Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced 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

Tumor assessments were evaluated at baseline by computerized tomography (CT) or magnetic resonance imaging (MRI). The primary objective of this study was to determine the overall objective response rate (ORR) per investigator assessment, defined as confirmed complete response (CR; disappearance of all target lesions) + partial response (PR; at least a 30% decrease in the sum of the longest diameter of target lesions) by RECIST v1.1, for seribantumab monotherapy (3,000 mg QW) in patients with centrally confirmed NRG1 fusion.

Among the 36 patients enrolled in Cohort 1, 29 of 36 patients met criteria (criteria includes centrally confirmed NRG1 fusion status and patient received 3,000 mg QW dosing) to be included in the primary efficacy population and were evaluable for investigator assessed response per RECIST v1.1. In Cohorts 2 and 3, one patient in each cohort was not evaluable for investigator assessed response per RECIST v1.1.

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Reported safety

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

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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-pancreatic-cancer-avgemsi-9fcc56af
nct id: NCT04383210
trial label: Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced 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: 1
harms Count: 3
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer-avgemsi-9fcc56af
nct id
NCT04383210
outcome key
om-0000
source section id
NCT04383210-om-0000
source outcome index
0
endpoint
Objective Response Rate
endpoint definition
Tumor assessments were evaluated at baseline by computerized tomography (CT) or magnetic resonance imaging (MRI). The primary objective of this study was to determine the overall objective response rate (ORR) per investigator assessment, defined as confirmed complete response (CR; disappearance of all target lesions) + partial response (PR; at least a 30% decrease in the sum of the longest diameter of target lesions) by RECIST v1.1, for seribantumab monotherapy (3,000 mg QW) in patients with centrally confirmed NRG1 fusion.
time origin
Up to 12 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Among the 36 patients enrolled in Cohort 1, 29 of 36 patients met criteria (criteria includes centrally confirmed NRG1 fusion status and patient received 3,000 mg QW dosing) to be included in the primary efficacy population and were evaluable for investigator assessed response per RECIST v1.1. In Cohorts 2 and 3, one patient in each cohort was not evaluable for investigator assessed response per RECIST v1.1.
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-pancreatic-cancer-avgemsi-9fcc56af
nct id
NCT04383210
outcome key
om-0000
arm key
OG000
arm label
Cohort 1
regimen
Enrolled 36 adult advanced solid tumor patients harboring NRG1 gene fusions, who have received prior standard treatment, excluding prior ERBB-directed therapy. Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively. Seribantumab: Anti-HER3 monoclonal antibody
analyzed count
29
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04383210-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer-avgemsi-9fcc56af
nct id
NCT04383210
outcome key
om-0000
arm key
OG001
arm label
Cohort 2
regimen
Enrolled 11 adult advanced solid tumor patients harboring NRG1 gene fusions, who have received prior standard treatment, including prior ERBB-directed therapy. Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively. Seribantumab: Anti-HER3 monoclonal antibody
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04383210-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer-avgemsi-9fcc56af
nct id
NCT04383210
outcome key
om-0000
arm key
OG002
arm label
Cohort 3
regimen
Enrolled 7 adult advanced solid tumor patients harboring NRG1 gene fusions lacking an EGF-like domain, who have received prior standard treatment, which may have included prior ERBB-directed therapy. Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively. Seribantumab: Anti-HER3 monoclonal antibody
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04383210-om-0000#groups/OG002

harms

release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer-avgemsi-9fcc56af
nct id
NCT04383210
harm key
EG000
source section id
NCT04383210-ae
event group key
EG000
event group label
Cohort 1
serious affected
17
serious at risk
36
other affected
35
other at risk
36
frequency threshold
5
collection period
3 years, 4 months
event definition
Source null
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-pancreatic-cancer-avgemsi-9fcc56af
nct id
NCT04383210
harm key
EG001
source section id
NCT04383210-ae
event group key
EG001
event group label
Cohort 2
serious affected
6
serious at risk
11
other affected
11
other at risk
11
frequency threshold
5
collection period
3 years, 4 months
event definition
Source null
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-pancreatic-cancer-avgemsi-9fcc56af
nct id
NCT04383210
harm key
EG002
source section id
NCT04383210-ae
event group key
EG002
event group label
Cohort 3
serious affected
4
serious at risk
7
other affected
7
other at risk
7
frequency threshold
5
collection period
3 years, 4 months
event definition
Source null
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