CRESTONE: Clinical study of response to seribantumab in tumors with neuregulin-1 (NRG1) fusions—A phase II study of the anti-HER3 mAb for advanced or metastatic solid tumors (NCT04383210)

Study Name
	CRESTONE: Clinical study of response to seribantumab in tumors with neuregulin-1 (NRG1) fusions—A phase II study of the anti-HER3 mAb for advanced or metastatic solid tumors (NCT04383210)
ClinicalTrials.gov Identifier (if applicable)
	NCT04383210
Clinical Trial Category (check all that apply)
	Beyond First Line Therapy Targeted Therapy Other Novel Therapy
Study Center
Institution Name
	Sarah Cannon Research Institute
Institution Address
	250 25th Ave. North
City
	Nashville
State
	Tennessee
Zip Code
	37203
Country
	United States
Phone
	(716) 371-1125
Website
	http://www.nrg1fusion.com
List additional Institutions (include address, phone number, and website)
	 Sarah Cannon /HCA Research Institute  VA Cancer Specialists – USOR  MD Anderson Cancer Center  Massachusetts General Hospital  Cedars-Sinai Medical Center  University of California – Irvine  University of Colorado Denver  Northwestern University  Levine Cancer Institute  Washington University School of Medicine  Henry Ford Health System  University of Wisconsin – Carbone Cancer Center  AdventHealth Orlando  Scottsdale Healthcare Hsps DBA HonorHealth  Montefiore Medical Center  Compassionate Cancer Care Med Grp – Fountain Valley  Northwest Medical Specialists, PLLC (NWMS)  Utah Cancer Specialists
Study Contacts
Principal Investigator
	Elevation Oncology, Inc.
P.I. Phone
	(716) 371-1125
P.I. Email
	clinical@elevationoncology.com
List additional Principal Investigators (include phone number and email)
	Current and open site PIs: Drs. David Spigel/Johanna Bendell (SCRI), Yasir Elamin (MDACC), Jessica Lin/Sam Klempner (MGH), Karen Reckamp (Cedars), Viola Zhu/Ignatius Ou (UC-Irvine), Tejas Patil/Ross Camidge (UC-Denver), Young Chae (Northwestern University), Daniel Carrizosa (Levine Cancer), Saiama Waqar/Kian-Huat Lim (Wash U), Shirish Gadgeel (HFHS), Mark Burkard/Noelle (Carbone-U of WI), Mark Socinski (AdventHealth), Frank Tsai/Erkut Borazanci (Honor Health-Scottsdale), Balazs Halmos (Montefiore), Alexander Spira/Robert Coleman (VA Cancer Specialists/USOR), Jhangiani (Compassionate Care – Fountain Valley, CA), Frank Senecal (NW Specialties- Tacoma, WA), Kendall (Utah); At least 10 sites in study start up and expansion ex-US in progress
Study Coordinator
	Clinical Operations/Medpace
Study Coordinator Phone
	(716) 371-1125
Study Coordinator Email
	clinical@elevationoncology.com
OVERVIEW – in layman’s terms (150 words max)
	CRESTONE is an open label, multicenter ph 2 trial of seribantumab in adult patients with NRG1 fusion-positive locally advanced or metastatic solid tumors who have progressed on or are nonresponsive to treatment. The trial will enroll previously treated patients across three cohorts no matter what prior treatments have been received.
Enrollment
	75
Study Start Date
	07/17/2020
Estimated Completion Date
	6/30/2023 (active, no longer recruiting as of 2/14/23)
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
	The primary objective of this study is to determine the overall objective response rate (ORR) by independent review to single agent seribantumab in patients with NRG1 gene fusion positive advanced cancer according to RECIST 1.1
Inclusion Criteria – Patients Must:
	NRG1 gene fusion from biomarker test: Locally-advanced or metastatic solid tumor with an NRG1 gene fusion identified through molecular assays, such as PCR, NGS (RNA or DNA) or FISH, by a CLIA-certified or similarly accredited laboratory Patients should have received a minimum of one prior standard therapy appropriate for their tumor type and stage of disease, progressed or been nonresponsive to these available therapies, with no further available curative therapy options Patients must have at least one measurable extra-cranial lesion as defined by RECIST v1.1
Exclusion Criteria – Patients Must NOT:
	Known, actionable oncogenic driver mutation other than NRG1 fusion where available standard therapy is indicated Symptomatic or untreated brain metastases (Note: Patients with asymptomatic brain metastases treated with radiation or surgery and without evidence of progression by imaging at screening are eligible to participate in the study. Patients requiring ongoing corticosteroids to treat brain metastases will not be eligible).
REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms
	Biomarker testing from a CLIA approved lab that identifies the tumor has a NRG1 gene fusion
POTENTIAL SIDE-EFFECTS – in layman’s terms
	Fatigue, Nausea, Diarrhea, Rash