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NCT Number: NCT07629726

A Phase 1/2 Study of KK2430 in Participants With Hematologic Neoplasms

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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Key information

Conditions

Hematologic Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KK2430

Drug

KK2430 administered intravenously

Primary outcomes

  1. Dose Level Toxicity (DLT)

    Time frame: Endpoint 28 days after first dose

    Number of Subjects Experiencing DLT; DLTs will be evaluated according to NCI-CTCAE Version 6.0.

  2. Adverse Events (AEs)

    Time frame: 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)

  3. Pregnancy Test

    Time frame: Screening through study completion, an average of 1.5 years

    Presence of hCG hormone

  4. ECG QT Interval

    Time frame: Treatment period, an average of 3months

    Duration in ms

  5. ECG QRS Interval

    Time frame: Treatment period, an average of 3months

    Duration in ms

  6. Vital Sign Measurements

    Time frame: Treatment period, an average of 3 months

    Axillary body temperature; Degrees Celsius

  7. Vital Sign Measurements

    Time frame: Treatment period, an average of 3 months

    Pulse Rate; beats per minute

  8. Vital Sign Measurements

    Time frame: Treatment period, an average of 3 months

    Respiratory rate; breaths per minute

  9. Vital Sign Measurements

    Time frame: Treatment period, an average of 3 months

    Systolic/Diastolic blood pressure; mm Hg

Study contacts

Contact information is provided by the study sponsor or research team.

Kyowa Kirin, Inc.

CONTACT

[email protected]

+1-609-919-1100

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study title

A Phase 1/2, Multicenter, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of KK2430 in Participants With Hematologic Neoplasms

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 5, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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