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

Launched by BIOSIGHT LTD. · Aug 14, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new combination treatment for adults with Acute Myeloid Leukemia (AML) who are not suitable for standard chemotherapy. The treatment involves two drugs: BST-236 and venetoclax. The first part of the trial will determine the highest safe dose of this combination, while the second part will look at how well this dose works for treating AML. Patients who respond positively will receive additional maintenance treatments with BST-236 alone. Throughout the study, participants will be monitored for safety and effectiveness for a total of two years.

To be eligible for this trial, participants must be at least 18 years old, have a diagnosis of AML, and be unable to receive standard chemotherapy. They should also meet certain health criteria, such as having specific blood counts and kidney function. Patients will receive two initial treatment courses and may continue with up to three additional courses if they respond well. Importantly, the study is currently recruiting participants, so there is an opportunity for those who qualify to take part in this potentially beneficial research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adult ≥18 years of age
• • 2. Diagnosis of AML (de-novo AML or AML secondary to MDS or secondary to exposure to potentially leukemogenic therapies or agents)
• • 3. Not eligible for standard induction chemotherapy
• • 4. Peripheral white blood cell (WBC) count of \<25,000/μL
• • 5. Creatinine clearance ≥45 mL/min
• • 6. AST and/or aALT ≤2.5 X ULN)
• • 7. Total bilirubin ≤1.5 x ULN
• 8. ECOG PS of:
• • 0 to 2 for patients ≥75 years of age
• • 0 to 3 for patients \<75 years of age
• • 9. Women of reproductive potential must have a negative serum pregnancy test within 48 hours of Study Day 1
• Exclusion Criteria:
• • 1. Patient has acute promyelocytic leukemia
• • 2. Any previous treatment for AML
• • 3. Patient has a known history of myeloproliferative neoplasm (MPN)
• • 4. Patient has known active central nervous system (CNS) involvement with AML
• • 5. Use of an investigational drug within 5 half-lives (or 30 days in case the half-life is unknown) prior to Study Day 1
• • 6. Previous BM/stem cell transplantation (SCT)
• • 7. Previous treatment for MDS with cytarabine, hypomethylating agents, or venetoclax
• • 8. For Part 1 only - use of known strong or moderate CYP3A inducers within 7 days prior to Study Day 1
• • 9. Patient has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges), or starfruit within 3 days prior to Study Day 1
• • 10. Patient has a malabsorption syndrome or other condition that precludes enteral route of drug administration
• • 11. Uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment)
• • 12. 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.
• • 13. Diagnosis of malignant disease other than AML within the previous 12 months
• • 14. Diagnosis of myeloid sarcoma as a sole manifestation of AML
• • 15. Unstable angina, significant cardiac arrhythmia, or New York Heart Association (NYHA) Class IV CHF
• • 16. History of allergic reactions attributed to compounds of similar chemical composition as BST-236 and/or cytarabine and/or venetoclax.
• • 17. Surgical procedure, excluding central venous catheter placement or other minor procedures (e.g. skin biopsy) in the 14 days prior to enrollment