Andecaliximab
DrugAdministered intravenous infusion
Other names: GS-5745
NCT Number: NCT01803282
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Alabama Oncology, Birmingham, Alabama, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Administered intravenous infusion
Other names: GS-5745
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)
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
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
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. Participants with any laboratory abnormality were reported.
Gilead Sciences
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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