NCT05372120招募中2 期
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of ICP-192 in Treated Patients With Advanced Solid Tumors With FGF/FGFR Gene Alterations
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 36
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This is a phase II clinical trial in treated patients with advanced solid tumors with FGF/FGFR gene alterations. The purpose of this study is to evaluate the efficacy and safety of ICP-192.
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
- •Signed the ICF and Age ≥ 18 years old, either sex.
- •Life expectancy of at least 3 months.
- •Part 1 (head and neck cancer cohort): Patients with HNC cancer who have failed or cannot tolerate standard therapy, and with FGF/FGFR gene alteration
- •Part 2 (other solid tumor cohorts): Patients with other solid tumor who have failed or cannot tolerate standard therapy, and with FGF/FGFR gene alteration
- •At least one measurable lesion as the target lesion at screening assessed according to RECIST V1.1 criteria.
排除标准
- •Prior treatment with selective FGFR inhibitors or FGFR antibodies.
- •Any corneal or retinal abnormalities that may result in an increased risk of ocular toxicity.
- •Previously or currently endocrine alterations affecting the regulation of calcium-phosphorus homeostasis. History and/or current evidence of extensive tissue calcification.
研究组 & 干预措施
ICP-192
Experimental
20 mg once daily
干预措施: ICP-192 (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: From the time of first dose until objective disease progression, an average of 6 months
ORR based on assessment of confirmed Complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST).
次要结局
- Duration of response (DOR)(From the time of first dose until objective disease progression, an average of 6 months)
- Disease Control Rate (DCR)(From the time of first dose until objective disease progression, an average of 6 months)
研究者
研究点 (36)
Loading locations...
相似试验
终止
1 期
A Study of PF-08046052/SGN-EGFRd2 in Advanced Solid TumorsCarcinoma, Non-Small-Cell LungColorectal NeoplasmsSquamous Cell Carcinoma of the Head and NeckPancreatic Ductal AdenocarcinomaNCT05983133Seagen, a wholly owned subsidiary of Pfizer68
终止
2 期
FGFR Inhibitor in FGFR Dysregulated CancerLung CancerPulmonary NeoplasmSquamous Cell Lung CancerNSCLC Stage IVNSCLCNCT03827850Lung Cancer Group Cologne22
已完成
2 期
Study of AXL1717 Compared to Docetaxel to Treat Squamous Cell Carcinoma or Adenocarcinoma of the LungNon-small-cell Lung CancerAdenocarcinoma of the LungSquamous Cell CarcinomaNCT01561456Axelar AB100
已完成
2 期
Anti-TGF Monoclonal Antibody (GC1008) in Relapsed Malignant Pleural MesotheliomaPleural Malignant MesotheliomaNCT01112293Abramson Cancer Center at Penn Medicine14
进行中（未招募）
1 期
REFOCUS: A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With ICC and Other Advanced Solid TumorsFGFR2 AmplificationFGFR2 Gene MutationFGFR2 Gene Fusion/RearrangementFGFR2 Gene TranslocationFGFR2 Gene ActivationOther Solid Tumors, AdultCholangiocarcinomaIntrahepatic CholangiocarcinomaNCT04526106Elevar Therapeutics540