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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04383210
Other study ID # ELVCAP-001-01
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date September 29, 2020
Est. completion date March 2025

Study information

Verified date August 2023
Source Elevation Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 75
Est. completion date March 2025
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • Bile Duct Cancer
  • Bile Duct Neoplasms
  • Bladder Cancer
  • Breast Cancer
  • Cholangiocarcinoma
  • Colorectal Cancer
  • Esophageal Cancer
  • Gallbladder Cancer
  • Gallbladder Neoplasms
  • Head and Neck Cancer
  • Kidney Cancer
  • Locally Advanced Solid Tumor
  • Lung Cancer
  • Metastatic Solid Tumor
  • Neoplasms
  • Ovarian Cancer
  • Pancreatic Cancer
  • Prostate Cancer
  • Sarcoma
  • Uterine Cancer
  • Uterine Neoplasms

Intervention

Drug:
Seribantumab
Anti-HER3 monoclonal antibody

Locations

Country Name City State
Australia Royal Hobart Hospital Hobart Tasmania
Australia Peter MacCallum Cancer Centre Melbourne Victoria
Australia Linear Clinical Research Ltd. Nedlands Western Australia
Australia St. Vincent's Hospital Sydney New South Wales
Canada William Osler Health System Brampton Ontario
Canada BC Cancer Vancouver British Columbia
Korea, Republic of Seoul National University Hospital Seoul
United States ThedaCare Regional Cancer Center Appleton Wisconsin
United States University Cancer And Blood Center Athens Georgia
United States University of Alabama at Birmingham Birmingham Alabama
United States Oncology & Hematology Associates of Southwest Virginia Inc., DBA Blue Ridge Cancer Care Blacksburg Virginia
United States Massachusetts General Hospital Cancer Center Boston Massachusetts
United States Montefiore Medical Center Bronx New York
United States Levine Cancer Institute Charlotte North Carolina
United States Northwestern University Chicago Illinois
United States The Ohio State University Columbus Ohio
United States Texas Oncology-Baylor Charles A. Sammons Cancer Center Dallas Texas
United States University of Colorado Denver Denver Colorado
United States Henry Ford Detroit Michigan
United States Virginia Cancer Specialists Fairfax Virginia
United States Compassionate Care Research Group Inc. Fountain Valley California
United States Penn State Health Hershey Medical Center Cancer Institute Hershey Pennsylvania
United States Hawaii Cancer Care Honolulu Hawaii
United States The University of Texas M.D. Anderson Cancer Center Houston Texas
United States Pacific Shores Medical Group Huntington Beach California
United States Cedars-Sinai Medical Center Los Angeles California
United States University of Wisconsin Madison Wisconsin
United States Sarah Cannon Research Institute Nashville Tennessee
United States Memorial Sloan Kettering Cancer Center New York New York
United States Medical Oncology Hematology Consultants Newark Delaware
United States Nebraska Methodist Hospital Omaha Nebraska
United States University of California - Irvine Medical Center Orange California
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States Oregon Health and Science University Portland Oregon
United States Washington University School of Medicine Saint Louis Missouri
United States Metro Minnesota CCOP Saint Louis Park Minnesota
United States Utah Cancer Specialists Salt Lake City Utah
United States HonorHealth Scottsdale Arizona
United States Sanford Oncology Clinic Sioux Falls South Dakota
United States Northwest Medical Specialties, PLLC Tacoma Washington
United States Moffitt Cancer Center Tampa Florida
United States Georgetown University Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Elevation Oncology

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective Response Rate The primary objective of this study is to determine the overall objective response rate (ORR) by independent radiologic review to single agent seribantumab in patients with NRG1 gene fusion positive advanced cancer according to RECIST 1.1 Up to 12 months
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