Gastric Adenocarcinoma
Conditions
Brief 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.
Interventions
DRUGAndecaliximab
Administered via intravenous (IV) infusion (approximately 30 minutes)
DRUGS-1
Administered orally
DRUGCisplatin
Administered via IV infusion on Day 8 of every 5 weeks
DRUGOxaliplatin
Administered via IV infusion for over 2 hours on Day 1 of each 21-day cycle
DRUGNivolumab
Administered via IV infusion (approximately 60 minutes) every 2 weeks
Sponsors
Gilead Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | First dose date up to 82.4 weeks plus 30 days (or if applicable, up to 5 months after permanent withdrawal of nivolumab) | 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). |
| Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities | First dose date up to 82.4 weeks plus 30 days (or if applicable, up to 5 months after permanent withdrawal of nivolumab) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK Parameter: AUClast of Andecaliximab | Cycle 1 only: 30 (± 15) minutes after the end of infusion on Day 1; anytime on Days 2, 4, and 8; prior to dosing on Day 15 (Cycle length= 28 days) (infusion duration= 30 to 35 minutes) | 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. |
| Cohort 1: Plasma Concentration of Andecaliximab | Pre-dose and 30 (±15) min after infusion on C2D1, C3D1, C5D1; EOS (3 years and 1 month); C1 only: 30 (±15) min after infusion on D1; anytime on D2, D4 and D8; Pre-dose and 30 (±15) minutes post infusion on D15 | 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 |
| Number of Participants With Positive Anti-Andecaliximab Antibodies | Pre-dose on Day 1 of Cycles 1, 2, 3, 5, 7 and every third cycle and anytime at EOT (82.4 weeks) and EOS visit (maximum: 3 years and 1 month) (Each Cycle= 28 days for Cohort 1, 2 and 4; 21 days for Cohort 3) | — |
| PK Parameter: AUC0-336h of Andecaliximab | Cycle 1 only: 30 (± 15) minutes after the end of infusion on Day 1; anytime on Days 2, 4, and 8; prior to dosing on Day 15 (Cycle length= 28 days) (infusion duration= 30 to 35 minutes) | AUC0-336h is defined as the area under the concentration versus time curve from time zero to time 336 hour. |
| PK Parameter: Cmax of Andecaliximab | Cycle 1 only: 30 (± 15) minutes after the end of infusion on Day 1; anytime on Days 2, 4, and 8; prior to dosing on Day 15 (Cycle length= 28 days) (infusion duration= 30 to 35 minutes) | Cmax is defined as the maximum concentration of drug. |
Countries
Japan
Participant flow
Recruitment details
Participants were enrolled at study sites in Japan. The first participant was screened on 20 Sep 2016. The last study visit occurred on 25 Oct 2019.
Pre-assignment details
39 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: ADX 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. | 8 |
| Cohort 2: ADX+S-1+Cisplatin 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. | 6 |
| Cohort 3: ADX+S-1+Oxaliplatin 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. | 10 |
| Cohort 4: ADX+Nivolumab 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. | 10 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 7 | 3 | 2 | 5 |
| Overall Study | Enrolled, not Treated | 1 | 0 | 0 | 1 |
| Overall Study | Study Terminated by Sponsor | 1 | 3 | 8 | 5 |
Baseline characteristics
| Characteristic | Cohort 1: ADX | Cohort 2: ADX+S-1+Cisplatin | Cohort 3: ADX+S-1+Oxaliplatin | Cohort 4: ADX+Nivolumab | Total |
|---|---|---|---|---|---|
| Age, Continuous | 59 years STANDARD_DEVIATION 14.7 | 69 years STANDARD_DEVIATION 7.9 | 56 years STANDARD_DEVIATION 15.1 | 63 years STANDARD_DEVIATION 11.8 | 61 years STANDARD_DEVIATION 13.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 6 Participants | 10 Participants | 10 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 6 Participants | 10 Participants | 10 Participants | 34 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 3 Participants | 1 Participants | 4 Participants | 1 Participants | 9 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 6 Participants | 9 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 7 / 8 | 3 / 6 | 2 / 10 | 5 / 10 |
| other Total, other adverse events | 8 / 8 | 6 / 6 | 10 / 10 | 10 / 10 |
| serious Total, serious adverse events | 2 / 8 | 2 / 6 | 1 / 10 | 5 / 10 |
Outcome results
Primary
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
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).
