At a glance
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A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-5745 as Monotherapy and in Combination With Chemotherapy in Subjects With Advanced Solid Tumors
In Brief
A Phase 1 clinical trial evaluating Andecaliximab, Gemcitabine, and 9 other interventions for Pancreatic Cancer and 4 related conditions. Completed, enrolled 236 participants across 18 sites.
Detailed Summary
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 Details
Timeline
Interventions
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)