A Phase I/II Dose Escalation and Expansion Study of BST-236 Plus Venetoclax in Patients With Unfit Newly Diagnosed AML
- Registration Number
- NCT05503355
- Lead Sponsor
- BioSight Ltd.
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
-
Adult ≥18 years of age
-
Diagnosis of AML (de-novo AML or AML secondary to MDS or secondary to exposure to potentially leukemogenic therapies or agents)
-
Not eligible for standard induction chemotherapy
-
Peripheral white blood cell (WBC) count of <25,000/μL
-
Creatinine clearance ≥45 mL/min
-
AST and/or aALT ≤2.5 X ULN)
-
Total bilirubin ≤1.5 x ULN
-
ECOG PS of:
- 0 to 2 for patients ≥75 years of age
- 0 to 3 for patients <75 years of age
-
Women of reproductive potential must have a negative serum pregnancy test within 48 hours of Study Day 1
- Patient has acute promyelocytic leukemia
- Any previous treatment for AML
- Patient has a known history of myeloproliferative neoplasm (MPN)
- Patient has known active central nervous system (CNS) involvement with AML
- Use of an investigational drug within 5 half-lives (or 30 days in case the half-life is unknown) prior to Study Day 1
- Previous BM/stem cell transplantation (SCT)
- Previous treatment for MDS with cytarabine, hypomethylating agents, or venetoclax
- For Part 1 only - use of known strong or moderate CYP3A inducers within 7 days prior to Study Day 1
- Patient has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges), or starfruit within 3 days prior to Study Day 1
- Patient has a malabsorption syndrome or other condition that precludes enteral route of drug administration
- Uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment)
- Any medical or surgical condition, presence of clinical safety laboratory abnormalities, or psychiatric illness that may preclude safe and complete study participation based on the Investigator's judgment.
- Diagnosis of malignant disease other than AML within the previous 12 months
- Diagnosis of myeloid sarcoma as a sole manifestation of AML
- Unstable angina, significant cardiac arrhythmia, or New York Heart Association (NYHA) Class IV CHF
- History of allergic reactions attributed to compounds of similar chemical composition as BST-236 and/or cytarabine and/or venetoclax.
- Surgical procedure, excluding central venous catheter placement or other minor procedures (e.g. skin biopsy) in the 14 days prior to enrollment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment BST-236 BSR-236 + venetoclax Treatment venetoclax BSR-236 + venetoclax
- Primary Outcome Measures
Name Time Method Dose limiting toxicity and maximal tolerated dose for part 2 Up to day 42 In part 2: Up to day 42 of second induction Complete remission rate
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
University of Virginia Cancer Center
🇺🇸Charlottesville, Virginia, United States