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

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Overview

Researchers want to find the best dose of DFV890 to use in people with myeloid diseases. Myeloid diseases include myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML). In people with these diseases, certain blood cells are not made correctly and blood counts are low. One cause may be increased inflammatory (stress) signals within MDS or CMML blood cells.

DFV890 may reduce inflammation within myeloid cells, which may help your body make healthy blood cells. It is taken orally (by mouth).

SparkCures ID 1752
Trial Phase Phase 1
Enrollment 62 Patients
Treatments
Tags
Trial Sponsors
  • Novartis
NCT Identifier

NCT05552469

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Key Inclusion Criteria:

1. Patients must be ≥ 18 years of age at the time of signing the informed consent form (ICF)
2. The Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
3. 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.
4. 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.

Key Exclusion Criteria:

1. 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.
2. History of hypersensitivity to the study treatment or its excipients or to drugs of similar chemical classes.
3. 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)).
4. 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.
5. 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 Section 6.8 and list of prohibited drugs in Appendix 8 for more details.

Other protocol-defined inclusion/exclusion criteria may apply.

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