A Study to Assess Safety and Preliminary Efficacy of LP-108 Combined With Azacitidine In Subjects With AML, MDS, CMML
Key claim: A Phase 1 dose-escalation and expansion study is evaluating the safety, pharmacokinetics, and preliminary efficacy of the BCL-2 inhibitor LP-108 combined with azacitidine in subjects with AML, MDS, and CMML.
Abstract
This is a Phase 1, open-label, multicenter, dose-escalation & expansion study to evaluate the safety,tolerability and pharmacokinetics (PK) of LP-108, a BCL-2 inhibitor, combined with azacitidine, to determine the dose limiting toxicity (DLT) and the recommended Phase 2 dose (RP2D), and to assess the preliminary efficacy of this combination.
Why this matters
BCL-2 inhibition combined with hypomethylating agents has become a cornerstone of AML and higher-risk CMML/MDS therapy via venetoclax, but venetoclax resistance and myelosuppression leave room for next-generation BCL-2 inhibitors. LP-108 is one of the first such agents to enter formal Phase 1 combination testing with azacitidine, expanding the pipeline of HMA-partner regimens tracked in this area.