Breast Cancer Clinical Trial
Official title:
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
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.
n/a
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