Study of AMG 910 in Subjects With CLDN18.2-Positive Gastr... | NCT04260191

NCT04260191

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1: AMG 910 6.5 μg	Experimental	For Cycles 1 and 2, participants received AMG 910 as a short-term intravenous (IV) infusion (approximately 60 minutes) at a dose of 6.5 μg twice a week on Days 1 and 3 of each week in a 28-day cycle. For Cycles 3 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 μg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.	Drug: AMG 910
Cohort 1b: AMG 910 6.5 μg	Experimental	For Cycle 1 Week 1, participants received AMG 910 as an extended IV (eIV) infusion (approximately 96 hours) at a dose of 6.5 μg. For the remainder of Cycles 1 and 2, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 μg twice a week on Days 1 and 3 of each week in a 28-day cycle. For Cycles 3 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 μg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.	Drug: AMG 910
Cohort 2b: AMG 910 15 μg	Experimental	For Cycle 1 Week 1, participants received AMG 910 as an eIV infusion (approximately 96 hours) at a dose of 15 μg. For the remainder of Cycles 1 and 2, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 15 μg twice a week on Days 1 and 3 of each week in a 28-day cycle. For Cycles 3 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 15 μg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.	Drug: AMG 910

Name	Type	Description	Arm Group Labels	Other Names
AMG 910	Drug	IV Infusion	Cohort 1: AMG 910 6.5 μg Cohort 1b: AMG 910 6.5 μg Cohort 2b: AMG 910 15 μg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT)	All DLTs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. DLTs were defined as any AEs at least possibly related to AMG 910 with an onset within the first 28 days following first dose with any of the following: Grade 2 gastric perforation or fistula Grade ≥ 3 non-hematologic AEs including laboratory abnormalities Re-challenge with AMG 910 after treatment interruption due to any stomach toxicity results in at least same stomach toxicity and is of CTCAE grade ≥ 3 or grade 2 and ongoing for more than 3 days despite optimal supportive treatment Grade 4 thrombocytopenia or grade 3 thrombocytopenia with bleeding Grade 4 neutropenia lasting > 28 days Febrile neutropenia of any grade Anemia requiring transfusion per local or international guidelines in the absence of bleeding Grade 5 toxicity Any other toxicity related to AMG 910 considered significant enough to be qualified as DLT in the opinion of the investigator	Day 1 to Day 28
Number of Participants Who Experienced a Treatment-emergent AE (TEAE)	A TEAE was defined as any adverse event starting on or after the first administration of investigational product, as determined by the flag indicating if the adverse event started prior to the first dose on the Events case report form, and up to and including 30 days after the last investigational product dose date. Evaluation of TEAEs included the number of participants with at least 1 TEAE or treatment-related TEAE. Clinically significant changes in vital signs, electrocardiogram (ECG) and clinical laboratory tests were recorded as TEAEs.	Day 1 to 30 days post-last dose; maximum duration was 10.97 months

Secondary Outcomes

Measure	Description	Time Frame
Maximum Serum Concentration (Cmax) of AMG 910	Mean Cmax values for the dosing intervals following short-term IV infusion (Cohort 1) and following extended IV infusions (Cohorts 1b and 2b) for Cycle 1 Week 1, and for short-term IV infusions in subsequent dosing intervals in Cycle 1. The timing of the pharmacokinetic (PK) sampling for Week 1 (Days 1 - 7) was based on hours after the start of the infusion and from Day 8 onwards was based on hours after the end of infusion (EOI). Due to the limited number of samples obtained and early termination of the study, PK data are summarized for Cycle 1 only.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects with histologically or cytologically confirmed metastatic or locally advanced unresectable gastric or GEJ adenocarcinoma positive for CLDN18.2.
Subjects should not be eligible for curative surgery and should have been refractory to or have relapsed after two or more prior lines of standard systemic therapy that included a platinum, a fluoropyrimidine, either a taxane or irinotecan, and an approved vascular endothelial growth factor receptor (VEGFR) antibody/tyrosine kinase inhibitor (TKI) and depending on country-specific standards and approvals.
For subjects eligible for human epidermal growth factor receptor 2 (HER2) directed therapy, prior systemic therapy should have included a HER2 targeting antibody approved for treatment of gastric cancer.
Subjects may also be included if the aforementioned therapeutic options were medically not appropriate for them. In these cases, the reason(s) why required prior therapies for gastric cancer were medically not appropriate should be documented in the subject's electronic case report form (eCRF).
For dose-expansion only: Subjects with at least 1 measurable lesion greater than or equal to 10mm which has not undergone biopsy within 3 months of screening scan. This lesion cannot be biopsied at any time during the study.
Subjects with stable condition and anti-coagulative therapy ongoing for at least 1 month, no obvious signs and symptoms of bleeding, and coagulation parameters are fulfilled.
Subjects should be able to use proton pump inhibitors.

