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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2430-001 Part 1 | Experimental | KK2430 intravenous administration (including placebo) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KK2430 | Drug | KK2430 administered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Level Toxicity (DLT) | Number of Subjects Experiencing DLT; DLTs will be evaluated according to NCI-CTCAE Version 6.0. | Endpoint 28 days after first dose |
| Adverse Events (AEs) | Number of participants with treatment-related adverse events as assessed by CTCAE v6.0 (all 72 potentially treated subjects) | Signing of ICF through study completion for an average of 1.5 years |
| Pregnancy Test | Presence of hCG hormone | Screening through study completion, an average of 1.5 years |
| ECG QT Interval | Duration in ms | Treatment period, an average of 3months |
| ECG QRS Interval | Duration in ms | Treatment period, an average of 3months |
| Vital Sign Measurements | Axillary body temperature; Degrees Celsius | Treatment period, an average of 3 months |
| Vital Sign Measurements | Pulse Rate; beats per minute | Treatment period, an average of 3 months |
| Vital Sign Measurements | Respiratory rate; breaths per minute |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kyowa Kirin, Inc. | Contact | +1-609-919-1100 | KKD.Clinical.82@kyowakirin.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prisma Health | Recruiting | Greenville | South Carolina | 29605 | United States |
The datasets generated and/or analyzed during the study sponsored by Kyowa Kirin will be available in the Vivli repository, https://vivli.org/ourmember/kyowa-kirin/ as long as conditions of data disclosure specified in the policy section of the Vivli website are satisfied.
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Treatment period, an average of 3 months |
| Vital Sign Measurements | Systolic/Diastolic blood pressure; mm Hg | Treatment period, an average of 3 months |