NCT05027867终止2 期
An Open-Label, Multicenter, Phase 2 Study of the Safety and Efficacy of KRT-232 in Subjects With Relapsed or Refractory Small Cell Lung Cancer (SCLC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 33
- 主要终点
- Objective response rate (ORR) of each arm
研究概览
简要总结
This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with relapsed or refractory small cell lung cancer.
This study will be conducted in 2 parts. Part 1 will evaluate two treatment arms, each with a different KRT-232 dose. Part 2 will continue the evaluation of the selected treatment arms from Part 1.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Histologically or cytologically confirmed diagnosis of SCLC documented as TP53WT
- •Disease must be measurable per RECIST Version 1.1
- •Evidence of radiographic progression during or after at least one prior platinum-containing therapy with no curative therapy available. Subjects who have received only one prior line of therapy must not be candidates for platinum-based regimens at relapse.
- •Subjects must have received a checkpoint inhibitor (PD-1 or PD-L1) unless contraindicated if checkpoint inhibitors are approved and available.
排除标准
- •Symptomatic or uncontrolled central nervous system (CNS) metastases.
- •Prior treatment with MDM2 inhibitors
- •Chemotherapy, immune therapy, cytokine therapy, or any investigational therapy within 14 days prior to the first dose of study treatment
- •Grade 2 or higher QTc prolongation (> 480 milliseconds per NCI-CTCAE criteria, version 5.0)
- •History of major organ transplant
研究组 & 干预措施
Arm 1
Experimental
KRT-232 240 mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles)
干预措施: KRT-232 (Drug)
Arm 2
Experimental
KRT-232 180 mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles)
干预措施: KRT-232 (Drug)
结局指标
主要结局
Objective response rate (ORR) of each arm
时间窗: 24 weeks
The proportion of subjects achieving partial response or better per RECIST 1.1
次要结局
- Progression-free survival (PFS) of each arm(1 year)
- Duration of response (DOR) of each arm(1 year)
- Disease control rate (DCR) of each arm(24 weeks)
- Overall survival (OS) of each arm(1 year)
研究者
研究点 (33)
Loading locations...
相似试验
招募中
1 期
KRT-232 and TKI Study in Chronic Myeloid LeukemiaChronic Myeloid LeukemiaNCT04835584Kartos Therapeutics, Inc.109
招募中
2 期
KRT-232 Versus Best Available Therapy for the Treatment of Subjects With Myelofibrosis Who Are Relapsed or Refractory to JAK Inhibitor TreatmentPrimary Myelofibrosis (PMF)Post-Polycythemia Vera MF (Post-PV-MF)Post-Essential Thrombocythemia MF (Post-ET-MF)NCT03662126Kartos Therapeutics, Inc.385
Unknown
2 期
KRT-232 Compared to Ruxolitinib in Patients With Phlebotomy-Dependent Polycythemia VeraPolycythemia VeraNCT03669965Kartos Therapeutics, Inc.20
招募中
1 期
Navtemadlin (KRT-232) With or Without Anti-PD-1/Anti-PD-L1 for the Treatment of Patients With Merkel Cell CarcinomaMerkel Cell CarcinomaNCT03787602Kartos Therapeutics, Inc.115
终止
1 期
An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 When Administered Alone and in Combination With Low-Dose Cytarabine (LDAC) or Decitabine in Patients With Acute Myeloid Leukemia (AML)Relapsed or Refractory Acute Myeloid Leukemia (AML)Acute Myeloid Leukemia (AML), Secondary to Myeloproliferative Neoplasms (MPN)NCT04113616Kartos Therapeutics, Inc.70