Phase I Study of Q702 With Azacitidine and Venetoclax for Relapsed or Refractory Acute Myeloid Leukemia
brief summary
To learn about the safety and tolerability of the drug combination of Q702, azacitidine, and venetoclax when given to participants with relapsed/refractory AML.
detailed description
Primary Objective:
\- To evaluate safety of Q702 and the combination of azacitidine, venetoclax.
Secondary Objectives:
* To estimate rate of CR/CRh/CRi by 4 treatment cycles * To estimate overall response rate (ORR) * To estimate rate of MRD negative by 4 treatment cycles * To estimate overall survival (OS) * To estimate relapse-free survival (RFS)
Exploratory Objectives:
* To determine the plasma concentration and pharmacokinetic (PK) parameters of Q702 when dosed in combination with azole antifungals in AML patients * To estimate duration of response (DOR) * To estimate median time to blood count recovery * To estimate median time to first response * To estimate median time to negative MRD * To study drug-drug interactions with CYP3A4 inhibitor azole antifungals * Additional response and survival endpoints * To explore biomarkers of response, pathway engagement, and resistance