CRESTONE FOR PHYSICIANS
What is CRESTONE?
CRESTONE, or Clinical study of REsponse to Seribantumab in TumOrs with NEuregulin 1 (NRG1) fusions, is a single arm Phase 2 study in a tumor-agnostic solid tumor patient population.
The primary objective of the CRESTONE is to describe the anti-tumor activity and tolerability of seribantumab specifically in patients with an NRG1 gene fusion. The safety profile and pharmacokinetics of seribantumab have been well characterized through prior clinical testing in over 800 patients to date. CRESTONE is being conducted with registrational intent following an accelerated approval pathway.
Who is eligible?
CRESTONE offers a clinical trial opportunity for patients with advanced cancer who have not responded or are no longer responding to treatment.
Review the statements below to determine if your patient may be eligible for the CRESTONE study. For detailed eligibility, refer to www.clinicaltrials.gov (NCT04383210), or contact the CRESTONE study team using the form below.
- Advanced solid tumor with an NRG1 gene fusion
- No longer benefiting from standard treatment, or no standard treatment available
- Healthy enough to participate (ECOG Performance Status 0 or 1)
- No prior treatment with anti-ERBB3 (HER3) directed therapy (distinct from pan-ERBB directed therapy)
- At least one measurable extra-cranial lesion as defined by RECIST v1.1
- Availability of fresh or archived FFPE tumor biopsy or liquid biopsy sample for central review
Additional clinical research options such as single-patient Investigational New Drug (sIND) proposals may be available for patients with tumors harboring an NRG1 gene fusion, even if the patient doesn’t meet every eligibility criterion for CRESTONE. Please contact the Elevation Oncology team at firstname.lastname@example.org or +1 (716) 371-1125 for more information.
Resources for discussion with your patients
The following downloadable resources may be helpful to use with your patients who may be eligible for the CRESTONE study:
Understanding the presence of driver mutations in a tumor can guide treatment plans. The following general resources may be helpful to use broadly with patients who could benefit from genomic testing of their tumor:
The CRESTONE study is open and enrolling patients at the US clinical sites listed below. Most of the clinical sites are part of a larger network, and all questions and/or referrals should be directed to the primary contact at the main operations center. We are actively opening new sites across the US and will update this list regularly.
|Clinical Trial Site||City||State||Status|
|Honor Health||Scottsdale||AZ||Open and Enrolling|
|Compassionate Cancer Care||Fountain Valley||CA||Open and Enrolling|
|University of California – Irvine Medical Center||Orange||CA||Open and Enrolling|
|Cedars Sinai||Los Angeles||CA||Open and Enrolling|
|University of Colorado||Denver||CO||Open and Enrolling|
|Advent Health||Orlando||FL||Open and Enrolling|
|University Cancer & Blood Center||Athens||GA||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|
|Metro Minnesota CCOP||St. Louis Park||MN||Open and Enrolling|
|Washington University at St. Louis||St. Louis||MO||Open and Enrolling|
|Levine Cancer Center||Charlotte||NC||Open and Enrolling|
|Montefiore||Bronx||NY||Open and Enrolling|
|Sarah Cannon Research Institute (SCRI)||Nashville||TN||Open and Enrolling|
|MD Anderson Cancer Center||Houston||TX||Open and Enrolling|
|Utah Cancer Specialists||Salt Lake City||UT||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|
Clinical sites interested in the CRESTONE study
If you would like to inquire about opening a new site at your institution, please contact the CRESTONE study team at email@example.com or +1 (716) 371-1125. More information about the study can be found at ClinicalTrials.gov (NCT04383210).
The Elevation Oncology team welcomes any questions you may have regarding CRESTONE or seribantumab. Please contact us, and we’ll return your message within 48 hours.
+1 (716) 371 – 1125