Neoplasms

All Conditions

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antineoplastic Agents

All Drugs and Chemicals

Cisplatin

Nivolumab

Oxaliplatin

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Participants will receive andecaliximab (ADX) 800 mg every 2 weeks on Days 1 and 15 of each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.

Participants will receive ADX 800 mg every 2 weeks on Days 1 and 15 of each 28-day treatment cycle in combination with S-1 orally twice daily plus cisplatin chemotherapy (dosage and regimen will be based on participant condition, investigator discretion, institutional practice, and/or the in-country label) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.

Participants will receive ADX 1200 mg every 3 weeks on Day 1 of each 21-day treatment cycle in combination with chemotherapy (S-1 80 mg/day to 120 mg/day according to the body surface area orally twice daily for first 14 days of 21 day cycle plus oxaliplatin 100 mg/m\^2) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study.

Participants will receive ADX 800 mg every 2 weeks followed by chemotherapy (nivolumab 3 mg/kg) on Days 1 and 15 of each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.

Administered via intravenous (IV) infusion (approximately 30 minutes)

Andecaliximab

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

Gilead Study Director

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.

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

A Phase 1b Study to Evaluate the Safety and Tolerability of Andecaliximab (GS-5745) as Monotherapy and in Combination With Anti-Cancer Agents in Japanese Subjects With Gastric or Gastroesophageal Junction Adenocarcinoma

TEAEs are any AEs with an onset date of on or after the date that ADX and if applicable, nivolumab was first administered and no later than 30 days after permanent discontinuation of ADX, or if applicable, 5 months after permanent discontinuation of nivolumab (whichever is later).

Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. If the relevant baseline laboratory value was missing, then any abnormality of at least Grade 1 observed within the specified time frame (first dose date up to 82.4 weeks plus 30 days (or if applicable, up to 5 months after permanent withdrawal of nivolumab)) was considered treatment-emergent.Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 was used for assigning toxicity grades to laboratory results for analysis.

Plasma concentration is defined as the measured drug concentration. Blood samples were drawn at pre-dose and 30 (±15) minutes after infusion on Day 1 of Cycles 2, 3, 5; End of study (EOS) (3 years and 1 month); Cycle 1 only: 30 (±15) minutes after infusion on Day 1; anytime on Day 2, 4, and 8; pre-dose and 30 (±15) minutes post infusion on Day 15. The duration of each cycle for Cohort 1, 2, and 4 was 28 days and for Cohort 3 was 21 days. Infusion duration = 30 to 35 minutes.

* min=minutes
* D=Days
* C=Cycle

Cmax is defined as the maximum concentration of drug.

AUClast is defined as the area under the concentration versus time curve to the last measurable concentration of drug from time zero to the last observable concentration.

AUC0-336h is defined as the area under the concentration versus time curve from time zero to time 336 hour.

Gilead Sciences

The Safety Analysis Set included all participants who took at least 1 dose of study drug.

Participants received ADX 800 mg as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks on Days 1 and 15 of each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.

Cohort 1: ADX

Participants received ADX 800 mg via IV infusion (approximately 30 minutes) every 2 weeks on Days 1 and 15 of each 28-day treatment cycle in combination with chemotherapy (S-1 administered orally twice daily plus cisplatin administered via IV infusion on Day 8 of every 5 weeks) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug. Dose of S-1 and cisplatin was based upon participant condition, investigator discretion, institutional practice or in country label.

Cohort 2: ADX + S-1 + Cisplatin

Participants received ADX 1200 mg via IV infusion (approximately 30 minutes) every 3 weeks on Day 1 of each 21-day treatment cycle in combination with chemotherapy (S-1 administered at 80 mg/day to 120 mg/day according to the body surface area orally twice daily for first 14 days of 21 day cycle plus oxaliplatin administered via IV infusion at 100 mg/m\^2 over 2 hours on Day 1 of each 21-day cycle) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study.

Cohort 3: ADX + S-1 + Oxaliplatin

Participants received ADX 800 mg via IV infusion (approximately 30 minutes) every 2 weeks followed by chemotherapy (nivolumab 3 mg/kg via IV infusion \[approximately 60 minutes\] every 2 weeks) on Days 1 and 15 of each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.

Cohort 4: ADX + Nivolumab

Cohort 2: ADX+S-1+Cisplatin

Cohort 3: ADX+S-1+Oxaliplatin

Cohort 4: ADX+Nivolumab

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Gilead Clinical Study Information Center

Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)

Any Laboratory abnormalities: Hematology

Any Laboratory abnormalities: Chemistry

Any Laboratory abnormalities: Coagulation

Participants in the Safety Analysis Set with available data were analyzed.

Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities

30 minutes Postdose: Cycle 1 Day 1

Postdose: Cycle 1 Day 2

Postdose: Cycle 1 Day 4

Postdose: Cycle 1 Day 8

Predose: Cycle 1 Day 15

30 minutes Postdose: Cycle 1 Day 15

Predose: Cycle 2 Day 1

30 minutes Postdose: Cycle 2 Day 1

Predose: Cycle 3 Day 1

30 minutes Postdose: Cycle 3 Day 1

Predose: Cycle 5 Day 1

30 minutes Postdose: Cycle 5 Day 1

End of study

The Pharmacokinetic (PK) Analysis Set included all enrolled participants who took at least 1 dose of study drug and had at least 1 nonmissing postdose concentration value reported by the PK laboratory with available data were analyzed. Due to program discontinuation data were not collected for Cohorts 2, 3, and 4.

Cohort 1: Plasma Concentration of Andecaliximab

Participants in the PK Analysis Set were analyzed. Due to program discontinuation data were not collected for Cohorts 2, 3, and 4.

PK Parameter: Cmax of Andecaliximab

PK Parameter: AUClast of Andecaliximab

Participants in the PK Analysis Set with available data were analyzed. Due to program discontinuation data were not collected for Cohorts 2, 3, and 4.

PK Parameter: AUC0-336h of Andecaliximab

The Immunogenicity Analysis Set included all participants who took at least 1 dose of study drug and had at least 1 nonmissing postdose antidrug antibody status reported.

Number of Participants With Positive Anti-Andecaliximab Antibodies

Participants received andecaliximab (ADX) 800 mg as monotherapy via intravenous (IV) infusion (approximately 30 minutes) every 2 weeks on Days 1 and 15 of each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.

Spots Global Cancer Trial Database for 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

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