Study to Evaluate the Safety and Tolerability of Andecaliximab as Monotherapy and in Combination With Anti-Cancer Agents in Japanese Participants With Gastric or Gastroesophageal Junction Adenocarcinoma
Condition: Gastric Adenocarcinoma
MeSH terms: Adenocarcinoma
Intervention: Andecaliximab; S-1; Cisplatin; Oxaliplatin; Nivolumab
Intervention description: Administered via intravenous (IV) infusion (approximately 30 minutes); Administered orally; Administered via IV infusion on Day 8 of every 5 weeks; Administered via IV infusion for over 2 hours on Day 1 of each 21-day cycle; Administered via IV infusion (approximately 60 minutes) every 2 weeks
Intervention MeSH terms: Oxaliplatin; Nivolumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to characterize the safety and tolerability of
      andecaliximab as monotherapy and in combination with anti-cancer agents in Japanese
      participants with inoperable advanced or recurrent gastric or recurrent gastroesophageal
      junction (GEJ) adenocarcinoma.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Must have been born in Japan and must not have lived outside of Japan for a period > 1
             year in the 5 years prior to Day 1

          -  Must be able to trace their maternal and paternal ancestry of parents and grandparents
             as ethnically Japanese

          -  Histologically confirmed inoperable advanced gastric adenocarcinoma (including
             adenocarcinoma of the GEJ) or relapsed gastric adenocarcinoma

          -  Cohorts 1, 2, and 3: Human Epidermal Growth Factor Receptor 2 (HER2)-negative tumor
             (primary tumor or metastatic lesion). Enrollment in Cohort 4 is not restricted by HER2
             status (adults with HER2-positive, HER2-negative, or unknown HER2 status are eligible)

          -  Cohort 1: Prior antitumor therapy or cytotoxic chemotherapy is acceptable. Individuals
             who are not eligible to receive standard treatments should enroll on the study.

          -  Cohorts 2 and 3: Prior antitumor therapy or cytotoxic chemotherapy for metastatic
             disease is not acceptable. Individuals must be chemo-naive in the metastatic setting

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1

          -  Adequate baseline organ function (within 28 days prior to Day 1)

          -  Coagulation: International Normalized Ratio (INR) ≤ 1.5 (unless receiving
             anticoagulation therapy)

          -  For females of childbearing potential, willingness to use a protocol-recommended
             method of contraception from the screening visit throughout the study treatment period
             and for defined periods following the last dose of andecaliximab and/or anti-cancer
             agent(s)

          -  For males of childbearing potential having intercourse with females of childbearing
             potential, willingness to use a protocol-recommended method of contraception from the
             start of andecaliximab, throughout the study treatment period, and for protocol
             defined periods following the last dose of andecaliximab and/or anti-cancer agent(s)

          -  Willingness to comply with scheduled visits, drug administration plan, imaging
             studies, laboratory tests, other study procedures, and study restrictions

          -  In addition to the applicable criteria above, participants in Cohort 4 must meet
             additional inclusion criteria to be eligible for participation in this study:

               -  Measurable gastric or GEJ adenocarcinoma

               -  Must have progressed on at least 1 prior systemic therapy or line of treatment
                  for unresectable/metastatic disease.

               -  Activated partial thromboplastin (aPTT) ≤ 1.5 times the upper limit of normal

               -  Thyroid function tests should be within normal limits.

        Key Exclusion Criteria:

          -  History or evidence of a clinically significant disorder, condition, or disease that,
             in the opinion of the investigator and medical monitor would pose a risk to
             participant safety or interfere with the study evaluations, procedures, or completion

          -  Pregnant or lactating. Enrollment of lactating females after discontinuation of
             breastfeeding is not acceptable.

          -  Individuals with known central nervous system (CNS) metastases, unless metastases are
             treated and stable and the individual does not require systemic steroids

          -  Radiotherapy within 28 days of Day 1

          -  Myocardial infarction, symptomatic congestive heart failure (New York Heart
             Association Classification > Class II), unstable angina, or serious uncontrolled
             cardiac arrhythmia within the last 6 months of Day 1

          -  History of major surgery within 28 days of Day 1

          -  Serious systemic fungal, bacterial, viral, or other infection that is not controlled
             or requires IV antibiotics

          -  Individuals known to be positive for human immunodeficiency virus (HIV), hepatitis C
             infection (per local standard diagnostic criteria), or acute or chronic hepatitis B
             infection (per local standard diagnostic criteria)

          -  In addition to the applicable criteria above, participants in Cohort 4 who meet any of
             the following exclusion criteria will not be enrolled in this study

               -  Have received only neoadjuvant or adjuvant therapy for gastric adenocarcinoma

               -  Prior treatment with anti-cytotoxic T-lymphocyte-associated protein 4
                  (anti-CTLA-4) agents, anti-programmed cell death protein 1 (anti PD-1) or
                  anti-programmed cell death ligand 1 (anti-PD-L1) agents, anti-programmed cell
                  death ligand 2 (anti-PD-L2) agents, anti-matrix metalloprotease (anti-MMP)
                  agents, or other immunomodulatory therapies

        NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.