Hematologic Neoplasms
Conditions
Brief 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.
Interventions
DRUGKK2430
KK2430 administered intravenously
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose Level Toxicity (DLT) | 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) | 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 | Screening through study completion, an average of 1.5 years | Presence of hCG hormone |
| ECG QT Interval | Treatment period, an average of 3months | Duration in ms |
| ECG QRS Interval | Treatment period, an average of 3months | Duration in ms |
| Vital Sign Measurements | Treatment period, an average of 3 months | Axillary body temperature; Degrees Celsius |
Countries
United States
Contacts
CONTACTKyowa Kirin, Inc.
Outcome results
None listed