Ascentage Pharma PHIb/II APG-115 (Leukemia & Myelodysplastic Syndrome) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find the most effective, safe dose of an experimental drug called APG-115. We want to know how well this study drug works in people with AML, CMML, or high risk MDS when it is given alone or in combination with a drug called 5-azacitidine.
Relapsed or Refractory Acute Myeloid Leukemia (AML), Chronic Myelomonocytic Leukemia (CMML), or Higher Risk Myelodysplastic Syndrome (MDS)
Who Can Participate in the Study?
- Are diagnosed with relapsed or refractory AML, CML, or Higher Risk MDS
- Have adequate organ function
- Do not have congestive heart failure with symptoms
- Do not have an uncontrolled infection
- Have not received an allogeneic (from a donor) stem cell transplant in the last 12 months
- Do not have active/ongoing graft versus host disease
For more information about who can join this study, please contact the study team at 919-660-2077.
What is Involved?
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
After the screening period, this study is divided into 2 parts. Part 1 is looking for the best dose of the study drug. Part 2 is looking at how the study drug behaves in your body and against your cancer when it is combined with 5-azacitidine. Whether you are able to participate in Part 1 or Part 2 depends on when you join the study.
If you join the study during Part 1, you will:
- Take the study drug by mouth on days 1-5 of each cycle (28 days)
If you join the study during Part 2, you will:
- Take the study drug by mouth on days 1-5 of each cycle and also receive 5-azacitidine (by injection or IV) for 7 days between days 1 and 9 of each cycle
Your participation in the study will last for up to 6 cycles (6 months).