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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
236
Administered intravenous infusion
Administered intravenously on Days 1, 8, and 15 of each 28-day treatment cycle
Administered intravenously on Days 1, 8, and 15 of each 28-day treatment cycle
Administered intravenously on Day 1 of each 21-day treatment cycle
Administered intravenously on Day 1 of each 21-day treatment cycle
Administered intravenously on Days 1 and 15 of each 28-day treatment cycle
Administered intravenously on Days 1 and 15 of each 28-day treatment cycle
Administered intravenously on Days 1 and 15 of each 28-day treatment cycle
Administered intravenously on Days 1 and 15 of each 28-day treatment cycle
Administered intravenously on Days 1 and 15 of each 28-day treatment cycle
Administered intravenously on Days 1, 8 and 15 of each 28-day treatment cycle (Breast cancer) or on Day 1 of each 21-day treatment cycle (NSCLC)
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
...and 8 more locations
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Time frame: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days
Percentage of Participants Experiencing Laboratory Abnormalities
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. Participants with any laboratory abnormality were reported.
Time frame: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days
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