Physicians

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.

Eligibility

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 clinical@elevationoncology.com or +1 (716) 371-1125 for more information.

Resources

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:

Trial Sites

Participating centers

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
Compassionate Cancer Care Fountain Valley CA 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
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 clinical@elevationoncology.com or +1 (716) 371-1125. More information about the study can be found at ClinicalTrials.gov (NCT04383210).

Contact Us

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.

Email

clinical@elevationoncology.com

Phone

+1 (716) 371 – 1125