Exclusion Criteria:

Any anticancer therapy or immunotherapy within 4 weeks of start of first dose (14 days for palliative radiation).
Untreated or symptomatic central nervous system (CNS) metastases, leptomeningeal disease, or spinal cord compression
Autoimmune disorders requiring chronic systemic steroid therapy or any other form of immunosuppressive therapy while on study, eg, ulcerative colitis, Crohn's disease, or any other gastrointestinal autoimmune disorder causing chronic nausea, vomiting, or diarrhea. Recent or current use of inhaled steroids or physiological substitution in case of adrenal insufficiency is not exclusionary.
Evidence or history within last 3 months of gastrointestinal inflammatory conditions not associated with the underlying cancer disease including gastrinomas, duodenitis, proven gastric ulcer, duodenal ulcer, pancreatitis, or subjects with recent gastric bleeding. Subjects may be included if the symptomatic/immunosuppressive treatment is discontinued more than 4 weeks prior to the first dose of AMG 910, symptoms have resolved, and gastroscopy does not indicate signs of active disease.
Subjects with inherited bleeding disorders (eg, Willebrand's disease, hemophilia A and other clotting factor deficiency) and subjects with known heparin-induced thrombocytopenia.
Subjects requiring non-steroidal anti-inflammatory drugs (NSAIDs) during study treatment. The NSAID(s) should be stopped within 7 days prior to start of treatment.

Contacts/Locations Module

Name	Affiliation	Role
MD	Amgen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
City of Hope National Medical Center		Duarte	California	91010	United States
University of California at Irvine Medical Center

References Module

Label	URL
AmgenTrials clinical trials website	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Cohort 1: AMG 910 6.5 µg	For Cycles 1 and 2, participants received AMG 910 as a short-term intravenous (IV) infusion (approximately 60 minutes) at a dose of 6.5 µg twice a week on Days 1 and 3 of each week in a 28-day cycle. For Cycles 3 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 2, 2021	Apr 24, 2023

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Safety Analysis Set: All participants that were enrolled and received at least 1 dose of AMG 910.

Arm/Group Information

ID	Title	Description
BG000	Cohort 1: AMG 910 6.5 µg	For Cycles 1 and 2, participants received AMG 910 as a short-term intravenous (IV) infusion (approximately 60 minutes) at a dose of 6.5 µg twice a week on Days 1 and 3 of each week in a 28-day cycle. For Cycles 3 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.
BG001	Cohort 1b: AMG 910 6.5 µg	For Cycle 1 Week 1, participants received AMG 910 as an extended IV (eIV) infusion (approximately 96 hours) at a dose of 6.5 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.
BG002	Cohort 2b: AMG 910 15 µg	For Cycle 1 Week 1, participants received AMG 910 as an eIV infusion (approximately 96 hours) at a dose of 15 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 15 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00055.5± 14.9 BG00154.3± 22.9 BG00263.6± 10.7 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0002 BG0011 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0011 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Asian	BG0001 BG0011 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT)

All DLTs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. DLTs were defined as any AEs at least possibly related to AMG 910 with an onset within the first 28 days following first dose with any of the following:

