A Phase 1/2, Multicenter, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of KK2430 in Participants With Hematologic Neoplasms
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Dose Level Toxicity (DLT)
研究概览
简要总结
KK2430 ("Study Drug") as a potential treatment for people with Hematologic Neoplasms. KK2430 is an experimental drug; it has not been approved for the treatment of any disease by health authorities such as United States Food and Drug Administration (FDA), and this is the first time it will be given to people. The purpose of this Study is to find out more information about KK2430, whether it is safe in humans, how the body processes it, and if it works for treating your condition.
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
- •Participants must be at least 18 years of age at the time of signing the informed consent.
- •At least 1 measurable diseases based on CT scan or MRI
- •Renal function values
- •Participants who have an ECOG PS score of 0, 1 or
- •Be willing to provide a fresh tissue taken at current relapse at screening period.
- •Meet laboratory values at Screening i.e., ANC, Platelets, Corrected serum calcium, AST and ALT, Total bilirubin etc
- •Contraceptive use by [men and women] should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •Women of childbearing potential and fertile men must agree to use highly effective contraceptive methods • At least 1 measurable diseases based on CT scan or MRI
- •Capable of giving signed informed consent
- •Health Information Access: Capable of providing access to personal health information via HIPAA authorization (US only).
- •Legal Status: Not under any administrative or legal supervision or institutionalization due to regulatory or juridical order.
排除标准
- •Medical Conditions
- •History of prior allogenic transplant.
- •Presence of Grade 2 peripheral neuropathy with pain.
- •Impaired cardiac function or clinically significant cardiac disease at Screening
- •Known active CNS involvement or clinical signs of meningeal involvement.
- •Evidence of HIV infection.
- •Active chronic HBV/HCV infection,
- •Participants with positive anti-HBc must have a negative HBV-DNA quantification test result to be enrolled.
- •Receipt of any anti-tumor therapy within three weeks or at least five half-lives prior to the Screening visit, whichever is shorter.
- •Toxicities from prior anticancer therapies that have not resolved to Grade 1 or less except for abnormal clinical values alopecia and peripheral neuropathy (participants with Grade 1 or 2 neuropathy without pain are eligible for enrollment).
- •Use of systemic corticosteroids exceeding 10 mg/day of prednisone or equivalent within 14 days prior to the first dose
研究组 & 干预措施
2430-001 Part 1
KK2430 intravenous administration (including placebo)
干预措施: KK2430 (Drug)
结局指标
主要结局
Dose Level Toxicity (DLT)
时间窗: Endpoint 28 days after first dose
Number of Subjects Experiencing DLT; DLTs will be evaluated according to NCI-CTCAE Version 6.0.
Adverse Events (AEs)
时间窗: Signing of ICF through study completion for an average of 1.5 years
Number of participants with treatment-related adverse events as assessed by CTCAE v6.0 (all 72 potentially treated subjects)
Pregnancy Test
时间窗: Screening through study completion, an average of 1.5 years
Presence of hCG hormone
ECG QT Interval
时间窗: Treatment period, an average of 3months
Duration in ms
ECG QRS Interval
时间窗: Treatment period, an average of 3months
Duration in ms
Vital Sign Measurements
时间窗: Treatment period, an average of 3 months
Axillary body temperature; Degrees Celsius
次要结局
未报告次要终点