NCT00056537

ABR-217620 in Patients With Advanced Non-Small Cell Lung Cancer, Renal Clear Cell Carcinoma or Pancreatic Cancer

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Active Biotech AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-Small-Cell Lung Carcinoma
• Renal Cell Carcinoma
• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	ABR-217620	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

Timeline

• Start date: 2003-04-01
• Primary completion: 2006-12-01
• Completion: 2006-12-01
• First posted: 2003-03-18
• Last updated: 2014-08-27

Locations

3 sites across 3 countries: United States, Norway, United Kingdom