This study will be a Phase I/II, open-label, non-randomized, dose-finding trial conducted at multiple clinical centers. The study is designed to determine the safety, tolerability and PK of TKM-080301 in adult patients with solid tumors or lymphomas that are refractory to standard therapy or for whom there is no standard therapy. After the determination of the maximum tolerated dose this dose will be utilized in an expansion cohort or subjects with refractory neuroendocrine tumors (NET) or adrenocortical carcinoma (ACC) tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
68
Repeat dose IV infusion.
Scottsdale Healthcare Research Institute
Scottsdale, Arizona, United States
Mayo Clinic Arizona
Scottsdale, Arizona, United States
Moffitt Cancer Center
Tampa, Florida, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Westchase Oncology Center
Houston, Texas, United States
Safety and tolerability of treatment with TKM-080301
Time frame: 6 months
Determine dose-limiting toxicities and maximum tolerated dose of TKM-080301
Time frame: 6 months
Characterize the pharmacokinetics of TKM-080301
Time frame: 2 months
Assess preliminary evidence of anti-tumor activity
Time frame: 6 months
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