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

Conditions: Gastric Adenocarcinoma

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.