NCT05808634招募中1 期
An Open-label, Multicenter, Phase 1 Study Evaluating the Safety, Pharmacokinetics, and Efficacy of BA3182, a Bispecific Epithelial Cell Adhesion Molecule (EpCAM)/CD3 Antibody, in Patients With Advanced Adenocarcinoma
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
- 168
- 试验地点
- 9
- 主要终点
- Part 1: Assess dose limiting toxicity as defined in the protocol
研究概览
简要总结
The objective of this study is to assess safety and efficacy of BA3182 in Advanced Adenocarcinoma
详细描述
This is a multi-center, open-label, Phase 1 study designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of BA3182 in patients with advanced adenocarcinoma.
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
- •Histologically or cytologically confirmed locally advanced unresectable or metastatic adenocarcinoma
- •Age ≥ 18 years
- •Adequate renal function
- •Adequate liver function
- •Adequate hematological function
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
排除标准
- •Patients must not have clinically significant cardiac disease.
- •Patients must not have known non-controlled CNS metastasis.
- •Patients must not have active autoimmune disease or a documented history of autoimmune disease.
- •Patients must not have a history of ≥ Grade 3 allergic reactions to mAb therapy as wellas known or suspected allergy or intolerance to any agent given during this study.
- •Patients must not incomplete recovery from the effects of major surgery or significant traumatic injury before the first dose of study treatment.
- •Patients must not have known human immunodeficiency virus (HIV) infection, active hepatitis B and/or hepatitis C.
- •Patients must not be women who are pregnant or breast feeding.
研究组 & 干预措施
BA3182
Experimental
All Patients will receive BA3182
干预措施: BA3182 (Drug)
结局指标
主要结局
Part 1: Assess dose limiting toxicity as defined in the protocol
时间窗: Up to 24 months
Phase 1 Part 1: Safety Profile of BA3182
Part 1: Assess maximum tolerated dose as defined in the protocol
时间窗: Up to 24 months
Phase 1 Part 1: Safety Profile of BA3182
Part 2: Confirmed overall response rate (ORR) per RECIST v1.1
时间窗: Up to 24 months
Phase 1 Part 2: Antitumor activity of BA3182
次要结局
- Confirmed overall response rate (ORR) per RECIST v1.1(Up to 24 months)
- Confirmed best overall response best overall response (BOR)(Up to 24 months)
- Confirmed duration of response (DOR)(Up to 24 months)
- Confirmed progression-free survival (PFS)(Up to 24 months)
- Confirmed disease control rate (DCR)(Up to 24 months)
- Confirmed time to response (TTR)(Up to 24 months)
- Confirmed overall survival (OS)(Up to 24 months)
- Confirmed percent change from baseline in target lesion sum of diameters.(Up to 24 months)
- Area under the plasma concentration versus time curve (AUC)(Up to 24 months)
- Peak Plasma Concentration (Cmax) Phase 1: Pharmacokinetics(Up to 24 months)
- Incidence of anti-drug antibody (ADAs) to BA3182 Phase 1: Pharmacokinetics Phase 1: Immunogenicity(Up to 24 months)
- Incidence of neutralizing antibodies (nAbs) to BA3182.(Up to 24 months)
研究者
研究点 (9)
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