An Open-label, Multi-center, Phase I Study to Evaluate the Safety/Tolerability and Pharmacokinetics of GFS202A in Advanced Solid Tumor Patients With Pre-cachexia or Cachexia
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Incidence of AE/SAE
研究概览
简要总结
An open-label, multi-center, phase I study to evaluate the safety/tolerability and pharmacokinetics of GFS202A in advanced solid tumor patients with pre-cachexia or cachexia. The primary objective is to assess the safety/tolerability of GFS202A, determine its maximum tolerated dose (MTD), and recommend a dose range for future studies.
Enroll participants with cancer cachexia or precachexia to receive GFS202A monotherapy. During the study period, participants will undergo assessments for safety and preliminary efficacy according to the visit schedule. Pharmacokinetic, anti-drug antibody (ADA), and pharmacodynamic (PD) /biomarker samples will be collected.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily participate in the study and sign the informed consent form.
- •Men or women between the ages of 18 and 80 years at the time of written informed consent.
- •Patients with histologically or cytologically confirmed solid tumors. Pre-cachectic and cachectic patients with weight loss or baseline BMI < 21 kg/m2 within 6 months before the first study dose.
- •Persistent concomitant appetite/eating problems related to cancer.
- •It has adequate organ function.
- •The ECOG PS score was 0-
- •The investigator judged the expected survival time to be ≥ 3 months.
排除标准
- •With active brain metastases.
- •With other active diseases that lead to reduced food intake or seriously affect digestion and absorption
- •Baseline BMI > 28 kg/m
- •With infectious diseases.
- •With clinically significant cardiovascular disease.
- •With uncontrolled metabolic diseases.
- •With known clinically significant allergic reactions to antibodies and excipients.
- •With history of drug or alcohol abuse.
- •Pregnant or lactating female subjects or women planning to become pregnant during the study.
- •With pleural, peritoneal, or pericardial effusion that causes overt symptoms or requires repeated drainage (frequency ≥ 1 time/month).
- •Use of any investigational drug within 28 days before the first study dose or within five half-lives of the drug, whichever was shorter, or planned for the duration of the study.
研究组 & 干预措施
GFS202A dose level 1
干预措施: GFS202A injection (Drug)
GFS202A dose level 3
干预措施: GFS202A injection (Drug)
GFS202A dose level 4
干预措施: GFS202A injection (Drug)
GFS202A dose level 5
干预措施: GFS202A injection (Drug)
GFS202A dose level 6
干预措施: GFS202A injection (Drug)
GFS202A dose level 2
干预措施: GFS202A injection (Drug)
结局指标
主要结局
Incidence of AE/SAE
时间窗: Up to 6 weeks after the last dose
Incidence of DLT
时间窗: Up to 21 days after the first dose
次要结局
- Peak Plasma Concentration (Cmax)(Baseline, up to 6 weeks after the last dose)
- Area under the plasma concentration versus time curve (AUC)(Baseline, up to 6 weeks after the last dose)
- Trough Plasma Concentration (Ctrough)(Baseline, up to 6 weeks after the last dose)
- Half-life (T1/2)(Baseline, up to 6 weeks after the last dose)
- Change from baseline in Functional Assessment of Cancer Therapy-General (FACT-G) scores(Baseline, up to 6 weeks after the last dose)
- Incidence of ADA(Baseline, up to 6 weeks after the last dose)
- Concentration of GDF-15 and IL-6(Baseline, up to 6 weeks after the last dose)
- Weight change from baseline(Baseline, up to 6 weeks after the last dose)
- L3SMI change from baseline(Baseline, up to 6 weeks after the last dose)
- Change from baseline in Functional Assessment of Anorexia-Cachexia Therapy (FAACT-ACS) scores(Baseline, up to 6 weeks after the last dose)