A Study of BN104 in the Treatment of Acute Leukemia

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

October 19, 2023

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2027

Conditions
ALL, AdultAML, AdultAcute LeukaemiaKMT2A RearrangementNPM1 MutationNUP98 Gene RearrangementMenin Inhibitors
Interventions
DRUG

BN104 monotherapy

Phase I(adults): Will be administered orally once daily (approximately every 24 hours) for the first cohort or twice daily (approximately every 12 hours) for the subsequent cohorts.

DRUG

BN104 monotherapy

Phase I(adolescent): Will be administered orally twice daily (approximately every 12 hours)

DRUG

BN104 monotherapy - rp2d

receiving oral BN104 treatment at a dose of 600 mg BID (300 mg BID when co-administered with strong CYP3A4 inhibitors)

Trial Locations (1)

215006

The First Affiliated Hospital of Soochow University, Suzhou

All Listed Sponsors
lead

Institut de Recherches Internationales Servier (I.R.I.S.)

INDUSTRY

NCT06052813 - A Study of BN104 in the Treatment of Acute Leukemia | Biotech Hunter | Biotech Hunter