The drug ABR-217620 is a combination of two proteins, one that recognizes tumor cells and one that triggers an attack on the tumor cells by activating some white blood cells belonging to the body's normal immune system. In animals, this results in an accumulation of white blood cells in the cancer that can fight the cancer. This study will test how much of the drug can be given to patients with non-small cell lung cancer, renal clear cell carcinoma, or pancreatic cancer without causing unacceptable side effects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Starting dose: 0.5 mcg/kg; subsequent doses: individual, based on pre-treatment level of anti-SEA/E-120, body weight, and toxicities observed in prior patients on study; IV; one bolus injection each day for 5 consecutive days; up to 3 cycles
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Det Norske Radiumhospitalet
Oslo, Norway
Paterson Institute for Cancer Research, Christie Hospital NHS Trust and Research Institute
Manchester, United Kingdom
Maximum Tolerated Dose (MTD) as a function of pre-treatment anti-SEA/E-120 levels
Time frame: 56 days after start of first treatment cycle
Safety profile
Time frame: During or after first treatment cycle, second treatment cycle, later cycles if available
Pharmacokinetic parameters
Time frame: Days 1 and 5 of each cycle
Immunological response
Time frame: Days 28 and 56 of first and second treatment cycles, later cycles if available
Objective response rate
Time frame: Days 28 and 56 of first and second treatment cycles, later cycles if available
Time to progression and Survival
Time frame: Followed for up to 2 years
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