Arm A as SC injections, during the 151 week study duration.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Eastern Cooperative Oncology Group (ECOG) performance of <=
- •Participants with relapsed or refractory multiple myeloma who have received 3-5 prior lines of therapies and with prior triple class exposure including a proteasome inhibitor, anti-CD38 monoclonal antibody and an immunomodulatory drug.
- •Must be naïve to treatment with ABBV-383.
排除标准
- •- Received B-cell maturation antigen (BCMA)xCD3 bispecific antibody.
研究组 & 干预措施
Etentamig Dose A
Participants will receive Dose A of Etentamig as a subcutaneous (SC) injection and intravenous (IV) infusions, during the 151 week study duration.
干预措施: Subcutaneous (SC) Etentamig (Drug)
Etentamig Dose A
Participants will receive Dose A of Etentamig as a subcutaneous (SC) injection and intravenous (IV) infusions, during the 151 week study duration.
干预措施: Intravenous (IV) Etentamig (Drug)
Etentamig Dose B
Participants will receive Dose B of Etentamig as an SC injection and IV infusions, during the 151 week study duration.
干预措施: Subcutaneous (SC) Etentamig (Drug)
Etentamig Dose B
Participants will receive Dose B of Etentamig as an SC injection and IV infusions, during the 151 week study duration.
干预措施: Intravenous (IV) Etentamig (Drug)
Etentamig Expansion
Participants will receive the selected dose from Arm A of Etentamig as SC injections, during the 151 week study duration.
干预措施: Subcutaneous (SC) Etentamig (Drug)
结局指标
主要结局
Percentage of Participants Experiencing Cytokine Release Syndrome (CRS) Events
时间窗: Up to 2 cycles (56 days)
Cytokine Release Syndrome events will be graded using American Society for Transplantation and Cellular Therapy (ASTCT), with a higher grade indicating higher severity.
Percentage of Participants Experiencing Immune Cell-Associated Neurotoxicity Syndrome (ICANS) Events
时间窗: Up to 2 cycles (56 days)
ICANS events will be graded using ASTCT, with a higher grade indicating higher severity.
Maximum Observed Concentration (Cmax) of ABBV-383
时间窗: Up to 32 weeks
Cmax of ABBV-383.
Trough Concentration (Ctrough) of ABBV-383
时间窗: Up to 32 weeks
Ctrough of ABBV-383.
Area Under the Plasma Concentration-time Curve (AUC) of ABBV-383
时间窗: Up to 24 weeks
AUC of ABBV-383.
Time to Cmax (Tmax) of ABBV-383
时间窗: Up to 32 weeks
Tmax of ABBV-383.
次要结局
- Percentage of Participants Achieving Complete Response (CR)(Up to 24 months)
- Overall Response Rate (ORR)(Up to 24 months)
- Duration of Response (DoR)(Up to 24 months)
- Immunogenicity of ABBV-383 as Determined by Neutralizing Anti-Drug Antibodies (NAbs)(Up to 27 months)
- Percentage of Participants Achieving Stringent Complete Response (sCR),(Up to 24 months)
- Percentage of Participants Achieving Partial Response (PR)(Up to 24 months)
- Progression Free Survival (PFS)(Up to 24 months)
- Time to Response (TTR)(Up to 24 months)
- Immunogenicity of ABBV-383 as Determined by Anti-Drug Antibodies (ADAs)(Up to 27 months)
- Percentage of Participants Achieving Very Good Partial Response (VGPR)(Up to 24 months)