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0C-16-2 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

Description

This is an open-label, multicenter, sequential dose-escalation, and expansion study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics 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 A will consist of between 12 to 48 participants. 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. Part B will consist of between 115 to 295 participants. Please note the study is currently only recruiting in the breast cancer cohorts.

Phase

Phase 1 - a new treatment that has not been tested, and researchers are looking for the best way to administer the treatment and how much can be given safely. Phase I trials are usually offered only to patients with advanced disease who would not be helped by other known treatments. Some patients are helped by these treatments, although in this early stage physicians don’t really know if the treatment will be effective.

Inclusion and Exclusion 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

  • 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.

Sites

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