A Phase 1b/2 Randomized Study of AVB-S6-500 Plus Nab-paclitaxel and Gemcitabine in Patients With Locally Advanced or Metastatic Pancreatic Adenocarcinoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 34
- 试验地点
- 17
- 主要终点
- Anti-tumor activity of batiraxcept in combination with nab-paclitaxel and gemcitabine in Phase 1b portion of the study
研究概览
简要总结
This is a Phase 1b/2 study of batiraxcept (AVB-S6-500) designed to evaluate the safety and efficacy of batiraxcept in combination with nab-paclitaxel and gemcitabine in subjects with locally advanced, recurrent, or metastatic pancreatic adenocarcinoma as first line therapy. The phase 1b portion of the study is open label and patients will receive batiraxcept, nab-paclitaxel, and gemcitabine. The Phase 2 portion of the study is randomized, 2-arm, open-label study to compare efficacy and tolerability of batiraxcept, nab-paclitaxel, and gemcitabine versus nab-paclitaxel and gemcitabine as first line therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Age 18 years or older
- •Histologically or cytologically confirmed pancreatic adenocarcinoma. Must have locally advanced, recurrent, or metastatic disease ineligible for curative intent treatment(s) and eligible for first line systemic treatment.
- •Must have radiologic imaging with a computed tomography (CT) scan or magnetic resonance imaging (MRI) within 22 days of study entry
- •Must have at least one measurable lesion according to RECIST 1.1
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •Adequate gastrointestinal (GI), bone marrow, liver and kidney function
- •Life expectancy minimum of > 12 weeks
- •Adequate recovery from surgery to Grade 1 or baseline with at least 28 days from time of major surgery
排除标准
- •Received last dose of chemotherapy (neoadjuvant or adjuvant), surgery, or radiation treatment with curative intent within 6 months prior to study entry
- •Islet-cell neoplasms
- •Prior malignancy within the past 3 years except adequately treated basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the prostate, cervix, breast or melanoma
- •Symptomatic uncontrolled central nervous system (CNS) metastasis or brain metastases unless adequately treated and controlled
- •Evidence of clinically significant third spacing (e.g. pleural effusion, ascites, anasarca, etc.) within 28 days prior to study entry
- •Serious active infection requiring IV antibiotics and/or hospitalization at study entry
- •Active human immune deficiency (HIV) syndrome, hepatitis B, hepatitis C, or other active viral illness
研究组 & 干预措施
Phase 1b: batiraxcept+ nab-paclitaxel and gemcitabine
Up to three dose levels of bactiraxcept plus nab-paclitaxel and gemcitabine
干预措施: batiraxcept (Drug)
Phase 1b: batiraxcept+ nab-paclitaxel and gemcitabine
Up to three dose levels of bactiraxcept plus nab-paclitaxel and gemcitabine
干预措施: Nab paclitaxel (Drug)
Phase 1b: batiraxcept+ nab-paclitaxel and gemcitabine
Up to three dose levels of bactiraxcept plus nab-paclitaxel and gemcitabine
干预措施: Gemcitabine (Drug)
Phase 2: batiraxcept+ nab-paclitaxel and gemcitabine
干预措施: batiraxcept (Drug)
Phase 2: batiraxcept+ nab-paclitaxel and gemcitabine
干预措施: Nab paclitaxel (Drug)
Phase 2: batiraxcept+ nab-paclitaxel and gemcitabine
干预措施: Gemcitabine (Drug)
Phase 2: nab-paclitaxel and gemcitabine alone
干预措施: Nab paclitaxel (Drug)
Phase 2: nab-paclitaxel and gemcitabine alone
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Anti-tumor activity of batiraxcept in combination with nab-paclitaxel and gemcitabine in Phase 1b portion of the study
时间窗: 12 months
Measured by Objective Response Rate (ORR): Proportion of subjects who have a partial or complete response to therapy relative to baseline in Phase 1b portion of the study.
Incidence of adverse events (AEs)
时间窗: 12 months
Measured by the number of patients with AEs in Phase 1b portion of the study.
Anti-tumor activity of batiraxcept in combination with nab-paclitaxel and gemcitabine in Phase 2 portion of the study
时间窗: 30 months
Measured by progression free survival (PFS) in patients receiving batiraxcept, nab-paclitaxel, and gemcitabine versus patients receiving nab-paclitaxel, and gemcitabine alone in Phase 2.
次要结局
- Pharmacokinetics: AUC(30 months)
- Pharmacokinetics: t1/2(30 months)
- Disease control rate(30 months)
- Overall survival(60 months)
- Pharmacokinetics: Cmax(30 months)
- Duration of response (DOR)(30 months)
- Pharmacokinetics: Tmax(30 months)
- Anti-drug antibody (ADA) titers(30 months)
- Pharmacodynamic marker assessment(30 months)