A Phase 1/2, First-in-Human, Dose Escalation and Expansion Study of BDC-4182 as a Single Agent in Patients With Advanced Gastric and Gastroesophageal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 122
- 试验地点
- 16
- 主要终点
- Incidence of adverse events (AEs) and serious adverse events (SAEs) graded according to CTCAE v5.0
研究概览
简要总结
A first-in-human study using BDC-4182 as a single agent in gastric and gastroesophageal cancers
详细描述
This is a dose escalation study designed to evaluate the safety and tolerability of BDC-4182 to establish the recommended Phase 2 dose (RP2D). Participants will be enrolled in each dose cohort until the maximum tolerated dose (MTD) is reached. Additional participants may be enrolled into backfill cohorts at dose levels that have been cleared to collect additional safety and tolerability data. Additional participants may be enrolled at the determined RP2D in an expansion portion of the study.
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
- •Has disease that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.
- •Subjects must have histologically/cytologically confirmed gastric or gastroesophageal cancer that is metastatic (Stage 4) or unresectable (Stage 3).
- •Subjects must have received at least 1-2 prior lines of locally available standard therapies or must be intolerant of standard therapies.
- •For subjects in escalation: If prior Claudin 18 IHC expression is known, the subject must have some degree of Claudin 18 expression as defined as Positive or have expression ≥ 1% of tumor cells IHC ≥ 2+. Consult with Medical Monitor as needed.
- •Adequate organ function
- •Agree to have a biopsy prior to enrollment, at acceptable risk in the judgement of the Investigator. If a biopsy is not safely accessible or clinically feasible, an adequate archival tumor sample must be submitted.
排除标准
- •Known central nervous system (CNS) metastases except for disease that is asymptomatic, clinically stable, and has not required steroids for at least 14 days before starting study treatment.
- •Cardiac disease, pulmonary disease, or hepatic disease
- •Active infection
- •History of inflammatory eye disease
- •Residual toxicity from a previous treatment
- •Any investigational agent or standard anti-cancer therapies within 28 days before starting study treatment or within 5 estimated elimination half-lives, whichever is shorter.
研究组 & 干预措施
Dose Escalation
Escalating doses followed by backfill of selected doses
干预措施: BDC-4182 (Drug)
Dose Expansion
Expansion at determined RP2D
干预措施: BDC-4182 (Drug)
结局指标
主要结局
Incidence of adverse events (AEs) and serious adverse events (SAEs) graded according to CTCAE v5.0
时间窗: approximately 2 years
Escalation period
Incidence and nature of AEs considered by the Investigator or Sponsor to be clinically relevant, attributable to study treatment, and meeting dose-limiting toxicity (DLT) criteria
时间窗: Up to 21 days
Escalation period
次要结局
- Objective response rate (ORR) according to RECIST v. 1.1(approximately 4 years)
- Duration of Response (DOR)(approximately 4 years)
- Disease control rate (DCR)(approximately 4 years)
- Progression-free survival (PFS)(approximately 4 years)
- Best Overall Response (BOR)(approximately 4 years)
- Overall survival (OS)(approximately 4 years)
- PK (Cmax) of BDC-4182(approximately 4 years)
- PK (Cmin) of BDC-4182(approximately 4 years)
- PK (AUC0-tau) of BDC-4182(approximately 4 years)
- PK (AUC0-inf) of BDC-4182(approximately 4 years)
- PK (CL) of BDC-4182(approximately 4 years)
- PK (Vc or Vss) of BDC-4182(approximately 4 years)
- PK (Terminal half-life) of BDC-4182(approximately 4 years)