Grade 2 gastric perforation or fistula
Grade ≥ 3 non-hematologic AEs including laboratory abnormalities
Re-challenge with AMG 910 after treatment interruption due to any stomach toxicity results in at least same stomach toxicity and is of CTCAE grade ≥ 3 or grade 2 and ongoing for more than 3 days despite optimal supportive treatment
Grade 4 thrombocytopenia or grade 3 thrombocytopenia with bleeding
Grade 4 neutropenia lasting > 28 days
Febrile neutropenia of any grade
Anemia requiring transfusion per local or international guidelines in the absence of bleeding
Grade 5 toxicity
Any other toxicity related to AMG 910 considered significant enough to be qualified as DLT in the opinion of the investigator

Safety Analysis Set: All participants that were enrolled and received at least 1 dose of AMG 910. Only participants who received study treatment (at least 80% of the planned dose for Cycle 1) and remained on study through the DLT assessment window were considered DLT-evaluable.

Posted

Count of Participants

Participants

Day 1 to Day 28

ID	Title	Description
OG000	Cohort 1: AMG 910 6.5 µg	For Cycles 1 and 2, participants received AMG 910 as a short-term intravenous (IV) infusion (approximately 60 minutes) at a dose of 6.5 µg twice a week on Days 1 and 3 of each week in a 28-day cycle. For Cycles 3 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.
OG001	Cohort 1b: AMG 910 6.5 µg	For Cycle 1 Week 1, participants received AMG 910 as an extended IV (eIV) infusion (approximately 96 hours) at a dose of 6.5 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.
OG002	Cohort 2b: AMG 910 15 µg	For Cycle 1 Week 1, participants received AMG 910 as an eIV infusion (approximately 96 hours) at a dose of 15 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 15 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.

Units	Counts
Participants	OG0004 OG0013 OG0025

Title

Denominators

Categories

Title	Measurements
	OG0002 OG0010 OG0021

Primary

Number of Participants Who Experienced a Treatment-emergent AE (TEAE)

A TEAE was defined as any adverse event starting on or after the first administration of investigational product, as determined by the flag indicating if the adverse event started prior to the first dose on the Events case report form, and up to and including 30 days after the last investigational product dose date.

Evaluation of TEAEs included the number of participants with at least 1 TEAE or treatment-related TEAE. Clinically significant changes in vital signs, electrocardiogram (ECG) and clinical laboratory tests were recorded as TEAEs.

Safety Analysis Set: All participants that were enrolled and received at least 1 dose of AMG 910.

Posted

Count of Participants

Participants

Day 1 to 30 days post-last dose; maximum duration was 10.97 months

ID	Title	Description
OG000	Cohort 1: AMG 910 6.5 µg	For Cycles 1 and 2, participants received AMG 910 as a short-term intravenous (IV) infusion (approximately 60 minutes) at a dose of 6.5 µg twice a week on Days 1 and 3 of each week in a 28-day cycle. For Cycles 3 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.
OG001	Cohort 1b: AMG 910 6.5 µg	For Cycle 1 Week 1, participants received AMG 910 as an extended IV (eIV) infusion (approximately 96 hours) at a dose of 6.5 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.

Secondary

Maximum Serum Concentration (Cmax) of AMG 910

Mean Cmax values for the dosing intervals following short-term IV infusion (Cohort 1) and following extended IV infusions (Cohorts 1b and 2b) for Cycle 1 Week 1, and for short-term IV infusions in subsequent dosing intervals in Cycle 1. The timing of the pharmacokinetic (PK) sampling for Week 1 (Days 1 - 7) was based on hours after the start of the infusion and from Day 8 onwards was based on hours after the end of infusion (EOI). Due to the limited number of samples obtained and early termination of the study, PK data are summarized for Cycle 1 only.

PK Analysis Set: Includes all participants who have received at least 1 dose of the AMG 910 and have at least 1 PK sample collected. Participants with data available at each time point are included.

