LeukemiaPhase 1NCT06501196
A Study of BH-30236 in Relapsed/ Refractory Acute Myelogenous Leukemia and Higher Risk Myelodysplastic Syndrome
A Phase 1 study testing BH-30236 and Venetoclax in people with Leukemia and Leukemia, Myeloid, run by BlossomHill Therapeutics at 13 sites in United States.
Trial summary
Study BH-30236-01 is a first-in-human (FIH), Phase 1/1b, open-label, dose escalation and expansion study in participants with relapsed/refractory acute myelogenous leukemia (R/R AML) or higher-risk myelodysplastic syndrome (HR-MDS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Leukemia, Myeloid, Leukemia, Myeloid, Acute
- What is being tested?
- BH-30236 and Venetoclax
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 13 sitesUnited States
- Study dates
- 19 Jun 2024to Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years.
- Diagnosis of relapsed/refractory acute myelogenous leukemia (R/R) AML or higher-risk myelodysplastic syndrome (HR-MDS) with ≥5% bone marrow blast at time of inclusion.
- Prior treatment history must include 1-5 prior lines of therapy.
- ECOG performance status ≤2.
- Adequate organ function evidenced by the following laboratory values:
- Hepatic: Transaminase levels aspartate aminotransferase [AST]/ alanine transaminase [ALT] ≤ 2.5 × upper limit of normal (ULN). In cases of liver involvement by AML or MDS, AST and ALT < 5.0 × ULN is acceptable. Total bilirubin ≤ 1.5 × ULN in the absence of documented Gilbert's disease.
- Renal: Measured or calculated creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula)
- The above are a summary, other inclusion criteria details may apply.
Who cannot join
- Diagnosis of acute promyelocytic leukemia or chronic myeloid leukemia with blast crisis.
- Prior allogeneic HSCT within 3 months or donor lymphocyte infusion within 30 days of start of therapy;
- Active and uncontrolled infections.
- Unresolved AEs greater than Grade from prior therapies.
- History of other active malignancy (with certain exceptions)
- Prior treatment with a CLK inhibitor.
- Any acute or chronic graft versus host disease requiring systemic therapy within 4 weeks prior to study drug administration with the exception of topical steroids or the equivalent of 20 mg of prednisone or less.
- The above is a summary, other exclusion criteria details may apply.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
United States13 sites, 13 recruiting
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
- Recruiting
Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion
Chicago, Illinois, 60611
- Recruiting
The Ohio State University Wexner Medical Center - James Cancer Hosp
Columbus, Ohio, 43210
- Recruiting
City of Hope Medical Center
Duarte, California, 91010
- Recruiting
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
University of California Los Angeles
Los Angeles, California, 90095
- Recruiting
University of Wisconsin Clinical Science Center
Madison, Wisconsin, 53792
- Recruiting
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
- Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Study Coordinator
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Study Coordinator
- Recruiting
Stanford Cancer Center
Palo Alto, California, 94304
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: A Phase 1/1b Open-Label, Dose Escalation, First-in- Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-leukemic Activity of the Orally Available CDC-Like Kinase (CLK) Inhibitor, BH-30236, in Adults With Relapsed or Refractory Acute Myelogenous Leukemia (R/R AML) or Higher-Risk Myelodysplastic Syndrome (HR-MDS)
Study BH-30236-01 is a first-in-human (FIH), Phase 1/1b, open-label, dose escalation and expansion study in participants with relapsed/refractory acute myelogenous leukemia (R/R AML) or higher-risk myelodysplastic syndrome (HR-MDS).
Phase 1, Part 1 Dose Escalation - Monotherapy will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of BH-30236 administered orally. Approximately 50 participants may be enrolled in Phase 1, Part 1 Dose Escalation - Monotherapy.
Read more
Phase 1, Part 2 Dose Escalation - Combination with Venetoclax will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of BH-30236 administered as a combination therapy with venetoclax. Approximately 48 participants may be enrolled in Phase 1, Part 2 Dose Escalation - Combination with Venetoclax.
