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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
BioSight Ltd.
Study ID
NCT05503355
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • AML, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • BST-236 — DRUG
    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
  • venetoclax — DRUG
    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

Study Details

An open label multi centre study to assess the safety and efficacy of BST-236 in combination with venetoclax in adult patients unfit for standard therapy with newly diagnosed Acute Myeloid Leukemia (AML) Part 1 of the study will define the maximal tolerate dose of the combination treatment, while part 2 will expend the chosen dose, to assesses efficacy and safety of this combination. All patients will receive 2 induction courses with both BST-236 and venetoclax, responding patients will then be followed with up to 3 maintenance courses with BST-236 alone. Patients will be followed for 1 year in the study and additional 1 year in post study follow-up

Key Dates

Start date
Aug 17, 2022
Status verified
Aug 2022
Primary completion
Aug 1, 2025
Completion
Dec 1, 2025

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    BSR-236 + venetoclax

Primary Outcome Measure

Dose limiting toxicity and maximal tolerated dose for part 2 [ Time Frame: Up to day 42 ]

Locations (3)

FacilityCityStateZIPSite coordinators
Northwestern Memorial HospitalChicagoIllinois60611
Jessica Altman, MD
Yasmin Abaza, (PRINCIPAL_INVESTIGATOR)
The University of Texas MD Anderson Cancer CenterHoustonTexas77030
Abhishek Maiti, MD
[email protected]
833-974-4697
University of Virginia Cancer CenterCharlottesvilleVirginia22903
Michael Keng, MD
[email protected]
434-924-9333
Michael Keng,, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By research site
Northwestern Memorial Hospital· Chicago, ILThe University of Texas MD Anderson Cancer Center· Houston, TXUniversity of Virginia Cancer Center· Charlottesville, VA

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