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Anti-tumor antibiotic

BH-30236 for Acute Myeloid Leukemia and Myelodysplastic Syndrome

Phase 1

Recruiting

Research Sponsored by BlossomHill Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate organ function evidenced by specific laboratory values: Transaminase levels aspartate aminotransferase [AST]/ alanine transaminase [ALT] ≤ 2.5 × upper limit of normal (ULN), Total bilirubin ≤ 1.5 × ULN in the absence of documented Gilbert's disease, Measured or calculated creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula)

ECOG performance status ≤2

Must not have

Prior treatment with a CLK inhibitor

Prior allogeneic HSCT within 3 months or donor lymphocyte infusion within 30 days of start of therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from time of first dose until discontinuation of bh-30236 (approximately 1 year).

Awards & highlights

No Placebo-Only Group

Summary

"This trial is studying a new drug for people with relapsed or refractory acute myelogenous leukemia or higher-risk myelodysplastic syndrome. The study has two phases: Phase 1

Who is the study for?

This trial is for people who have acute myelogenous leukemia (AML) or high-risk myelodysplastic syndrome (MDS) that has come back or didn't respond to treatment. The study will involve about 74 participants in total.

What is being tested?

The trial is testing BH-30236, a new oral medication. It's divided into two phases: Phase 1 tests safety and how the body reacts to different doses, while Phase 1b looks at how well it works and its effects at specific doses.

What are the potential side effects?

Since this is a first-in-human study of BH-30236, side effects are being evaluated but may include typical reactions seen with cancer treatments such as nausea, fatigue, blood count changes, and potential organ-related toxicities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself but might not be able to do heavy physical work.

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I am 18 years old or older.

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I have relapsed AML or high-risk MDS with more than 5% bone marrow blasts.

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I have had between 1 to 5 treatments for my condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with a CLK inhibitor before.

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I had a stem cell transplant or donor immune cell infusion recently.

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I do not have any active or uncontrolled infections.

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I have no severe side effects from previous treatments.

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I have been diagnosed with acute promyelocytic leukemia or chronic myeloid leukemia in blast crisis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from time of first dose until discontinuation of bh-30236 (approximately 1 year).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from time of first dose until discontinuation of bh-30236 (approximately 1 year).

This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of first dose until discontinuation of bh-30236 (approximately 1 year). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Dose Escalation: Frequency of dose limiting toxicities (DLTs)

Dose Expansion: Composite Complete Remission (CR) Rate

Secondary study objectives

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

Dose Escalation and Expansion: Concentration before dose at steady state (Ctrough).

Dose Escalation and Expansion: Duration of Response (DoR)

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