Study on KK2430 for Treating Blood Cancers
Sponsor: Kyowa Kirin Co., Ltd.
ClinicalTrials ID:NCT07629726
This clinical trial is testing a new experimental drug called KK2430 to see if it is safe and effective for treating blood cancers. This is the first time KK2430 will be given to people, and the study aims to learn how the body processes it and if it helps with the condition.
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Program Overview
The purpose of this study is to evaluate a new experimental drug, KK2430, as a potential treatment for blood cancers. KK2430 has not been approved by health authorities like the FDA, and this trial will be the first time it is tested in humans. The study aims to determine if KK2430 is safe, how it is processed by the body, and whether it is effective in treating blood cancers.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have at least one measurable disease based on a CT scan or MRI.
- Have acceptable kidney function.
- Have an ECOG performance status score of 0, 1, or 2, indicating full activity or some restriction in strenuous activities.
- Be willing to provide a fresh tissue sample if the cancer has returned.
- Meet specific laboratory test values for blood counts, liver function, and other health indicators.
- Agree to use effective contraception if of childbearing potential or fertile.
- Be able to give informed consent and allow access to personal health information.
- Not be under any legal or institutional restrictions.
Exclusion Criteria
- Have certain medical conditions.
- Have had a previous allogenic transplant.
- Have Grade 2 peripheral neuropathy with pain.
- Have significant heart problems.
- Have active central nervous system involvement or signs of meningeal involvement.
- Have evidence of HIV infection.
- Have active chronic hepatitis B or C infection.
- Have received any anti-cancer treatment within three weeks or less before the screening visit.
- Have unresolved side effects from previous cancer treatments, except for hair loss and mild nerve damage without pain.
- Use systemic corticosteroids exceeding 10 mg/day of prednisone or equivalent within 14 days before the first dose.
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