18 and older, any sex, with Locally Advanced Solid Tumor or Metastatic Solid Tumor. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Objective Response RatePrimary· Up to 12 months
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.
Group
Value
95% CI
Cohort 1
10
Cohort 2
1
Cohort 3
0
Adverse events — posted to ClinicalTrials.gov
Time frame: 3 years, 4 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Cohort 1
Serious: 17/36 (47%)
Deaths: 21/36
Cohort 2
Serious: 6/11 (55%)
Deaths: 8/11
Cohort 3
Serious: 4/7 (57%)
Deaths: 7/7
Serious adverse events (35 terms)
Reaction
System
Cohort 1
Cohort 2
Cohort 3
Pneumonia
Infections and infestations
—
—
—
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This study is an open-label, international, multi-center, Phase 2 study in adult patients with recurrent, locally-advanced or metastatic solid tumors, which harbor the NRG1 gene fusion.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04790695 — Single Patient Protocol for an NRG1 Fusion Positive Metastatic Pancreatic Cancer Patient Using Seribantumab
· Phase 2
· completed
NCT03241810 — Phase 2 Trial of Seribantumab Plus Fulvestrant in Postmenopausal Women With Metastatic Breast Cancer
· Phase 2
· terminated
Other recruiting trials for Locally Advanced Solid Tumor
Currently open trials in the same condition.
NCT07213817 — A Study to Assess the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, Immunogenicity and Antitumour Activity of
· Phase 1, PHASE2
· recruiting
NCT06658353 — Phase III Clinical Study of VC004 in Patients With Localized Advanced/ Metastatic Solid Tumors
· Phase 3
· recruiting
NCT06349408 — IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors
· Phase 1
· recruiting
NCT06415487 — ACE2016 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (
· Phase 1
· recruiting
NCT06416007 — Lattice Radiotherapy for Dose-Escalated Palliation of Bulky Tumors
· Phase 2
· recruiting
Other Elevation Oncology trials
Trials by the same sponsor.
NCT05980416 — Study of EO-3021 in Adult Patients With Solid Tumors Likely to Express CLDN18.2
· Phase 1
· terminated
NCT03241810 — Phase 2 Trial of Seribantumab Plus Fulvestrant in Postmenopausal Women With Metastatic Breast Cancer
· Phase 2
· terminated
NCT02387216 — A Study of MM-121 in Combination With Chemotherapy Versus Chemotherapy Alone in Heregulin Positive NSCLC
· Phase 2
· terminated
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Elevation Oncology
Last refreshed: 3 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04383210.