A Dose Finding Study of TKM-080301 Infusion in Neuroendocrine Tumors (NET) and Adrenocortical Carcinoma (ACC) Patients

Phase 1

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Patients must have a histologically and cytologically confirmed solid tumor that is refractory to standard therapy or for which no standard therapy is known to exist, or who are not candidates for standard therapy, or non-Hodgkin's lymphoma or Hodgkin's disease that is refractory to standard therapy (i.e., patients have relapsed following at least 2 prior therapies) or for which no standard therapy is known to exist. For the Neuroendocrine (NET) and adrenocortical carcinoma (ACC) expansion cohort subjects must have histologically or cytologically confirmed, measurable (per RECIST 1.1) NET or ACC tumor that is refractory to standard therapy or for which no standard therapy is known to exist, or who are not candidates for standard therapy.
Patient has an ECOG performance status of 0 - 1,
Patient has adequate hematologic, hepatic and renal function,
Patient is seronegative for hepatitis B virus (HBV) and hepatitis C virus (HCV),
Patients must have a life expectancy of at least 12 weeks.

Exclusion Criteria

Unresolved toxicities (> Grade 1) of previous chemotherapy,
Patients with primary tumors of the central nervous system (CNS),
Prophylactic hematologic growth factors administered </= 2 weeks prior to start of therapy,
Patient has history of or existing clinically significant cardiovascular disease,
Patient has a history of clinically significant asthma or COPD requiring daily medication within the last 6 months,
Patient has a seizure disorder not controlled on medication,
Patient has a known or suspected viral, parasitic, or fungal infection,
Patient has known hypersensitivity or previous severe reactions to oligonucleotide- or lipid-based products, including liposomal drug products and phospholipid-based products,
Patient has been treated with any investigational drugs, biologics, or devices within 28 days prior to study treatment.

Arm && Interventions

Group	Intervention	Description
TKM-080301	TKM-080301	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of treatment with TKM-080301	6 months
Determine dose-limiting toxicities and maximum tolerated dose of TKM-080301	6 months

Secondary Outcome Measures

Name	Time	Method
Characterize the pharmacokinetics of TKM-080301	2 months
Assess preliminary evidence of anti-tumor activity	6 months

Locations (8): Moffitt Cancer Center
🇺🇸
Tampa, Florida, United States
Westchase Oncology Center
🇺🇸
Houston, Texas, United States
Mayo Clinic
🇺🇸
Rochester, Minnesota, United States
Mayo Clinic Arizona
🇺🇸
Scottsdale, Arizona, United States
Scottsdale Healthcare Research Institute
🇺🇸
Scottsdale, Arizona, United States
Dana Farber Cancer Institute
🇺🇸
Boston, Massachusetts, United States
University of Iowa/Holden Comprehensive Cancer Center
🇺🇸
Iowa City, Iowa, United States
University of Michigan Comprehensive Cancer Center
🇺🇸
Ann Arbor, Michigan, United States