A Phase I/II Open-Label, Three-Part, Dose-Finding and Separate Cohort Expansion Trial to Assess the Safety, Tolerability and Preliminary Efficacy of Repeated Doses of CLEVER-1 Antibody FP-1305, in Subjects With Advanced Solid Tumours
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 216
- 试验地点
- 11
- 主要终点
- Dose Limiting Toxicities (DLT) in the Trial Subjects.
研究概览
简要总结
This is a first in human study to identify whether FP-1305 is suitable to use in humans. The previous pre-clinical studies have demonstrated that FP-1305 binds to a receptor known as CLEVER-1. CLEVER-1 has been shown to support tumour growth. No significant adverse events were witnessed in primates and the dose used will be 300 fold lower than the dose provided to primates which showed no toxicity.
The patients with advanced melanoma, uveal melanoma, cholangiocarcinoma, gallbladder cancer, ER+ breast, gastric, ovarian, pancreatic, colorectal, liver or anaplastic thyroid cancer who have exhausted all licenced therapeutic options will die due to their disease. Based on the investigator's existing data CLEVER-1 is expressed in these tumour types. Inhibition of CLEVER-1 with FP-1305 may have an anti-tumour effect in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
FP-1305 (bexmarilimab) 0.3 mg/kg
Part I, Dose-escalation FP-1305 0.3 mg/kg is administered in Q3W intervals
干预措施: FP-1305 (bexmarilimab) (Biological)
FP-1305 (bexmarilimab) 1 mg/kg
Part I and II, Dose-escalation FP-1305 1 mg/kg is administered in Q3W, Q2W or Q1W intervals
干预措施: FP-1305 (bexmarilimab) (Biological)
FP-1305 (bexmarilimab) 3 mg/kg
Part I and II, Dose-escalation FP-1305 3 mg/kg is administered in Q3W, Q2W or Q1W intervals
干预措施: FP-1305 (bexmarilimab) (Biological)
FP-1305 (bexmarilimab) 10 mg/kg
Part I and II, Dose-escalation FP-1305 10 mg/kg is administered in Q3W, Q2W or Q1W intervals
干预措施: FP-1305 (bexmarilimab) (Biological)
FP-1305 (bexmarilimab) 0.1 mg/kg
Part I Dose-escalation FP-1305 0.1 mg/kg is administered in three-week intervals
干预措施: FP-1305 (bexmarilimab) (Biological)
FP-1305 (bexmarilimab) 30 mg/kg
Part II Dose-escalation FP-1305 30 mg/kg is administered in Q3W, Q2W or Q1W intervals
干预措施: FP-1305 (bexmarilimab) (Biological)
结局指标
主要结局
Dose Limiting Toxicities (DLT) in the Trial Subjects.
时间窗: Up to one year
Tolerable dose(s) will be determined by the TITE-CRM based on the occurrence/non-occurrence of dose limiting toxicities in the trial subjects.
Number of Participants With Treatment Emergent Adverse Events (Safety and Tolerability)
时间窗: approximately 4 years and 9 months
Number of adverse events and serious adverse events. Adverse events are collected, graded and reported according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
The Response Objective Response Rate (ORR) to the Treatment Was Planned to be Determined by Tumor Imaging According to RECIST 1.1.
时间窗: approximately 4 years and 9 months
The objective response rate (ORR) to the treatment will be determined by tumour imaging (tumor size) according to RECIST v.1.1. Results from each tumour type, dose level and dosing frequency are reported separately.
The Disease Control Rate (DCR) Response to the Treatment Was Planned to be Determined by Tumor Imaging According to RECIST 1.1.
时间窗: approximately 4 years and 9 months
The disease control rate (DCR) response to the treatment will be determined by tumour imaging (tumor size) according to RECIST v.1.1 are presented by cycles and by doing so there is no difference in the definition of DCR and Clinical Benefit Rate (CBR)
次要结局
未报告次要终点