NEW YORK – Elevation Oncology and the community-based oncology study site management firm US Oncology Research on Wednesday announced they will collaborate to optimize patient enrollment for Elevation's CRESTONE study.
The Phase II clinical trial is evaluating Elevation's investigational HER3-inhibiting monoclonal antibody seribantumab as a treatment for patients with advanced NRG1 fusion-positive solid tumors.
For its part, US Oncology Research will incorporate the CRESTONE study into its Selected Trials for Accelerated Rollout (STAR) program, which enables any one of the 60 research sites within its network to become a study site for a given trial should a patient treated at that location be eligible for enrollment. To aid enrollment within CRESTONE, US Oncology Research will prescreen patients in its network to assess if they are potentially eligible for the trial. If so, then the organization will train the treating physicians in the trial's protocols so specific community oncology practices can become study sites within a two-week timeframe.
"The ability to accurately detect rare genomic driver alterations in a patient's tumor and subsequently open up a clinical study site in response is paramount to bringing precision therapy opportunities to patients that may benefit from treatment," Shawn Leland, Elevation's founder and chief business officer, said in a statement. "A key component of this collaboration is the ability to quickly open CRESTONE clinical trial sites via the US Oncology Research STAR program, which minimizes patient travel and disruption in clinical care, a major advantage particularly given the current travel complexities due to COVID-19."
In partnering with US Oncology Research, Elevation Oncology intends to limit lengthy travel to distant study sites, which can be an enrollment barrier for patients whose cancers have NRG1 fusions — an oncogenic driver, which given its occurrence in roughly 0.2 percent of solid tumors, already makes it difficult to identify patients who may benefit from seribantumab. Elevation aims to enroll roughly 75 NRG1 fusion-positive patients onto CRESTONE, and the collaboration with US Oncology Research is in addition to earlier partnerships it has inked with molecular diagnostic companies Caris Life Sciences and Strata Oncology to identify and enroll these patients.