AN OPEN-LABEL, PHASE 1 STUDY EVALUATING THE PHARMACOKINETICS, SAFETY AND ANTI-TUMOR ACTIVITY OF PF-07901801 (TTI-622) MONOTHERAPY IN CHINESE PARTICIPANTS WITH ADVANCED HEMATOLOGIC MALIGNANCIES
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 10
- 试验地点
- 5
- 主要终点
- Number of Participants With Dose-Limiting Toxicity (DLT)
研究概览
简要总结
The purpose of this study is to learn about the safety and what the body does to the medicine (Maplirpacept) when taken for the treatment of non-Hodgkin lymphoma or multiple myeloma.
Non-Hodgkin lymphoma is any of a large group of cancers of lymphocytes (white blood cells). Multiple myeloma is a type of cancer that begins in plasma cells (white blood cells that produce antibodies).
This study is seeking participants who:
- have non-Hodgkin lymphoma or multiple myeloma.
- have worsened with (or lack of improvement to) a standard treatment taken before.
- have relatively normal functioning organs.
All participants in this study will receive Maplirpacept as an intravenous (IV) infusion (given directly into a vein) at the study clinic every week.
Participants will continue to receive Maplirpacept until:
- the cancer worsens.
- some serious side effects show up.
- the participants do not wish to take the study medicine any more.
The experiences of the people receiving the study medicine will be collected. This will help to understand if the study medicine Maplirpacept, is safe and can be given to Chinese people.
详细描述
The study is composed of 2 parts. In Part A, approximately 3-6 participants are expected to be enrolled to confirm the tolerability in Chinese participants. If deemed safe, the enrollment of Part B will proceed to include a total of approximately 9 participants in the study to continue to evaluate the pharmacokinetics, safety and preliminary efficacy of single agent PF-07901801 (Maplirpacept).
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
- •Histologically confirmed relapsed/refractory non-Hodgkin lymphoma without other effective therapeutic option. Or relapsed/refractory multiple myeloma exposed to therapies including PI, IMiD and anti-CD38 antibody.
- •With measurable disease
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or
- •Adequate organ functions (including hematologic status, coagulation, hepatic, and renal)
排除标准
- •Active plasma cell leukemia, or POEMS syndrome.
- •Known, current central nervous system disease involvement.
- •Significant cardiovascular disease.
- •Chronic use of systemic corticosteroids of more than 20 mg/day of prednisone or equivalent.
- •Radiation therapy within 14 days of study treatment administration.
- •Hematopoietic stem cell transplant within 90 days before the planned start of study treatment or participants with active GVHD disease.
- •Use of any anticancer drug within 14 days before planned start of study treatment.
- •Prior anti-CD47 or anti-SIRP alpha therapy.
- •Participation in other studies involving investigational drug(s) or vaccines within 4 weeks from the last dose
- •Known active, uncontrolled bacterial, fungal, or viral infection.
研究组 & 干预措施
Maplirpacept (PF-07901801)
single arm study
干预措施: Maplirpacept (Drug)
结局指标
主要结局
Number of Participants With Dose-Limiting Toxicity (DLT)
时间窗: Cycle 1：up to 21 days
Part A only. To characterize the dose limiting toxicities (DLTs) of Maplirpacept.
Single-dose Cmax
时间窗: 0, 1, 2, 4, 24, 72 hours post-dose up to Day 8
Maximum Observed Plasma Concentration
Single-dose AUClast
时间窗: 0, 1, 2, 4, 24, 72 hours post-dose up to Day 8
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Single-dose AUCtau
时间窗: 0, 1, 2, 4, 24, 72 hours post-dose up to Day 8
Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 1 week.
次要结局
- Number of Participants With Adverse Events (AEs) by type, frequency, severity (as graded by NCI CTCAE verision 5.0), timing, seriousness and relationship to study treatment(Baseline up to 28 days after the last dose of study drug)
- Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing(Baseline up to 28 days after the last dose of study drug)
- Single-dose Tmax (Time to Reach Maximum Observed Plasma Concentration)(0, 1, 2, 4, 24, 72 hours post-dose up to Day8)
- Multiple-dose Cmax (Maximum Observed Plasma Concentration)(Through study completion, up to 18 months)
- Multiple-dose Ctrough (trough concentration)(Through study completion, up to 18 months)
- Multiple-dose Cmin (Minimum Observed Plasma Trough Concentration)(Through study completion, up to 18 months)
- Multiple-dose Tmax (Time to Reach Maximum Observed Plasma Concentration)(Through study completion, up to 18 months)
- Multiple-dose AUClast (Area under the plasma concentration time-curve from zero to the last measured concentration)(Through study completion, up to 18 months)
- Multiple-dose AUCtau (Area Under the Curve from Time Zero to end of dosing interval)(Through study completion, up to 18 months)
- Multiple-dose Rac (Accumulation Ratio)(Through study completion, up to 18 months)
- CL (Systemic Clearance)(Through study completion, up to 18 months)
- Vss (Volume of Distribution at Steady State)(Through study completion, up to 18 months)
- t½ (Plasma Decay Half-Life)(Through study completion, up to 18 months)
- AUCinf (Area Under the Curve From Time Zero to Extrapolated Infinite Time)(Through study completion, up to 18 months)
- Incidence and titers of anti-drug antibodies against TTI-622(Through study completion, up to 18 months)
- Incidence and titers of neutralizing antibodies against TTI-622(Through study completion, up to 18 months)
- Objective Response(Baseline to measured progressive disease, up to 18 months)
- Time to Tumor Response (TTR)(Baseline to measured progressive disease, up to 18 months)
- Duration of Response (DOR)(Baseline to measured progressive disease, up to 18 months)
- Progression-Free Survival (PFS)(Baseline to measured progressive disease, up to 18 months)
- Minimal Residual Disease (MRD)(Baseline to measured progressive disease, up to 18 months)