[Translation] A Phase IB/II open-label study evaluating the safety, pharmacokinetics, pharmacodynamics, and efficacy of elranatamab (PF 06863135) in Chinese subjects with multiple myeloma refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 antibody (triple-refractory MM)
主要目的:
Ib 期:确定 Elranatamab 在中国受试者中的安全性特征,以确认RP2D
II 期:确定 Elranatamab 在中国 RRMM 受试者中的疗效
次要目的:
1.进一步评价 Elranatamab 在中国 RRMM 受试者中的疗效
2.确定 Elranatamab 的安全性和耐受性
3.评价 Elranatamab 的 PK
4.评价 Elranatamab 的免疫原性
5.评估 Elranatamab 对患者报告症状和功能的影响
探索性目的:
1.探索 Elranatamab 暴露量与生物标志物、安全性和 PD/生物标志物终点之间的关联
2.探索 Elranatamab 和受试者 MM 生物学之间的关系
[Translation] Primary objectives:
Phase Ib: Determine the safety profile of Elranatamab in Chinese subjects to confirm RP2D
Phase II: Determine the efficacy of Elranatamab in Chinese RRMM subjects
Secondary objectives:
1. Further evaluate the efficacy of Elranatamab in Chinese RRMM subjects
2. Determine the safety and tolerability of Elranatamab
3. Evaluate the PK of Elranatamab
4. Evaluate the immunogenicity of Elranatamab
5. Evaluate the effect of Elranatamab on patient-reported symptoms and function
Exploratory objectives:
1. Explore the association between Elranatamab exposure and biomarkers, safety, and PD/biomarker endpoints
2. Explore the relationship between Elranatamab and MM biology in subjects