Overview
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
Status:
Terminated
Terminated
Trial end date:
2019-10-25
2019-10-25
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Gilead SciencesTreatments:
Cisplatin
Nivolumab
Oxaliplatin
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.