A First-in-human, Dose-escalation Followed by Expansion Study to Assess the Safety and Preliminary Efficacy of a Bispecific Antibody OT-A201 As Monotherapy and in Combination Therapy in Patients with Selected Hematological Malignancies and Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Maximum tolerated dose(s) (MTD) and recommended dose(s) of OT-A201
研究概览
简要总结
This phase 1 study is aimed at establishing the safety basis of OT-A201 in the treatment of hematological malignancies and solid tumors. In the dose of escalation part it is to characterize the overall safety and tolerability profile and determine the recommended dose(s) of OT-A201 as monotherapy, and in various combination regimens. Preliminary information about anti-cancer activity will be further explored in the expansion part of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 or cytologically confirmed relapsed/refractory hematological malignancy or advanced/metastatic solid cancer
- •Measurable disease
- •Have had all available therapeutic standards for their disease
- •Willingness to undergo baseline biopsy/bone marrow aspiration in case biopsy was not collected after completion of the most recent prior therapy
- •ECOG performance status ≤ 1
- •Life expectancy > 3 months as assessed by the investigator
- •Acceptable clinical lab results
排除标准
- •Systemic steroids at a daily dose of > 10 mg of prednisone or equivalent within 28 days before study treatment. Transient use of steroids for other medical condition may be allowed
- •Ongoing immune-related adverse events irAEs and or AEs ≥ grade 2 from previous therapies not resolved except vitiligo, stable neuropathy up to grade 2, hair loss, and stable endocrinopathies with substitutive hormone therapy
- •Within 4 weeks of major surgery
- •Documented history of active autoimmune disorder requiring systemic immunosuppressive therapy within the last 12 months
- •Prior solid organ transplant
- •Primary or secondary immune deficiency
- •Active and uncontrolled infection requiring intravenous antibiotic or antiviral treatment
- •Seropositive (except after vaccination or confirmed cure for hepatitis) for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
- •Clinically significant disease
研究组 & 干预措施
OT-A201 monotherapy
OT-A201 administered by IV infusion on a weekly (qw) basis. An alternative dosing schedule of every 2 weeks (q2w) may be implemented based on the clinical safety and laboratory data.
干预措施: OT-A201 (Drug)
OT-A201 in combination with iMiD
OT-A201 in combination with lenalidomide or pomalidomide at the approved dose
干预措施: OT-A201 (Drug)
OT-A201 in combination with iMiD
OT-A201 in combination with lenalidomide or pomalidomide at the approved dose
干预措施: IMids (Drug)
OT-A201 in combination with a specific agent
OT-A201 in combination with late stage approved treatment (combination to be defined by a protocol amendment)
干预措施: OT-A201 (Drug)
OT-A201 in combination with a specific agent
OT-A201 in combination with late stage approved treatment (combination to be defined by a protocol amendment)
干预措施: TBD Compound (Drug)
OT-A201 in combination with bevacizumab
OT-A201 in combination with bevacizumab at the approved dose
干预措施: OT-A201 (Drug)
OT-A201 in combination with bevacizumab
OT-A201 in combination with bevacizumab at the approved dose
干预措施: Bevacizumab (Drug)
OT-A201 in combination with paclitaxel
OT-A201 in combination with paclitaxel at the approved dose
干预措施: OT-A201 (Drug)
OT-A201 in combination with paclitaxel
OT-A201 in combination with paclitaxel at the approved dose
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Maximum tolerated dose(s) (MTD) and recommended dose(s) of OT-A201
时间窗: 28 days
Evaluate dose-limiting toxicity (DLT) during the DLT observation period
Safety profile of OT-A201
时间窗: 6 months
Incidence, severity, and relationship of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), TEAEs leading to discontinuation of study treatment; and clinically significant findings on clinical laboratory tests, vital signs, ECGs, and physical examinations
次要结局
未报告次要终点