Clinical Trial: ABR-217620 in Patients With Advanced Non-Small Cell Lung Cancer, Renal Clear Cell Carcinoma or Pancreatic Cancer
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Open-Label, Phase I, Repeat Dose-Escalation Study of ABR-217620 in Patients With Advanced Non-Small Cell Lung Cancer, Renal Clear Cell Carcinoma or Pancreatic Cancer
Brief Summary: 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.
Detailed Summary:
Sponsor: Active Biotech AB
Current Primary Outcome: 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 ]
Original Primary Outcome:
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome:
Information By: Active Biotech AB
Dates:
Date Received: March 16, 2003
Date Started: April 2003
Date Completion:
Last Updated: August 26, 2014
Last Verified: August 2014
