Trial Identifiers
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Scientific Title
A Phase 1b Study of JNJ-75276617 in Combination With AML Directed Therapies for Participants With Acute Myeloid Leukemia Harboring KMT2A or NPM1 Alterations
Commercial Sponsor
Janssen Research & Development, LLC
Summary
This study has two phases: dose selection and dose expansion.
In the dose selection phase, participants with relapsed or refractor acute myeloid leukaemia (AML) with either NPM1 or KMT2A alterations will receive JNJ-75276617 in combination with venetoclax and/ or azacitidine to select the recommended phase 2 dose (RP2D) of JNJ-75276617 in combination with venetoclax and/or azacitidne. There will be three cohorts. Cohort A1 will receive JNJ-75276617 (orally) + venetoclax (orally). Cohort A2 will receive JNJ-75276617 (orally) + azacitidine (intravenously). Cohort A3 will receive JNJ-75276617 (orally) + venetoclax (orally) + azacitidine (intravenously).
In the dose expansion phase of the study, participants will receive JNJ-75276617 in combination with AML directed therapies (venetoclax and/or azacitidine) at the RP2D(s).