Posted

Mean

Full Range

ng/mL

Cycle 1: Days 1-7 at pre-infusion, 1, 2, 4, 24, 48, 72, 96, 120 and 144 hr; Days 8 and 10* at pre-infusion, EOI, 4 and 24 hr post-EOI; Days 15, 17* and 22* at pre-infusion and EOI; Day 24* at pre-infusion, EOI, 2, 4 and 24 hr post-EOI (*=Cohort 1 only)

ID	Title	Description
OG000	Cohort 1: AMG 910 6.5 µg	For Cycles 1 and 2, participants received AMG 910 as a short-term intravenous (IV) infusion (approximately 60 minutes) at a dose of 6.5 µg twice a week on Days 1 and 3 of each week in a 28-day cycle. For Cycles 3 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.
OG001	Cohort 1b: AMG 910 6.5 µg

Secondary

Minimum Serum Concentration (Ctrough) of AMG 910

Mean Ctrough values for the dosing intervals following short-term IV infusion (Cohort 1) and following extended IV infusions (Cohorts 1b and 2b) for Cycle 1 Week 1, and for short-term IV infusions in subsequent dosing intervals in Cycle 1 are presented. The timing of the PK sampling for Week 1 (Days 1-7) was based on hours after the start of infusion and from Day 8 onwards was based on hours after EOI. Due to the limited number of samples obtained and early termination of the study, PK data are summarized for Cycle 1 only.

PK Analysis Set: Includes all participants who have received at least 1 dose of the AMG 910 and have at least 1 PK sample collected. Participants with data available at each time point are included.

Posted

Mean

Full Range

ng/mL

ID	Title	Description
OG000	Cohort 1: AMG 910 6.5 µg	For Cycles 1 and 2, participants received AMG 910 as a short-term intravenous (IV) infusion (approximately 60 minutes) at a dose of 6.5 µg twice a week on Days 1 and 3 of each week in a 28-day cycle. For Cycles 3 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.
OG001	Cohort 1b: AMG 910 6.5 µg

Secondary

Area Under the Concentration-time Curve (AUC) Over the Dosing Interval (AUC0_168hr)

The timing of the PK sampling for Week 1 (Days 1-7) was based on hours after the start of infusion, and for Day 8 after EOI.

PK Analysis Set: Includes all participants who have received at least 1 dose of the AMG 910 and have at least 1 PK sample collected. Participants with data available are included.

Posted

Mean

Standard Deviation

hr•ng/mL

Cycle 1 Day 1 at pre-infusion, 1, 2, 4, 24, 48, 72, 96, 120 and 144 hr after infusion start and Cycle 1 Day 8 pre-infusion through 168 hr post-EOI

ID	Title	Description
OG000	Cohort 1: AMG 910 6.5 µg	For Cycles 1 and 2, participants received AMG 910 as a short-term intravenous (IV) infusion (approximately 60 minutes) at a dose of 6.5 µg twice a week on Days 1 and 3 of each week in a 28-day cycle. For Cycles 3 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.
OG001	Cohort 1b: AMG 910 6.5 µg	For Cycle 1 Week 1, participants received AMG 910 as an extended IV (eIV) infusion (approximately 96 hours) at a dose of 6.5 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.

Secondary

Cohort 1 Only: Accumulation Ratio (AR) of AMG 910

Calculated as AR = Cycle 1 Day 22 pre-infusion concentration/Cycle 1 Day 8 pre-infusion concentration.

PK Analysis Set: Includes all participants who have received at least 1 dose of the AMG 910 and have at least 1 PK sample collected. Participants with data available at both time points are included.

Posted

Number

ratio

Cycle 1 Day 8 pre-infusion and Cycle 1 Day 22 pre-infusion

ID	Title	Description
OG000	Cohort 1: AMG 910 6.5 µg	For Cycles 1 and 2, participants received AMG 910 as a short-term intravenous (IV) infusion (approximately 60 minutes) at a dose of 6.5 µg twice a week on Days 1 and 3 of each week in a 28-day cycle. For Cycles 3 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.

