QUILT-3.026: AMG 655 in Combination With AMG 479 in Advanced, Refractory Solid Tumors

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Incidence of adverse events and clinical laboratory abnormalities defined as DLTs. Dose-limiting toxicities included any grade 3 or higher hematologic or nonhematologic toxicity related to conatumumab or the combination of conatumumab with ganitumab except for lymphocytopenia and anemia.

Source null

→

primary · POSTED

The objective response rate (ORR) is defined as confirmed complete response or partial response using modified Response Evaluation Criteria in Solid Tumors \[RECIST\]: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

A subject was included in the analysis if they received at least one dose of study drug.

→

secondary · POSTED

Progression-free survival is defined as the number of days from study day 1 (first dose of investigational product) to the first observation of disease progression (by modified RECIST; or clinical progression, whichever came first) or death due to any cause. Disease progression by RECIST is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression.

Source null

→

secondary · POSTED

To Evaluate Anti-AMG 655 Antibody Formation and Anti-AMG 479 Antibody Formation

Antibody Population = All subjects in the full analysis set tested for antibodies during the study.

→

secondary · POSTED

Median, minimum, and maximum concentration of AMG 655 at specified time points.

PK population = All subjects in the full analysis set who underwent blood sampling for PK evaluation during the study.

→

secondary · POSTED

Median, minimum, and maximum concentration of AMG 479 at specified time points.

PK population = All subjects in the full analysis set who underwent blood sampling for PK evaluation during the study.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id: NCT00819169
trial label: QUILT-3.026: AMG 655 in Combination With AMG 479 in Advanced, Refractory Solid Tumors
applicability: unclear
applicability note: Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 9
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT00819169
outcome key
om-0000
source section id
NCT00819169-om-0000
source outcome index
0
endpoint
Number of Participants With Dose-limiting Toxicities
endpoint definition
Incidence of adverse events and clinical laboratory abnormalities defined as DLTs. Dose-limiting toxicities included any grade 3 or higher hematologic or nonhematologic toxicity related to conatumumab or the combination of conatumumab with ganitumab except for lymphocytopenia and anemia.
time origin
Time from first dose up to 24 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT00819169
outcome key
om-0001
source section id
NCT00819169-om-0001
source outcome index
1
endpoint
Objective Response Rate
endpoint definition
The objective response rate (ORR) is defined as confirmed complete response or partial response using modified Response Evaluation Criteria in Solid Tumors \[RECIST\]: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
time origin
Time from first dose up to 24 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
A subject was included in the analysis if they received at least one dose of study drug.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT00819169
outcome key
om-0002
source section id
NCT00819169-om-0002
source outcome index
2
endpoint
Progression Free Survival
endpoint definition
Progression-free survival is defined as the number of days from study day 1 (first dose of investigational product) to the first observation of disease progression (by modified RECIST; or clinical progression, whichever came first) or death due to any cause. Disease progression by RECIST is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression.
time origin
Time from first dose up to 24 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT00819169
outcome key
om-0003
source section id
NCT00819169-om-0003
source outcome index
3
endpoint
To Evaluate Anti-AMG 655 Antibody Formation and Anti-AMG 479 Antibody Formation
endpoint definition
To Evaluate Anti-AMG 655 Antibody Formation and Anti-AMG 479 Antibody Formation
time origin
Time from first dose up to 24 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Antibody Population = All subjects in the full analysis set tested for antibodies during the study.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT00819169
outcome key
om-0004
source section id
NCT00819169-om-0004
source outcome index
4
endpoint
To Evaluate the Concentration Level of AMG 655
endpoint definition
Median, minimum, and maximum concentration of AMG 655 at specified time points.
time origin
Cycle 1 Day 1 end of infusion; Cycle 3 Day 1 end of infusion (each cycle is 28 days, each infusion is up to 1 hour)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
PK population = All subjects in the full analysis set who underwent blood sampling for PK evaluation during the study.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT00819169
outcome key
om-0005
source section id
NCT00819169-om-0005
source outcome index
5
endpoint
To Evaluate the Concentration Level of AMG 479
endpoint definition
Median, minimum, and maximum concentration of AMG 479 at specified time points.
time origin
Cycle 1 Day 1 end of infusion; Cycle 3 Day 1 end of infusion (each cycle is 28 days, each infusion is up to 1 hour)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
PK population = All subjects in the full analysis set who underwent blood sampling for PK evaluation during the study.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT00819169
outcome key
om-0000
arm key
OG000
arm label
Part 1 Cohort 1
regimen
AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00819169-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT00819169
outcome key
om-0000
arm key
OG001
arm label
Part 1 Cohort 2
regimen
AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00819169-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT00819169
outcome key
om-0000
arm key
OG002
arm label
Part 1 Cohort 3
regimen
AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00819169-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT00819169
outcome key
om-0001
arm key
OG000
arm label
Part 1 Cohort 1
regimen
AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00819169-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT00819169
outcome key
om-0001
arm key
OG001
arm label
Part 1 Cohort 2
regimen
AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00819169-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT00819169
outcome key
om-0001
arm key
OG002
arm label
Part 1 Cohort 3
regimen
AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00819169-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT00819169
outcome key
om-0001
arm key
OG003
arm label
Part 2 Cohort 1
regimen
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Non-squamous NSCLC
analyzed count
15
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00819169-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT00819169
outcome key
om-0001
arm key
OG004
arm label
Part 2 Cohort 2
regimen
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Squamous Non -Small Cell Lung Cancer (NSCLC)
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00819169-om-0001#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT00819169
outcome key
om-0001
arm key
OG005
arm label
Part 2 Cohort 3
regimen
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Colorectal Cancer (CRC)
analyzed count
16
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00819169-om-0001#groups/OG005
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT00819169
outcome key
om-0001
arm key
OG006
arm label
Part 2 Cohort 4
regimen
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Pancreatic Cancer
analyzed count
16
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00819169-om-0001#groups/OG006
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT00819169
outcome key
om-0001
arm key
OG007
arm label
Part 2 Cohort 5
regimen
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Ovarian Cancer
analyzed count
9
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00819169-om-0001#groups/OG007
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT00819169
outcome key
om-0001
arm key
OG008
arm label
Part 2 Cohort 6
regimen
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Sarcoma
analyzed count
15
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00819169-om-0001#groups/OG008

