跳至主要内容
临床试验/jRCT2021220030
jRCT2021220030已完成不适用

A PHASE I, OPEN LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TTI-622 (PF-07901801), A SINGLE AGENT IN JAPANESE PARTICIPANTS WITH RELAPSED OR REFRACTORY HEMATOLOGIC MALIGNANCIES

Pfizer Japan Inc.0 个研究点目标入组 7 人开始时间: 2022年11月2日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
7
主要终点
Number of Participants with Dose Limiting Toxicity (DLT) in lymphoma

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Single Arm Study
干预模型
Single Assignment
主要目的
Treatment Purpose
盲法
Open(masking Not Used)

入排标准

年龄范围
18age old over 至 No limit(—)
性别
All

入选标准

  • Inclusion Criteria:
  • Relapsed or refractory lymphoma (Hodgkin's or non-Hodgkin's) or multiple myeloma
  • Disease must have progressed with standard anticancer therapies
  • measurable disease
  • Capable of giving signed informed consent
  • Eastern cooperative oncology group performance status 0 or 1
  • Adequate organ functions

排除标准

  • Exclusion Criteria:
  • Known, current central nervous system or interstitial lung disease involvement
  • History of hemolytic anemia or positive direct antiglobulin test or active bleeding disorder
  • Chronic use of systemic corticosteroids of more than 20 mg/day of prednisone or equivalent
  • Significant cardiovascular disease
  • Other significant medical condition unrelated to the primary malignancy
  • Radiation therapy within 14 days of study treatment administration
  • Hematopoietic stem cell transplant within 90 days before the planned start of study treatment
  • Antiplatelet/anticoagulant agents within 14 days before planned start of study treatment
  • Patients sustaining major surgery at least 4 weeks prior to study enrollment
  • Use of any investigational agent or any anticancer drug within 14 days before planned start of study treatment
  • Prior anti-CD47 and anti-Signal Regulatory Protein alpha therapy
  • Active, uncontrolled bacterial, fungal, or viral infection
  • Investigator site staff directly involved in the conduct of the study and their family members

结局指标

主要结局

Number of Participants with Dose Limiting Toxicity (DLT) in lymphoma

时间窗: up to 21 days

Number of participants with DLTs

次要结局

未报告次要终点

研究者

相似试验