Study of Mivavotinib (CB-659) in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Stopped early · Phase 2

Conditions studied: Non-GCB/ABC Diffuse Large B-Cell Lymphoma, With and Without MyD88 and/or CD79B Mutations

In brief

Study CX-659-401 is a multicenter, open-label, phase 2 study of mivavotinib to evaluate the single-agent activity of mivavotinib in patients with relapsed/refractory non-GCB/ABC DLBCL, incorporating ctDNA-based next-generation sequencing (NGS) to identify DLBCL patients harboring MyD88 and/or CD79B mutations within the study. This goal of this strategy is to evaluate its activity both in the cell-of-origin subgroup of non-GCB/ABC DLBCL and in the genetically defined subgroups of MyD88/CD79B-mutated and wild type DLBCL.

Key facts

Study ID

NCT05319028

Run by

Calithera Biosciences, Inc

People needed

2

Starts

2022-06-23

Expected to finish

2023-02-24

Last updated by the study team

2023-04-04

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patients aged 18 years or older
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
• Life expectancy of > 3 months
• Histologically confirmed de novo or transformed non-GCB DLBCL.
• Relapsed or refractory to ≥ 2 prior lines of chemotherapy based on standard of care
• Patients should not have failed more than 5 prior lines of therapy
• Must have [18F]Fluorodeoxyglucose-positron emission tomography (FDG-PET)-avid measurable disease that meets the size criteria per International Working Group (IWG) criteria.
• Must have recovered from adverse events of prior anti-cancer therapy to severity ≤ Grade 1.
• Adequate organ function as assessed by laboratory values.
• If female of childbearing potential, agreement to use protocol specified contraception methods. If male, agreement to use an effective barrier method of contraception.

You may not qualify if…

• DLBCL with central nervous system (CNS) involvement with active brain or leptomeningeal disease
• Known human immunodeficiency (HIV; testing not required) or HIV-related malignancy
• Known hepatitis B surface antigen positive or known or active hepatitis C infection
• Prior autologous stem cell transplant (ASCT) or chimeric antigen receptor T-cell (CAR-T) cell infusion within 90 days of screening
• Prior allogeneic stem cell transplantation
• Unstable/inadequate cardiac function
• Known gastrointestinal (GI) disease or GI procedure that interferes with swallowing/absorption of oral drug
• Major surgery within 14 days before the first dose of study drug
• Serious infection (bacterial/fungal/viral) requiring parenteral antibiotic/antiviral therapy for >5 days within 21 days prior to first dose of study drug
• Treatment with high-dose corticosteroids for anticancer purposes within 7 days before the first dose of mivavotinib.
• Use of medication known to be inhibitors or inducers of P-glycoprotein (P-gp) and/or Cytochrome P (CYP)3A
• Female patients who are pregnant, lactating or breastfeeding.
• Any radiation therapy within 3 weeks prior to first dose of study treatment.
• Systemic anticancer treatment within 3 weeks before first dose of study treatment

Where it is running

• Northwestern University — Evanston, Illinois, United States
• Henry Ford Health — Detroit, Michigan, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Toledo Clinic Cancer Center — Toledo, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• The University of Texas, M. D. Anderson Cancer Center — Houston, Texas, United States
• The University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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