Study to Evaluate the Safety and Tolerability of Andecaliximab as Monotherapy and in Combination With Chemotherapy in Participants With Advanced Solid Tumors
Completed · Phase 1
Conditions studied: Pancreatic Cancer, Non-small Cell Lung Cancer, Esophagogastric Cancer, Colorectal Cancer, Breast Cancer
In brief
The primary objective of the study is to determine the maximum tolerated dose of andecaliximab monotherapy and to evaluate the safety and tolerability of andecaliximab (formerly GS-5745) alone and in combination with chemotherapy. The study consists of 2 parts (Parts A and B). Participants can only qualify for and participate in 1 part. Part A is a sequential dose escalation to determine the maximum tolerated dose of andecaliximab in participants with advanced solid tumors that are refractory to or intolerant to standard therapy or for which no standard therapy exists. In Part A, participants will receive andecaliximab only. Part B is a dose expansion to obtain additional safety and tolerability data for andecaliximab in participants with advanced pancreatic adenocarcinoma, lung adenocarcinoma, lung squamous cell carcinoma, esophagogastric adenocarcinoma, colorectal cancer, or breast cancer. In Part B, participants will receive andecaliximab in combination with standard-of-care chemotherapy.
Key facts
- Study ID
- NCT01803282
- Run by
- Gilead Sciences
- People needed
- 236
- Starts
- 2013-03-29
- Expected to finish
- 2019-04-23
- Last updated by the study team
- 2020-06-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Alabama Oncology — Birmingham, Alabama, United States
- Pinnacle Oncology Hematology — Scottsdale, Arizona, United States
- Comprehensive Blood and Cancer Center — Bakersfield, California, United States
- San Diego Pacific Oncology and Hematology Associates, Inc. — Encinitas, California, United States
- University of Southern California (USC) — Los Angeles, California, United States
- California Pacific Medical Center — San Francisco, California, United States
- UCLA Medical Center — Santa Monica, California, United States
- Florida Cancer Specialists — Sarasota, Florida, United States
- Parkview Research Center — Fort Wayne, Indiana, United States
- Indiana University Health Goshen Center for Cancer Care — Goshen, Indiana, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Cornell University — New York, New York, United States
- Greenville Health System, Institute for Translational Oncology Research — Greenville, South Carolina, United States
- Sarah Cannon Research Institute — Nashville, Tennessee, United States
- Vanderbilt — Nashville, Tennessee, United States
- UT Southwestern — Dallas, Texas, United States
- University of Utah — Salt Lake City, Utah, United States
- Northwest Medical Specialties — Tacoma, Washington, United States
Full record on ClinicalTrials.gov
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