harms

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT00819169
harm key
EG000
source section id
NCT00819169-ae
event group key
EG000
event group label
Part 1 Cohort 1
serious affected
2
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
event definition
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT00819169
harm key
EG001
source section id
NCT00819169-ae
event group key
EG001
event group label
Part 1 Cohort 2
serious affected
0
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
event definition
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT00819169
harm key
EG002
source section id
NCT00819169-ae
event group key
EG002
event group label
Part 1 Cohort 3
serious affected
2
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
event definition
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT00819169
harm key
EG003
source section id
NCT00819169-ae
event group key
EG003
event group label
Part 2 Cohort 1
serious affected
3
serious at risk
15
other affected
15
other at risk
15
frequency threshold
5
collection period
All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
event definition
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT00819169
harm key
EG004
source section id
NCT00819169-ae
event group key
EG004
event group label
Part 2 Cohort 2
serious affected
6
serious at risk
7
other affected
7
other at risk
7
frequency threshold
5
collection period
All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
event definition
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT00819169
harm key
EG005
source section id
NCT00819169-ae
event group key
EG005
event group label
Part 2 Cohort 3
serious affected
2
serious at risk
16
other affected
15
other at risk
16
frequency threshold
5
collection period
All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
event definition
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT00819169
harm key
EG006
source section id
NCT00819169-ae
event group key
EG006
event group label
Part 2 Cohort 4
serious affected
3
serious at risk
16
other affected
14
other at risk
16
frequency threshold
5
collection period
All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
event definition
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT00819169
harm key
EG007
source section id
NCT00819169-ae
event group key
EG007
event group label
Part 2 Cohort 5
serious affected
3
serious at risk
9
other affected
9
other at risk
9
frequency threshold
5
collection period
All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
event definition
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT00819169
harm key
EG008
source section id
NCT00819169-ae
event group key
EG008
event group label
Part 2 Cohort 6
serious affected
2
serious at risk
15
other affected
11
other at risk
15
frequency threshold
5
collection period
All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
event definition
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice