A Phase 1, Multi-Center, Open-Label Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT8009 in Patients With Advanced Solid Tumours
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity(DLT)
研究概览
简要总结
Primary objectives:
- To evaluate the safety and tolerability of BAT8009 in patients with advanced solid tumours.
- To determine the maximum tolerated dose (MTD) and recommended dose for Phase 2 (RP2D).
详细描述
This is a first-in-human (FIH), multicentre, open-label, Phase 1 dose escalation and dose expansion study of BAT8009 (a B7H3-targeting antibody-drug conjugate) in patients with advanced solid tumours.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to give voluntary informed consent and understand the study and are willing to follow and complete all the study required procedures.
- •Aged ≥ 18 years and ≤ 75 years.
- •Life expectancy ≥ 3 months.
- •ECOG performance status ≤
- •Histologically/cytologically confirmed, locally advanced unresectable or metastatic solid tumours that are refractory to standard therapy.
- •Has measurable or evaluable disease per RECIST v1.
- •Adequate haematological, liver, kidney, cardiac and coagulation function.
- •Is willing to provide pre-existing diagnostic or resected tumour samples (if available).
- •Female patients must: Be of non-child-bearing potential; Male patients must: be willing not to donate sperm.
- •Must agree to adhere to the current state and national advice regarding minimising exposure to COVID-19 from the first Screening visit until the end of study (28-day Safety Follow-up Visit).
排除标准
- •Females who are pregnant or nursing.
- •Receiving concurrent anticancer therapy or investigational therapy.
- •Persisting AEs that are > Grade 1 from prior antitumour treatment as per CTCAE v5.
- •Patients with primacy central nervous system (CNS) malignancy, symptomatic CNS metastases, meningeal metastases or leptomeningeal disease are not allowed.
- •Had major surgery within 28 days of the Screening visit.
- •History of autologous transplantation ≤ 3 months.
- •History of severe infection deemed clinically significant by the PI or designee within 4 weeks.
- •History of human immunodeficiency virus (HIV) infection.
- •Active hepatitis B or C.
- •History of a Grade 3 or Grade 4 allergic reaction to treatment with other antibodies.
研究组 & 干预措施
Cohort 1
Experimental: BAT8009 for Injection 0.6 mg/kg (frequency: Q3W)
干预措施: BAT8009 for Injection (Drug)
Cohort 2
Drug: BAT8009 for Injection 1.2 mg/kg (frequency: Q3W)
干预措施: BAT8009 for Injection (Drug)
Cohort 3
Drug: BAT8009 for Injection 2.4 mg/kg (frequency: Q3W)
干预措施: BAT8009 for Injection (Drug)
Cohort 4
Drug: BAT8009 for Injection 3.6mg/kg (frequency: Q3W)
干预措施: BAT8009 for Injection (Drug)
Cohort 5
Drug: BAT8009 for Injection 4.8mg/kg (frequency: Q3W)
干预措施: BAT8009 for Injection (Drug)
Cohort6
Drug: BAT8009 for Injection 6.0mg/kg (frequency: Q3W)
干预措施: BAT8009 for Injection (Drug)
Cohort 7
Drug: BAT8009 for Injection 7.2mg/kg (frequency: Q3W)
干预措施: BAT8009 for Injection (Drug)
Cohort 8
Drug: BAT8009 for Injection 8.4mg/kg (frequency: Q3W)
干预措施: BAT8009 for Injection (Drug)
结局指标
主要结局
Dose-limiting toxicity(DLT)
时间窗: A minimum of 21 days after first dose of BAT8009
A DLT is defined as a toxicity occurring during the DLT observation period
次要结局
- Cmax (Maximum serum concentration)(126 days after first dosing)
- Immunogenicity(126 days after first dosing)
- AUC0-inf after Cycle 1 administration and AUC0- λ after Cycle 6 administration(126 days after first dosing)