A Phase 1 Open-Label, Dose-Finding Study Evaluating Safety and Pharmacokinetics of FPA144 in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 26
- 主要终点
- Number of Participants With Protocol Specified Dose-limiting Toxicities (Part 1 Only).
研究概览
简要总结
This is a three-part, open-label, safety, tolerability, and PK study of FPA144. Patients will be enrolled in Part 1 (A or B, dose escalation) or Part 2 (dose expansion) of the study, but not both.
详细描述
Part 1A is a dose-escalation study in patients with any locally advanced or metastatic solid tumor or lymphoma for which standard therapies have been exhausted. Part 1B will further assess safety and evaluate PK of FPA144 in gastric cancer patients.
Part 2 patients will be enrolled and treated in order to further characterize safety and preliminary efficacy in a selected cancer patient population with the greatest potential for clinical benefit from FPA144 treatment.
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
- •Life expectancy of at least 3 months
- •ECOG performance status of 0 to 1
- •In sexually-active patients, willingness to use 2 effective methods of contraception
- •Adequate hematological and organ function, confirmed by lab values
- •Tumor tissue must be available for prospective determination of FGFR2b overexpression
- •Locally recurrent or metastatic disease that has progressed on or following standard treatment, or is not a candidate for standard treatment
- •Histologically or cytologically confirmed transitional cell carcinoma of the genitourinary tract
- •Measurable disease as defined by RECIST version 1.1
排除标准
- •Untreated or symptomatic central nervous system (CNS) metastases
- •Impaired cardiac function or clinically significant cardiac disease
- •Treatment with any anticancer therapy or participation in another therapeutic clinical study with investigational drugs </=14 days (</=28 days for patients in Korea) prior to first dose of FPA144
- •Ongoing acute adverse effects from prior anticancer or investigational therapy > NCI CTCAE Grade 1
- •Retinal disease or a history of retinal disease or detachment
- •Corneal defects, corneal ulcerations, keratitis, keratoconus, history of corneal transplant, or other known abnormalities of the cornea
- •Major surgical procedures are not allowed ≤28 days prior to FPA144 administration
- •Females who are pregnant or breastfeeding; women of childbearing potential must not be considering getting pregnant during the study
- •Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study
- •Known allergy or hypersensitivity to components of the FPA144 formulation including polysorbate
- •History of prior malignancy except:
- •a) Curatively treated non-melanoma skin cancer or
- •b) Solid tumor treated curatively more than 5 years previously without evidence of recurrence or
- •c) History of other malignancy that in the Investigator's opinion would not affect the determination of study treatment effect
- •Prior treatment with any selective inhibitor (e.g., AZD4547, BGJ398, JNJ-42756493, BAY1179470) of the FGF-FGFR pathway
研究组 & 干预措施
Part 1A: FPA144 Dose Escalation Solid Tumors
Dose escalation of FPA144 (0.3 mg/kg to 15 mg/kg)
干预措施: FPA144 (Drug)
Part 1B: FPA144 Dose Escalation Gastric Cancer
Dose escalation of FPA144 (3-10 mg/kg) in patients with gastric cancer
干预措施: FPA144 (Drug)
Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors
Evaluation of objective responses in patients with tumors with various levels of FGFR2b overexpression
干预措施: FPA144 (Drug)
结局指标
主要结局
Number of Participants With Protocol Specified Dose-limiting Toxicities (Part 1 Only).
时间窗: 4 weeks on average
Number of participants with grade 3 and grade 4 adverse events (AE) and clinical laboratory abnormalities defined as dose limiting toxicities (DLTs)
Number of Participants With AEs and Clinical Laboratory Abnormalities (Parts 1B and 2 Only)
时间窗: 16 weeks on average
Number of Participants with AEs and clinical laboratory abnormalities (Parts 1B and 2 only)
次要结局
- Pharmacokinetic (PK) Profile of FPA144: Maximum Serum Concentration(16 weeks on average)
- Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1(16 weeks on average)
- Duration of Response Per RECIST 1.1 (Part 2 Only)(16 weeks on average)
- Pharmacokinetic (PK) Profile of FPA144: Area Under Serum Concentration-time Curve(16 weeks on average)