A Study of JNJ-75276617 in Combination With Acute Myeloid Leukemia (AML) Directed Therapies

• Status: Not yet recruiting
• Trial end date: 2024-12-26
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the recommended Phase 2 dose (RP2D) candidate(s) of JNJ-75276617 in combination with AML directed therapies (dose selection) and further to evaluate safety and tolerability of JNJ-75276617 in combination with AML directed therapies at the RP2D(s) (dose expansion).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Azacitidine; Venetoclax

Criteria

Inclusion Criteria:

• Diagnosis of AML according to World Health Organization (WHO) 2016 criteria a) De novo or secondary AML; b) relapsed /refractory (Arm A); c) harboring NPM1 / KMT2A alterations

• Pretreatment clinical laboratory values meeting the following criteria -listed below:

White blood cell (WBC) count: less than or equal to <=25 x 10^9 per liter (/L), adequate liver and renal function

• ECOG performance status grade of 0, 1 or 2

• A woman of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin at screening and within 48 hours prior to the first dose of study treatment

• Must sign an informed consent form (ICF) indicating participant understands the purpose of the study and procedures required for the study and is willing to participate in the study.

• Willing and able to adhere to the prohibitions and restrictions specified in this protocol

Exclusion Criteria:

• Acute promyelocytic leukemia according to WHO 2016 criteria

• Leukemic involvement of the central nervous system

• Recipient of solid organ transplant

• Cardiovascular disease that is uncontrolled, increases risk for Torsades de Pointes or that was diagnosed within 6 months prior to the first dose of study treatment including, but not limited to:(a) Myocardial infarction; (b) Severe or unstable angina; (c) Clinically significant cardiac arrhythmias, including bradycardia (less than [<] 50 beats per minute); (d) Uncontrolled (persistent) hypertension: (example, blood pressure greater than [>] 140/90 millimeters of mercury [mm Hg]; (e) Acute neurologic events such as stroke or transient ischemic attack, intracranial or subarachnoid hemorrhage, intracranial trauma; (f) Venous thromboembolic events (example, pulmonary embolism) within 1 month prior to the first dose of study treatment (uncomplicated Grade less than or equal to [≤]2 deep vein thrombosis is not considered exclusionary);(g)Congestive heart failure (NYHA class III to IV); (h) Pericarditis or clinically significant pericardial effusion; (i) Myocarditis; (j) Endocarditis (k) Clinically significant hypokalemia, hypomagnesemia, hypocalcemia (corrected for hypoalbuminemia)

• Any toxicity (except for alopecia, stable peripheral neuropathy, thrombocytopenia, neutropenia, anemia) from previous anticancer therapy that has not resolved to baseline or to grade 1 or less

• Pulmonary compromise that requires the need for supplemental oxygen use to maintain adequate oxygenation