A Phase 1/2, Multicenter, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of KK2430 in Participants With Hematologic Neoplasms
Summary
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.
Arms & interventions
- DrugKK2430
KK2430 administered intravenously
Outcome measures
Primary
Dose Level Toxicity (DLT)
Number of Subjects Experiencing DLT; DLTs will be evaluated according to NCI-CTCAE Version 6.0.
Time frame: Endpoint 28 days after first dose
Adverse Events (AEs)
Number of participants with treatment-related adverse events as assessed by CTCAE v6.0 (all 72 potentially treated subjects)
Time frame: Signing of ICF through study completion for an average of 1.5 years
Pregnancy Test
Presence of hCG hormone
Time frame: Screening through study completion, an average of 1.5 years
ECG QT Interval
Duration in ms
Time frame: Treatment period, an average of 3months
ECG QRS Interval
Duration in ms
Time frame: Treatment period, an average of 3months
Vital Sign Measurements
Axillary body temperature; Degrees Celsius
Time frame: Treatment period, an average of 3 months
Vital Sign Measurements
Pulse Rate; beats per minute
Time frame: Treatment period, an average of 3 months
Vital Sign Measurements
Respiratory rate; breaths per minute
Time frame: Treatment period, an average of 3 months
Vital Sign Measurements
Systolic/Diastolic blood pressure; mm Hg
Time frame: Treatment period, an average of 3 months
Eligibility criteria
Study locations (1)
Prisma Health
Greenville, South Carolina, 29605