Units	Counts
Participants	OG000

Secondary

Half-life (t1/2) of AMG 910

Mean t1/2 values for the dosing intervals following short-term IV infusion (Cohort 1) and following extended IV infusions (Cohorts 1b and 2b) for Cycle 1 Week 1, and for short-term IV infusions in subsequent dosing intervals in Cycle 1 are presented. The timing of the PK sampling for Week 1 (Days 1-7) was based on hours after the start of infusion and from Day 8 onwards was based on hours after EOI. Due to the limited number of samples obtained and early termination of the study, PK data are summarized for Cycle 1 only.

PK Analysis Set: Includes all participants who have received at least 1 dose of the AMG 910 and have at least 1 PK sample collected. Participants with data available at each time point are included.

Posted

Mean

Full Range

Cycle 1: Days 1-7 at pre-infusion, 1, 2, 4, 24, 48, 72, 96, 120 and 144 hr; Days 8 and 10* at pre-infusion, EOI, 4 and 24 hr post-EOI (*=Cohort 1 only)

ID	Title	Description
OG000	Cohort 1: AMG 910 6.5 µg	For Cycles 1 and 2, participants received AMG 910 as a short-term intravenous (IV) infusion (approximately 60 minutes) at a dose of 6.5 µg twice a week on Days 1 and 3 of each week in a 28-day cycle. For Cycles 3 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.
OG001	Cohort 1b: AMG 910 6.5 µg	For Cycle 1 Week 1, participants received AMG 910 as an extended IV (eIV) infusion (approximately 96 hours) at a dose of 6.5 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.

Secondary

Number of Participants With an Objective Response (OR) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

OR was defined as a best overall response (BOR) of complete response (CR) or partial response (PR) per RECIST v1.1:

CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to < 10 mm.
PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Non target lesions must be non-progressive Disease (non-PD).

RECIST Evaluable Analysis Set: Included all participants that were enrolled and received at least 1 dose of AMG 910 with at least 1 tumor lesion that was measurable in contrast-enhanced computed tomography (CT) as defined by RECIST 1.1 at baseline.

Posted

Count of Participants

Participants

Day 1 to end of study (EOS); maximum time on study was 18.76 months

ID	Title	Description
OG000	Cohort 1: AMG 910 6.5 µg	For Cycles 1 and 2, participants received AMG 910 as a short-term intravenous (IV) infusion (approximately 60 minutes) at a dose of 6.5 µg twice a week on Days 1 and 3 of each week in a 28-day cycle. For Cycles 3 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.
OG001	Cohort 1b: AMG 910 6.5 µg	For Cycle 1 Week 1, participants received AMG 910 as an extended IV (eIV) infusion (approximately 96 hours) at a dose of 6.5 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.

Secondary

ORR Per Immune RECIST (iRECIST)

ORR was defined as the incidence of a BOR of immune complete response (iCR) or immune partial response (iPR) per iRECIST:

iCR: Disappearance of all non-nodal target and non-target lesions and normalization of pathological lymph nodes (whether target or non-target) to <10 mm in short axis.
iPR: At least a 30% decrease in the sum of measures of target lesions, taking as reference the baseline target lesion sum.

Data was not collected due to early termination of study, therefore data are not available.

Data were not collected.

Posted

Day 1 to EOS; maximum time on study was 18.76 months

ID	Title	Description
OG000	Cohort 1: AMG 910 6.5 µg	For Cycles 1 and 2, participants received AMG 910 as a short-term intravenous (IV) infusion (approximately 60 minutes) at a dose of 6.5 µg twice a week on Days 1 and 3 of each week in a 28-day cycle. For Cycles 3 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.
OG001	Cohort 1b: AMG 910 6.5 µg	For Cycle 1 Week 1, participants received AMG 910 as an extended IV (eIV) infusion (approximately 96 hours) at a dose of 6.5 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.

Secondary

Duration of Response (DOR) Per RECIST 1.1

As no participants experienced an objective response, data were not available.

