JPRN-jRCT2031210112招募中1 期
Open-label, dose-escalation trial to evaluate the safety and pharmacokinetics of GEN1046 in Japanese subjects with advanced solid malignancies - GEN1046 safety and PK in subjects with advanced solid malignancies
jRCT Inquiry Receipt Center0 个研究点目标入组 39 人开始时间: 2021年5月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 39
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
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Participant must have a histologically-confirmed non-central nervous system (CNS) solid tumor that is metastatic or unresectable and for whom there is no available standard therapy likely to confer clinical benefit; or a participant who is not a candidate for such available therapy and for whom, in the opinion of the investigator, experimental therapy with acasunlimab or acasunlimab in combination with pembrolizumab may be beneficial.
- •- Asian race and Japanese ethnicity.
- •- Have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- •- Have Eastern Cooperative Oncology Group (ECOG) 0-1.
- •- Have an acceptable hematological status.
- •- Have acceptable liver function.
- •- Have an acceptable coagulation status.
- •- Have acceptable renal function.
- •- Should provide a tumor tissue sample (formalin-fixed paraffin-embedded [FFPE] blocks/slides) from archival tissue or fresh biopsy collected before C1D1, preferably derived from advanced disease stage.
排除标准
- •* Have uncontrolled intercurrent illness, including but not limited to:
- •- Ongoing or active infection requiring intravenous treatment with anti-infective therapy.
- •- Symptomatic congestive heart failure (Grade III or IV as classified by the New York Heart Association), unstable angina pectoris or cardiac arrhythmia.
- •- Uncontrolled hypertension defined as systolic blood pressure >= 160 mmHg and/or diastolic blood pressure >= 100 mmHg, despite optimal medical management.
- •- Ongoing or recent evidence of autoimmune disease.
- •- History of irAEs that led to prior checkpoint treatment discontinuation.
- •- Prior history of myositis, Guillain-Barre syndrome, or myasthenia gravis of any grade.
- •- History of chronic liver disease or evidence of hepatic cirrhosis.
- •- Evidence of interstitial lung disease.
- •- History of non-infectious pneumonitis that has required steroids or currently has pneumonitis.
- •- History of organ allograft (except for corneal transplant) or autologous or allogeneic bone marrow transplant, or stem cell rescue within 3 months prior to the first dose of trial treatment.
- •- Serious, non-healing wound, skin ulcer (of any grade), or bone fracture.
- •* Any history of intracerebral arteriovenous malformation, cerebral aneurysm, new (younger than 6 months) or progressive brain metastases or stroke.
- •* Prior therapy:
- •- Radiotherapy: Radiotherapy within 14 days prior to the first dose of trial treatment administration. Palliative radiotherapy will be allowed.
- •- Treatment with an anti-cancer agent (within 28 days or after at least 5 half-lives of the drug, whichever is shorter), prior to trial treatment administration.
- •* Toxicities from previous anti-cancer therapies that have not adequately resolved.
研究者
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