This is a Phase 1, multicenter, open-label, multiple-ascending dose study to evaluate the safety, PK, and preliminary clinical activity of KPG-818 as a single agent in adult subjects with selected hematological malignancies. The study center(s) will be in the US.
After providing informed consent, subjects will be assessed for study eligibility at the Screening visit (Days -28 to -1). Cohorts of 3 to 6 subjects per dose level will be given escalating doses of KPG-818 during Days 1 to 21 of each 28-day cycle orally until progressive disease (PD), unacceptable toxicity, the subject withdraws, or any other study withdrawal criterion is met. The 5 planned dose escalation cohorts will be 2, 5, 10, 20, and 30 mg followed by dose expansion. The dose of KPG-818 for the first cohort will be 2 mg/day. The highest dose level which may be tested is 30 mg KPG-818. Dose escalation will follow a 3+3 design and dose-limiting toxicity (DLT) will be assessed during the 28-day DLT evaluation period. The Safety Monitoring Committee (SMC) will be responsible for dose escalation decisions, including whether to modify the dose escalation based on the DLT observations or determine RP2D. Escalation to the Maximal Tolerated Dose (MTD) is not appropriate if activity plateaus at a lower dose.
The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.
The following criteria is provided for health care professionals.
Participants are eligible to be included in the study only if all the following criteria apply.
For Multiple Myeloma:
For MCL, FL, DLBCL, indolent lymphoma, ATL, or CLL:
• At least 1 bidimensionally measurable lesion larger than 1.5 cm in largest dimension by computed tomography (CT), positron emission tomography-CT (PET-CT), or magnetic resonance imaging (MRI) scan.
Exclusion Criteria Participants are excluded from the study if any of the following criteria apply.
The following is a listing of trial locations that are open and accepting patients.
Port Jefferson Station, NY
Port Jefferson Station, NY
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