NL-OMON51352已完成不适用
Phase 1, open label study of intravenous GSK3745417 to evaluate safety, tolerability, harmacokinetics, pharmacodynamics and determine RP2D and schedule in participants with relapsed or refractory myeloid malignancies including acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (HR-MDS) - 209801 - STING AM
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Must be >=18 years of age and <=75 years of age
- •- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- •- Participants with AML/High Risk MDS are eligible for participation in Part 1
- •and Part 2 if they have:
- •o A diagnosis of AML, with relapsed or refractory disease and ineligible for or
- •have exhausted standard therapeutic options.
- •o Have high-risk or high/very high by IPSS-Revised criteria MDS (restricted to
- •Part 1) that has relapsed after or been refractory to prior therapy with
- •hypomethylating agent.
- •o Adequate organ function as defined in the protocol
- •- Agree to abide by the gender specific contraceptive requirements.
排除标准
- •- Diagnosis of acute promyelocytic leukemia Patients with biphenotypic disease
- •are excluded.
- •- Active central nervous system involvement or disorder.
- •- Immediate life-threatening, severe complications of leukemia
- •- Participants with extramedullary disease as the sole site of AML
- •- Active severe or uncontrolled infection, known human immunodeficiency virus
- •infection, or presence of hepatitis B surface antigen (HBsAg) or positive
- •hepatitis C antibody test at screening.
- •- Participants with signs/symptoms suggestive of COVID-19 within 14 days of
- •study entry, or with known exposure to COVID-19 within 14 days prior to study
- •- Active autoimmune disease that has required systemic disease modifying or
- •immunosuppressive treatment within the last 2 years.
- •- Concurrent medical condition requiring the use of systemic immunosuppressive
- •treatment within 28 days before the first dose of study treatment.
- •- Recent history of allergen desensitization therapy within 4 weeks of starting
- •study treatment.
- •- History or evidence of cardiovascular (CV) risk
- •- Prior STING therapy.
- •- Prior solid organ transplantation.
- •- Recent prior therapy defined as follows:
- •o Any non-monoclonal anti-cancer therapy within 14 days or 5 half-lives,
- •whichever is longer, prior to start of study treatment
- •o Prior therapy with biological agents within 28 days prior to start of study
- •o Any radiotherapy or major surgery within 14 days prior to start of study
- •o Currently receiving investigational therapy in a clinical trial
- •- Receipt of any live vaccine within 30 days of start of study treatment.
- •- Immune-related toxicity related to prior treatment that has not resolved to
- •Grade <=1
- •- Concomitant administration of drugs that are sensitive substrates or narrow
- •therapeutic range substrates for cytochrome p450 (CYP)3A4 enzyme, P-gp, BCRP,
- •OATP1B1 and OATP1B3 transporter, and moderate to strong inducers and inhibitors
- •of CYP3A4, P-gp, OATP1B1 and OATP1B3 should be excluded during the study and
- •for 7 days prior to and following treatment with GSK3745417
- •- Ongoing drug or alcohol abuse.
研究者
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