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 firstname.lastname@example.org or +1 (716) 371 – 1125.
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.
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: email@example.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.
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.
+1 (716) 371 – 1125