Recruiting
Phase 1
Phase 2

KK2430

Sponsor:

Kyowa Kirin Co., Ltd.

Code:

NCT07629726

Conditions

Hematologic Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

KK2430

Study Details

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.

Conditions

Hematologic Neoplasms

Study ID

NCT07629726

Start date

Aug, 2026

Status verified date

Aug, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

72 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 2430-001 Part 1

KK2430 intravenous administration (including placebo)

Interventions

KK2430

KK2430 administered intravenously

Primary outcome measure

  • Dose Level Toxicity (DLT) [ Time Frame: Endpoint 28 days after first dose ]
  • Adverse Events (AEs) [ Time Frame: Signing of ICF through study completion for an average of 1.5 years ]
  • Pregnancy Test [ Time Frame: Screening through study completion, an average of 1.5 years ]
  • ECG QT Interval [ Time Frame: Treatment period, an average of 3months ]
  • ECG QRS Interval [ Time Frame: Treatment period, an average of 3months ]
  • Vital Sign Measurements [ Time Frame: Treatment period, an average of 3 months ]
  • Vital Sign Measurements [ Time Frame: Treatment period, an average of 3 months ]
  • Vital Sign Measurements [ Time Frame: Treatment period, an average of 3 months ]
  • Vital Sign Measurements [ Time Frame: Treatment period, an average of 3 months ]

Central Contacts and Locations

Central contacts

Kyowa Kirin, Inc.

+1-609-919-1100KKD.Clinical.82@kyowakirin.com

Locations

Prisma Health

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Dr Bhumika Patel

+1 864-455-3600Bhumika.Patel@prismahealth.org

Janine Benedetto

Janine.Benedetto@prismahealth.org

More Information

Sponsor

Kyowa Kirin Co., Ltd.

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kyowa Kirin Co., Ltd. on 2026-08-07.