This is an open, multi-center clinical study designed to evaluate the safety, tolerability and efficacy of TQB3909 tablets in combination with azacitidine in subjects with myeloid malignancies.
Voluntary and signed informed consent, good compliance
Age: ≥18 years old (at the time of signing the informed consent); expected survival time greater than 3 months.
Myelodysplastic Syndromes (MDS)
Major organ functions are normal.
Diagnosis of or current concomitant malignancy within 3 years prior to the first dose;
Presence of multiple factors affecting oral drug intake and/or absorption;
Major surgical procedures or significant traumatic injuries within 28 days prior to the first dose;
History of arterial/venous thrombotic events within 6 months prior to the first dose;
Single group
TQB3909 Tablets + Azacitidine
DrugTQB3909 is a protein inhibitor; Azacitidine is a cytidine nucleoside analogue
Incidence and severity of adverse events (AE) and serious adverse events (SAE), abnormal laboratory parameters
Any adverse medical event that occurred from the time the subject signed the informed consent until 28 days after the last dose/start of the new antitumor therapy (whichever occurs first)
Complete Remission + Complete Remission with Partial Hematologic Recovery (CR+CRh) Rate
Complete Remission + Complete Remission with Partial Hematologic Recovery (CR+CRh) Rate
Acute Myeloid Leukemia: Investigator-Assessed Objective Response Rate (ORR)
Proportion of subjects with best response as Complete Remission (CR), Complete Remission with Incomplete Hematologic Recovery (CRi), Morphologic Leukemia-Free State (MLFS), or Partial Remission (PR)
Myelodysplastic Syndromes: Investigator-Assessed Objective Response Rate (ORR)
Proportion of subjects with best response as CR, Morphological Complete Remission (mCR), or PR
Acute Myeloid Leukemia: Complete Remission + Complete Remission with Incomplete Hematologic Recovery (CR+CRi) Rate
Proportion of subjects with best response as CR+CRi. CRi refers to meeting all CR criteria except for residual neutrophil count decrease (ANC \< 1.0 × 109/L) or platelet count decrease (PLT \< 100 × 109/L).
Acute Myeloid Leukemia: Complete Remission + Complete Remission with Partial Hematologic Recovery (CR+CRh) Rate
Proportion of subjects with best response as CR
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