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Phase 1/2 Study of KK2430 for Hematologic Neoplasms

This study is testing an experimental drug called KK2430 for people with hematologic neoplasms (cancers of the blood, bone marrow, or lymph nodes). KK2430 has not been approved by health authorities like the FDA, and this is the first time it will be given to people. The main goals are to find out if KK2430 is safe, how your body handles it, and if it helps treat your condition. You may be able to join if you are at least 18 years old, have measurable disease, and meet certain health and lab requirements. The study aims to enroll 72 participants.

Study design
This is a Phase 1/2 interventional study, meaning it's an early-stage trial to test a new treatment. It plans to enroll 72 participants.
What's involved
You would need to provide a fresh tissue sample from your current relapse at screening. You will also have regular pregnancy tests throughout the study.
Compensation
Not stated in the trial record.
Follow-up
Adverse events will be monitored from the signing of the informed consent form through study completion, for an average of 1.5 years. Pregnancy tests will also continue for an average of 1.5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07629726

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Kyowa Kirin Co., Ltd.
~72 participants
Updated 2026-08-07 on ClinicalTrials.gov
What's tested:KK2430

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose Level Toxicity (DLT)
Measured over Endpoint 28 days after first dose
+8 more outcomes measured

Conditions

Hematologic Neoplasms

Explore related trials

Hematologic Neoplasm

Where it's being run

1 sites across 1 states
South Carolina1

Who to contact

Kyowa Kirin, Inc.
[email protected]
+1-609-919-1100
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Dose Level Toxicity (DLT)Endpoint 28 days after first dose

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

  • Adverse Events (AEs)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)

  • Pregnancy TestScreening through study completion, an average of 1.5 years

    Presence of hCG hormone

  • ECG QT IntervalTreatment period, an average of 3months

    Duration in ms

  • ECG QRS IntervalTreatment period, an average of 3months

    Duration in ms

  • Vital Sign MeasurementsTreatment period, an average of 3 months

    Axillary body temperature; Degrees Celsius

  • Vital Sign MeasurementsTreatment period, an average of 3 months

    Pulse Rate; beats per minute

  • Vital Sign MeasurementsTreatment period, an average of 3 months

    Respiratory rate; breaths per minute

  • Vital Sign MeasurementsTreatment period, an average of 3 months

    Systolic/Diastolic blood pressure; mm Hg