NCT07629726 · Kyowa Kirin Co., Ltd.
A Phase 1/2 Study of KK2430 in Participants With Hematologic Neoplasms
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
KK2430
KK2430 administered intravenously
Primary outcome measures
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.
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)
Pregnancy Test
Time frame: Screening through study completion, an average of 1.5 years
Presence of hCG hormone
ECG QT Interval
Time frame: Treatment period, an average of 3months
Duration in ms
ECG QRS Interval
Time frame: Treatment period, an average of 3months
Duration in ms
Vital Sign Measurements
Time frame: Treatment period, an average of 3 months
Axillary body temperature; Degrees Celsius
Vital Sign Measurements
Time frame: Treatment period, an average of 3 months
Pulse Rate; beats per minute
Vital Sign Measurements
Time frame: Treatment period, an average of 3 months
Respiratory rate; breaths per minute
Vital Sign Measurements
Time frame: Treatment period, an average of 3 months
Systolic/Diastolic blood pressure; mm Hg
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Greenville, South Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 7, 2026 · Source of record for eligibility and locations