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)
Population: The Safety Analysis Set included all participants who took at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: ADX | Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | 100.0 percentage of participants |
| Cohort 2: ADX + S-1 + Cisplatin | Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | 100.0 percentage of participants |
| Cohort 3: ADX + S-1 + Oxaliplatin | Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | 100.0 percentage of participants |
| Cohort 4: ADX + Nivolumab | Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | 100.0 percentage of participants |
Primary
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
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.
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)
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: ADX | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities | Any Laboratory abnormalities: Hematology | 87.5 percentage of participants |
| Cohort 1: ADX | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities | Any Laboratory abnormalities: Coagulation | 0 percentage of participants |
| Cohort 1: ADX | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities | Any Laboratory abnormalities: Chemistry | 100.0 percentage of participants |
| Cohort 2: ADX + S-1 + Cisplatin | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities | Any Laboratory abnormalities: Hematology | 83.3 percentage of participants |
| Cohort 2: ADX + S-1 + Cisplatin | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities | Any Laboratory abnormalities: Coagulation | 0 percentage of participants |
| Cohort 2: ADX + S-1 + Cisplatin | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities | Any Laboratory abnormalities: Chemistry | 100.0 percentage of participants |
| Cohort 3: ADX + S-1 + Oxaliplatin | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities | Any Laboratory abnormalities: Chemistry | 100.0 percentage of participants |
| Cohort 3: ADX + S-1 + Oxaliplatin | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities | Any Laboratory abnormalities: Hematology | 90.0 percentage of participants |
| Cohort 3: ADX + S-1 + Oxaliplatin | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities | Any Laboratory abnormalities: Coagulation | 0 percentage of participants |
| Cohort 4: ADX + Nivolumab | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities | Any Laboratory abnormalities: Hematology | 70.0 percentage of participants |
| Cohort 4: ADX + Nivolumab | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities | Any Laboratory abnormalities: Coagulation | 10.0 percentage of participants |
| Cohort 4: ADX + Nivolumab | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities | Any Laboratory abnormalities: Chemistry | 80.0 percentage of participants |
Secondary
Cohort 1: Plasma Concentration of Andecaliximab
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
Time frame: Pre-dose and 30 (±15) min after infusion on C2D1, C3D1, C5D1; EOS (3 years and 1 month); C1 only: 30 (±15) min after infusion on D1; anytime on D2, D4 and D8; Pre-dose and 30 (±15) minutes post infusion on D15
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: ADX | Cohort 1: Plasma Concentration of Andecaliximab | 30 minutes Postdose: Cycle 3 Day 1 | 349,300.0 nanograms per milliliter | — |
| Cohort 1: ADX | Cohort 1: Plasma Concentration of Andecaliximab | 30 minutes Postdose: Cycle 1 Day 1 | 262,625.0 nanograms per milliliter | Standard Deviation 57410.64 |
| Cohort 1: ADX | Cohort 1: Plasma Concentration of Andecaliximab | Postdose: Cycle 1 Day 2 | 211,875.0 nanograms per milliliter | Standard Deviation 56688.21 |
| Cohort 1: ADX | Cohort 1: Plasma Concentration of Andecaliximab | Postdose: Cycle 1 Day 4 | 133,100.0 nanograms per milliliter | Standard Deviation 57485.39 |
