Trial Outcomes & Findings for Study of AMG 994 Monotherapy and AMG 994 and AMG 404 Combination Therapy in Participants With Advanced Solid Tumors (NCT NCT04727554)

Last Updated: 2025-01-06

Results Overview

DLTs were defined as: * Grade 5 events * Grade 4 neutropenia/thrombocytopenia of any duration * Grade 3 thrombocytopenia w/ clin significant bleeding or lasting \>7 days * Febrile neutropenia * Grade 4 anemia * Grade 3/4 non-hematologic toxicity, except: Grade 3 nausea/vomiting or diarrhea \< 72 hours; Grade 3 fatigue \< 1 week; Asymptomatic grade 3 electrolyte abnormalities that last \< 72 hours, are not clinically complicated, and resolve spontaneously or respond to conventional medical interventions; Grade 3 amylase/ lipase elevations; Other laboratory parameters of grade 3, not considered clinically relevant and improved to grade ≤ 2 within 72 hours. * Any grade 3 event requiring hospitalization * Recurrent grade 2 pneumonitis * Delay in cycle 2 treatment for \> 14 days due to an adverse event in the dose escalation portion of the study * Any event requiring discontinuation of AMG 994

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

11 participants

Primary outcome timeframe

Up to Day 28 of Cycle 1 (one cycle = 28 days)

Results posted on

2025-01-06

Participant Flow

This study was conducted at 7 centers in Belgium, France, Japan, Poland, Spain, and the United States between 29 April 2021 and 05 June 2023.

The study was planned to be conducted in 2 parts: part 1 (dose exploration) and part 2 (dose expansion); however, no participants enrolled beyond Cohort 2 due to a business decision to discontinue development of AMG 994. This decision was unrelated to the safety or efficacy.

Participant milestones

Participant milestones
Measure	Cohort 1 (Low Dose) Participants were administered AMG 994 as a monotherapy treatment at dose level 1 (low dose) via short-term IV infusion once weekly (QW) for cycles 1 to 12 (on days 1, 8, 15, and 22). From Cycle 2, participants were also administered AMG 404 via short-term IV infusion every 4 weeks (Q4W) for up to 12 cycles (cycle= 28 days).	Cohort 2 (High Dose) Participants were administered AMG 994 as a monotherapy treatment at dose level 2 (high dose) via short-term IV infusion QW for cycles 1 to 12 (on days 1, 8, 15, and 22). From Cycle 2, participants were also administered AMG 404 via short-term IV infusion Q4W for up to 12 cycles (cycle= 28 days).
Overall Study STARTED	3	8
Overall Study Received AMG 994	3	8
Overall Study Received AMG 404	3	6
Overall Study COMPLETED	0	1
Overall Study NOT COMPLETED	3	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1 (Low Dose) Participants were administered AMG 994 as a monotherapy treatment at dose level 1 (low dose) via short-term IV infusion once weekly (QW) for cycles 1 to 12 (on days 1, 8, 15, and 22). From Cycle 2, participants were also administered AMG 404 via short-term IV infusion every 4 weeks (Q4W) for up to 12 cycles (cycle= 28 days).	Cohort 2 (High Dose) Participants were administered AMG 994 as a monotherapy treatment at dose level 2 (high dose) via short-term IV infusion QW for cycles 1 to 12 (on days 1, 8, 15, and 22). From Cycle 2, participants were also administered AMG 404 via short-term IV infusion Q4W for up to 12 cycles (cycle= 28 days).
Overall Study Lost to Follow-up	0	1
Overall Study Death	2	6
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Study of AMG 994 Monotherapy and AMG 994 and AMG 404 Combination Therapy in Participants With Advanced Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 (Low Dose) n=3 Participants Participants were administered AMG 994 as a monotherapy treatment at dose level 1 via short-term IV infusion QW for cycles 1 to 12 (on days 1, 8, 15, and 22). From Cycle 2, participants were also administered AMG 404 via short-term IV infusion Q4W for up to 12 cycles (cycle= 28 days).	Cohort 2 (High Dose) n=8 Participants Participants were administered AMG 994 as a monotherapy treatment at dose level 2 via short-term IV infusion QW for cycles 1 to 12 (on days 1, 8, 15, and 22). From Cycle 2, participants were also administered AMG 404 via short-term IV infusion Q4W for up to 12 cycles (cycle= 28 days).	Total n=11 Participants Total of all reporting groups
Age, Continuous	66.0 years STANDARD_DEVIATION 7.2 • n=5 Participants	61.1 years STANDARD_DEVIATION 11.8 • n=7 Participants	62.5 years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to Day 28 of Cycle 1 (one cycle = 28 days)

