A Phase 1/2, First-in-Human Study of the Menin-KMT2A (MLL1) Inhibitor Bleximenib in Participants With Acute Leukemia (cAMeLot-1)
Janssen Research & Development, LLC
Summary
The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D\[s\]) of bleximenib in phase 1 Part 1 (Dose Escalation) and to determine the safety and tolerability at RP2D in Phase 1 Part 2 (Dose expansion). The purpose of the Phase 2 part of the study is to evaluate the efficacy of bleximenib at the RP2D.
Eligibility
- Age range
- 2+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Phase 1: * Age 2 years to less than (\<) 18 years of age (pediatric cohort only), all other cohorts 18 years and above * Relapsed or refractory (R/R) acute leukemia and has exhausted, or is ineligible for, available therapeutic options * Acute leukemia harboring histone-lysine N-methyltransferase 2A (KMT2A), nucleophosmin 1 gene (NPM1) or nucleoporin 98 gene or nucleoporin 214 gene (NUP98 or NUP214) alterations Phase: 2 * Participants greater than 18 years are eligible * Must have had an initial diagnosis of acute myeloid leukemia (AML) per the WHO 2022 classification c…
Interventions
- DrugBleximenib
Bleximenib is administered orally.
Locations (103)
- City of Hope PhoenixGoodyear, Arizona
- City of HopeDuarte, California
- University of California Irvine Medical CenterOrange, California
- University of California San FranciscoSan Francisco, California
- UCSF Benioff Children's HospitalSan Francisco, California
- University of ChicagoChicago, Illinois