Posted

Day 1 to EOS; maximum time on study was 18.76 months

ID	Title	Description
OG000	Cohort 1: AMG 910 6.5 µg	For Cycles 1 and 2, participants received AMG 910 as a short-term intravenous (IV) infusion (approximately 60 minutes) at a dose of 6.5 µg twice a week on Days 1 and 3 of each week in a 28-day cycle. For Cycles 3 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.
OG001	Cohort 1b: AMG 910 6.5 µg	For Cycle 1 Week 1, participants received AMG 910 as an extended IV (eIV) infusion (approximately 96 hours) at a dose of 6.5 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.
OG002	Cohort 2b: AMG 910 15 µg

Secondary

DOR Per iRECIST

Data was not collected due to early termination of study, therefore data are not available.

Data were not collected.

Posted

Day 1 to EOS; maximum time on study was 18.76 months

ID	Title	Description
OG000	Cohort 1: AMG 910 6.5 µg	For Cycles 1 and 2, participants received AMG 910 as a short-term intravenous (IV) infusion (approximately 60 minutes) at a dose of 6.5 µg twice a week on Days 1 and 3 of each week in a 28-day cycle. For Cycles 3 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.
OG001	Cohort 1b: AMG 910 6.5 µg	For Cycle 1 Week 1, participants received AMG 910 as an extended IV (eIV) infusion (approximately 96 hours) at a dose of 6.5 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.
OG002	Cohort 2b: AMG 910 15 µg	For Cycle 1 Week 1, participants received AMG 910 as an eIV infusion (approximately 96 hours) at a dose of 15 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 15 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.

Secondary

Time to Progression Per RECIST 1.1

Data was not collected due to early termination of study, therefore data are not available.

Data were not collected.

Posted

Day 1 to EOS; maximum time on study was 18.76 months

ID	Title	Description
OG000	Cohort 1: AMG 910 6.5 µg	For Cycles 1 and 2, participants received AMG 910 as a short-term intravenous (IV) infusion (approximately 60 minutes) at a dose of 6.5 µg twice a week on Days 1 and 3 of each week in a 28-day cycle. For Cycles 3 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.
OG001	Cohort 1b: AMG 910 6.5 µg	For Cycle 1 Week 1, participants received AMG 910 as an extended IV (eIV) infusion (approximately 96 hours) at a dose of 6.5 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.
OG002	Cohort 2b: AMG 910 15 µg	For Cycle 1 Week 1, participants received AMG 910 as an eIV infusion (approximately 96 hours) at a dose of 15 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 15 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.

Secondary

Time to Progression Per iRECIST

Data was not collected due to early termination of study, therefore data are not available.

Data were not collected.

Posted

Day 1 to EOS; maximum time on study was 18.76 months

ID	Title	Description
OG000	Cohort 1: AMG 910 6.5 µg	For Cycles 1 and 2, participants received AMG 910 as a short-term intravenous (IV) infusion (approximately 60 minutes) at a dose of 6.5 µg twice a week on Days 1 and 3 of each week in a 28-day cycle. For Cycles 3 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.
OG001	Cohort 1b: AMG 910 6.5 µg	For Cycle 1 Week 1, participants received AMG 910 as an extended IV (eIV) infusion (approximately 96 hours) at a dose of 6.5 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.
OG002	Cohort 2b: AMG 910 15 µg	For Cycle 1 Week 1, participants received AMG 910 as an eIV infusion (approximately 96 hours) at a dose of 15 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 15 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.

Secondary

Progression-free Survival (PFS) Per RECIST 1.1

Data was not collected due to limited follow up time due to study termination, therefore data are not available.

Data were not collected.

Posted

6 months and 1 year

ID	Title	Description
OG000	Cohort 1: AMG 910 6.5 µg	For Cycles 1 and 2, participants received AMG 910 as a short-term intravenous (IV) infusion (approximately 60 minutes) at a dose of 6.5 µg twice a week on Days 1 and 3 of each week in a 28-day cycle. For Cycles 3 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.
OG001	Cohort 1b: AMG 910 6.5 µg	For Cycle 1 Week 1, participants received AMG 910 as an extended IV (eIV) infusion (approximately 96 hours) at a dose of 6.5 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.
OG002	Cohort 2b: AMG 910 15 µg	For Cycle 1 Week 1, participants received AMG 910 as an eIV infusion (approximately 96 hours) at a dose of 15 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 15 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.

