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

Status: Recruiting
Location: See all (28) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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 three 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), lower risk chronic myelomonocytic leukemia (LR CMML) and High-Risk Clonal Cytopenia of Undetermined Significance (HR CCUS).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

∙ 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:

• In dose optimization: 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

• 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.

• changes for dose expansion (applicable as of amendment 3):

‣ LR MDS with ≤ 10% bone marrow blasts, IPSS-R score of ≤ 3.5, transfusion independent (TID) status as per IWG 2006 criteria (requiring \<4U pRBC in 8 weeks), clinically meaningful cytopenia(s) and no or limited (\<4 months) prior therapy for MDS.

⁃ LR CMML patients with symptomatic cytopenias and/or constitutional symptoms refractory, intolerant or unsuitable for standard first-line therapy.

⁃ HR-CCUS: Diagnosis of high-risk CCUS by clonal hematopoiesis risk score (CHRS) with clinically meaningful cytopenias and no prior therapy for a myeloid neoplasm.

Locations
United States
California
Stanford Cancer Center
RECRUITING
Stanford
Florida
H Lee Moffitt Cancer Center and Research Institute
RECRUITING
Tampa
Illinois
Northwestern University
RECRUITING
Chicago
Massachusetts
Dana Farber Cancer Institute
COMPLETED
Boston
Maryland
Sidney Kimmel CCC At JH
RECRUITING
Baltimore
Minnesota
Mayo Clinic Rochester
RECRUITING
Rochester
New York
Memorial Sloan Kettering Cancer Ctr
RECRUITING
New York
Weill Cornell Medicine NY-Presb
RECRUITING
New York
Tennessee
Vanderbilt University Medical Ctr
RECRUITING
Nashville
Texas
Univ of TX MD Anderson Cancer Cntr
RECRUITING
Houston
Utah
Huntsman Cancer Institute
RECRUITING
Salt Lake City
Other Locations
France
Novartis Investigative Site
RECRUITING
Grenoble
Novartis Investigative Site
RECRUITING
Marseille
Novartis Investigative Site
RECRUITING
Nantes
Novartis Investigative Site
RECRUITING
Paris
Germany
Novartis Investigative Site
RECRUITING
Dresden
Novartis Investigative Site
RECRUITING
Düsseldorf
Novartis Investigative Site
RECRUITING
Leipzig
Novartis Investigative Site
RECRUITING
Lübeck
Novartis Investigative Site
WITHDRAWN
Velbert
Hong Kong Special Administrative Region
Novartis Investigative Site
RECRUITING
Hong Kong
Italy
Novartis Investigative Site
RECRUITING
Brescia
Novartis Investigative Site
RECRUITING
Rozzano
Singapore
Novartis Investigative Site
RECRUITING
Singapore
Novartis Investigative Site
WITHDRAWN
Singapore
Spain
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Madrid
United Kingdom
Novartis Investigative Site
RECRUITING
Cardiff
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
+41613241111
Time Frame
Start Date: 2023-05-08
Estimated Completion Date: 2027-02-01
Participants
Target number of participants: 105
Treatments
Experimental: Dose escalation: DFV890 low dose
DFV890 given as single agent at a low dose
Experimental: Dose escalation: DFV890 high dose
DFV890 given as single agent at a high dose
Experimental: Dose expansion: DFV890 low dose
DFV890 given as single agent at a low dose
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov

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