Purpose of this Study
We are doing this study to find out if an experimental drug called KPG-818 (the study drug) is a safe and effective treatment for various hematological malignancies. The study drug will be combined with dexamethasone for participants who have multiple myeloma.
Who Can Participate?
Eligibility
Adults diagnosed with hematological malignancies who:
- Have relapsed from previous treatment; OR
- Did not have an adequate response to standard treatments; OR
- Have not received treatment yet
What is Involved?
Description
If you choose to join this study, you will go through a screening period to find out if you are eligible. During this screening period, you will:
- Have a physical exam
- Have a heart scan (ECG)
- Have blood draws and give urine samples
- Have bone marrow samples taken
- Have images taken (X-ray or CT scan)
- During Part 1, increasing doses of the study drug will be given to participants who have certain hematological malignancies
- During Part 2, a fixed dose of the study drug will be given to participants who have certain hematological malignancies based on the results of Part 1
- During the first study drug cycle, you will have 4 visits
- Cycle 2 will have 4 visits
- Cycles 3 and onward will have 1 visit
Study Details
Full Title
A Phase 1, Multicenter, Open-label, Multiple-ascending Dose Study to Evaluate the Safety, Pharmacokinetics and Clinical Activity of KPG-818 in Subjects with Hematological Malignancies
Principal Investigator
Cristina
Gasparetto
Protocol Number
PRO00107334
NCT ID
NCT04643067
Phase
I
Enrollment Status
Open to Enrollment