NCT05824585已完成1 期
A Phase 1, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of DZD8586 in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (B-NHL)
Dizal Pharmaceuticals6 个研究点 分布在 2 个国家目标入组 17 人开始时间: 2023年5月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 6
- 主要终点
- Part A: Incidence of adverse events
研究概览
简要总结
This study will treat patients with B-NHL who have relapsed, progressed, or were intolerant to systemic therapy progressed following prior therapy. This study will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body and assess its anti-cancer activity as monotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Male or female participants who have provided ICF with age ≥ 18 yrs
- •ECOG performance 0-2, no deterioration in the past 2 weeks
- •Participants with relapsed or refractory B-NHL must have cytologically or histologically confirmed B-cell lymphoma
- •Adequate bone marrow reserve and organ system functions
- •Participants willing to comply with contraceptive restrictions
排除标准
- •Any unresolved > Grade 1 adverse event at the time of starting study treatment with the exception of alopecia.
- •Prior history of allogeneic hematopoietic stem cell transplantation
- •Stem cell transplantation, cell therapy, or gene therapy within 90 days. Approved small molecule therapy within 5 half-lives, investigational small molecule therapy within 14 days. Monoclonal antibodies and antibody-drug conjugates within 28 days Radiation therapy within 1 weeks
- •Live attenuated vaccines or viral vector vaccines within 4 weeks. Major surgery or significant traumatic injury within 4 weeks. History of stroke or intracranial hemorrhage within 6 months
- •Participants with non-CNSL presence of CNS or intraocular lymphoma lesions.
- •CNSL participants with systemic presence of lymphoma, unable to complete lumbar puncture, under systemic corticosteroids at a dose > 8 mg/day (dexamethasone equivalent dose) within 14 days or requiring immunosuppressive or biologic therapy."
- •Participants with infectious disease:
- •Clinically significant cardiac disorders or abnormalities
- •Another malignancy within 5 years prior to enrollment with the exception of adequately treated in-situ carcinoma of the cervix, uterus, basal or squamous cell carcinoma or non-melanomatous skin cancer.
- •Refractory nausea and vomiting if not controlled by supportive therapy, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption
- •Women who are breast feeding
- •Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol
研究组 & 干预措施
DZD8586
Experimental
干预措施: DZD8586 (Drug)
结局指标
主要结局
Part A: Incidence of adverse events
时间窗: 30 days after the last dose, assessed up to 2 years
Part B: Objective Response Rate assessed by investigators
时间窗: assessed up to 2 years
次要结局
- Part B: Duration of Response assessed by investigators(from date of first documented response until the date of documented progression, assessed up to 2 years)
- Part A: Objective Response Rate assessed by investigators(assessed up to 2 years)
- Part A: Plasma and CSF concentration of DZD8586(through discontinuation of treatment up to 10 weeks)
- Part B: Incidence of adverse events(30 days after the last dose, assessed up to 2 years)
- Part B: Plasma and CSF concentration of DZD8586(through discontinuation of treatment, assessed up to 2 years)
研究者
研究点 (6)
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