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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04383210
Recruitment Status : Recruiting
First Posted : May 12, 2020
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Elevation Oncology

Brief 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.

Condition or disease Intervention/treatment Phase
Locally Advanced Solid Tumor Metastatic Solid Tumor Pancreatic Cancer Lung Cancer Head and Neck Cancer Breast Cancer Kidney Cancer Colorectal Cancer Bladder Cancer Ovarian Cancer Sarcoma Gallbladder Cancer Bile Duct Cancer Esophageal Cancer Uterine Cancer Cholangiocarcinoma Prostate Cancer Drug: Seribantumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CRESTONE: A Phase 2 Study of Seribantumab in Adult Patients With Neuregulin-1 (NRG1) Fusion Positive Locally Advanced or Metastatic Solid Tumors
Actual Study Start Date : September 29, 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2023


Arm Intervention/treatment
Experimental: Cohort 1

A minimum of 55 adult advanced solid tumor patients harboring NRG1 gene fusions, who have received prior standard treatment, excluding prior ERBB-directed therapy.

Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively.

Drug: Seribantumab
Anti-HER3 monoclonal antibody

Experimental: Cohort 2

Up to 10 adult advanced solid tumor patients harboring NRG1 gene fusions, who have received prior standard treatment, including prior ERBB-directed therapy.

Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively.

Drug: Seribantumab
Anti-HER3 monoclonal antibody

Experimental: Cohort 3

Up to 10 adult advanced solid tumor patients harboring NRG1 gene fusions lacking an EGF-like domain, who have received prior standard treatment, which may have included prior ERBB-directed therapy.

Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively.

Drug: Seribantumab
Anti-HER3 monoclonal antibody




Primary Outcome Measures :
  1. Objective Response Rate [ Time Frame: Up to 12 months ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04383210


Contacts
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Contact: VP, Clinical Operations 716-371-1125 clinical@elevationoncology.com
Contact: VP, Medical Affairs 716-371-1125 medicalaffairs@elevationoncology.com

Locations
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United States, California
Compassionate Care Research Group Inc. Recruiting
Fountain Valley, California, United States, 92708
Contact    714-698-0300      
Principal Investigator: Haresh Jhangiani, MD         
United States, Massachusetts
Massachusetts General Hospital Cancer Center Recruiting
Boston, Massachusetts, United States, 02114
Contact    877-726-5130      
Principal Investigator: Jessica Lin, MD         
United States, Michigan
Henry Ford Recruiting
Detroit, Michigan, United States, 48202
Contact    313-916-3721    CTOResearch@hfhs.org   
Principal Investigator: Shirish M. Gadgeel, MD         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact    800-600-3606    info@siteman.wustl.edu   
Principal Investigator: Saiama N. Waqar, MD         
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Misty Moore       Misty.Moore@scresearch.net   
Principal Investigator: David R. Spigel, MD         
United States, Texas
The University of Texas M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Yasir Elamin, MD         
United States, Virginia
Virginia Cancer Specialists Recruiting
Fairfax, Virginia, United States, 22031
Principal Investigator: Alexander I. Spira, MD         
United States, Washington
Northwest Medical Specialties, PLLC Recruiting
Tacoma, Washington, United States, 98405
Contact: Study Coordinator    253-428-8750      
Principal Investigator: Frank M. Senecal, MD         
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53792
Contact    800-323-8942      
Principal Investigator: Mark E. Burkard, MD, PhD         
Sponsors and Collaborators
Elevation Oncology
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Responsible Party: Elevation Oncology
ClinicalTrials.gov Identifier: NCT04383210    
Other Study ID Numbers: ELVCAP-001-01
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Elevation Oncology:
NRG1
Neuregulin 1
Gene fusion
Additional relevant MeSH terms:
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Neoplasms
Cholangiocarcinoma
Gallbladder Neoplasms
Bile Duct Neoplasms
Uterine Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Neoplasms by Histologic Type
Genital Neoplasms, Female
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Biliary Tract Neoplasms
Biliary Tract Diseases
Gallbladder Diseases
Bile Duct Diseases
Uterine Diseases