Population: Early DLT evaluable analysis set: included participants that were enrolled and received at least 1 dose of AMG 994 with an evaluable early DLT endpoint (evaluable in AMG 994 monotherapy cohort).

Outcome measures

Outcome measures
Measure	Cohort 1 (Low Dose) n=3 Participants Participants were administered AMG 994 as a monotherapy treatment at dose level 1 via short-term IV infusion QW for cycles 1 to 12 (on days 1, 8, 15, and 22). From Cycle 2, participants were also administered AMG 404 via short-term IV infusion Q4W for up to 12 cycles (cycle= 28 days).	Cohort 2 (High Dose n=8 Participants Participants were administered AMG 994 as a monotherapy treatment at dose level 2 via short-term IV infusion QW for cycles 1 to 12 (on days 1, 8, 15, and 22). From Cycle 2, participants were also administered AMG 404 via short-term IV infusion Q4W for up to 12 cycles (cycle= 28 days).
Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)	0 Number of participants	3 Number of participants

PRIMARY outcome

Timeframe: From first dose of investigational product through 140 days after last dose (AMG 994 or AMG 404, whichever is later), or end of study (whichever is first); median (min, max) duration was 12.5 ( 1.48, 19.32) months.

Population: Safety analysis set: defined as all participants that are enrolled and receive at least 1 dose of AMG 994 or AMG 404.

TEAEs were those that occurred after the first intervention dose. A serious adverse event (SAE) included outcomes such as death, life-threatening situations, hospitalization or an extended hospital stay, significant incapacity, congenital defects, or other crucial medical events. AE severity followed the CTCAE Version 5.0 scale: grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (life-threatening), and grade 5 (death). Clinically significant laboratory results or other assessments (e.g., ECGs, scans, vital signs) that worsened from baseline and were deemed important by the investigator, independent of disease progression, were also considered.

Outcome measures

Outcome measures
Measure	Cohort 1 (Low Dose) n=3 Participants Participants were administered AMG 994 as a monotherapy treatment at dose level 1 via short-term IV infusion QW for cycles 1 to 12 (on days 1, 8, 15, and 22). From Cycle 2, participants were also administered AMG 404 via short-term IV infusion Q4W for up to 12 cycles (cycle= 28 days).	Cohort 2 (High Dose n=8 Participants Participants were administered AMG 994 as a monotherapy treatment at dose level 2 via short-term IV infusion QW for cycles 1 to 12 (on days 1, 8, 15, and 22). From Cycle 2, participants were also administered AMG 404 via short-term IV infusion Q4W for up to 12 cycles (cycle= 28 days).
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) All TEAEs	3 Number of participants	8 Number of participants
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) All Grade ≥ 3 TEAEs	3 Number of participants	6 Number of participants
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) All SAEs	3 Number of participants	6 Number of participants
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) All Fatal AEs (FAEs)	2 Number of participants	6 Number of participants
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) All AMG 994 related TEAEs	2 Number of participants	4 Number of participants
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) AMG 994 related Grade ≥ 3 TEAEs	0 Number of participants	1 Number of participants
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) AMG 994 related SAEs	0 Number of participants	0 Number of participants
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) AMG 994 related FAEs	0 Number of participants	0 Number of participants
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) All AMG 404 related TEAEs	1 Number of participants	4 Number of participants
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) AMG 404 related TEAEs Grade ≥ 3 TEAEs	0 Number of participants	1 Number of participants
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) AMG 404 related SAEs	0 Number of participants	0 Number of participants
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) AMG 404 related FAEs	0 Number of participants	0 Number of participants

SECONDARY outcome

Timeframe: Up to approximately 19.32 months

Population: Safety analysis set: defined as all participants that are enrolled and receive at least 1 dose of AMG 994 or AMG 404.