Phase 1b (Dose Expansion) will follow Phase 1 to further understand the relationships among dose, exposure, toxicity, tolerability, and clinical activity. Up to 72 participants may be enrolled in Phase 1b of the study as a monotherapy or in combination with venetoclax.
Read the detailed description
This is a Phase 1/1b, multi-center, open-label, dose escalation, first-in-human study to evaluate the safety, tolerability, PK, PD, and preliminary anti-leukemic activity of the CLK inhibitor, BH-30236 as a monotherapy or in combination with venetoclax, in adult participants with R/R AML or HR-MDS.
The study consists of three parts: Phase 1, Part 1 Dose Escalation - Monotherapy, Phase 1, Part 2 Dose Escalation - Combination with Venetoclax, and Phase 1b Dose Expansion.
Phase 1, Part 1 Dose Escalation - Monotherapy is anticipated to enroll approximately 50 participants to evaluate the safety, tolerability, PK, PD, and preliminary anti-leukemic activity of BH-30236, as well as determine the MTD and/or the preliminary recommended dose(s) for expansion (RDEs).
Phase 1, Part 2 Dose Escalation - Combination with Venetoclax is anticipated to enroll approximately 48 participants to evaluate the safety, tolerability, PK, PD, and preliminary anti-leukemic activity of BH-30236, as well as determine the MTD and/or the preliminary recommended dose(s) for expansion (RDEs).
Phase 1 will follow a Bayesian optimal interval (BOIN) design dose escalation, where participants will receive ascending doses of BH-30236 to determine the recommended RDEs.
Phase 1b Dose Expansion will enroll approximately 72 participants to evaluate the safety, tolerability, and preliminary anti-leukemic activity of BH-30236 as a monotherapy or in combination with venetoclax at selected RDEs determined in Phase 1 Dose Escalation.
- Conditions
- Leukemia, Leukemia, Myeloid, Leukemia, Myeloid, Acute, Preleukemia, Myelodysplastic Syndromes, Refractory Acute Myeloid Leukemia
- Being tested
- BH-30236, Venetoclax
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Leukemia, Myeloid, Acute, Preleukemia, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BH-30236Drug
BH-30236 will be provided as either a 5 mg, 15 mg or 30 mg tablet. Participants will take BH-30236 tablets orally depending on their dose level assignment.
VenetoclaxDrug
Also called venclexta, venclyxto
Venetoclax will be provided as 10 mg, 50 mg or 100 mg tablets. Participants will take venetoclax orally per label instructions.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Cohort - Monotherapy | Experimental | BH-30236 Monotherapy for Dose Escalation Receives: Drug: BH-30236 |
| Dose Escalation Cohort - Combination with Venetoclax | Experimental | BH-30236 in Combination with Venetoclax for Dose Escalation. Receives: Drug: BH-30236; Drug: Venetoclax |
| Dose Expansion Cohort - Monotherapy | Experimental | BH-30236 based on Monotherapy dose escalation data. Receives: Drug: BH-30236 |
| Dose Expansion Cohort - Combination with Venetoclax | Experimental | BH-30236 in Combination with Venetoclax based on Dose Escalation data Receives: Drug: BH-30236; Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation: Frequency of dose limiting toxicities (DLTs)
DLTs are dose-limiting toxicities as defined in the study protocol.
Measured: Dose-limiting toxicities are collected during the first treatment cycle (28 days)
Dose Escalation and Expansion: Safety evaluation of BH-30236: Number of participants with treatment-related adverse events as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Frequency, severity and relationship to study drug of AEs and SAEs
Measured: From first dose until 28 days after last dose of BH-30236
Dose Expansion: Composite Complete Remission (CR) Rate
Composite CR rate disease assessment in accordance with the following guidelines: European Leukemia Network (ELN) 2022 for acute myelogenous leukemia (AML) and International Working Group (IWG) 2023 for myelodysplastic syndrome (MDS).
Measured: From first dose of BH-30236 until disease progression (up to approximately 1 year)
Secondary outcomes (10)
Dose Escalation and Expansion: Maximum observed blood concentration (Cmax) of BH-30236.
Blood samples for PK analyses will be collected at predetermined time points and analyzed.
