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Protocol No.1600GCCPrincipal InvestigatorRosenblatt, Paula
PhasePhase I (Cancer Control)
Age GroupAdult
TitleA Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Andecaliximab (GS-5745) as Monotherapy and in Combination with Chemotherapy in Subjects with Advanced Solid Tumors
DescriptionThis is an open-label, multicenter, sequential dose-escalation, and expansion study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of GS-5745 alone and in combination with chemotherapy.

Site will only particpate in Part B of the study.

Part B is a dose expansion to obtain additional safety and tolerability data for GS-5745 in participants with colorectal cancer or breast cancer. In Part B, participants will receive GS-5745 in combination with standard-of-care chemotherapy. Part B will consist of between 115 to 265 participants.
TreatmentGS-5745 alone and in combination with chemotherapy.
Key EligibilityInclusion Criteria:
Part B: First-Line Colorectal Cancer
-Histologically confirmed inoperable advanced adenocarcinoma of the colon or rectum
-Radiographically measureable disease
-No prior cytotoxic chemotherapy to treat their metastatic disease

Part B: Second-Line Colorectal Cancer
-Histologically confirmed inoperable advanced adenocarcinoma of the colon or rectum
-Radiographically measureable disease
-Received first-line combination therapy containing oxaliplatin and fluoropyrimidine with or without bevacizumab for metastatic disease with documented evidence of disease progression during or after treatment completion

Part B: Breast Cancer
-Histologically or cytologically confirmed metastatic breast cancer
-Radiographically measureable disease
-Previous hormonal therapy for metastatic breast cancer or cytotoxic adjuvant chemotherapy is allowed
-Treatment with weekly single-agent paclitaxel is appropriate in the opinion of the treating physician
-HER-2 negative tumor (primary tumor or metastatic lesion)

-Adequate organ function
Applicable Disease SitesBreast - Female
Breast - Male
Colon
Therapies InvolvedChemotherapy multiple agents systemic
Immunotherapy
Therapy (NOS)
Drugs InvolvedGS-5745
StatusOpen
Treatment TypeTreatment
ClinicalTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT01803282
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