A Phase Ib/Ⅱ Clinical Study to Evaluate the Safety and Efficacy of ANO31905 for Injection in Combination With Chemotherapy as the First-line Treatment for Patients With CLDN18.2-Positive Locally Advanced Unresectable or Metastatic Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity (DLT) (Phase Ib).
研究概览
简要总结
The goal of this clinical trial is to assess the safety and efficacy of ANO31905 in combination with chemotherapy as the first-line treatment for subjects with CLDN18.2-positive locally advanced unresectable or metastatic pancreatic cancer.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged ≥ 18 at the time of signing the ICF;
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
- •Expected survival ≥ 3 months;
- •Histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma;
- •At least one measurable lesion according to RECIST v1.1;
- •Tumor tissue samples are determined to be CLDN18.2-positive by immunohistochemistry (IHC) in the central laboratory;
- •Patients with sufficient organ function within 7 days before the first study dose;
- •Non-pregnant or -lactating women.
排除标准
- •Patients with other malignant tumors except pancreatic adenocarcinoma within 5 years before the first dose of the study treatment; Any previous systematic anti-cancer therapy
- •Any previous systematic anti-cancer therapy;
- •Previous treatment targeting CLDN18.2;
- •Patients with a history of active autoimmune disorders or autoimmune disorders requiring systemic treatment;
- •Patients with known hypersensitivity to any component or excipient of ANO31905, gemcitabine, and nanoparticle albumin-bound paclitaxel;
- •Patients with known metastases to the central nervous system;
- •Patients with severe cardiovascular and cardiovascular diseases;
- •Presence risks of thrombosis or bleeding;
- •Patients who have received attenuated live vaccines within 28 days before the first study dose or are expected to receive attenuated live vaccines during study treatment;
- •Patients with gastrointestinal diseases that are not suitable for enrollment as judged by the investigator;
- •Patients with other conditions that may place the patients at increased undue study-related risks.
研究组 & 干预措施
ANO31905 (low dose) plus GEM+Nab-P
干预措施: ANO31905 (Biological)
ANO31905 (high dose) plus GEM+Nab-P
干预措施: ANO31905 (Biological)
ANO31905 (high dose) plus GEM+Nab-P
干预措施: Nanoparticle Albumin-Bound Paclitaxel (Drug)
ANO31905 (high dose) plus GEM+Nab-P
干预措施: Gemcitabine (Drug)
ANO31905 (low dose) plus GEM+Nab-P
干预措施: Nanoparticle Albumin-Bound Paclitaxel (Drug)
ANO31905 (low dose) plus GEM+Nab-P
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Dose-limiting toxicity (DLT) (Phase Ib).
时间窗: At the end of Cycle 1 (each cycle is 28 days)
The severity of adverse events (AEs) will be graded according to the Common Terminology Criteria for Adverse Events Version 6.0. AEs that occur during the DLT observation period and are judged to be "definitely related", "probably related", or "possibly related" to any investigational products will be deemed as a DLT event.
Objective response rate (ORR) assessed by the investigator according to Response Evaluation Criteria for Solid Tumors Version 1.1 (RECIST v1.1) (Phase Ⅱ)
时间窗: Up to 12 months
Objective response rate (ORR) is defined as the proportion of patients with the best efficacy evaluation of complete response (CR) or partial response (PR) during the study. From date of treatment start until disease progression, date of death or withdrawal from study, whichever came first.
次要结局
未报告次要终点