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
Kyowa Kirin Co., Ltd.
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 2. * 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…
Interventions
- DrugKK2430
KK2430 administered intravenously
Location
- Prisma HealthGreenville, South Carolina