Study to Evaluate the Safety and Tolerability of Andecaliximab as Monotherapy and in Combination With Chemotherapy in Participants With Advanced Solid Tumors
Condition: Pancreatic Cancer; Non-small Cell Lung Cancer; Esophagogastric Cancer; Colorectal Cancer; Breast Cancer
Intervention: Andecaliximab; Gemcitabine; Nab-paclitaxel; Carboplatin; Pemetrexed; Leucovorin; Oxaliplatin; 5-FU; Bevacizumab; Irinotecan; Paclitaxel
Intervention description: Administered intravenous infusion; 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)
Intervention MeSH terms: Leucovorin; Paclitaxel; Albumin-Bound Paclitaxel; Bevacizumab; Carboplatin; Gemcitabine; Oxaliplatin; Irinotecan; Pemetrexed
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 236.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Solid Tumor

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.
    

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.