A Phase I/II Dose Escalation and Expansion Study of BST-236 Plus Venetoclax in Patients With Unfit Newly Diagnosed AML

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

August 17, 2022

Primary Completion Date

August 1, 2025

Study Completion Date

December 1, 2025

Conditions
AML, Adult
Interventions
DRUG

BST-236

"In part 1: During the induction (in combination with venetoclax), the BST-236 doses are:~In cohort 1 - 2.3 g/m2/d X6 days In cohort 2 - 2.3 g/m2/d X6 days In cohort 3 - 4.5 g/m2/d X6 days In cohort 4 - 4.5 g/m2/d X6 days In cohort 5 - 4.5 g/m2/d X6 days In part 1: During maintenances (for responding patients) the BST-236 dose- 4.5 g/m2/d X6 days In part 2, the dose chosen as safe and efficacious for induction in part 1 will be used"

DRUG

venetoclax

"In part 1: During the induction (in combination with BST-236), the venetoclax doses are:~In cohort 1 - 200 mg QD X 7 days In cohort 2 - 400 mg QD X 7 days In cohort 3 - 200 mg QD X 7 days In cohort 4 - 400 mg QD X 7 days In cohort 5 - 200 mg QD X 14 days In part 2, the dose chosen as safe and efficacious for induction in part 1 will be used"

Trial Locations (3)

22903

RECRUITING

University of Virginia Cancer Center, Charlottesville

60611

NOT_YET_RECRUITING

Northwestern Memorial Hospital, Chicago

77030

RECRUITING

The University of Texas MD Anderson Cancer Center, Houston

All Listed Sponsors
lead

BioSight Ltd.

INDUSTRY