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

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedSeribantumab

The study team can explain what participation involves.

Who it may be forLocally advanced · Metastatic or stage IV · Recurrent or relapsed

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 3, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?42 U.S. locations

Locations may change over time.

Who runs it?Elevation Oncology

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: Elevation Oncology
Interventions being studied: Drug: Seribantumab

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Disease setting

Locally advanced→Metastatic or stage IV→Recurrent or relapsed→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

To be eligible for participation in the study, patients must meet the following inclusion criteria:
Locally-advanced or metastatic solid tumor with an NRG1 gene fusion identified through molecular assays, such as PCR, NGS (RNA or DNA) or FISH, by a CLIA-certified or similarly accredited laboratory
Availability of fresh or archived FFPE tumor sample to be submitted to a central laboratory for confirmation of NRG1 gene fusion status
Patients should have received a minimum of one prior standard therapy appropriate for their tumor type and stage of disease, progressed or been nonresponsive to these available therapies, with no further available curative therapy options
≥ 18 years of age
ECOG performance status (PS) 0, 1 or 2
Patients must have at least one measurable extra-cranial lesion as defined by RECIST v1.1
Adequate hepatic function defined as:
Serum AST and serum ALT \< 2.5 × upper limit of normal (ULN), or AST and ALT \< 5 × ULN if liver function abnormalities due to underlying malignancy
Total bilirubin \< 2.0 ULN. Subjects with a known history of Gilberts Disease and an isolated elevation of indirect bilirubin are eligible
Adequate hematologic status, defined as:
Absolute neutrophil count (ANC) ≥1.5 × 109/L not requiring growth factor support for at least 7 days prior to Screening, and
Platelet count ≥100.0×109/L not requiring transfusion support for at least 7 days prior to Screening
Able to provide informed consent or have a legal representative able and willing to do so
Ability to comply with outpatient treatment, laboratory monitoring, and required clinic visits for the duration of study participation
Willingness of men and women of reproductive potential to observe conventional and effective birth control for the duration of treatment and for 3 months following study completion; this may include barrier methods such as condom or diaphragm with spermicidal gel.

Reasons someone may not be able to joinExclusion criteria

Known, actionable oncogenic driver mutation other than NRG1 fusion where available standard therapy is indicated
Life expectancy \< 3 months
Pregnant or lactating
Prior treatment with ERBB3/HER3 directed therapy (Cohort 1 only)
Prior treatment with pan-ERBB or any ERBB/HER2/HER3 directed therapy (Cohort 1 only)
Symptomatic or untreated brain metastases (Note: Patients with asymptomatic brain metastases treated with radiation or surgery and without evidence of progression by imaging at screening are eligible to participate in the study. Patients requiring ongoing corticosteroids to treat brain metastases will not be eligible).
Received other investigational agent or anticancer therapy within 28 days prior to planned start of seribantumab or 5 half-lives, whichever is shorter
Prior to initiation of seribantumab treatment, patients must have recovered from clinically significant toxicities from prior anticancer or investigational therapy
Any other active malignancy requiring systemic therapy
Known hypersensitivity to any of the components of seribantumab or previous CTCAE grade 3 or higher hypersensitivity reactions to fully human monoclonal antibodies
Clinically significant cardiac disease, including symptomatic congestive heart failure, unstable angina, acute myocardial infarction within 12 months of planned first dose, or unstable cardiac arrhythmia requiring therapy (including torsades de pointes)
Active uncontrolled systemic bacterial, viral, or fungal infection
Patients who are not appropriate candidates for participation in this clinical study for any other reason as deemed by the investigator

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

University of Alabama at BirminghamBirmingham, Alabama
HonorHealthScottsdale, Arizona
Compassionate Care Research Group Inc.Fountain Valley, California
Pacific Shores Medical GroupHuntington Beach, California
Cedars-Sinai Medical CenterLos Angeles, California
University of California - Irvine Medical CenterOrange, California
University of Colorado DenverDenver, Colorado
Medical Oncology Hematology ConsultantsNewark, Delaware
Georgetown UniversityWashington D.C., District of Columbia
Moffitt Cancer CenterTampa, Florida
University Cancer And Blood CenterAthens, Georgia
Hawaii Cancer CareHonolulu, Hawaii

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 3, 2025. Always confirm current availability with the study team.

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