Ascentage Pharma PHIb/II APG-115 (Leukemia & Myelodysplastic Syndrome)

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.

What is the Condition Being Studied?

Relapsed or Refractory Acute Myeloid Leukemia (AML), Chronic Myelomonocytic Leukemia (CMML), or Higher Risk Myelodysplastic Syndrome (MDS)

Who Can Participate in the Study?

Adults who:
- 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.

Age Group

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).

Study Details

Full Title
A Phase Ib/II Study of APG-115 Alone or in Combination with Azacitidine in Patients with Relapse/Refractory AML
Principal Investigator
Professor of Medicine
Protocol Number
IRB: PRO00106392
NCT: NCT04358393
Phase I/II
Enrollment Status