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.

Participating centers

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).

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 (“Compassionate Use”)

Elevation Oncology is dedicated to developing new therapies that have a positive impact on patient health, and to serving patients, patient families, and patient communities through education, compassion, urgency and awareness. We believe the best way for patients to access our investigational therapies is through participation in clinical trials, but understand that there are seriously ill patients who will not be eligible for our clinical trials and may not have options for alternative therapies.

The Expanded Access or “Compassionate Use” pathway is intended to enable a patient with an immediately life-threatening condition or serious disease or condition to gain access to seribantumab for treatment outside of ongoing clinical trials when no comparable or satisfactory alternative therapy options are available. While Elevation Oncology does not currently have a formal expanded access program in place, we will consider requests on a case-by-case basis.

As guided by the FDA, expanded access may be appropriate when all of the following apply:

• Patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition.
• There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
• Patient enrollment in a clinical trial is not possible.
• Potential patient benefit justifies the potential risks of treatment.
• Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.

Patients with tumors harboring an NRG1 gene fusion that do not meet every eligibility criterion for CRESTONE may also be eligible for additional clinical research options such as single-patient Investigational New Drug (sIND) proposals.

Please contact the Elevation Oncology team at clinical@elevationoncology.com or +1 (716) 371-1125 for more information.