Clinical Trial 23254

• Overview

  Study 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)

  Summary:

  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, in adult subjects with R/R AML or HR-MDS.

  Objective:

  Primary Objectives: Dose Escalation: To evaluate the safety and tolerability of BH-30236 in adult subjects with R/R AML or HR-MDS and to determine the maximum tolerated dose (MTD). To identify the recommended doses for expansion (RDEs). Dose Expansion: To evaluate the safety, tolerability, and preliminary anti-leukemic activity of BH-30236 at selected RDEs to determine the recommended Phase 2 dose (RP2D). Secondary Objectives: To characterize the pharmacokinetic (PK) properties of BH-30236. To characterize the preliminary anti-leukemic activity of BH-30236 in terms of objective response rate (ORR), CR/CRh rate for AML and CR/PR rate in HR-MDS.

• Treatments

  Therapies:

  Therapy (NOS)

  Medications:

  BH-30236 (); GDC-0199 (Venetoclax); Venetoclax ()

• Inclusion Criteria

  Inclusion Criteria:
  • 18 years of age or older.
  • Diagnosis of relapsed/refractory acute myelogenous leukemia (R/R) AML or higher-risk myelodysplastic syndrome (HR-MDS) with 5% or greater bone marrow blast at time of inclusion.
  • Prior treatment history must include 1-5 prior lines of therapy.
  • ECOG performance status 2 or less.
  • Adequate organ function evidenced by the following laboratory values:
  • Renal: Measured or calculated creatinine clearance 60 mL/min or greater (Cockcroft-Gault formula)

• Exclusion Criteria

  Exclusion Criteria:
  • 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.

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