AML, AdultPhase 1/2NCT05503355
A Phase I/II Dose Escalation and Expansion Study of BST-236 Plus Venetoclax in Patients With Unfit Newly Diagnosed AML
A Phase 1/2 study testing BST-236 and venetoclax in people with AML, Adult, run by BioSight Ltd. at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- AML, Adult
- What is being tested?
- BST-236 and venetoclax
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Aug 2022to 1 Dec 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
University of Virginia Cancer Center
Charlottesville, Virginia, 22903
Michael Keng, MD, 434-924-9333, MK2PV@hscmail.mcc.virginia.edu
Michael Keng,, MD
- Not yet recruiting
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Jessica Altman, MD
Yasmin Abaza,
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Abhishek Maiti, MD, 833-974-4697, AMaiti@mdanderson.org
About this study
Official title: 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
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
- Conditions
- AML, Adult
- Being tested
- BST-236, venetoclax
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BST-236Drug
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
venetoclaxDrug
Also called Venclevta
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 group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | BSR-236 + venetoclax Receives: Drug: BST-236; Drug: venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity and maximal tolerated dose for part 2
Measured: Up to day 42
In part 2:
Complete remission rate
Measured: Up to day 42 of second induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start17 Aug 2022
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AML, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioSight Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503355
- Sponsor's protocol ID
- BST005
- Status last verified
- Aug 2022
- First submitted
- 14 Aug 2022
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05503355
- Acronym / sponsor ID
- BST005
- Conditions
- AML, Adult
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- BioSight Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 16 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: BST-236, Drug: venetoclaxBSR-236 + venetoclax |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BST-236In 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 | Treatment |
| venetoclaxAlso: VenclevtaIn 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 | Drug | Treatment |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The University of Texas MD Anderson Cancer Center
Houston, United States
University of Virginia Cancer Center
Charlottesville, United States
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BST-236 and venetoclax in people with AML, Adult, run by BioSight Ltd. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity and maximal tolerated dose for part 2 (time frame: Up to day 42). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.