A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HDP-101 in Chinese Patients With Plasma Cell Disorders Including Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 5
- 主要终点
- Number of patients who experience a dose-limiting toxicity (DLT) during the first cycle of treatment.
研究概览
简要总结
This study is a 2-part study with a dose-escalation part and a dose-expansion part. The aim of the dose-escalation part is to determine the maximum tolerated dose (MTD) and/or establish the recommended Phase 2 dose (RP2D) in the Chinese population, in order to select the treatment dose for the dose-expansion part. The dose-escalation part will be followed by the dose-expansion part once the MTD(s) and/or RP2D of HDP-101 monotherapy in the Chinese population have been determined. The dose-expansion part of the study is intended to collect preliminary evidence of antitumor activity and to confirm the safety of the HDP-101 as monotherapy in Chinese patients with r/r MM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged ≥18 years.
- •Life expectancy >12 weeks.
- •Eastern Cooperative Oncology Group Performance Status (PS) of 0 to
- •A confirmed diagnosis of active MM according to the diagnostic criteria established by the International Myeloma Working Group (IMWG).
- •Must have undergone SCT or is considered transplant ineligible.
- •Must have undergone prior treatments with antimyeloma therapy which must have included an immunomodulatory drug, proteasome inhibitor, and anti-CD38 treatment, alone or in combination. In addition, the patient should either refractory or intolerant to any established standard of care therapy providing a meaningful clinical benefit for the patient assessed by the Investigator.
- •Measurable disease as per IMWG criteria (Dose-escalation part only: patients with non-secretory or oligo-secretory myeloma (NSMM) not meeting the measurability criteria are eligible).
- •Adequate organ system function as defined in protocol.
排除标准
- •Known central nervous system involvement.
- •Plasma cell leukemia.
- •History of congestive heart failure.
- •Autologous or allogenic SCT within 12 weeks before the first infusion or is planning for autologous SCT.
- •Symptomatic graft versus host disease post allogenic hemopoietic cell transplant within 12 months prior to the first study treatment infusion.
- •Radiotherapy within 21 days prior to the first study treatment infusion.
- •History of any other malignancy known to be active.
- •Known human immunodeficiency virus infection.
- •Patients with active infection requiring systemic anti-infective therapy.
- •Patients with positive hepatitis B virus (HBV) infection or positive hepatitis C virus (HCV) infection.
- •Current active liver or biliary disease.
- •Pregnancy or breast feeding.
- •Pneumonia or symptomatic pneumonitis.
研究组 & 干预措施
HDP-101
Participants will receive HDP-101 intravenously in a 21 day cycle until disease progression, intolerable toxicity, Investigator's discretion or patient withdrawal.
During the part 1 tolerability of two or three different dose levels will be evaluated. During the part 2 dose expansion part the recommended phase 2 dose (RP2D) of HDP-101 will be administered.
干预措施: HDP-101 (Drug)
结局指标
主要结局
Number of patients who experience a dose-limiting toxicity (DLT) during the first cycle of treatment.
时间窗: Up to Day 21 (from first dose)
次要结局
- Number of patients with serious and non-serious adverse events(Through study completion, an average of 1 year)
- Objective response rate (ORR)(Through study completion, an average of 1 year)
- Minimal residual disease (MRD) negativity rate(Through study completion, an average of 1 year)
- Progression-free survival (PFS)(Through study completion, an average of 1 year)
- Duration of response (DOR)(Through study completion, an average of 1 year)
- Time to objective response (TOR)(Through study completion, an average of 1 year)
- Overall survival (OS)(Through study completion, an average of 1 year)