NCT04338659已完成1 期
A Phase 1a Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Advanced Malignant Tumors
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 8
- 主要终点
- Dose Limiting Toxicity (DLT)
研究概览
简要总结
This is a phase I study evaluating the safety, tolerability and preliminary efficacy of IBI322 in cancer subjects who failed standard treatment.
详细描述
A Phase 1a study evaluating the safety, tolerability and preliminary efficacy of IBI322 in subjects with advanced malignant tumors
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
- •Subjects with histologically/cytologically confirmed unresectable or metastatic solid tumors or relapsed/recurrent lymphomas for which there are no available therapies known to confer clinical benefit.
- •At least one evaluable lesion in Part A or at least one measurable lesion in Part B.
- •Male or female subject > 18 years old.
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or
- •Must have adequate organ function including the following.
- •Subjects with life expectancy ≥ 12 weeks.
- •Female subjects of childbearing age or male subjects whose partners are women at childbearing age, need to use 2 highly effective contraceptive measures, including one barrier method, throughout the treatment period and 6 months after the treatment period.
- •Willing to sign informed consent form and be able to comply with the study's rules and visits/related procedures.
排除标准
- •Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein.
- •Subjects participating in another interventional clinical study, except for: observational (non-interventional) clinical studies or survival follow-up phase of interventional studies.
- •Subjects who are on anticoagulants and/or require concomitant aspirin or other nonsteroids anti-inflammatory medications.
- •Subjects who have a history of blood transfusion within 2 weeks prior to screening, or the use of erythropoietin (EPO), granulocyte-colony stimulating factor (G-CSF), granulocyte-macrophage-colony stimulating factor (GM-CSF), thrombopoietin (TPO) or IL-11 therapy.
- •Subjects who received the last dose of antineoplastic therapy (chemotherapy, endocrine therapy, targeted therapy, immunotherapy or tumor embolization) within 4 weeks prior to the first dose of study drug. Subjects who received the last dose of radiotherapy within 3 weeks prior to the first dose of study drug.
- •Subjects that received immunosuppressive drugs within 7 days prior to the first dose of study drug, excluding topical, intra-nasal, or inhaled glucocorticoids or systemic glucocorticoids (i.e. equivalent to no more than 10 mg prednisone/day) or other glucocorticoids of equivalent dosage through nasal spray, inhalation or other routes.
- •Any ongoing AEs Grade 2 or higher as per NCI CTCAE v5.0 directly attributed to prior anti-tumor treatment with the exception of residual hair loss and fatigue
- •Subjects who received whole pelvic radiotherapy prior to the enrollment.
- •Subjects with known cerebrospinal metastases and other known central nervous system metastases.
- •Subjects with active or suspected autoimmune diseases or with a history of documented autoimmune disease over the past 2 years (subjects can be included in the study: vitiligo, psoriasis, alopecia or Grave's disease subjects who do not require systemic treatment within 2 years; hypothyroidism subjects who require only thyroid hormone replacement therapy, and type I diabetes subjects who require only insulin replacement therapy).
- •Known history of primary immunodeficiency.
- •Known history of active pulmonary tuberculosis.
- •Known history of allogenic organ transplantation and hematopoietic stem cell transplantation.
- •Known history of hypersensitivity to any components of the IBI322 injection.
结局指标
主要结局
Dose Limiting Toxicity (DLT)
时间窗: .Day 1 - Day 21
Treatment-related Adverse Events (TRAEs)
时间窗: Day 1 - 90 days after last administration
次要结局
- Positive rate of ADA and Nab(Up to 90 days post last dose)
- Positive rate of Circulating Immune Complex(Through study completion, an average of 1 year)
- PK parameters(Up to 90 days post last dose)
研究者
研究点 (8)
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