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

NCT07629726 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 2430-001
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (9)

• 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

  Treatment period, an average of 3 months

• Vital Sign Measurements

  Systolic/Diastolic blood pressure; mm Hg

  Treatment period, an average of 3 months

Study Arms (1)

2430-001 Part 1

EXPERIMENTAL

KK2430 intravenous administration (including placebo)

Drug: KK2430

Interventions

KK2430 DRUG

KK2430 administered intravenously

2430-001 Part 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead

Study Sites (1)

Prisma Health

Greenville, South Carolina, 29605, United States

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Kyowa Kirin, Inc.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: June 5, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)