Secondary

PFS Per iRECIST

Data was not collected due to early termination of study, therefore data are not available.

Data were not collected.

Posted

6 months and 1 year

ID	Title	Description
OG000	Cohort 1: AMG 910 6.5 µg	For Cycles 1 and 2, participants received AMG 910 as a short-term intravenous (IV) infusion (approximately 60 minutes) at a dose of 6.5 µg twice a week on Days 1 and 3 of each week in a 28-day cycle. For Cycles 3 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.
OG001	Cohort 1b: AMG 910 6.5 µg	For Cycle 1 Week 1, participants received AMG 910 as an extended IV (eIV) infusion (approximately 96 hours) at a dose of 6.5 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.
OG002	Cohort 2b: AMG 910 15 µg	For Cycle 1 Week 1, participants received AMG 910 as an eIV infusion (approximately 96 hours) at a dose of 15 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 15 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.

Secondary

Overall Survival

Data was not collected due to limited follow up time due to study termination, therefore data are not available.

Data were not collected.

Posted

1 year and 2 years

ID	Title	Description
OG000	Cohort 1: AMG 910 6.5 µg	For Cycles 1 and 2, participants received AMG 910 as a short-term intravenous (IV) infusion (approximately 60 minutes) at a dose of 6.5 µg twice a week on Days 1 and 3 of each week in a 28-day cycle. For Cycles 3 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.
OG001	Cohort 1b: AMG 910 6.5 µg	For Cycle 1 Week 1, participants received AMG 910 as an extended IV (eIV) infusion (approximately 96 hours) at a dose of 6.5 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.
OG002	Cohort 2b: AMG 910 15 µg	For Cycle 1 Week 1, participants received AMG 910 as an eIV infusion (approximately 96 hours) at a dose of 15 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 15 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cohort 1: AMG 910 6.5 µg	For Cycles 1 and 2, participants received AMG 910 as a short-term intravenous (IV) infusion (approximately 60 minutes) at a dose of 6.5 µg twice a week on Days 1 and 3 of each week in a 28-day cycle. For Cycles 3 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.	4	6	4	6	6	6
EG001	Cohort 1b: AMG 910 6.5 µg	For Cycle 1 Week 1, participants received AMG 910 as an extended IV (eIV) infusion (approximately 96 hours) at a dose of 6.5 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 6.5 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.	3	4	3	4	4	4
EG002	Cohort 2b: AMG 910 15 µg	For Cycle 1 Week 1, participants received AMG 910 as an eIV infusion (approximately 96 hours) at a dose of 15 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 15 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.	2	5	2	5	5	5

