NCT04811560

A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia (cAMeLot-1)

A Phase 1/2, First-in-Human Study of the Menin-KMT2A (MLL1) Inhibitor Bleximenib in Participants With Acute Leukemia (cAMeLot-1)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 420 (estimated)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Leukemias
• Acute Myeloid Leukemia
• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	Bleximenib	Bleximenib is administered orally.

Timeline

• Start date: 2021-05-19
• Primary completion: 2026-06-30
• Completion: 2030-09-22
• First posted: 2021-03-23
• Last updated: 2026-04-14

Locations

103 sites across 13 countries: United States, Australia, Belgium, Brazil, Canada, China, France, Israel, Japan, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study