A Phase Ib Study of APG-115 Single Agent or in Combination With Azacitidine or Cytarabine in Patients With AML and MDS.

Launched by ASCENTAGE PHARMA GROUP INC. · Feb 18, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called APG-115 for patients with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS), which are types of blood cancers. APG-115 is a medication that may help stop the growth of cancer cells. In this trial, researchers want to see how safe APG-115 is when given alone and in combination with other drugs, azacitidine or cytarabine. The study is in its early phase, which means they are primarily focused on safety and how the body processes the drug. Eligible participants are adults aged 18 and older who have been diagnosed with relapsed or refractory AML or high-risk MDS and have good overall health.

During the trial, participants will receive treatment for up to six cycles, but they can continue if they are benefiting from the medication and it remains safe for them. They will have regular check-ups to monitor their health and how well the treatment is working. This trial is currently recruiting participants, and it’s important for anyone considering joining to discuss it with their doctor to understand the potential benefits and risks.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with a diagnosis of histologically confirmed relapsed or refractory (R/R) acute myeloid leukemia by WHO classification or relapsed/progressed high/very high risk MDS (score≥4.5) according to IPSS-R risk stratification
• • 2. Age \>/= 18 years.
• • 3. Adequate organ function
• • 4. Subject must have a projected life expectancy of at least 12 weeks.
• • 5. ECOG performance status of 0-1.
• • 6. Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol.
• • 7. Subject has a white blood cell count\< 50 × 109/L. Note: Hydroxyurea is permitted to meet this criterion.
• Exclusion Criteria:
• • 1. Subject has acute promyelocytic leukemia.
• • 2. Patients must not have had leukemia biotherapy 4 weeks prior to starting investigational drug, or less than 5 half-lives small molecular targeted drug therapy, or 28 days any anti-cancer therapy (whichever is longer)
• • 3. Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• • 4. Active infection requiring systemic antibiotic/antifungal medication, known clinically active hepatitis B or C, or HIV infection.
• • 5. Participants who have received allogeneic HSCT, or autologous HSCT within 12 months.
• • 6. Patients with active, uncontrolled CNS leukemia will not be eligible.
• • 7. Any prior systemic MDM2-p53 inhibitor treatment
• • 8. Any other condition or circumstance that would, in the opinion of the investigator, make the patient unsuitable for participation in the study.
• 9. Subject has a history of other malignancies within 2 years prior to study entry, with the exception of:
• • Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast;
• • Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
• • Previous malignancy confined and surgically resected (or treated with other modalities) with curative intention: requires discussion with sponsor.