OR was defined as achieving complete response (CR) or partial response (PR) per the modified RECIST 1.1 where CR is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm and PR is at 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Outcome measures
Measure	Cohort 1 (Low Dose) n=3 Participants Participants were administered AMG 994 as a monotherapy treatment at dose level 1 via short-term IV infusion QW for cycles 1 to 12 (on days 1, 8, 15, and 22). From Cycle 2, participants were also administered AMG 404 via short-term IV infusion Q4W for up to 12 cycles (cycle= 28 days).	Cohort 2 (High Dose n=8 Participants Participants were administered AMG 994 as a monotherapy treatment at dose level 2 via short-term IV infusion QW for cycles 1 to 12 (on days 1, 8, 15, and 22). From Cycle 2, participants were also administered AMG 404 via short-term IV infusion Q4W for up to 12 cycles (cycle= 28 days).
Objective Response (OR) Per Modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 CR	0 Number of participants	0 Number of participants
Objective Response (OR) Per Modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 PR	0 Number of participants	2 Number of participants

SECONDARY outcome

Timeframe: Up to approximately 19.32 months

Population: Safety analysis set: defined as all participants that are enrolled and receive at least 1 dose of AMG 994 or AMG 404. Only participants with response are included in duration of response analysis.

DoR was defined as the number of months between first OR to disease progression or death (due to any cause), whichever occurs first. Median and 95% CI estimates of survival time were based on the Kaplan-Meier analysis.

Outcome measures

Outcome measures
Measure	Cohort 1 (Low Dose) Participants were administered AMG 994 as a monotherapy treatment at dose level 1 via short-term IV infusion QW for cycles 1 to 12 (on days 1, 8, 15, and 22). From Cycle 2, participants were also administered AMG 404 via short-term IV infusion Q4W for up to 12 cycles (cycle= 28 days).	Cohort 2 (High Dose n=2 Participants Participants were administered AMG 994 as a monotherapy treatment at dose level 2 via short-term IV infusion QW for cycles 1 to 12 (on days 1, 8, 15, and 22). From Cycle 2, participants were also administered AMG 404 via short-term IV infusion Q4W for up to 12 cycles (cycle= 28 days).
Duration of Response (DoR) Per Modified RECIST 1.1	—	11.09 Months Interval 11.05 to Upper limit not reached.

SECONDARY outcome

Timeframe: Up to approximately 19.32 months

Population: Safety analysis set: defined as all participants that are enrolled and receive at least 1 dose of AMG 994 or AMG 404.

OS was defined as the time from initiation of AMG 994 until event of death due to any cause. Median and 95% CI estimates of survival time were based on the Kaplan-Meier analysis.

Outcome measures

Outcome measures
Measure	Cohort 1 (Low Dose) n=3 Participants Participants were administered AMG 994 as a monotherapy treatment at dose level 1 via short-term IV infusion QW for cycles 1 to 12 (on days 1, 8, 15, and 22). From Cycle 2, participants were also administered AMG 404 via short-term IV infusion Q4W for up to 12 cycles (cycle= 28 days).	Cohort 2 (High Dose n=8 Participants Participants were administered AMG 994 as a monotherapy treatment at dose level 2 via short-term IV infusion QW for cycles 1 to 12 (on days 1, 8, 15, and 22). From Cycle 2, participants were also administered AMG 404 via short-term IV infusion Q4W for up to 12 cycles (cycle= 28 days).
Overall Survival (OS) Per Modified RECIST 1.1	5.99 Months Interval 5.03 to Upper CI limit not reached due to the low number of observations.	12.50 Months Interval 1.48 to Upper CI limit not reached due to the low number of observations.

SECONDARY outcome

Timeframe: Up to approximately 19.32 months

Population: Safety analysis set: defined as all participants that are enrolled and receive at least 1 dose of AMG 994 or AMG 404.

