This is a Phase 1 clinical trial evaluating the safety and tolerability of escalating doses of EC0489 in patients with refractory or metastatic tumors who have exhausted standard therapeutic options.
This is a Phase 1, dose escalation study of EC0489 administered by intravenous bolus (IV) during weeks 1 and 3 of a 4-week cycle in PART A and weekly on a 4-week cycle in PART B. Both Parts are open to patients with refractory or metastatic cancer who have exhausted standard therapeutic options. EC0489 is a drug that is specifically designed to enter cells via a folate vitamin receptor. Experimental evidence shows that the target receptor is over-expressed in many human cancers. There are no previous human studies of EC0489; however, lab research (research in test tubes or animals) using EC0489 has shown activity against tumors in animals. This activity in animal models suggests that EC0489 may be useful as chemotherapy against human cancers. The primary objective of this study is to determine the safety and maximum tolerated dose of EC0489 given by intravenous bolus. The efficacy of treatment will also be measured.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
65
PART A: Dose escalation from a starting dose of 1.0 mg/m2 IV bolus on Monday, Wednesday, and Friday Weeks 1 and 3 of a 4-week cycle to the Maximum Tolerated Dose (MTD)
20-25 mCi 99mTc-EC20 administered IV bolus 1-2 hours prior to imaging and at end of study for subjects who received 1 cycle or more of EC0489.
PART B: Once PART A MTD is determined, PART B will begin. Dose escalation from a starting dose of 4.2 mg/m2 IV bolus once weekly in a 4-week cycle to the Maximum Tolerated Dose (MTD).
Horizon Oncology Center
Lafayette, Indiana, United States
Greenebaum Cancer Center - University of Maryland
Baltimore, Maryland, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
Barbara Ann Karmanos Cancer Institute - Wayne State University
Detroit, Michigan, United States
Maximum tolerated dose (MTD)
Time frame: Dose escalation to the highest dose that can be safely administered to produce acceptable, manageable and reversible toxicity in no more than 0 or 1 of 6 patients
Pharmacokinetic and pharmacodynamic parameters
Time frame: Obtained during the first cycle of therapy on Days 1 and 3
Anti-tumor activity
Time frame: Initial dose of study therapy to disease progression
Uptake of 99mTc-EC20 in tumors and normal tissues
Time frame: 1-2 hours post administration of 99mTc-EC20
Safety and Tolerability
Time frame: Initiation of study therapy through 30 day post last dose of study therapy
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Great Lakes Cancer Institute - Michigan State University
Lansing, Michigan, United States
Providence Cancer Institute
Southfield, Michigan, United States