NCT07107126招募中1 期
A Phase 1 Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Leukemia Activity of RPT1G in Patients With Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndromes (MDS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Incidence of adverse events, serious adverse events, and treatment-emergent adverse events
研究概览
简要总结
The main goals of this study are to learn if RPT1G is safe and tolerable and to determine the best dose and schedule of RPT1G for patients with relapsed or refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS).
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
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- •Histological confirmation of AML (ELN 2022 criteria) that relapsed and/or refractory AML or high-risk MDS as defined by International Consortium for MDS (icMDS) 2023 criteria that have received appropriate standard of care therapy, in the opinion of the investigator or declined receipt of these
- •Organ function/reserve as per the following laboratory criteria:
- •Hepatic: Aspartate aminotransferase (AST) ≤2.5 x upper limit of normal (ULN), alanine aminotransferase (ALT) ≤2.5 x ULN, and total bilirubin <2 x ULN (except for study patients with known Gilbert's where 1.5 x UL of the subject's baseline or in the case of suspected Gilbert's syndrome where a maximum total bilirubin level of 4.0 mg/dL is acceptable) for the local laboratory. If due to disease, higher values may be approved after discussion with medical monitor.
- •Renal: Adequate renal function as defined by calculated creatinine clearance >50 mL/min for the CLIA certified local laboratory. Creatinine clearance must be calculated by Cockcroft-Gault equation.
排除标准
- •Patients without evidence of blood or marrow involvement
- •Acute promyelocytic leukemia
- •Symptomatic central nervous system involvement by AML
- •Clinical signs/symptoms of leukostasis requiring urgent therapy
- •Active infections
- •Radiotherapy <14 days prior to the first day of RPT1G administration
- •Ongoing complications from prior therapy
- •Prior or concurrent malignancy
- •Any other condition, therapy, treatment, or comorbidity that leads the investigator to determine that the study is not in the best interest of the patient
研究组 & 干预措施
Cohort 3
Experimental
3rd ascending dose of RPT1G
干预措施: RPT1G (Drug)
Cohort 1
Experimental
Starting Dose of RPT1G
干预措施: RPT1G (Drug)
Cohort 2
Experimental
2nd ascending dose of RPT1G
干预措施: RPT1G (Drug)
结局指标
主要结局
Incidence of adverse events, serious adverse events, and treatment-emergent adverse events
时间窗: 3 years
Incidence and nature of dose-limiting toxicity(ies) (DLTs)
时间窗: 3 years
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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相关资讯
Remedy Plan Advances First-in-Class Hyperbolic NAMPT Inhibitor RPT1G Into Cohort 2 in R/R AML and HR-MDS; FDA Accepts Solid Tumor IND- Remedy Plan Therapeutics has initiated enrollment in Cohort 2 of its Phase 1 dose escalation trial of RPT1G in relapsed/refractory AML and higher-risk MDS.
- The FDA has accepted an Investigational New Drug application for RPT1G in solid tumors, expanding the program beyond hematologic malignancies.
- Cohort 1 patients completed the first full 28-day treatment cycle, which the company says marks the first sustained therapeutic NAMPT inhibition without limiting toxicity in cancer patients.
- The company closed a Series A extension of approximately $30 million and appointed Oleg Zernovak, M.D. as Vice President, Clinical Development.2 days agoRemedy Plan Therapeutics Strengthens Leadership with Appointment of Jotin Marango as CFO and CBO- Remedy Plan Therapeutics appointed Jotin Marango, M.D., Ph.D., as Chief Financial and Business Officer to strengthen financial position and advance corporate goals.
- Dr. Marango brings over 15 years of biotechnology experience, including leadership roles at Ikena Oncology and Aptose Biosciences in hematology and oncology.
- The appointment comes as the company advances its lead NAMPT inhibitor RPT1G through Phase 1 trials for relapsed/refractory acute myeloid leukemia and myelodysplastic syndromes.
- RPT1G utilizes a unique hyperbolic inhibition mechanism designed to overcome historical toxicity limitations of NAMPT inhibitors while targeting cancer cell metabolism.5 months ago