Researchers

CRESTONE FOR RESEARCHERS

 

What is CRESTONE?

CRESTONE, or the Clinical study of REsponse to Seribantumab in TumOrs with NEuregulin 1 (NRG1) fusions, offers a clinical trial opportunity for research collaborators to advance the understanding of gene fusions and their role as oncogenic driver alterations across solid tumors.

Access the study overview

For additional supporting data and materials, please contact our team at medicalaffairs@elevationoncology.com or +1 (716) 371 – 1125.

Research Goals

Advancing Clinical Research

  • Describe the anti-tumor activity and toxicity of seribantumab as a precision therapy for solid tumors with an NRG1 gene fusion.
  • Continue to build clinical experience in support of a tumor-agnostic approach to oncology drug development.
  • Explore diagnostic collaborations in support of clinical trial enrollment for patients with rare genomic alterations.

Trial Sites

Participating centers

The CRESTONE study is open and enrolling patients at the US clinical sites listed below. We are actively opening new sites across the US and will update this list regularly. More information about the study can be found at ClinicalTrials.gov (NCT04383210).

 

Clinical Trial Site City State Status
Compassionate Cancer Care Fountain Valley CA Open and Enrolling
University of California – Irvine Medical Center Irvine CA Open and Enrolling
Robert H. Lurie Comprehensive Cancer Center of Northwestern University Chicago IL Open and Enrolling
Massachusetts General Hospital (MGH) Boston MA Open and Enrolling
Henry Ford Detroit MI Open and Enrolling
Washington University at St. Louis St. Louis MO Open and Enrolling
Sarah Cannon Research Institute (SCRI) Nashville TN Open and Enrolling
MD Anderson Cancer Center Houston TX Open and Enrolling
VA Cancer Specialists Fairfax VA Open and Enrolling
Northwest Medical Specialists Tacoma WA Open and Enrolling
University of Wisconsin Madison WI Open and Enrolling

Eligibility and Access

NRG1 Fusion Identification

Eligible patients for CRESTONE must have an NRG1 gene fusion positive cancer. Initial testing to determine patient eligibility and cohort assignment in the CRESTONE study may be completed using local CLIA-certified or equivalent directed analysis of tumor tissue.

The most sensitive testing method for identifying NRG1 gene fusions is RNA-based Next Generation Sequencing (NGS).  Other genomic testing methodologies may be utilized, but those testing methodologies are not as sensitive as RNA-based NGS.

An adequate archival or fresh tumor sample will also be required for an NRG1 gene fusion confirmation using a qualified NRG1 gene fusion test prior to the conclusion of the study.

Expanded Access Program

At Elevation Oncology, we are committed to developing precision medicines to address unmet needs in cancer. We believe the best way for patients to access our investigational therapies is through participation in clinical trials, with the goal of obtaining regulatory approval of our products to enable access to patients as early as possible. To learn more about our clinical trials visit clinicaltrials.gov and search Elevation Oncology.

However, we recognize that not all patients who might benefit from treatment with our investigational product(s) will be eligible to participate in a clinical trial. Elevation Oncology may provide physician-requested expanded access (often referred to as expanded access or compassionate use) to its investigational product(s) outside of the clinical trial setting when the following criteria are met:

  • The patient has a serious or immediately life-threatening disease and cannot join an active clinical trial of the investigational product.
  • There is sufficient evidence the potential benefits to the patient are greater than the known risks and alternative treatment options have been exhausted or no suitable treatment is available.
  • A request is made by a qualified and licensed physician who will comply with all institutional, ethics, and health authority requirements in the region where the patient will be treated and who will routinely exchange patient safety data with Elevation Oncology under an exchange agreement.
  • An adequate supply of the investigational product is available.
  • There is a regulatory mechanism in the country or region to support expanded access.

Process for Expanded Access:  

Treating physicians may request access to our investigational product(s) for a patient by contacting Elevation Oncology Clinical Operations at: clinical@elevationoncology.com. Elevation Oncology will respond within 3 business days.

Patient eligibility is determined by Elevation Oncology in accordance with established policies and procedures. Requests for access to our investigational product(s) are assessed on a case by case basis by Elevation Oncology. The policies and procedures to determine eligibility for the Expanded Access Program are subject to change.

Contact Us

Elevation Oncology is the sponsor of the clinical trial and the developer of seribantumab. We invite you to learn more about our company at www.ElevationOncology.com.

Our team welcomes any questions you may have regarding Elevation Oncology, CRESTONE, genomic testing, seribantumab, or NRG1 gene fusions. Please contact us, and we’ll return your message within 48 hours.

Email

clinical@elevationoncology.com

Phone

+1 (716) 371 – 1125