Breast Cancer Clinical Trial

Study to Evaluate the Safety and Tolerability of Andecaliximab as Monotherapy and in Combination With Chemotherapy in Participants With Advanced Solid Tumors

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.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Part A: histologically or cytologically confirmed advanced malignant solid tumor that is refractory to or intolerant of standard therapy or for which no standard therapy is available

Part B: Pancreatic Adenocarcinoma

Presence of histologically confirmed inoperable locally advanced or metastatic pancreatic adenocarcinoma

Part B: NSCLC

Stage IIIB with malignant pleural effusion/pleural seeding or stage IV histologically confirmed NSCLC
Absence of known epidermal growth factor receptor (EGFR) mutation
Absence of known translocation or inversion events involving the ALK gene locus (resulting in EML4-ALK fusion)

Part B: Esophagogastric Adenocarcinoma:

Histologically confirmed inoperable advanced gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction) or relapsed gastric adenocarcinoma
Human epidermal growth factor receptor 2 (HER2)-negative tumor (primary tumor or metastatic lesion)

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

Key Exclusion Criteria:

Pregnant or lactating
Individuals with known central nervous system (CNS) metastases, unless metastases are treated and stable and the individual does not require systemic steroids
Myocardial infarction, symptomatic congestive heart failure, unstable angina, or serious uncontrolled cardiac arrhythmia within the last 6 months
Anti-tumor therapy within 28 days of study drug dosing; concurrent use of hormone therapy for breast or prostate cancer is permitted

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

236

Study ID:

NCT01803282

Recruitment Status:

Completed

Sponsor:

Gilead Sciences

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There are 18 Locations for this study

See Locations Near You

Alabama Oncology
Birmingham Alabama, 35243, United States
Pinnacle Oncology Hematology
Scottsdale Arizona, 85258, United States
Comprehensive Blood and Cancer Center
Bakersfield California, 93309, United States
San Diego Pacific Oncology and Hematology Associates, Inc.
Encinitas California, 92024, United States
University of Southern California (USC)
Los Angeles California, 90033, United States
California Pacific Medical Center
San Francisco California, 94115, United States
UCLA Medical Center
Santa Monica California, 90404, United States
Florida Cancer Specialists
Sarasota Florida, 34232, United States
Parkview Research Center
Fort Wayne Indiana, 46845, United States
Indiana University Health Goshen Center for Cancer Care
Goshen Indiana, 46526, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Cornell University
New York New York, 10021, United States
Greenville Health System, Institute for Translational Oncology Research
Greenville South Carolina, 29605, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
Vanderbilt
Nashville Tennessee, 37232, United States
UT Southwestern
Dallas Texas, 75390, United States
University of Utah
Salt Lake City Utah, 84112, United States
Northwest Medical Specialties
Tacoma Washington, 98405, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

236

Study ID:

NCT01803282

Recruitment Status:

Completed

Sponsor:


Gilead Sciences

How clear is this clinincal trial information?

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