A Phase Ib/II, Open-Label, Dose-Escalation and Cohort Expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of PBSS1113 in Combination With Azacitidine in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
Acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) are highly heterogeneous myeloid malignancies where few effective targeted therapies are available. While venetoclax has significantly advanced the treatment landscape, therapeutic resistance remains a critical challenge. Consequently, patients with relapsed or refractory (R/R) AML/MDS face a profound unmet medical need for novel therapeutic options. PBSS1113 has demonstrated robust anti-leukemic activity in both in vitro and in vivo models, alongside an acceptable safety profile in a Phase I study. This Phase Ib/II trial will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of PBSS1113 in combination with azacitidine for treatment-naive unfit AML, R/R AML, and higher-risk MDS populations.
National Medical Products Administration, China
A Study to Assess the Effect of CC-95251 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndromes
A Phase Ib Study of APG-115 Single Agent or in Combination With Azacitidine or Cytarabine in Patients With AML and MDS.
A Study to Investigate APL-4098 Alone and in Combination in Adults With AML or MDS
A Study of AK117 in Combination With Azacitidine in Patients With Myelodysplastic Syndromes
A Study of APG-2575 in Combination With Azacitidine in Patients With Acute Myeloid Leukemia (AML)