KK2430 in people with hematologic cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1/2 interventional study evaluating KK2430 in participants with hematologic neoplasms. The trial will assess safety, dosing, pharmacokinetics, and preliminary signs of activity. Eligible adults will have measurable disease and meet health criteria, including performance status and organ function. The study is conducted at least at Prisma Health in Greenville, SC, sponsored by Kyowa Kirin Co., Ltd. It represents an early development step to determine whether KK2430 could be a viable treatment option for hematologic cancers.

Why it matters

Who can join: the full rules

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 it's running

• Prisma Health
  Greenville, South Carolina, United States Recruiting

Study contacts

• Study coordinator: Kyowa Kirin, Inc.
• Email: KKD.Clinical.82@kyowakirin.com
• Phone: +1-609-919-1100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.