PFS was defined as the time from initiation of AMG 994 until disease progression or death whichever occurs first. Death due to any cause counted as the event. Median and 95% CI estimates of survival time were based on the Kaplan-Meier analysis.

Outcome measures

Outcome measures
Measure	Cohort 1 (Low Dose) n=3 Participants Participants were administered AMG 994 as a monotherapy treatment at dose level 1 via short-term IV infusion QW for cycles 1 to 12 (on days 1, 8, 15, and 22). From Cycle 2, participants were also administered AMG 404 via short-term IV infusion Q4W for up to 12 cycles (cycle= 28 days).	Cohort 2 (High Dose n=8 Participants Participants were administered AMG 994 as a monotherapy treatment at dose level 2 via short-term IV infusion QW for cycles 1 to 12 (on days 1, 8, 15, and 22). From Cycle 2, participants were also administered AMG 404 via short-term IV infusion Q4W for up to 12 cycles (cycle= 28 days).
Progression-free Survival Per Modified RECIST 1.1	2.63 Months Interval 2.63 to Upper CI limit not reached due to the low number of observations.	1.61 Months Interval 0.92 to 13.65

SECONDARY outcome

Timeframe: Up to approximately 19.32 months

Population: Safety analysis set: defined as all participants that are enrolled and receive at least 1 dose of AMG 994 or AMG 404.

TTP was defined as time from initiation of AMG 994 until disease progression. Median and 95% CI estimates of survival time were based on the Kaplan-Meier analysis.

Outcome measures

Outcome measures
Measure	Cohort 1 (Low Dose) n=3 Participants Participants were administered AMG 994 as a monotherapy treatment at dose level 1 via short-term IV infusion QW for cycles 1 to 12 (on days 1, 8, 15, and 22). From Cycle 2, participants were also administered AMG 404 via short-term IV infusion Q4W for up to 12 cycles (cycle= 28 days).	Cohort 2 (High Dose n=8 Participants Participants were administered AMG 994 as a monotherapy treatment at dose level 2 via short-term IV infusion QW for cycles 1 to 12 (on days 1, 8, 15, and 22). From Cycle 2, participants were also administered AMG 404 via short-term IV infusion Q4W for up to 12 cycles (cycle= 28 days).
Time to Progression (TTP) Per Modified RECIST 1.1	2.63 Months Interval 2.63 to Upper CI limit not reached due to the low number of observations.	1.74 Months Interval 0.92 to 13.65

SECONDARY outcome

Timeframe: Up to approximately 19.32 months

Population: Safety analysis set: defined as all participants that are enrolled and receive at least 1 dose of AMG 994 or AMG 404.

Time to subsequent therapy was defined as the time from initiation of AMG 994 until the first subsequent therapy. Median and 95% CI estimates of survival time were based on the Kaplan-Meier analysis.

Outcome measures

Outcome measures
Measure	Cohort 1 (Low Dose) n=3 Participants Participants were administered AMG 994 as a monotherapy treatment at dose level 1 via short-term IV infusion QW for cycles 1 to 12 (on days 1, 8, 15, and 22). From Cycle 2, participants were also administered AMG 404 via short-term IV infusion Q4W for up to 12 cycles (cycle= 28 days).	Cohort 2 (High Dose n=8 Participants Participants were administered AMG 994 as a monotherapy treatment at dose level 2 via short-term IV infusion QW for cycles 1 to 12 (on days 1, 8, 15, and 22). From Cycle 2, participants were also administered AMG 404 via short-term IV infusion Q4W for up to 12 cycles (cycle= 28 days).
Time to Subsequent Therapy	NA Months Interval 4.74 to Median and upper CI limit not reached due to the low number of observations.	NA Months Interval 16.64 to Median and upper CI limit not reached due to the low number of observations.

SECONDARY outcome

Timeframe: Cycle 1 and 2, Day 1 (pre-dose, end of infusion [EOI], 2, 4.5, 6.5, and 12 hours post dose); Cycle 1, Day 22 (pre-dose, EOI, 6, and 12 hours post dose)

Population: Only participants with available data are included for each time point.

