A Phase 1/2, Open Label Trial to Investigate the Safety, Tolerability, and Preliminary Efficacy of EIS-12656 as Single Agent and in Combination With a Poly-ADP Ribose Polymerase (PARP) Inhibitor or Trastuzumab Deruxtecan (T-DXd), an Antibody Drug Conjugate (ADC), in Participants With Specified Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Number and percentage of participants experiencing treatment-emergent adverse events (TEAEs)
研究概览
简要总结
This trial investigates a new drug, EIS-12656, in participants with specified advanced solid tumors carrying pre-specified mutations. The trial consists of a dose escalation part (Phase 1) and a dose expansion part (Phase 2).
详细描述
The trial is a Phase 1/2, open label, uncontrolled trial to investigate the safety and preliminary efficacy of EIS-12656 alone or in combination with a PARPi or T-DXd in patients with specified advanced or metastatic solid tumors with homologous recombination deficient (HRD) mutations.
In the Phase 1 dose escalation phase participants will receive ascending doses of EIS-12656 to evaluate the safety and tolerability and to determine an effective and safe dose for the Phase 2 part.
In the Phase 2 dose expansion phase participants will either receive EIS-12656 monotherapy at the recommended Phase 2 dose (RP2D) (Module 1) or EIS-12656 in combination with a PARPi or T-DXd (Modules 2 and 3). The objective is to evaluate the safety and tolerability and anti-tumor activity of EIS-12656 alone or in combination.
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
- •Recurrent locally advanced or metastatic solid tumors
- •Homologous recombination deficient mutations
- •Progressed on at least on prior line of treatment or intolerant to additional effective standard therapy
- •Measurable disease (RECIST 1.1 Criteria)
- •Adequate organ and bone marrow function
- •ECOG Performance Status 0 or 1
- •Life expectancy > 3 months
排除标准
- •History or evidence of any clinically relevant gastrointestinal disease
- •Radiation therapy within ≤2 weeks
- •Significant cardiovascular disease
- •Uncontrolled, active, symptomatic brain metastases
研究组 & 干预措施
EIS-12656 Dose Escalation
干预措施: EIS-12656 (Drug)
Dose Expansion Module 1 (EIS-12656 Monotherapy)
干预措施: EIS-12656 (Drug)
Dose Expansion Module 2 (EIS-12656 + Olaparib)
EIS-12656 will be given in combination with Olaparib
干预措施: EIS-12656 (Drug)
Dose Expansion Module 2 (EIS-12656 + Olaparib)
EIS-12656 will be given in combination with Olaparib
干预措施: Olaparib (Drug)
Dose Expansion Module 3 (EIS-12656 + T-DXd)
EIS-12656 will be given in combination with Trastuzumab deruxtecan
干预措施: EIS-12656 (Drug)
Dose Expansion Module 3 (EIS-12656 + T-DXd)
EIS-12656 will be given in combination with Trastuzumab deruxtecan
干预措施: Trastuzumab deruxtecan (Drug)
结局指标
主要结局
Number and percentage of participants experiencing treatment-emergent adverse events (TEAEs)
时间窗: From screening until end of treatment follow-up (45 days after last dose) (up to 7 months)
Number and percentage of participants with adverse events, serious adverse events, adverse events of special interest including changes in safety lab parameters, physical examinations, vital signs, and electrocardiogram (ECG)
Number and percentage of participants experiencing a dose limiting toxicity (DLT) (dose escalation part only)
时间窗: Within 21 days of first dose
A DLT is defined as an EIS-12656 related adverse event during the first treatment cycle that meets the criteria outlined in the study protocol
次要结局
- Maximum plasma concentration of EIS-12656 (Cmax)(At pre-defined intervals from pre-dose Day 1 to Day 29)
- Progression Free Survival(From screening to disease progression or death (approximately 1 year))
- Area under the curve (AUC0-24)(At pre-defined intervals from pre-dose Day 1 to Day 29)
- Time to maximum concentration (Tmax)(At pre-defined intervals from pre-dose Day 1 to Day 29)
- Duration of Response(From screening to disease progression or death (approximately 1 year))
- Overall Response Rate(From screening to disease progression (approximately 1 year))