Measured: Evaluation performed in Cycle 1 (cycle duration is 28 days).
Dose Escalation: Area under the blood concentration time curve (AUC) of BH-30236.
Blood samples for PK analyses will be collected at predetermined time points and analyzed.
Measured: Evaluation performed in Cycle 1 (cycle duration is 28 days).
Dose Escalation and Expansion: Concentration before dose at steady state (Ctrough).
Blood samples for PK analyses will be collected at predetermined time points and analyzed.
Measured: Evaluation performed in all treatment cycles up to one year (cycle duration is 28 days).
Dose Escalation and Expansion: Objective Response Rate (ORR)
Objective response rate disease assessments in accordance with the following guidelines: ELN 2022 recommendations for AML and IWG 2023 for MDS (CR, CR with partial hematologic recovery [CRh], CR with incomplete count recovery [CRi], CR with limited count recovery [CRL], morphologic leukemia-free state [MLFS], or partial response [PR]).
Measured: From first dose of BH-30236 until disease progression (up to approximately 1 year)
Dose Escalation and Expansion: Duration of Response (DoR)
Time from first documented response until the date of relapse or death.
Measured: Time from first documented response until disease progression or death (approximately 1 year).
Dose Escalation and Expansion: Time to remission (TTR)
Time from first dose to the achievement of first remission Disease assessments will follow the following guidelines: ELN 2022 for AML and IWG 2023 for MDS.
Measured: From first dose of BH-30236 until complete remission, disease progression or death (approximately 1 year).
Dose Escalation and Expansion: Relapse-free Survival (RFS)
The time from the start of treatment date to disease progression, death, or initiation of a new anti-leukemic therapy.
Measured: From first dose of BH-30236 until disease progression, death, or initiation of a new anti-leukemic therapy (approximately 1 year).
Dose Escalation and Expansion: Measurable Residual Disease (MRD)
For AML, using ELN 2022 criteria for disease assessment from Screening, then at the beginning of Cycle 2 and 3, and then every second cycle thereafter.
Measured: From time of first dose until discontinuation of BH-30236 (approximately 1 year).
Dose Escalation and Expansion: Measurement of the change in RNA alternative splicing markers on BH-30236 treatment
Peripheral blood samples for pharmacodynamic (PD) analyses will be collected at predetermined time points and analyzed.
Measured: From time of first dose until discontinuation of BH-30236 (approximately 1 year).
Dose Escalation and Expansion: Complete remission (CR) / complete remission with partial hematologic recovery (CRh) rate for AML and complete remission/partial remission (CR/PR) rate for HR-MDS
In accordance with the following guidelines: ELN 2022 recommendations for AML and IWG 2023 for MDS (CR, CR with partial hematologic recovery [CRh], CR with incomplete count recovery [CRi], CR with limited count recovery CRL, morphologic leukemia-free state [MLFS], or partial response [PR])
Measured: Time from first documented response until disease progression or death (approximately 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start19 Jun 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LeukemiaStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BlossomHill Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sponsor Contact, Study director, BlossomHill Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06501196
- Sponsor's protocol ID
- BH-30236-01
- Status last verified
- Sep 2025
- First submitted
- 17 Jun 2024
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maron MI, Abdel-Wahab O. Outstanding Questions to Understand and Target Splicing Factor-Mutant Blood Cancers. Blood Cancer Discov. 2026 May 5;7(3):348-352. doi: 10.1158/2643-3230.BCD-26-0047.
PubMed 42013378
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/1b Open-Label, Dose Escalation, First-in- Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-leukemic Activity of the Orally Available CDC-Like Kinase (CLK) Inhibitor, BH-30236, in Adults With Relapsed or Refractory Acute Myelogenous Leukemia (R/R AML) or Higher-Risk Myelodysplastic Syndrome (HR-MDS)
- ClinicalTrials.gov ID
- NCT06501196
- Acronym / sponsor ID
- BH-30236-01
- Conditions
- Leukemia, Leukemia, Myeloid, Leukemia, Myeloid, Acute, Preleukemia, Myelodysplastic Syndromes, Refractory Acute Myeloid Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- BlossomHill TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 15 Jul 2024 (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.
