A Phase 1/2 Study of BIO-106 As Monotherapy or In Combination With Pembrolizumab in Patients With Advanced Cancers (StarBridge-1)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 332
- 试验地点
- 3
- 主要终点
- Anti-tumor activity by objective response rate (ORR), disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS) - (Phase 2)
研究概览
简要总结
A first-in-human study using BIO-106 as a single agent and in combination with pembrolizumab in advanced cancers.
详细描述
This is an open-label, Phase 1/2, first-in-human (FIH), multiple ascending dose and dose-expansion study of BIO-106 administered as monotherapy and in combination with pembrolizumab. Phase 1 will define the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of BIO-106 that can be advanced to Phase 2. Phase 2 will define the preliminary efficacy of these regimens in the setting of advanced solid tumors with high unmet medical needs.
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
- •Patients histologically or cytologically documented, locally advanced or metastatic solid tumor.
- •Disease progression confirmed by imaging or other objective evidence after having received standard treatment; or patients with refractory solid tumors who cannot tolerate standard treatment or have contraindications to standard treatment.
- •Measurable disease as determined by RECIST v.1.1 or bone only disease.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
排除标准
- •History of severe hypersensitivity to any ingredient of the study drug(s), including pembrolizumab or other monoclonal antibody.
- •Impaired cardiac function or history of clinically significant cardiac disease
- •Human Immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.
- •Active SARS-CoV-2 infection.
- •Untreated central nervous system (CNS), epidural tumor or metastasis, or brain metastasis.
- •Other protocol defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Single agent BIO-106
Escalating doses followed by expansion targeting advanced cancers
干预措施: BIO-106 (Drug)
Combination BIO-106 plus pembrolizumab
Escalating doses followed by expansion targeting advanced cancers
干预措施: BIO-106 (Drug)
Combination BIO-106 plus pembrolizumab
Escalating doses followed by expansion targeting advanced cancers
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Anti-tumor activity by objective response rate (ORR), disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS) - (Phase 2)
时间窗: 2 years
Expansion period
Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1)
时间窗: 1 year
Escalation period
Incidence and nature of dose-limiting toxicities (DLTs) - (Phase 1)
时间窗: up to 21 days
Escalation period
Maximum tolerable dose (MTD) or a tolerated dose below MTD - (Phase 1)
时间窗: 1 year
Escalation period
次要结局
- PK (Cmax) of BIO-106 - (Phase 1/2)(2 years)
- PK (AUC) of BIO-106 - (Phase 1/2)(2 years)
- Anti-tumor activity by objective response rate (ORR), disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS) - (Phase 1)(1 year)
- Incidence of adverse event of special interest (AESI) - (Phase 2)(2 years)
- Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 2)(2 years)
- Incidence of anti-BIO-106 antibodies - (Phase 1/2)(2 years)