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

STATUS

Recruiting
participants needed

75
sponsor

Elevation Oncology

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Updated on 19 February 2024

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cancer

blood transfusion

platelet count

absolute neutrophil count

solid tumour

direct bilirubin

gilbert's syndrome

neutrophil count

solid tumor

formalin-fixed paraffin-embedded

growth factor

solid tumors

solid neoplasm

metastatic malignant solid tumor

ffpe

metastatic solid tumor

gene fusion

indirect bilirubin

seribantumab

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.

Details

Condition	Locally Advanced Solid Tumor, Metastatic Solid Tumor
Age	18-100 years
Treatment	Seribantumab
Clinical Study Identifier	NCT04383210
Sponsor	Elevation Oncology
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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
	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 100.0109/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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Step 3 Enroll in the clinical study

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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