Clinical Trial 22190

• Overview

  Study Title:

  A phase 1b, open label, multi-center, dose optimization and dose expansion study to assess the safety and efficacy of DFV890 in adult patients with myeloid diseases

  Summary:

  Study CDFV890G12101 is an open-label, phase 1b, multicenter study with a randomized two-dose optimization part, and a dose expansion part consisting of two groups evaluating DFV890 in patients with myeloid diseases. The purpose of this study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, efficacy and recommended dose for single agent DFV890 in patients with lower risk (LR: very low, low or intermediate risk) myelodysplastic syndromes (LR MDS) and lower risk chronic myelomonocytic leukemia (LR CMML).

  Objective:

  Primary Objective(s): Assess the safety and tolerability and determine the optimal recommended dose for single agent DFV890. Secondary Objective(s): Evaluate the preliminary on transfusion burden and hematologic parameters. Assess the pharmacokinetics of DFV890.

• Treatments

  Therapies:

  Therapy (NOS)

  Medications:

  DFV890 ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • Patients must be ≥ 18 years of age at the time of signing the informed consent form (ICF)
  • The Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
  • Patient must be a candidate for serial bone marrow aspirate and/or biopsy according to the institutions guidelines and must be willing to undergo a bone marrow aspirate.
  • Patients must have one of the following for eligibility into the study: (1) In dose optimization and expansion: IPSS-R defined very low, low or intermediate risk Myelodysplastic Syndrome (LR MDS) who failed to respond to or did not tolerate ESAs or luspatercept or HMAs and patients with del 5q who failed to respond to or did not tolerate lenalidomide; or (2) In dose optimization and expansion: IPSS-R defined very low, low or intermediate risk Chronic Myelomonocytic Leukemia (LR CMML) who failed to respond to or did not tolerate hydroxyurea or HMAs.
  • Other criteria may apply

• Exclusion Criteria

  Key Exclusion Criteria:
  • Systemic antineoplastic therapy (including cytotoxic chemotherapy, alpha-interferon, kinase inhibitors or other targeted small molecules, and toxin-immunoconjugates) or any experimental therapy within 28 days or 5 half-lives, whichever is longer, and recovered from the toxicities before the first dose of study treatment. For patients that received antibodies the washout period is 4 weeks prior to study treatment.
  • History of hypersensitivity to the study treatment or its excipients or to drugs of similar chemical classes.
  • Patients who have previously been treated with agents that have the same mechanism of action as DFV890 as defined in Table 6-8, list of prohibited medications (e.g., drugs targeting the NLRP3 inflammasome pathway and the IL-1 pathway (canakinumab and anakinra)).
  • Use of hematopoietic colony-stimulating growth factors (e.g., G-CSF, GM-CSF, M-CSF), thrombopoietin mimetics or erythroid stimulating agents anytime ≤ 1 week (or 5 half lives, whichever is longer) prior to start of study treatment.
  • Patients receiving: (1) concomitant medications that are known to be modulators of cytochrome P450 enzymes CYP2C9 and/or CYP3A (specifically strong or moderate inducers of CYP2C9, strong inducers of CYP3A enzymes, strong inhibitors of CYP2C9 and/or strong or moderate dual inhibitors of CYP2C9/CYP3A); and (2) patients, who are poor CYP2C9 metabolizers receiving concomitant medications known to be strong or moderate inhibitors of CYP3A, whose concomitant medications cannot be discontinued or switched to a different medication within 5 half-lives or 1 week (whichever is longer) prior to start of study treatment and for duration of the study. See protocol for details.
  • Other exclusions may apply

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