Actively Recruiting
A Phase 1/2 Study to Evaluate Safety, Tolerability, and Effects of KK2430 in People With Hematologic Neoplasms
Led by Kyowa Kirin Co., Ltd. · Updated on 2026-06-05
72
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating KK2430, an experimental drug, as a potential treatment for people with hematologic neoplasms. This Phase 1/2 study aims to learn about the safety, how the body processes KK2430, and its effects on this condition. KK2430 has not been approved by health authorities and this trial represents the first time it will be given to humans. Participants will receive KK2430 through intravenous administration, with some possibly receiving a placebo. The study includes a treatment period averaging three months during which various health measurements will be taken. The trial focuses on safety and tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy in treating hematologic neoplasms. During the study, participants will be monitored for dose level toxicity, adverse events, vital signs, and heart function through ECG tests. Pregnancy tests will also be conducted throughout the study, which lasts about 1.5 years from signing consent. Researchers will regularly assess health status and laboratory values to understand the drug's effects and safety.
CONDITIONS
Brief Title
A Phase 1/2 Study of KK2430 in Participants With Hematologic Neoplasms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be at least 18 years old at the time of informed consent
- Have at least one measurable disease based on CT scan or MRI
- Have renal function values within required limits
- Have an ECOG Performance Status score of 0, 1, or 2
- Willing to provide fresh tissue taken at current relapse during screening
- Meet specified laboratory values at screening including ANC, platelets, calcium, liver enzymes, and bilirubin
- Use contraception consistently according to local regulations if of childbearing potential or fertile
- Capable of providing signed informed consent
- Able to provide access to personal health information via HIPAA authorization (US only)
- Not under administrative or legal supervision or institutionalization due to regulatory or judicial order
You will not qualify if you...
- 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 central nervous system involvement or signs of meningeal involvement
- Evidence of HIV infection
- Active chronic hepatitis B or C infection
- Positive anti-HBc test with detectable HBV-DNA
- Received any anti-tumor therapy within three weeks or at least five half-lives prior to screening, whichever is shorter
- Toxicities from prior anticancer therapies not resolved to Grade 1 or less except alopecia and peripheral neuropathy without pain
- Use of systemic corticosteroids exceeding 10 mg/day prednisone or equivalent within 14 days prior to first dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 months
Participants receive intravenous administration of KK2430 as part of the treatment.
Multiple visits during treatment period for dosing and assessments
Duration - Up to 1.5 years after treatment
Participants are monitored for adverse events and pregnancy through study completion, averaging 1.5 years.
Periodic visits for safety monitoring and pregnancy testing
Trial Site Locations
Total: 1 location
1
Prisma Health
Greenville, South Carolina, United States, 29605
Actively Recruiting
Research Team
K
Kyowa Kirin, Inc.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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