Outcome measures

Outcome measures
Measure	Cohort 1 (Low Dose) n=3 Participants Participants were administered AMG 994 as a monotherapy treatment at dose level 1 via short-term IV infusion QW for cycles 1 to 12 (on days 1, 8, 15, and 22). From Cycle 2, participants were also administered AMG 404 via short-term IV infusion Q4W for up to 12 cycles (cycle= 28 days).	Cohort 2 (High Dose n=8 Participants Participants were administered AMG 994 as a monotherapy treatment at dose level 2 via short-term IV infusion QW for cycles 1 to 12 (on days 1, 8, 15, and 22). From Cycle 2, participants were also administered AMG 404 via short-term IV infusion Q4W for up to 12 cycles (cycle= 28 days).
Maximum Serum Concentration (Cmax) of AMG 994 Cycle 1, Day 1	667 ng/mL Standard Deviation 1150	2450 ng/mL Standard Deviation 1140
Maximum Serum Concentration (Cmax) of AMG 994 Cycle 1, Day 22	4450 ng/mL Standard Deviation 3020	2550 ng/mL Standard Deviation 1290
Maximum Serum Concentration (Cmax) of AMG 994 Cycle 2, Day 1	2340 ng/mL Standard Deviation 3180	2830 ng/mL Standard Deviation 1260

SECONDARY outcome

Timeframe: Cycle 1 and 2, Day 1 (pre-dose, end of infusion [EOI], 2, 4.5, 6.5, and 12 hours post dose); Cycle 1, Day 22 (pre-dose, EOI, 6, and 12 hours post dose)

Population: Only participants with available data are included for each time point.

Outcome measures

Outcome measures
Measure	Cohort 1 (Low Dose) n=3 Participants Participants were administered AMG 994 as a monotherapy treatment at dose level 1 via short-term IV infusion QW for cycles 1 to 12 (on days 1, 8, 15, and 22). From Cycle 2, participants were also administered AMG 404 via short-term IV infusion Q4W for up to 12 cycles (cycle= 28 days).	Cohort 2 (High Dose n=8 Participants Participants were administered AMG 994 as a monotherapy treatment at dose level 2 via short-term IV infusion QW for cycles 1 to 12 (on days 1, 8, 15, and 22). From Cycle 2, participants were also administered AMG 404 via short-term IV infusion Q4W for up to 12 cycles (cycle= 28 days).
Time to Maximum Serum Concentration (Tmax) of AMG 994 Cycle 1, Day 1	8.4 hours Standard Deviation 15	1.4 hours Standard Deviation 0.68
Time to Maximum Serum Concentration (Tmax) of AMG 994 Cycle 1, Day 22	3.7 hours Standard Deviation 1.1	1.5 hours Standard Deviation 0.74
Time to Maximum Serum Concentration (Tmax) of AMG 994 Cycle 2, Day 1	3.0 hours Standard Deviation 0.0096	2.7 hours Standard Deviation 2.0

SECONDARY outcome

Timeframe: Cycle 1 and 2, Day 1 (pre-dose, end of infusion [EOI], 2, 4.5, 6.5, and 12 hours post dose); Cycle 1, Day 22 (pre-dose, EOI, 6, and 12 hours post dose)

Population: Only participants with available data are included for each time point.

Outcome measures

Outcome measures
Measure	Cohort 1 (Low Dose) n=3 Participants Participants were administered AMG 994 as a monotherapy treatment at dose level 1 via short-term IV infusion QW for cycles 1 to 12 (on days 1, 8, 15, and 22). From Cycle 2, participants were also administered AMG 404 via short-term IV infusion Q4W for up to 12 cycles (cycle= 28 days).	Cohort 2 (High Dose n=7 Participants Participants were administered AMG 994 as a monotherapy treatment at dose level 2 via short-term IV infusion QW for cycles 1 to 12 (on days 1, 8, 15, and 22). From Cycle 2, participants were also administered AMG 404 via short-term IV infusion Q4W for up to 12 cycles (cycle= 28 days).
Minimum Observed Serum Concentration (Cmin) of AMG 994 Cycle 1, Day 1	0.00 ng/mL Standard Deviation 0.00	0.00 ng/mL Standard Deviation 0.00
Minimum Observed Serum Concentration (Cmin) of AMG 994 Cycle 1, Day 22	0.00 ng/mL Standard Deviation 0.00	0.00 ng/mL Standard Deviation 0.00
Minimum Observed Serum Concentration (Cmin) of AMG 994 Cycle 2, Day 1	0.00 ng/mL Standard Deviation 0.00	0.00 ng/mL Standard Deviation 0.00

