Status:
RECRUITING
A Phase Ib Study of APG-115 Single Agent or in Combination With Azacitidine or Cytarabine in Patients With AML and MDS.
Lead Sponsor:
Ascentage Pharma Group Inc.
Collaborating Sponsors:
Suzhou Yasheng Pharmaceutical Co., Ltd.
Conditions:
Acute Myeloid Leukemia (AML)
Myelodysplastic Syndromes (MDS)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Acute myeloid leukemia is a malignant disorder characterized by the rapid, uncontrolled proliferation of malignant clonal hematopoietic stem cells that accumulate as immature, undifferentiated cells (...
Detailed Description
Stage 1: This will be a 3+3 dose escalation to determine the DLTs and MTD/RP2D of APG-115 given according to the different dose levels once daily from Days 1 to 7 every 28 days. Stage 2: After stage ...
Eligibility Criteria
Inclusion
- 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
- Age \>/= 18 years.
- Adequate organ function
- Subject must have a projected life expectancy of at least 12 weeks.
- ECOG performance status of 0-1.
- 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.
- Subject has a white blood cell count\< 50 × 109/L. Note: Hydroxyurea is permitted to meet this criterion.
Exclusion
- Subject has acute promyelocytic leukemia.
- 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)
- 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.
- Active infection requiring systemic antibiotic/antifungal medication, known clinically active hepatitis B or C, or HIV infection.
- Participants who have received allogeneic HSCT, or autologous HSCT within 12 months.
- Patients with active, uncontrolled CNS leukemia will not be eligible.
- Any prior systemic MDM2-p53 inhibitor treatment
- Any other condition or circumstance that would, in the opinion of the investigator, make the patient unsuitable for participation in the study.
- 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.
Key Trial Info
Start Date :
July 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT04275518
Start Date
July 6 2020
End Date
December 31 2025
Last Update
October 15 2024
Active Locations (14)
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1
The First Hospital of Peking University
Beijing, Beijing Municipality, China, 100034
2
Guangzhou panyu central hospital
Guangzhou, Guangdong, China
3
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
4
Henan Provincial Oncology Hospital
Zhengzhou, Henan, China