Clareo Health | Study to Evaluate the Safety and Tolerability of Andecaliximab as Monotherapy and in Combination With Chemotherapy in Participants With Advanced Solid Tumors
Study to Evaluate the Safety and Tolerability of Andecaliximab as Monotherapy and in Combination With Chemotherapy in Participants With Advanced Solid Tumors
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
