A Phase 2, Open-Label, Multi-cohort Study of PD-L1 Probody Therapeutic CX-072 in Combination With Other Anticancer Therapy in Adults With Solid Tumors
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 27
- 主要终点
- Overall Response Rate by RECIST v 1.1
研究概览
简要总结
To obtain evidence of antitumor effect of CX-072 in combination with anticancer therapy in adult patients with solid tumor based upon overall response rate by Response Evaluation Criteria in Solid Tumors (RECIST)
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
- •At least 18 years of age
- •Measurable disease as defined by RECIST v1.1
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
- •Agree to provide tumor tissue and blood samples for biomarker assessment
排除标准
- •Treatment with cytotoxic chemotherapy, biologic agents, radiation, immunotherapy, or any investigational agent within 28 days prior to the first dose of study treatment.
- •Prior therapy with a chimeric antigen receptor T cell-containing regimen
- •History of active autoimmune disease(s) including but not limited to inflammatory bowel diseases, rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis, systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies, type 1 insulin-dependent diabetes mellitus
- •History of myocarditis regardless of the cause
- •History of intolerance to prior checkpoint inhibitor therapy defined as the need to discontinue treatment due to an irAE
- •History of any syndrome or medical condition that required treatment with systemic steroids (≥10 mg daily prednisone equivalents) or immunosuppressive medications.
- •History of severe allergic or anaphylactic reactions to human mAb therapy or known hypersensitivity to any Probody therapeutic
研究组 & 干预措施
CX-072 in combination with anti-cancer therapy-Neoadjuvant
neo-adjuvant study in subjects with histologically confirmed solid tumor
干预措施: CX-072 (Drug)
CX-072 in combination with anti-cancer therapy-front line
histologically or cytologically confirmed solid tumor who have received no prior treatment
干预措施: CX-072 (Drug)
CX-072 in combination with ipilimumab
histologically or cytologically confirmed Stage III (unresectable) or Stage IV melanoma who have experienced progressive disease or relapse following treatment with a PD-1/PD-L1 immune checkpoint inhibitor
干预措施: CX-072 (Drug)
CX-072 in combination with ipilimumab
histologically or cytologically confirmed Stage III (unresectable) or Stage IV melanoma who have experienced progressive disease or relapse following treatment with a PD-1/PD-L1 immune checkpoint inhibitor
干预措施: Ipilimumab (Drug)
CX-072 in combination with anti-cancer therapy-Progressed
histologically or cytologically confirmed, advanced/unresectable or metastatic solid tumor that have experienced disease progression during or following treatment with platinum based therapy
干预措施: CX-072 (Drug)
结局指标
主要结局
Overall Response Rate by RECIST v 1.1
时间窗: 1 year
ORR by RECIST v1.1
次要结局
- The Numbers of Patients Experiencing Anti-tumor Activity by irRECIST(2 years)
- The Percentage of Patients Experiencing Treatment Related Adverse Events(2 years)