RYZ401 / BMS, RayzeBio - LARVOL DELTA

A phase 1 first-in-human, dose-escalation and -expansion study of RYZ401, a novel radiopharmaceutical therapy (RPT) labeled with actinium-225 (225Ac), in patients with neuroendocrine tumors (NETs) and other solid tumors expressing somatostatin receptors (SSTRs). (ASCO-GI 2026) - P1 | "Use of the α-emitter 225Ac as the radioactive component has shown promising results in clinical studies: initial data from ACTION-1 suggest promising efficacy for RYZ101, a first-in-class, highly potent α-emitting RPT, in patients with SSTR+ GEP-NETs progressing after 2–4 cycles of 177Lu-somatostatin analogs. RYZ401 dosimetry will be evaluated in a sub-study of 10−16 patients. Enrollment is ongoing in the USA."

Clinical • First-in-human • P1 data • Gastrointestinal Cancer • Oncology • Solid Tumor • SSTR

Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs. (clinicaltrials.gov) - P1 | N=104 | Recruiting | Sponsor: RayzeBio, Inc. | Not yet recruiting ➔ Recruiting | Trial completion date: Oct 2032 ➔ Apr 2033

Enrollment open • First-in-human • Trial completion date • Adrenal Cortex Carcinoma • Carcinoid Tumor • Endocrine Cancer • Gastrointestinal Neuroendocrine Tumor • Neuroendocrine Tumor • Oncology • Solid Tumor • SSTR

The Huntsman Cancer Institute at the University of Utah has treated the first three patients in a phase I first-in-human clinical trial of RYZ401, an investigational actinium-225 (AC-225)-based radiopharmaceutical targeting somatostatin receptors in neuroendocrine tumors (NETs) and other solid tumors. (AuntMinnie.com) - "The trial is currently enrolling."

First-in-human • Trial status • Gastrointestinal Neuroendocrine Tumor • Neuroendocrine Tumor • Pancreatic Cancer • Solid Tumor

Novel SSTR2 RPT agent RYZ401 demonstrates significant improvement in Biodistribution and Efficacy compared to DOTATATE (EANM 2025) - No abstract available

Clinical • Oncology • SSTR2

Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs. (clinicaltrials.gov) - P1 | N=104 | Not yet recruiting | Sponsor: RayzeBio, Inc.

New P1 trial • Carcinoid Tumor • Endocrine Cancer • Neuroendocrine Tumor • Solid Tumor