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Atrial fibrillation	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0020 affected5 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0020 affected5 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0020 affected5 at risk
Oesophageal stent stenosis	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected5 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0020 affected5 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected5 at risk
Pyrexia	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG0020 affected5 at risk
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0020 affected5 at risk
Cytokine release syndrome	Immune system disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0020 affected5 at risk
Peritonitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0020 affected5 at risk
Staphylococcal infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0020 affected5 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected5 at risk
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0012 affected4 at risk EG0020 affected5 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0020 affected5 at risk
Paraparesis	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected5 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG0020 affected5 at risk
Hypotension	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0020 affected5 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0003 affected6 at risk EG0012 affected4 at risk EG0022 affected5 at risk
Tachycardia	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG0020 affected5 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0003 affected6 at risk EG0011 affected4 at risk EG0021 affected5 at risk
Ascites	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected6 at risk EG0011 affected4 at risk EG0020 affected5 at risk
Constipation	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected6 at risk EG0012 affected4 at risk EG0021 affected5 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0023 affected5 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0020 affected5 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0020 affected5 at risk
Faecal vomiting	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0020 affected5 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0020 affected5 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG0020 affected5 at risk
Nausea	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0003 affected6 at risk EG0012 affected4 at risk EG0023 affected5 at risk
Obstruction gastric	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected5 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected5 at risk
Vomiting	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0003 affected6 at risk EG0011 affected4 at risk EG0022 affected5 at risk
Asthenia	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG0020 affected5 at risk
Fatigue	General disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected6 at risk EG0013 affected4 at risk EG0021 affected5 at risk
Generalised oedema	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected5 at risk
Oedema peripheral	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG0020 affected5 at risk
Pyrexia	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG0021 affected5 at risk
Bile duct stenosis	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0020 affected5 at risk
Cholestasis	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0020 affected5 at risk
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected6 at risk EG0010 affected4 at risk EG0020 affected5 at risk
Cytokine release syndrome	Immune system disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected6 at risk EG0012 affected4 at risk EG0022 affected5 at risk
COVID-19	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0020 affected5 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected5 at risk
Oral candidiasis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0020 affected5 at risk
Urinary tract infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG0020 affected5 at risk
Afferent loop syndrome	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0020 affected5 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected5 at risk
Procedural vomiting	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG0020 affected5 at risk
Alanine aminotransferase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0020 affected5 at risk
Amylase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG0020 affected5 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0020 affected5 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0020 affected5 at risk
C-reactive protein increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0020 affected5 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0020 affected5 at risk
International normalised ratio increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected5 at risk
Lipase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0001 affected6 at risk EG0011 affected4 at risk EG0020 affected5 at risk
Lymphocyte count decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0020 affected5 at risk
Neutrophil count decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0020 affected5 at risk
Serum ferritin decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG0020 affected5 at risk
Weight decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0021 affected5 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected6 at risk EG0011 affected4 at risk EG0022 affected5 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0020 affected5 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0020 affected5 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0012 affected4 at risk EG0020 affected5 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0022 affected5 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected5 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected6 at risk EG0010 affected4 at risk EG0020 affected5 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG0020 affected5 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected6 at risk EG0011 affected4 at risk EG0020 affected5 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0021 affected5 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected6 at risk EG0011 affected4 at risk EG0020 affected5 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG0020 affected5 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected5 at risk
Dizziness	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0020 affected5 at risk
Depression	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected4 at risk EG0020 affected5 at risk
Insomnia	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected6 at risk EG0011 affected4 at risk EG0020 affected5 at risk
Calculus bladder	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected5 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG0020 affected5 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG0020 affected5 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG0020 affected5 at risk
Hypertrichosis	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected4 at risk EG0020 affected5 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected5 at risk
Hypertension	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected6 at risk EG0011 affected4 at risk EG0020 affected5 at risk
Hypotension	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0002 affected6 at risk EG0010 affected4 at risk EG0021 affected5 at risk
Thrombosis	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected4 at risk EG0021 affected5 at risk

The study was discontinued due to a strategic decision to end clinical development for AMG 910 that was unrelated to safety.

Certain Agreements

For Cycle 1 Week 1, participants received AMG 910 as an eIV infusion (approximately 96 hours) at a dose of 15 µg. For the remainder of Cycle 1 (from Day 8) and for Cycles 2 to 6, participants received AMG 910 as a short-term IV infusion (approximately 60 minutes) at a dose of 15 µg weekly, ie, Days 1, 8, 15 and 22 in a 28-day cycle.

OG00215.8(1.47 to 30.2)

OG00113.6(1.63 to 47.6)

OG00222.3(9.02 to 28.1)

OG0014.99(1.35 to 8.62)

OG00210.5(5.79 to 17.3)

OG0027.27(2.24 to 11.0)

OG0011.54(0.316 to 3.40)

OG0023.70(1.06 to 5.55)

OG0011.02(0.00 to 2.03)

OG0022.54(0.809 to 4.37)

OG00266.9(60.0 to 74.0)