This study is a dose escalation, and cohort expansion study in subjects with advanced cancer for which no standard therapy exists. Subjects must have received prior treatment for cancer that has not worked, or has stopped working.
The study will be conducted in two parts. Part A is a dose escalation study to determine a safe and tolerable dose of ASN002 for subjects with relapsed or refractory lymphoma, or advanced solid tumors. Part A will also characterize the pharmacokinetics and pharmacodynamics of ASN002 through blood sampling. Subjects in Part B will enroll subjects with four types of lymphoma Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL) and Peripheral T-cell lymphoma (PTCL). Additional groups of subjects with Myelofibrosis (MF) and Chronic Lymphocytic Leukemia (CLL) will be enrolled. Subjects will be treated with the highest safe and tolerable dose determined in Part A of the study to determine preliminary efficacy. Subjects may continue to receive ASN002 for up to 1 year in the absence of severe side effects or disease progression.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
51
Multiple ascending doses of ASN002 assigned by cohort
Recommended dose of ASN002 from Part A
Arizona Oncology
Tempe, Arizona, United States
University of California, San Francisco
San Francisco, California, United States
Winship Cancer Institute - Emory
Atlanta, Georgia, United States
University of Michigan
Ann Arbor, Michigan, United States
START - Midwest
Grand Rapids, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Gabrail Cancer Center
Canton, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
...and 4 more locations
Objective Response Rate
Due to the early termination of the study, data for efficacy endpoints were insufficient for the planned efficacy analyses.
Time frame: First 29 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.