NCT05982080招募中1 期
A Phase 1 Study to Investigate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics Activity of FP002 in Subjects With Advanced Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 27
- 试验地点
- 3
- 主要终点
- Severity (as graded by CTCAE v5.0) of adverse events of special interest (AESIs)
研究概览
简要总结
The goal of this phase 1 study is to assess the safety, and tolerability of FP002 to determine the dose recommended for dose expansion in subjects with advanced solid tumor.
详细描述
This study is a phase 1 study of FP002 as monotherapy in patients with advanced solid tumor. The study will evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic profile, immunogenicity, and preliminary anti-tumor activity of FP002 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent form (ICF) and was able to comply with the protocol.
- •Male or female subjects ≥ 18 years of age on the day of ICF signing.
- •A life expectancy of > 3 months.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Adequate organ and bone marrow function confirmed at screening and within 7 days before the first dose of study treatment.
- •Subjects with histologically or cytological confirmed malignancy diagnosis.
- •Documented advanced solid tumors, defined as patients have no standard treatment or who have failed/are intolerant to standard treatment according to the investigator's judgment.
- •Documented with at least 1 measurable lesion as assessed by RECIST 1.
- •Toxicity from prior anti-tumor treatment has resolved to ≤ Grade 1 as defined by NCI CTCAE v5.0.
排除标准
- •Subjects who have received other anti-CD47 or anti- SIRPα agents.
- •Prior organ or tissue allograft except for hematopoietic stem cell transplantation.
- •Treatment with investigational therapy within 4 weeks prior to initiation of study drug.
- •Severe infection requiring hospitalization or IV antibiotics, antivirals or antifungals within 14 days prior to enrollment.
- •Subjects who have received chemotherapy within 4 weeks or 5 half-lives (whichever is shorter) before the first dose (within 6 weeks before the first dose of mitomycin or nitrosoureas) or received immunotherapy, radical radiotherapy or major surgery within 4 weeks or palliative radiotherapy within 2 weeks.
- •Subjects who have experienced active autoimmune disease requiring systemic therapy within the past 2 years.
- •A positive test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by a certified nucleic acid test within the last 30 days before the first dose of study treatment.
- •Cardiovascular dysfunction or clinically significant cardiac disease.
- •Active infection with hepatitis C.
- •Receipt of a live vaccine within 30 days prior to the first dose of study treatment.
- •Known hypersensitivity to either the drug substances or inactive ingredient of FP
- •Known human immunodeficiency virus (HIV) positive.
- •A history of other malignancies other than effectively treated basal cell carcinoma of skin, squamous cell carcinoma of skin, or effectively resected carcinoma in situ of the cervix.
- •Known inherited or acquired bleeding disorders.
- •Any other medical, family, social or mental conditions that the investigator considers unsuitable for participation in the study.
- •Daily requirement for corticosteroids (≥10 mg/kg) within 2 weeks prior to Day 1 of Cycle
- •Women who are lactating or pregnant as confirmed by pregnancy test within 7 days before the first dose of study treatment. Unwilling to use adequate contraceptive methods during the study and for at least 7 months after the last dose of study treatment.
- •Presence of active brain metastases
研究组 & 干预措施
FP002 Injection
Experimental
Dose escalation: FP002
干预措施: FP002 Injection (Drug)
结局指标
主要结局
Severity (as graded by CTCAE v5.0) of adverse events of special interest (AESIs)
时间窗: up to 24 months
Severity (as graded by CTCAE v5.0) of Dose Limiting Toxicity (DLT)
时间窗: During the first 4 week treatment cycle
Severity (as graded by CTCAE v5.0) of treatment-emergent AEs (TEAEs)
时间窗: up to 24 months
Severity (as graded by CTCAE v5.0) of serious adverse events (SAEs)
时间窗: up to 24 months
Severity (as graded by CTCAE v5.0) of adverse events assessed
时间窗: up to 24 months
次要结局
- Apparent volume of distribution (Vd) of FP002(up to 24 months)
- Terminal elimination rate constant (λz)(up to 24 months)
- Maximum plasma concentration (Cmax) of FP002(up to 24 months)
- Area under the curve from time zero to the last measurable time point (AUC0-t) of FP002(up to 24 months)
- Area under the curve extrapolated to infinity (AUC0-inf)of FP002(up to 24 months)
- Terminal elimination half-life (t1/2) of FP002(up to 24 months)
- Mean retention time (MRT)(up to 24 months)
- Accumulation index (Rac)(up to 24 months)
- Neutralizing antibody(Up to 24 months)
- Average steady state concentration (Cav)(up to 24 months)
- Overall response rate (ORR) based on RECIST V1.1(Up to 24 months)
- Clearance rate (CLz)(up to 24 months)
- Minimum plasma concentration during the dosing interval at steady state (Cmin,ss)(up to 24 months)
- Steady-state clearance rate (CLss)(up to 24 months)
- Progression free survival (PFS) based on RECIST V1.1(Up to 24 months)
- Steady-state volume of distribution (Vss)(up to 24 months)
- Degree of fluctuation (DF)(up to 24 months)
- Time to reach maximum plasma concentration (Tmax) of FP002(up to 24 months)
- Maximum plasma concentration during the dosing interval at steady state (Cmax,ss)(up to 24 months)
- Duration of response (DoR) based on RECIST V1.1(Up to 24 months)
- Disease control rate (DCR) based on RECIST V1.1(Up to 24 months)
- Anti-drug antibody(Up to 24 months)
- Receptor of occupancy in RBC/CD3+ T cell(Up to 24 months)
研究者
研究点 (3)
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