Phase I/Ib First-in-Human Study of EOS100850 as a Single Agent and in Combination With Pembrolizumab and/or Chemotherapy in Participants With Advanced Cancers
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 119
- 试验地点
- 19
- 主要终点
- Incidence of Dose-Limiting Toxicities (DLTs) in patients with advanced solid tumors receiving EOS100850
研究概览
简要总结
Multicenter, open-label, dose-escalation Phase I/Ib clinical study to evaluate the safety and tolerability, the MTD/RP2D, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of EOS100850 as a Single Agent and in Combination with Pembrolizumab and/or Chemotherapy in Participants with Advanced Cancers.
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
- •Women and men ≥18 years of age with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Subject with histologically or cytologically confirmed advanced solid tumor for whom no standard treatment is further available.
- •At least 4 weeks since any previous treatment for cancer
- •Subject must consent to pretreatment and on treatment tumor biopsies
- •Adequate organ and marrow function
排除标准
- •Patients with primary brain tumors or primary tumors with central nervous system metastases as only location of disease. Controlled brain metastases are permitted
- •Participants with second/other active cancers requiring current treatment
- •Uncontrolled/significant heart disease
- •Known History of chronic hepatitis, Positive test for Hepatitis B virus surface antigen or Hepatitis C antibody (except participants with liver cancer) or Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome(HIV/AIDS)
- •Active/uncontrolled autoimmune disease
- •Active infection
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
1A Dose escalation EOS100850
Dose Escalation- EOS100850 Monotherapy: to confirm RP2D
干预措施: EOS100850 (Drug)
1B Dose escalation EOS100850 and Pembrolizumab
EOS100850 and Pembrolizumab Combination Therapy: to confirm RP2D as combination
干预措施: EOS100850 (Drug)
1B Dose escalation EOS100850 and Pembrolizumab
EOS100850 and Pembrolizumab Combination Therapy: to confirm RP2D as combination
干预措施: Pembrolizumab (Drug)
2A Dose Expansion- EOS100850
Dose Expansion - EOS100850 Monotherapy: to explore safety, PK, PD, and antitumor activity of inupadenant as monotherapy
干预措施: EOS100850 (Drug)
2B Dose Expansion - EOS100850 and Pembrolizumab
Dose Expansion - EOS100850 and Pembrolizumab Combination Therapy: to explore safety, PK, PD, and antitumor activity of inupadenant in combination with pembrolizumab in melanoma and CRPC patients
干预措施: EOS100850 (Drug)
2B Dose Expansion - EOS100850 and Pembrolizumab
Dose Expansion - EOS100850 and Pembrolizumab Combination Therapy: to explore safety, PK, PD, and antitumor activity of inupadenant in combination with pembrolizumab in melanoma and CRPC patients
干预措施: Pembrolizumab (Drug)
2D Dose expansion - EOS100850 and Chemotherapy in TNBC
Dose expansion - EOS100850 and Chemotherapy Combination: to explore safety, PK, PD, and antitumor activity of inupadenant in combination with chemotherapy SOC carboplatin and paclitaxel in patients with TNBC
干预措施: EOS100850 (Drug)
2D Dose expansion - EOS100850 and Chemotherapy in TNBC
Dose expansion - EOS100850 and Chemotherapy Combination: to explore safety, PK, PD, and antitumor activity of inupadenant in combination with chemotherapy SOC carboplatin and paclitaxel in patients with TNBC
干预措施: Chemotherapy (Drug)
3 EOS100850 in BMK-H participants
Dose expansion - EOS100850 Monotherapy : to evaluate the safety, PD, and antitumor activity of inupadenant as monotherapy at the mono-RP2D in BMK-H participants in 4 disease-specific cohorts: NSCLC; HNSCC; EC; and other forms of cancer
干预措施: EOS100850 (Drug)
结局指标
主要结局
Incidence of Dose-Limiting Toxicities (DLTs) in patients with advanced solid tumors receiving EOS100850
时间窗: During the DLT evaluation period that is cycle 1 (each cycle is 3 or 4 weeks)
To define the maximum tolerated dose (MTD) or the recommended Phase 2 dose (RP2D) of EOS100850 in patients receiving EOS100850
Incidence and severity of AEs in patients receiving EOS100850
时间窗: Up to 30 months
To assess safety and tolerability as measured by incidence and severity of AEs
次要结局
- Plasma concentration of EOS100850 vs. time profiles(Up to 30 months)
- Maximum observed serum concentration (Cmax)(Up to 30 months)
- Time of maximum observed concentration (Tmax)(Up to 30 months)
- Area under the concentration-time curve in 1 dosing interval [AUC(TAU)](Up to 30 months)
- Plasma concentration half-life (T-HALF)(Up to 30 months)
- Overall response rate per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1(Up to 30 months)