This study is a phase Ib/II study of Max-40279-01 in combination with Azacitidine (AZA) in patients with Myelodysplastic Syndrome (MDS) or Relapsed/Refractory Acute Myeloid Leukemia (R/R AML). This study include Phase Ib and Phase II study. The phase Ib study is designed to evaluate the safety and tolerability of MAX-40279-01 in combination with Azacitidine (AZA) in patients with Relapsed or Refractory AML. The phase II study is designed to preliminarily assess the efficacy and safety of Max-40279-01 in combination with Azacitidine (AZA) in patients with Myelodysplastic Syndrome (MDS) or Relapsed/Refractory Acute Myeloid Leukemia (R/R AML).
This is a two-part study comprised of a dose escalation part and a dose expansion part.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Drug: AZA AZA will be administered at 75 mg/m\^2 by subcutaneous injection for 7 consecutive days from D1 to D7 in 28-day treatment cycles. Other Name: Azacitidine Drug: Max-40279-01 Max-40279-01 will be administered as a combination of multiple oral capsules containing 5 and 25 mg. An alternate combination of 35 mg, 50 mg and 60 mg Max-40279-01 twice a day may be utilized. Other Name: NA
Institute of Hematology & Blood Diseases Hospital
Tianjin, China
RECRUITINGMaximum tolerated dose (MTD)
To explore the maximum tolerable dose (MTD) of Max-40279-01 in combination with Azacitidine (AZA) for patients with r/r AML or MDS, the recommended phase II dose (RP2D).
Time frame: Through study Part 1 completion, an average of 6 months
Phase II dose (RP2D)
Recommended phase II dose (RP2D)
Time frame: Through study Part 1 completion, an average of 6 months
Overall survival(OS)
Time frame: Up to 24 months
Rate of complete remission (CRc)
including Complete Remission with incomplete Platelet recovery (CRp) and Complete Remission with incomplete hematologic recovery (CRi)
Time frame: Up to 24 months
Tmax
Time to maximum plasma concentration
Time frame: Approximately 4 weeks
Cmax
Maximum plasma drug concentration
Time frame: Approximately 4 weeks
AUC
Area under the time-concentration curve
Time frame: Approximately 4 weeks
t1/2
Observed terminal half-life
Time frame: Approximately 4 weeks
Objective response rate (ORR)
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on IRWG.
Time frame: 1 months (anticipated)
Safety and tolerability assessed by incidence and severity of adverse events
All grade ≥ 3 toxicities according to CTCAE (Common Terminology Criteria for Adverse Events) version 5 will be tabulated
Time frame: 24 months
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