Study BH-30236-01 is a first-in-human (FIH), Phase 1/1b, open-label, dose escalation and expansion study in participants with relapsed/refractory acute myelogenous leukemia (R/R AML) or higher-risk myelodysplastic syndrome (HR-MDS).
Phase 1, Part 1 Dose Escalation - Monotherapy will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of BH-30236 administered orally. Approximately 50 participants may be enrolled in Phase 1, Part 1 Dose Escalation - Monotherapy.
Phase 1, Part 2 Dose Escalation - Combination with Venetoclax will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of BH-30236 administered as a combination therapy with venetoclax. Approximately 48 participants may be enrolled in Phase 1, Part 2 Dose Escalation - Combination with Venetoclax.
Phase 1b (Dose Expansion) will follow Phase 1 to further understand the relationships among dose, exposure, toxicity, tolerability, and clinical activity. Up to 72 participants may be enrolled in Phase 1b of the study as a monotherapy or in combination with venetoclax.
Detailed description
This is a Phase 1/1b, multi-center, open-label, dose escalation, first-in-human study to evaluate the safety, tolerability, PK, PD, and preliminary anti-leukemic activity of the CLK inhibitor, BH-30236 as a monotherapy or in combination with venetoclax, in adult participants with R/R AML or HR-MDS.
The study consists of three parts: Phase 1, Part 1 Dose Escalation - Monotherapy, Phase 1, Part 2 Dose Escalation - Combination with Venetoclax, and Phase 1b Dose Expansion.
Phase 1, Part 1 Dose Escalation - Monotherapy is anticipated to enroll approximately 50 participants to evaluate the safety, tolerability, PK, PD, and preliminary anti-leukemic activity of BH-30236, as well as determine the MTD and/or the preliminary recommended dose(s) for expansion (RDEs).
Phase 1, Part 2 Dose Escalation - Combination with Venetoclax is anticipated to enroll approximately 48 participants to evaluate the safety, tolerability, PK, PD, and preliminary anti-leukemic activity of BH-30236, as well as determine the MTD and/or the preliminary recommended dose(s) for expansion (RDEs).
Phase 1 will follow a Bayesian optimal interval (BOIN) design dose escalation, where participants will receive ascending doses of BH-30236 to determine the recommended RDEs.
Phase 1b Dose Expansion will enroll approximately 72 participants to evaluate the safety, tolerability, and preliminary anti-leukemic activity of BH-30236 as a monotherapy or in combination with venetoclax at selected RDEs determined in Phase 1 Dose Escalation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Cohort - Monotherapy | Experimental | Drug: BH-30236BH-30236 Monotherapy for Dose Escalation |
| Dose Escalation Cohort - Combination with Venetoclax | Experimental | Drug: BH-30236, Drug: VenetoclaxBH-30236 in Combination with Venetoclax for Dose Escalation. |
| Dose Expansion Cohort - Monotherapy | Experimental | Drug: BH-30236BH-30236 based on Monotherapy dose escalation data. |
| Dose Expansion Cohort - Combination with Venetoclax | Experimental | Drug: BH-30236, Drug: VenetoclaxBH-30236 in Combination with Venetoclax based on Dose Escalation data |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥18 years.
- Diagnosis of relapsed/refractory acute myelogenous leukemia (R/R) AML or higher-risk myelodysplastic syndrome (HR-MDS) with ≥5% bone marrow blast at time of inclusion.
- Prior treatment history must include 1-5 prior lines of therapy.
- ECOG performance status ≤2.
- Adequate organ function evidenced by the following laboratory values:
Key exclusion criteria (8 listed)
- Diagnosis of acute promyelocytic leukemia or chronic myeloid leukemia with blast crisis.
- Prior allogeneic HSCT within 3 months or donor lymphocyte infusion within 30 days of start of therapy;
- Active and uncontrolled infections.
- Unresolved AEs greater than Grade from prior therapies.
