Hematologic Neoplasms
Conditions
Interventions
KK2430 administered intravenously
Sponsors
Shibata Shoyo
Eligibility
Inclusion criteria
Inclusion criteria: -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 2. -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.
Exclusion criteria
Exclusion criteria: -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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -DLT -AEs -Laboratory test values -Vital sign measurements -ECG parameters | — |
Secondary
| Measure | Time frame |
|---|---|
| -Plasma KK2430 concentration -PK parameter -preliminary efficacy of KK2430 | — |
Countries
Australia, Japan, United States
Contacts
Public ContactClinical trial information contact
Kyowa Kirin Co., Ltd.
Outcome results
None listed