A Phase 1B Dose Escalation Study of AV-380 in Combination With Standard of Care Chemotherapy in Metastatic Cancer Patients With Cachexia and Elevated GDF-15 Levels
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 23
- 主要终点
- Assessment of adverse events (AEs)
研究概览
简要总结
This open label ascending dose study is designed to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AV-380 in cancer patients with Cachexia. AV-380 is an immunoglobulin (Ig) G1 monoclonal antibody (mAb) intended to bind circulating human growth differentiation factor 15 (GDF-15), a cytokine involved in cancer-induced cachexia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Patient must be ≥ 18 years of age at the time of signing the informed consent.
- •Patients with histologically confirmed solid tumor cancer who are actively receiving SoC therapy for this cancer.
- •Patients with cachexia as defined by Fearon criteria:
- •Weight loss > 5% over past 6 months (in absence of simple starvation), or
- •BMI < 20 kg/m2 and any degree of weight loss > 2%, or
- •Sarcopenia and any degree of weight loss > 2%
- •Patients with life expectancy ≥ 3 months
排除标准
- •History of allergic or anaphylactic reaction to any monoclonal antibody (IgG protein) or molecules made of components of monoclonal antibody
- •Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 2 weeks before first dose of study treatment.
- •Myocardial infarction or heart failure of New York Heart Association Grade 3-4 within 3 months prior to start of protocol therapy
- •Uncontrolled pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
- •Cachexia is caused by other reasons (e.g., severe chronic obstructive pulmonary disease, heart failure, or HIV/AIDS), or the patient has uncontrolled reversible causes of reduced oral food intake, including, but not limited to, oral mucositis, nausea/vomiting, diarrhea, and/or obstruction, impairing the patient's ability to eat as determined by the Investigator.
- •Patients receiving tube feedings or parenteral nutrition at the time of Screening.
研究组 & 干预措施
Dose Escalation Cohorts
Experimental: Dose escalation cohorts of AV-380 administered by IV infusion
干预措施: AV-380 (Biological)
结局指标
主要结局
Assessment of adverse events (AEs)
时间窗: From enrollment to the last follow-up visit approximately 60-days post dose
AEs as characterized by incidence, type, frequency, and severity (graded according to National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\])
Toxicity
时间窗: While receiving study drug (up to 4 months)
Dose-limiting Toxicity (DLT) events observed at increasing doses of AV-380
Laboratory Abnormalities
时间窗: From enrollment to the last follow-up visit approximately 60-days post dose.
Laboratory abnormalities as characterized by type, frequency, severity (graded according to NCI-CTCAE v5.0) and timing.
次要结局
- Cmax(From first dose to the last follow-up visit approximately 60-days post dose.)
- Tmax(From first dose to the last follow-up visit approximately 60-days post dose)
- AUC(0-t)(From first dose to the last follow-up visit approximately 60-days post dose.)