Dose Optimization and Expansion Study of DFV890 in Adult Patients With Myeloid Diseases

Launched by NOVARTIS PHARMACEUTICALS · Sep 20, 2022

Keywords

ClinConnect Summary

The clinical trial titled "Dose Optimization and Expansion Study of DFV890 in Adult Patients With Myeloid Diseases" is investigating a new treatment called DFV890 for adults with certain blood disorders known as myeloid diseases. Specifically, this study is looking at patients who have lower-risk myelodysplastic syndromes (a type of blood cancer) or lower-risk chronic myelomonocytic leukemia. The main goals of the trial are to find out how safe DFV890 is, how well it works, and what the best dose is for patients who haven’t had success with other treatments.

To participate in this trial, patients must be at least 18 years old and have specific types of blood disorders that meet certain criteria. They should also be able to undergo a bone marrow test, which is a procedure to assess their blood cells. Participants can expect to receive the study treatment and will be closely monitored by the medical team throughout the trial. It’s important to note that some patients may not be eligible if they have recently received other types of cancer treatments or have certain health issues. This trial is currently recruiting participants, and it offers a potential new option for those who have not responded well to existing therapies.

Gender

ALL

Eligibility criteria

• 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.