臨床研究等提出・公開システム

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

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

Shibata Shoyo

Kyowa Kirin Co., Ltd.

1-9-2, Otemachi , Chiyoda-ku, Tokyo

clinical.info.jp@kyowakirin.com

Clinical trial information contact

Kyowa Kirin Co., Ltd.

1-9-2, Otemachi , Chiyoda-ku, Tokyo

+81-3-5205-7200

clinical.info.jp@kyowakirin.com

Recruiting

May. 15, 2026

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

-Participants must be at least 18 years of age at the time of signing the informed consent.
-Participants who have an ECOG PS score of 0, 1 or 2.
-Be willing to provide tissue taken at initial diagnosis or relapse during screening period.
-Meet the criteria of hematopoietic, renal and hepatic laboratory values at Screening.
-Contraceptive use should be consistent with local regulations.
-Capable of giving signed informed consent
-Not under any administrative or legal supervision or institutionalization due to regulatory or juridical order.

-History of prior allogenic transplant.
-Autologous transplant within 12 weeks prior to the first dose of study drug
-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.
-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.
-Use of systemic corticosteroids exceeding 10 mg/day of prednisone or equivalent within 14 days prior to the first dose of study drug

Hematologic Neoplasms

KK2430 administered intravenously

-DLT
-AEs
-Laboratory test values
-Vital sign measurements
-ECG parameters

-Plasma KK2430 concentration
-PK parameter
-preliminary efficacy of KK2430

+81-3-3542-2511

Yes

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.

United States/Australia