| Cohort 1: ADX | Cohort 1: Plasma Concentration of Andecaliximab | Postdose: Cycle 1 Day 8 | 90100.0 nanograms per milliliter | Standard Deviation 18127.25 |
| Cohort 1: ADX | Cohort 1: Plasma Concentration of Andecaliximab | Predose: Cycle 1 Day 15 | 54800.0 nanograms per milliliter | Standard Deviation 12011.66 |
| Cohort 1: ADX | Cohort 1: Plasma Concentration of Andecaliximab | 30 minutes Postdose: Cycle 1 Day 15 | 310,971.4 nanograms per milliliter | — |
| Cohort 1: ADX | Cohort 1: Plasma Concentration of Andecaliximab | Predose: Cycle 2 Day 1 | 122,200.0 nanograms per milliliter | Standard Deviation 52872.68 |
| Cohort 1: ADX | Cohort 1: Plasma Concentration of Andecaliximab | 30 minutes Postdose: Cycle 2 Day 1 | 458,666.7 nanograms per milliliter | — |
| Cohort 1: ADX | Cohort 1: Plasma Concentration of Andecaliximab | Predose: Cycle 3 Day 1 | 158,000.0 nanograms per milliliter | Standard Deviation 16970.56 |
| Cohort 1: ADX | Cohort 1: Plasma Concentration of Andecaliximab | Predose: Cycle 5 Day 1 | 154,500.0 nanograms per milliliter | Standard Deviation 6363.96 |
| Cohort 1: ADX | Cohort 1: Plasma Concentration of Andecaliximab | 30 minutes Postdose: Cycle 5 Day 1 | 510,500.0 nanograms per milliliter | — |
| Cohort 1: ADX | Cohort 1: Plasma Concentration of Andecaliximab | End of study | 61960.0 nanograms per milliliter | Standard Deviation 37635.4 |
Secondary
Number of Participants With Positive Anti-Andecaliximab Antibodies
Time frame: Pre-dose on Day 1 of Cycles 1, 2, 3, 5, 7 and every third cycle and anytime at EOT (82.4 weeks) and EOS visit (maximum: 3 years and 1 month) (Each Cycle= 28 days for Cohort 1, 2 and 4; 21 days for Cohort 3)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: ADX | Number of Participants With Positive Anti-Andecaliximab Antibodies | 0 Participants |
| Cohort 2: ADX + S-1 + Cisplatin | Number of Participants With Positive Anti-Andecaliximab Antibodies | 0 Participants |
| Cohort 3: ADX + S-1 + Oxaliplatin | Number of Participants With Positive Anti-Andecaliximab Antibodies | 0 Participants |
| Cohort 4: ADX + Nivolumab | Number of Participants With Positive Anti-Andecaliximab Antibodies | 0 Participants |
Secondary
PK Parameter: AUC0-336h of Andecaliximab
AUC0-336h is defined as the area under the concentration versus time curve from time zero to time 336 hour.
Time frame: Cycle 1 only: 30 (± 15) minutes after the end of infusion on Day 1; anytime on Days 2, 4, and 8; prior to dosing on Day 15 (Cycle length= 28 days) (infusion duration= 30 to 35 minutes)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: ADX | PK Parameter: AUC0-336h of Andecaliximab | 34341.9 h*μg/mL | Standard Deviation 8697.66 |
Secondary
PK Parameter: AUClast of Andecaliximab
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.
Time frame: Cycle 1 only: 30 (± 15) minutes after the end of infusion on Day 1; anytime on Days 2, 4, and 8; prior to dosing on Day 15 (Cycle length= 28 days) (infusion duration= 30 to 35 minutes)
Population: Participants in the PK Analysis Set were analyzed. Due to program discontinuation data were not collected for Cohorts 2, 3, and 4.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: ADX | PK Parameter: AUClast of Andecaliximab | 33500.2 hours*micrograms per milliliter(h*μg/mL) | Standard Deviation 8397.01 |
Secondary
PK Parameter: Cmax of Andecaliximab
Cmax is defined as the maximum concentration of drug.
Time frame: Cycle 1 only: 30 (± 15) minutes after the end of infusion on Day 1; anytime on Days 2, 4, and 8; prior to dosing on Day 15 (Cycle length= 28 days) (infusion duration= 30 to 35 minutes)
Population: Participants in the PK Analysis Set were analyzed. Due to program discontinuation data were not collected for Cohorts 2, 3, and 4.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: ADX | PK Parameter: Cmax of Andecaliximab | 264.0 micrograms per milliliter | Standard Deviation 56.42 |