A Phase 1/2 Study of KK2430 in Participants With Hematologic Neoplasms
ConditionHematologic Neoplasms
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorKyowa Kirin Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
KK2430
DrugKK2430 administered intravenously
Treatment groups
72 Participants
are divided into 1 treatment groupGroup A: 2430-001 Part 1Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 dose2
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 years3
Pregnancy Test
Presence of hCG hormone
Time frame
Screening through study completion, an average of 1.5 years4
ECG QT Interval
Duration in ms
Time frame
Treatment period, an average of 3monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov