A Phase Ib, Open-label, Multicenter Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Activity of XmAb24306 in Combination With Cevostamab in Patients With Relapsed/Refractory Multiple Myeloma
概览
- 阶段
- 1 期
- 干预措施
- Cevostamab
- 疾病 / 适应症
- Multiple Myeloma
- 发起方
- Genentech, Inc.
- 入组人数
- 90
- 试验地点
- 26
- 主要终点
- Percentage of Participants with Adverse Events (AEs)
- 状态
- 进行中（未招募）
- 最后更新
- 2个月前
概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and activity of XmAb24306 in combination with cevostamab in participants with relapsed/refractory multiple myeloma (R/R MM) who have received a minimum of three prior treatments, including at least one immunomodulatory drug (IMiD), one proteasome inhibitor (PI), and one anti-CD38 monoclonal antibody.
研究者
入排标准
入选标准
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •Life expectancy of at least 12 weeks
- •Participants must have received a minimum of 3 prior lines of therapy, including at least one PI, one IMiD, and an anti-CD38 monoclonal antibody.
- •Documented evidence of progressive disease on or after the last prior therapy, or participants who were intolerant to the last prior therapy.
- •Measurable disease, as defined by the protocol
- •Participants agree to follow contraception or abstinence requirements as defined in the protocol
排除标准
- •Any anti-cancer therapy within 3 weeks prior to initiation of study treatment with exception defined by the protocol
- •Participants with autologous stem cell transplantation (SCT) within 100 days prior to first dose of study treatment
- •Participants with prior allogeneic SCT or solid organ transplantation
- •Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)
- •Active or history of autoimmune disease
- •Participants with current or history of Central Nervous System (CNS) disease, or current CNS involvement by Multiple Myeloma (MM)
- •Significant cardiovascular disease
- •Participants with known clinically significant liver disease
- •Symptomatic active pulmonary disease requiring supplemental oxygen
- •Known active infection requiring intravenous anti-microbial therapy within 14 days prior to first study drug administration
研究组 & 干预措施
Arm A: Dose-Escalation and Expansion: XmAb24306+Cevostamab
Participants will receive escalating doses of XmAb24306 with a fixed dose regimen for cevostamab up to the maximum tolerated dose (MTD). After dose escalation has been completed, up to two expansion cohorts each investigating different XmAb24306 doses in combination with cevostamab may be enrolled.
干预措施: Cevostamab
Arm A: Dose-Escalation and Expansion: XmAb24306+Cevostamab
Participants will receive escalating doses of XmAb24306 with a fixed dose regimen for cevostamab up to the maximum tolerated dose (MTD). After dose escalation has been completed, up to two expansion cohorts each investigating different XmAb24306 doses in combination with cevostamab may be enrolled.
干预措施: XmAb24306
Arm A: Dose-Escalation and Expansion: XmAb24306+Cevostamab
Participants will receive escalating doses of XmAb24306 with a fixed dose regimen for cevostamab up to the maximum tolerated dose (MTD). After dose escalation has been completed, up to two expansion cohorts each investigating different XmAb24306 doses in combination with cevostamab may be enrolled.
干预措施: Tocilizumab
Arm B: Single-Agent Cevostamab Expansion
Participants will receive cevostamab alone.
干预措施: Cevostamab
Arm B: Single-Agent Cevostamab Expansion
Participants will receive cevostamab alone.
干预措施: Tocilizumab
结局指标
主要结局
Percentage of Participants with Adverse Events (AEs)
时间窗: Up to approximately 3 years
Adverse events will be reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0), and Cytokine Release Syndrome (CRS), will be graded based on the American Society for Transplantation and Cellular Therapy (ASTCT) criteria.
次要结局
- Rate of Complete Response (CR)/ Stringent Complete Response (sCR)(Up to approximately 3 years)
- Serum Concentration of XmAb24306(Up to approximately 3 years)
- Serum Concentration of Cevostamab(Up to approximately 3 years)
- Objective Response Rate (ORR)(Up to approximately 3 years)
- Percentage of Participants With Anti-Drug Antibodies (ADA) to XmAb24306 and Cevostamab(Up to approximately 3 years)
- Rate of Very Good Partial Response (VGPR)(Up to approximately 3 years)