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 (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 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:

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
University of Alabama at Birmingham Birmingham AL Open and Enrolling
Honor Health Scottsdale AZ Open and Enrolling
Compassionate Cancer Care Fountain Valley CA Open and Enrolling
Pacific Shores Medical Group Huntington Beach CA Open and Enrolling
Cedars Sinai Los Angeles CA Open and Enrolling
University of California – Irvine Medical Center Orange CA Open and Enrolling
University of Colorado Denver CO Open and Enrolling
Georgetown University Washington DC Open and Enrollling
Medical Oncology Hematology Consultants Newark DE Open and Enrollling
Advent Health Orlando FL Open and Enrolling
Moffit Cancer Center Tampa FL Open and Enrolling
University Cancer & Blood Center Athens GA Open and Enrolling
Hawaii Cancer Care, Inc. Honolulu HI 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
Nebraska Methodist Hospital Omaha NE Open and Enrolling
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center New York NY Open and Enrolling
Montefiore Bronx NY Open and Enrolling
Ohio State University Columbus OH Open and Enrolling
Oregon Health and Science University Portland OR Open and Enrolling
The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center Hershey PA Open and Enrolling
Fox Chase Cancer Center Philadelphia PA Open and Enrolling
Sanford Health Sioux Falls SD Open and Enrolling
Sarah Cannon Research Institute (SCRI) Nashville TN Open and Enrolling
Texas Oncology Dallas TX 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
The Kinghorn Cancer Centre Darlinghurst, NSW AUS Open and Enrolling
Peter MacCallum Cancer Centre Melbourne, VIC AUS Open and Enrolling
William Osler Health System Brampton, ON CAN Open and Enrolling
British Columbia Cancer Agency Vancouver, BC CAN Open and Enrolling
Seoul National University Hospital Seoul KOR 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 or +1 (716) 371-1125. More information about the study can be found at (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.



+1 (716) 371 – 1125