NCT04636515Unknown2 期
A Phase 2, Open-label, Single-arm，Multicenter Study of F520 in Patients With Urothelial Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 主要终点
- Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the investigator
研究概览
简要总结
This is a multicenter, Phase 2 study to evaluate the efficacy and safety of the anti- programmed cell death-1(PD-1) monoclonal antibody F520 in participants with locally advanced or metastatic Urothelial Cancer (UC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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,locally advanced（T4b,any N or any T,N2-3 or metastatic carcinoma（including renal pelvic, ureter bladder and urethra）;
- •Cohort 1：Patients with First-line platinum ineligible must meet criteria for either option a or option b (below):
- •Has a tumor(s) with PD-L1 combined positive and is considered ineligible to receive cisplatin-based combination therapy, based on 1 of the following:
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 2 within 7 days prior to randomization
- •National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 Grade ≥2 audiometric hearing loss
- •NCI CTCAE Version 5.0 Grade ≥2 peripheral neuropathy OR
- •In the opinion of the investigator, is considered ineligible to receive any platinum-based chemotherapy (i.e., ineligible for cisplatin and carboplatin) based on:
- •ECOG PS of 2 within 7 days prior to randomization. and ≥1 of the following:
- •Documented visceral metastatic disease
- •NCI CTCAE Version 5.0 Grade ≥2 audiometric hearing loss
- •NCI CTCAE Version 5.0 Grade ≥2 peripheral neuropathy
- •Cohort 2: Inoperable Patients in sencond line（or beyond）with locally advanced or metastatic urothelial carcinoma who have disease recurrence or progression during or after a platinum-based chemotherapy regimen;
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1
- •Calculated creatinine clearance ≥ 30 milliliter (mL)/min (Cockcroft-Gault formula)
排除标准
- •Has received prior therapy with an anti-PD-1, anti-PD-L1 agent or with CTLA-4 receptor;
- •Has a known hypersensitivity to anti-PD-1 / PD-L1 agent;
- •Known pia meningeal metastasis or active central nervous system (CNS) metastasis revealed by CT or MRI. Participants with asymptomatic brain metastases may participate without evidence of progression for at least 1 month.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Single Arm
Experimental
干预措施: F520 (Drug)
结局指标
主要结局
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the investigator
时间窗: Approximately 24 months
ORR is defined as CR+PR
次要结局
未报告次要终点
研究者
相似试验
终止
2 期
Evaluation of Infigratinib in Patients With Locally Advanced or Metastatic Gastric Cancer or GEJ AdenocarcinomaGastroesophageal Junction AdenocarcinomaGastric CancerNCT06206278LianBio LLC6
已完成
2 期
Study of Surufatinib Single Agent or Surufatinib Combined With Toripalimab in Patients With Advanced Solid TumorsAdvanced Solid TumorsNCT04169672Hutchison Medipharma Limited248
招募中
2 期
HL-085 in Adults With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform NeurofibromasNeurofibromatosis 1Plexiform NeurofibromasNCT05331105Shanghai Kechow Pharma, Inc.70
Unknown
2 期
A Study to Evaluate the Efficacy and Safety of SG001 in Combination With Nab-Paclitaxel in Patients With Advanced Triple-Negative Breast Cancer (TNBC)Triple Negative Breast CancerNCT05068141CSPC ZhongQi Pharmaceutical Technology Co., Ltd.79
已完成
2 期
PM8002 in Combination With Chemotherapy as First Line Therapy in Hepatocellular CarcinomaHepatocellular CarcinomaNCT05864105Biotheus Inc.35