NCT05503355RecruitingPhase 1
A Phase I/II Dose Escalation and Expansion Study of BST-236 Plus Venetoclax in Patients With Newly Diagnosed Acute Myeloid Leukemia Unfit for Intensive Induction Chemotherapy
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- BioSight Ltd.
- Enrollment
- 80
- Locations
- 3
- Primary Endpoint
- Dose limiting toxicity and maximal tolerated dose for part 2
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Treatment
Experimental
BSR-236 + venetoclax
Intervention: BST-236 (Drug)
Treatment
Experimental
BSR-236 + venetoclax
Intervention: venetoclax (Drug)
Outcomes
Primary Outcomes
Dose limiting toxicity and maximal tolerated dose for part 2
Time Frame: Up to day 42
In part 2:
Time Frame: Up to day 42 of second induction
Complete remission rate
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (3)
Loading locations...
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