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Dose Optimization and Expansion Study of DFV890 in Adult Patients With Myeloid Diseases
Trial ID: NCT05552469
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).
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
Key Inclusion Criteria:
1. Patients must be ≥ 18 years of age at the time of signing the informed consent form
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
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.