A Phase 1/2, Multicenter, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of KK2430 in Participants with with Hematologic Neoplasms

未提供0 个研究点目标入组 20 人开始时间: 待定

适应症

试验速览

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•Participants must be at least 18 years of age at the time of signing the informed consent.
•Participants who have an ECOG PS score of 0, 1 or
•Be willing to provide tissue taken at initial diagnosis or relapse during screening period.
•Meet the criteria of hematopoietic, renal and hepatic laboratory values at Screening.
•Contraceptive use should be consistent with local regulations.
•Capable of giving signed informed consent
•Not under any administrative or legal supervision or institutionalization due to regulatory or juridical order.

•History of prior allogenic transplant.
•Autologous transplant within 12 weeks prior to the first dose of study drug
•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.
•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.
•Use of systemic corticosteroids exceeding 10 mg/day of prednisone or equivalent within 14 days prior to the first dose of study drug

发起方

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