A First-in-Human Open-label, Phase I/Ib Dose Escalation and Expansion Cohort Study of EOS006215 as Monotherapy and in Combination With Pembrolizumab or Other Anticancer Treatments in Participants With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Incidence of dose-limiting toxicities (DLTs), adverse events (AEs)/serious adverse events (SAEs) [Safety and Tolerability]
研究概览
简要总结
TRM-010 is a first-in-human (FIH) clinical study designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of EOS006215, a fully human monoclonal antibody that binds to the triggering receptor expressed on myeloid cells 2 (TREM2). The study includes EOS006215 monotherapy and combination therapy with other anticancer agents in participants with advanced solid tumors.
详细描述
The study will be conducted in 2 parts:
- Part 1 - Dose Escalation Phase I dose escalation cohorts for EOS006215 as monotherapy and in combination with anticancer treatments in participants with specific tumor types.
- Part 2 - Dose Expansion Phase Ib dose expansion cohort(s) may be included to further evaluate the safety, tolerability, efficacy, PK and PD of EOS006215 as monotherapy or in combination with anticancer treatments in participants with specific tumor types.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Histologically or cytologically confirmed advanced or metastatic unresectable solid tumors for which standard approved treatment is not available or the participant is ineligible or did not tolerate the standard approved treatment.
- •At least one tumor lesion measurable per RECIST v1.1
- •Have an estimated minimum life expectancy of ≥ 12 weeks.
- •Adequate organ/marrow and liver function
- •Agree to use adequate highly effective method of contraception during the study is mandatory, if WOCBP or male
排除标准
- •Prior systemic anticancer treatment including investigational agents within 3 weeks (or 5 half-lives, whichever is shorter) before the first dose of study treatment
- •Major surgery planned or within 5 weeks before the first dose of study treatment, or minor surgical procedure (except tumor biopsy) within 7 days before the first dose of study treatment.
- •Radiotherapy within 2 weeks before the first dose of study treatment.
- •Evidence of severe active or chronic infections requiring systemic antibacterial, antiviral, or antifungal treatment, including tuberculosis infection
- •Known seropositivity for or active infection with human immunodeficiency virus (HIV)
- •Known seropositivity for hepatitis B virus (HBV), with evidence of active HBV infection
- •Known seropositivity for hepatitis C virus (HCV), with evidence of active HCV infection
- •Live or live-attenuated vaccine within 30 days before the first dose of study treatment.
- •History or current evidence of uncontrolled or significant cardiovascular disease
- •History or current evidence of significant autoimmune disease that required systemic
- •treatment
- •Diagnosis of immunodeficiency or any condition requiring systemic treatment with immunosuppressive medication
- •Pregnant or breastfeeding.
研究组 & 干预措施
Part 1 Dose Escalation (Monotherapy)
EOS006215 dose escalation as monotherapy
干预措施: EOS006215 (Drug)
Part 1 Dose Escalation (Combination Therapy)
EOS006215 dose escalation in combination with pembrolizumab or with other anticancer agents
干预措施: EOS006215 (Drug)
Part 1 Dose Escalation (Combination Therapy)
EOS006215 dose escalation in combination with pembrolizumab or with other anticancer agents
干预措施: Anticancer agent (Drug)
结局指标
主要结局
Incidence of dose-limiting toxicities (DLTs), adverse events (AEs)/serious adverse events (SAEs) [Safety and Tolerability]
时间窗: DLTs - At the end of Cycle 1 AEs/SAES - Duration of intervention (up to 24 months) plus 30 days follow-up
Rate of treatment modifications (interruption or permanent discontinuation) [Safety and Tolerability]
时间窗: Duration of intervention (up to 24 months)
Changes in safety parameters (clinical laboratory tests, vital signs, and electrocardiogram [ECG] / QTcF) [Safety and Tolerability]
时间窗: Duration of intervention (up to 24 months) plus 30 days follow-up
次要结局
- Overall response rate (ORR) [Efficacy](From randomization to confirmed radiological improvement, if applicable, assessed up to 24 months.)
- Duration of response (DoR)(From first confirmed CR or PR (whichever is first recorded) until the date of documented disease progression or death in the absence of disease progression, assessed up to 24 months.)
- Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [Efficacy](Time from starting treatment until disease progression or death for any reason.)
- Serum concentrations and PK parameters of EOS006215(From start of treatment until end of treatment (EOT))
- Incidence of antidrug antibody (ADA) against EOS006215(From start of treatment until end of treatment (EOT))
- Dose-finding to determine recommended Phase 2 dose(Duration of intervention (up to 24 months) plus 30 days follow-up)