- History of other active malignancy (with certain exceptions)
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 |
|---|---|---|
| BH-30236BH-30236 will be provided as either a 5 mg, 15 mg or 30 mg tablet. Participants will take BH-30236 tablets orally depending on their dose level assignment. | Drug | Dose Escalation Cohort - Combination with Venetoclax, Dose Escalation Cohort - Monotherapy, Dose Expansion Cohort - Combination with Venetoclax, Dose Expansion Cohort - Monotherapy |
| VenetoclaxAlso: venclexta, venclyxtoVenetoclax will be provided as 10 mg, 50 mg or 100 mg tablets. Participants will take venetoclax orally per label instructions. | Drug | Dose Escalation Cohort - Combination with Venetoclax, Dose Expansion Cohort - Combination with Venetoclax |
Primary outcome
Dose Escalation: Frequency of dose limiting toxicities (DLTs)
Time frame: Dose-limiting toxicities are collected during the first treatment cycle (28 days)
DLTs are dose-limiting toxicities as defined in the study protocol.
Dose Escalation and Expansion: Safety evaluation of BH-30236: Number of participants with treatment-related adverse events as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: From first dose until 28 days after last dose of BH-30236
Frequency, severity and relationship to study drug of AEs and SAEs
Dose Expansion: Composite Complete Remission (CR) Rate
Time frame: From first dose of BH-30236 until disease progression (up to approximately 1 year)
Composite CR rate disease assessment in accordance with the following guidelines: European Leukemia Network (ELN) 2022 for acute myelogenous leukemia (AML) and International Working Group (IWG) 2023 for myelodysplastic syndrome (MDS).
10 secondary outcomes
Dose Escalation and Expansion: Maximum observed blood concentration (Cmax) of BH-30236.
Time frame: Evaluation performed in Cycle 1 (cycle duration is 28 days).
Dose Escalation: Area under the blood concentration time curve (AUC) of BH-30236.
Time frame: Evaluation performed in Cycle 1 (cycle duration is 28 days).
Dose Escalation and Expansion: Concentration before dose at steady state (Ctrough).
Time frame: Evaluation performed in all treatment cycles up to one year (cycle duration is 28 days).
Dose Escalation and Expansion: Objective Response Rate (ORR)
Time frame: From first dose of BH-30236 until disease progression (up to approximately 1 year)
Dose Escalation and Expansion: Duration of Response (DoR)
Time frame: Time from first documented response until disease progression or death (approximately 1 year).
Dose Escalation and Expansion: Time to remission (TTR)
Time frame: From first dose of BH-30236 until complete remission, disease progression or death (approximately 1 year).
Dose Escalation and Expansion: Relapse-free Survival (RFS)
Time frame: From first dose of BH-30236 until disease progression, death, or initiation of a new anti-leukemic therapy (approximately 1 year).
Dose Escalation and Expansion: Measurable Residual Disease (MRD)
Time frame: From time of first dose until discontinuation of BH-30236 (approximately 1 year).
Dose Escalation and Expansion: Measurement of the change in RNA alternative splicing markers on BH-30236 treatment
Time frame: From time of first dose until discontinuation of BH-30236 (approximately 1 year).
Dose Escalation and Expansion: Complete remission (CR) / complete remission with partial hematologic recovery (CRh) rate for AML and complete remission/partial remission (CR/PR) rate for HR-MDS
Time frame: Time from first documented response until disease progression or death (approximately 1 year)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Derived from this study: PubMed 42013378Maron MI, Abdel-Wahab O. Outstanding Questions to Understand and Target Splicing Factor-Mutant Blood Cancers. Blood Cancer Discov. 2026 May 5;7(3):348-352. doi: 10.1158/2643-3230.BCD-26-0047.
- Individual participant dataSharing planned: No
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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.
Sponsor Contact study director
BlossomHill Therapeutics, Inc.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BH-30236 and Venetoclax in people with Leukemia and Leukemia, Myeloid, run by BlossomHill Therapeutics at 13 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 8 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sponsor Contact ((858) 732-3880, clinicaltrials@bhtherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Escalation: Frequency of dose limiting toxicities (DLTs) (time frame: Dose-limiting toxicities are collected during the first treatment cycle (28 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06501196, which also lists 1 linked publication.
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 24 Sep 2025.