SECONDARY outcome

Timeframe: Cycle 1 and 2, Day 1 (pre-dose, end of infusion [EOI], 2, 4.5, 6.5, and 12 hours post dose); Cycle 1, Day 22 (pre-dose, EOI, 6, and 12 hours post dose)

Population: Only participants with available data are included for each time point.

Outcome measures

Outcome measures
Measure	Cohort 1 (Low Dose) n=3 Participants Participants were administered AMG 994 as a monotherapy treatment at dose level 1 via short-term IV infusion QW for cycles 1 to 12 (on days 1, 8, 15, and 22). From Cycle 2, participants were also administered AMG 404 via short-term IV infusion Q4W for up to 12 cycles (cycle= 28 days).	Cohort 2 (High Dose n=8 Participants Participants were administered AMG 994 as a monotherapy treatment at dose level 2 via short-term IV infusion QW for cycles 1 to 12 (on days 1, 8, 15, and 22). From Cycle 2, participants were also administered AMG 404 via short-term IV infusion Q4W for up to 12 cycles (cycle= 28 days).
Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of AMG 994 Cycle 1, Day 1	12100 h*ng/mL Standard Deviation NA SD not calculable when n=1	15000 h*ng/mL Standard Deviation 16700
Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of AMG 994 Cycle 1, Day 22	18900 h*ng/mL Standard Deviation 15000	21900 h*ng/mL Standard Deviation 23100
Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of AMG 994 Cycle 2, Day 1	6460 h*ng/mL Standard Deviation 8010	22900 h*ng/mL Standard Deviation 23300

SECONDARY outcome

Timeframe: Cycle 1 and 2, Day 1 (pre-dose, end of infusion [EOI], 2, 4.5, 6.5, and 12 hours post dose); Cycle 1, Day 22 (pre-dose, EOI, 6, and 12 hours post dose)

Population: Only participants with available data are included for each time point.

Outcome measures

Outcome measures
Measure	Cohort 1 (Low Dose) n=3 Participants Participants were administered AMG 994 as a monotherapy treatment at dose level 1 via short-term IV infusion QW for cycles 1 to 12 (on days 1, 8, 15, and 22). From Cycle 2, participants were also administered AMG 404 via short-term IV infusion Q4W for up to 12 cycles (cycle= 28 days).	Cohort 2 (High Dose n=7 Participants Participants were administered AMG 994 as a monotherapy treatment at dose level 2 via short-term IV infusion QW for cycles 1 to 12 (on days 1, 8, 15, and 22). From Cycle 2, participants were also administered AMG 404 via short-term IV infusion Q4W for up to 12 cycles (cycle= 28 days).
Area Under the Serum Concentration-time Curve During a Dosing Interval (AUCtau) of AMG 994 Cycle 1, Day 1	20300 h*ng/mL Standard Deviation 35200	20400 h*ng/mL Standard Deviation 21400
Area Under the Serum Concentration-time Curve During a Dosing Interval (AUCtau) of AMG 994 Cycle 1, Day 22	24500 h*ng/mL Standard Deviation 18400	45400 h*ng/mL Standard Deviation 61100
Area Under the Serum Concentration-time Curve During a Dosing Interval (AUCtau) of AMG 994 Cycle 2, Day 1	8260 h*ng/mL Standard Deviation 10100	29500 h*ng/mL Standard Deviation 31100

SECONDARY outcome

Timeframe: Cycle 1 and 2, Day 1 (pre-dose, end of infusion [EOI], 2, 4.5, 6.5, and 12 hours post dose); Cycle 1, Day 22 (pre-dose, EOI, 6, and 12 hours post dose)

Population: Only participants with available data are included for each time point.