JPRN-jRCT2031220077暂停1 期
A Phase I First Time in Human Open Label Study of GSK3745417 Administered With and Without Anticancer Agents in Participants With Advanced Solid Tumors
Ishibashi Hideyasu0 个研究点目标入组 300 人开始时间: 2022年5月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
- 入组人数
- 300
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Participant must be more than or equal to (>=)18 years of age.
- •Participants with advanced/recurrent solid tumors, who have progressed on, be intolerant of, or ineligible for, all available therapies for which clinical benefit has been established.
- •Histological or cytological documentation of an advanced solid tumor.
- •Participants must provide a fresh biopsy.
- •Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
- •Adequate organ function per protocol specifications.
- •Male or female participants.
- •Female participants are eligible to participate if they are not breastfeeding or pregnant (or intend to breastfeed or become pregnant). Women of childbearing potential must use a highly effective method of contraception.
- •Capable of giving signed informed consent.
排除标准
- •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.
- •Current unstable liver or biliary disease.
- •History of vasculitis at any time prior to study treatment.
- •Evidence or history of significant active bleeding or coagulation disorder.
- •Active infection requiring systemic treatment, known human immunodeficiency virus infection, or positive test for hepatitis B surface antigen or hepatitis C.
- •QT duration corrected for heart rate by Fridericia's formula (QTcF) more than (>)450 milliseconds (msec) or QTcF >480 msec for participants with bundle branch block.
- •Recent history (within the past 6 months) of acute diverticulitis, inflammatory bowel disease, intra-abdominal abscess, or gastrointestinal obstruction.
- •Recent history of allergen desensitization therapy within 4 weeks of starting study treatment.
- •History or evidence of cardiovascular (CV) risk
- •Recent (within the past 6 months) history of symptomatic pericarditis.
- •History of idiopathic pulmonary fibrosis, interstitial lung disease, or organizing pneumonia, or evidence of active, non-infectious pneumonitis.
- •History of (non-infectious) pneumonitis that required steroids or current pneumonitis.
- •Recent history (within 6 months) of uncontrolled symptomatic ascites or pleural effusions.
- •Prior treatment with the following agents:
- •Stimulator of Interferon Genes (STING) agonist at any time.
- •Anticancer therapy or investigational therapy or used an investigational device within 28 days or 5 half-lives of the drug, whichever is shorter.
- •Checkpoint inhibitors, including Programmed death receptor-1 (PD-1), Programmed death Ligand-1 (PD-L1), PD-L2 and Cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) inhibitors within 28 days.
- •Prior radiation therapy: permissible if at least 1 non-irradiated measurable lesion is available for assessment according to RECIST version 1.1 or if a solitary measurable lesion was irradiated, objective progression is documented.
- •Pregnant and/or breast feeding participants or those who plan to become pregnant and/or breastfeed.
- •Receipt of any live vaccine within 30 days of the start of study treatment.
- •Prior allogeneic or autologous bone marrow transplantation or other solid organ transplantation.
- •Major surgery less than or equal to (<=)28 days before the first dose of study treatment. Participants must have also fully recovered from any surgery (major or minor) and/or its complications before initiating study treatment.
- •Participants with signs/symptoms suggestive of Coronavirus Disease-2019 (COVID-19) within 14 days of study entry, or with known exposure to COVID-19 within 14 days prior to study entry.
- •Participants are excluded from Part 2A of the study if they have known hypersensitivity to dostarlimab or associated excipients.
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