NCT05165849撤回1 期
A Multicenter, Open-label, Phase I/Ⅱ Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Efficacy of GFS101A in Combination With Toripalimab Treating Patients With Advanced Solid Tumors
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Phase II: Overall response rate (ORR) per RECIST 1.1
研究概览
简要总结
The purpose of this study is to evaluate the safety/tolerability, pharmacokinetics, and efficacy of GFS101A in combination with Toripalimab in patients with advanced solid tumors.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily participate in this clinical trial, and are willing to sign informed consent forms.
- •Male or female aged from 18-75 years old (inclusive).
- •Diagnosed with histologically or cytologically confirmed advanced solid tumors.
- •Evaluable lesions defined by RECIST v1.
- •Eastern Cooperative Oncology Group performance status of 0 to
- •Subjects or their legal representatives are able to communicate well with Investigators and are willing to comply with the protocol and complete the study.
排除标准
- •With clinically significant cardiac diseases
- •With clinically significant digestive disorders.
- •Other severe disease.
- •Pregnant or lactating women.
- •Other unfavorable situations for subjects to participate in the study judged by Investigators.
研究组 & 干预措施
GFS101A+Toripalimab
Experimental
Patient will be administrated with GFS101A IV in combination with Toripalimab IV. The duration of the treatment cycle is defined as 21 days.
干预措施: GFS101A (Drug)
GFS101A+Toripalimab
Experimental
Patient will be administrated with GFS101A IV in combination with Toripalimab IV. The duration of the treatment cycle is defined as 21 days.
干预措施: Toripalimab (Drug)
结局指标
主要结局
Phase II: Overall response rate (ORR) per RECIST 1.1
时间窗: approximately 12 months after first dose
Phase I：Incidence of dose limiting toxicity (DLT) events
时间窗: 21days
次要结局
未报告次要终点
研究者
相似试验
已完成
1 期
Safety and Preliminary Efficacy Assessment of AZD7789 in Patients With Relapsed or Refractory Classical Hodgkin LymphomaRelapsed or Refractory Classical Hodgkin LymphomaNCT05216835AstraZeneca45
招募中
2 期
AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2Gastric CancerNCT06219941AstraZeneca226
已完成
1 期
Open Label Phase 1 Study in Japan for Patient With Advanced Solid MalignanciesAdvanced Solid MalignancyAdvanced Solid TumorNCT01353781AstraZeneca39
终止
1 期
A Study to Evaluate KIN-3248 in Participants With Advanced Tumors Harboring FGFR2 and//or FGFR3 Gene AlterationsSolid Tumor, AdultUrothelial CarcinomaIntrahepatic CholangiocarcinomaNCT05242822Kinnate Biopharma54
招募中
1 期
Study of YK012 in B-cell Acute Lymphoblastic LeukemiaB-cell Acute Lymphoblastic LeukemiaNCT06580301Excyte Biopharma Ltd46