Breast Cancer Clinical Trial
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
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.
Eligibility Criteria
Inclusion 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.
Exclusion 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
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There are 42 Locations for this study
Birmingham Alabama, 35294, United States
Scottsdale Arizona, 85258, United States
Fountain Valley California, 92708, United States
Huntington Beach California, 92648, United States
Los Angeles California, 90048, United States
Orange California, 92868, United States
Denver Colorado, 80220, United States
Newark Delaware, 19713, United States
Washington District of Columbia, 20007, United States
Tampa Florida, 33612, United States
Athens Georgia, 30607, United States
Honolulu Hawaii, 96813, United States
Chicago Illinois, 60611, United States
Boston Massachusetts, 02114, United States
Detroit Michigan, 48202, United States
Saint Louis Park Minnesota, 55416, United States
Saint Louis Missouri, 63110, United States
Omaha Nebraska, 68114, United States
Bronx New York, 10467, United States
New York New York, 10065, United States
Charlotte North Carolina, 28204, United States
Columbus Ohio, 43210, United States
Portland Oregon, 97239, United States
Hershey Pennsylvania, 17033, United States
Philadelphia Pennsylvania, 19111, United States
Sioux Falls South Dakota, 57104, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75246, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84106, United States
Blacksburg Virginia, 24060, United States
Fairfax Virginia, 22031, United States
Tacoma Washington, 98405, United States
Appleton Wisconsin, 54911, United States
Madison Wisconsin, 53792, United States
Sydney New South Wales, 2010, Australia
Hobart Tasmania, 7000, Australia
Melbourne Victoria, 3000, Australia
Nedlands Western Australia, 6009, Australia
Vancouver British Columbia, V5Z 4, Canada
Brampton Ontario, L6R 3, Canada
Seoul , 03080, Korea, Republic of
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