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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
2430-001 Part 1 		KK2430 intravenous administration (including placebo)
  • Drug: KK2430
    KK2430 administered intravenously

Recruiting Locations

Prisma Health
Greenville, South Carolina 29605
Contact:
Dr Bhumika Patel
+1 864-455-3600
Bhumika.Patel@prismahealth.org

More Details

Status
Recruiting
Sponsor
Kyowa Kirin Co., Ltd.

Study Contact

Kyowa Kirin, Inc.
+1-609-919-1100
KKD.Clinical.82@kyowakirin.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.