Adham Jurdi, Sr Medical Director of GI Oncology and Innovations at Natera, shared a post by Natera, adding:
“Incredibly exciting news this morning! Here’s the skinny version:
STELLAR-316. Randomized Ph 3 trial.
- CRC patients who are Signatera-positive post ACT will be randomized to Zanzalintinib +/- checkpoint inhibitor.
- Primary endpoint DFS with ctdna clearance among secondary endpoints.
- The trial leverages Signatera’s commercial ordering and infrastructure to identify patients with molecular relapse, who currently don’t have a SOC treatment, and funnel them to the trial.
Why is this important?
By embedding MRD testing directly into trial enrollment and follow-up, STELLAR-316 represents a true convergence of precision diagnostics and therapeutic development—intervening earlier, when disease burden is lowest, with the potential to redefine standards of care.
If interested in learning more about how to successfully create a funnel for such trials, make sure to catch “Optimizing Colorectal Treament through ctDNA” session at GI26 on Saturday Jan 10th, 10:45 am. Hideaki Bando will present data on ALTAIR patient recruitment.”
“We are proud to collaborate with Exelixis, underscoring our shared commitment to improving care for patients with colorectal cancer. This planned, phase III pivotal trial (STELLAR-316) is another example of Natera’s “Treat on Molecular Recurrence” approach, where patients will be treated with therapy if they test positive with Signatera™.
STELLAR-316 will also be fully enrolled with patients who are receiving commercial Signatera testing as part of their routine standard of care. Such important news heading into ASCO GI!”