A Phase 1/2a, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HDP-101 in 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
- 78
- 试验地点
- 34
- 主要终点
- Number of patients who experience dose-limiting toxicity (DLT) during the first cycle of treatment - Part 1 as defined in Clinical Study Protocol
研究概览
简要总结
This study will assess the safety, tolerability, pharmacokinetics (PK) and the therapeutic potential of HDP-101 in patients with plasma cell disorders including multiple myeloma.
详细描述
The study will consists of two parts: a Part 1 dose escalation phase and a Part 2a expansion phase for safety, tolerability, PK, PD, and clinical activity testing. The study will enroll subjects with relapsed/refractory MM or other plasma cell disorders expressing BCMA. An adaptive 2-parameter Bayesian logistic regression model (BLRM) for dose-escalation with overdose control will be used in the dose-escalation phase for determination of the MTD or the RP2D. Dose-expansion phase of the study aims to collect preliminary evidence of antitumor activity and to confirm the safety of the HDP-101 as a monotherapy.
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
- 18 Years 至 —（Adult, Older 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.
- •Adequate organ system function as defined in protocol.
排除标准
- •For patient entering the Phase 2a part only: Prior treatment with any approved or experimental BCMA-targeting modalities are not allowed.
- •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.
- •Patients with positive test results for hepatitis B surface antigen or Hepatitis B core antigen.
- •Patients with positive test results for hepatitis C virus (HCV) infection.
- •Current active liver or biliary disease.
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 phase 1 tolerability of different dose levels will be evaluated. During the phase 2a 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 dose-limiting toxicity (DLT) during the first cycle of treatment - Part 1 as defined in Clinical Study Protocol
时间窗: Up to Day 21 (from first dose)
Objective response rate (ORR)
时间窗: Through study completion, an average of 1 year
Proportion of enrolled subjects who achieve a partial response (PR) or better, i.e. stringent complete response (sCR), complete response (CR), very good partial response (VGPR) and PR, according to the IMWG criteria.
次要结局
- Assess the safety and tolerability of HDP-101(Through study completion, an average of 1 year)
- To assess the anticancer activity of HDP-101 in terms of time-to-event (TTE)(Through study completion, an average of 1 year)