XTR024 / Sinotau Pharma - LARVOL DELTA

Safety and preliminary efficacy of 225Ac-DOTATATE in patients with advanced, SSTR-positive gastroenteropancreatic neuroendocrine neoplasms (GEP-NENs): A phase I/II dose-escalation and expansion study (ESMO 2026) - P1 | "Background 177Lu-DOTATATE is the standard-of-care for SSTR-positive GEP-NENs; however, responses are often incomplete and outcomes after 177Lu-PRRT progression remain poor...This study (NCT06732505) evaluates the safety and preliminary efficacy of 225Ac-DOTATATE in advanced SSTR-positive GEP-NENs, including both 177Lu-PRRT-treated and PRRT-naive patients.Methods The trial (XTR024) comprises dose-escalation and expansion phases...The median follow-up time was 4 months, median PFS has not been reached.Conclusions 225Ac-DOTATATE demonstrated a manageable safety profile and encouraging antitumor activity across the spectrum of SSTR-positive GEP-NENs. These data support further evaluation in expanded cohorts."

Clinical • Metastases • P1/2 data • Endocrine Cancer • Neuroendocrine Neoplasm • Oncology • Solid Tumor • SSTR