Phase 1 Study of the PKMYT1 Inhibitor RP-6306 in Combination With FOLFIRI for the Treatment of Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 38
- 试验地点
- 9
- 主要终点
- Safety and Tolerability of RP 6306 in Combination With FOLFIRI
研究概览
简要总结
The primary purpose of this study is to assess the safety and tolerability of RP-6306 with FOLFIRI in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD), identify a recommended phase 2 dose (RP2D) and preferred schedule, and assess preliminary anti-tumor activity.
详细描述
To assess the safety and tolerability of RP-6306 in combination with FOLFIRI in patients with eligible, advanced solid tumors. Incidence and severity of treatment-emergent adverse events (TEAEs), laboratory assessments, vital signs, electrocardiograms (ECGs), and use of concomitant medications.
The Sponsor of the study has changed from 'Repare Therapeutics' to 'Debiopharm International SA' in the United States.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Male or female and ≥18 years-of-age at the time of signature of the informed consent
- •Confirmed advanced solid tumors resistant or refractory to standard treatment
- •Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or
- •All patients must have locally advanced or metastatic CRC, GI, or esophageal cancer(s) and radiographic evidence of progressing disease.
- •Measurable disease as per RECIST v1.1
- •Submission of available tumor tissue or willingness to have a biopsy performed if safe and feasible
- •Acceptable hematologic and organ function at screening
- •Negative pregnancy test for women of childbearing potential at Screening and prior to first study drug.
排除标准
- •Inability to swallow and retain oral medications.
- •Chemotherapy or small molecule antineoplastic agent given within 21 days or <5 half- lives, whichever is shorter, prior to first dose of study treatment.
- •History or current condition, therapy, or laboratory abnormality that might confound the study results, or interfere with the patient's participation for the full duration of the study treatment.
- •Patients who are pregnant or breastfeeding
- •Life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction or other reasons which, in the investigator's opinion, could compromise the participating patient's safety.
- •Major surgery within 4 weeks prior to first study treatment dose.
- •Uncontrolled, symptomatic brain metastases.
- •Uncontrolled high blood pressure
- •Active, uncontrolled bacterial, fungal, or viral infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS) related illness.
- •Moderate or severe hepatic impairment
- •Cardiac diseases currently or within the last 6 months as defined by New York Heart Association (NYHA) ≥Class 2
- •Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.
研究组 & 干预措施
Phase 1: RP-6306 in combination with FOLFIRI Dose Escalation
RP-6306 will be administered as oral capsules Multiple dose levels of RP-6306 (oral) and FOLFIRI (IV)
干预措施: RP-6306 (oral PKMYT1 inhibitor) (Drug)
结局指标
主要结局
Safety and Tolerability of RP 6306 in Combination With FOLFIRI
时间窗: Start of treatment to 30 days post last dose. up to 1.5 years
Incidence of grade 3 and above Treatment Related Emergent Adverse Events (TRAEs)
Recommended Phase 2 Dose (RP2D) and Schedule of RP-6306 in Combination With FOLFIRI
时间窗: During 28 days (2 cycles) from the initiation of the study treatment
Evaluation of dose-limiting toxicities (DLTs) at or below a frequency of 25%.
次要结局
未报告次要终点