NEW YORK – Aadi Bioscience said on Monday that it has partnered with next-generation sequencing providers including Foundation Medicine and Tempus to identify patients for enrollment in Aadi's ongoing PRECISION 1 basket trial.
The Phase II trial is designed to evaluate Aadi's mTOR inhibitor Fyarro (nab-sirolimus) as treatment for about 120 patients with solid tumors harboring TSC1 or TSC2 inactivating mutations. According to Aadi, there are approximately 12,000 patients across the US with these genetic alterations.
In collaborating with these and other unnamed NGS providers, Aadi hopes to expedite patient identification for the registration-directed trial and reduce screen failure rate. Many of the clinical trial sites involved in PRECISION 1 have already been using patients' NGS reports from these companies. In officially partnering with them, Aadi can tap into established patient enrollment programs.
"We are pleased with our progress to date and remain confident we will meet our enrollment goals," Aadi chief medical officer Loretta Itri said in a statement.
The agent already has US Food and Drug Administration approval for advanced malignant perivascular epithelioid cell tumors (PEComa), a type of sarcoma associated with TSC1 and TSC2 mutations. The firm began officially dosing patients on the PRECISION 1 trial earlier this spring and expects to report out initial data during the first half of next year.